Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

ERIC Educational Resources Information Center

Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

2009-01-01

When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

Feasibility of a Latin Dance Program for Older Latinos With Mild Cognitive Impairment.

PubMed

Aguiñaga, Susan; Marquez, David X

2017-12-01

This study investigates the feasibility of a Latin dance program in older Latinos with mild cognitive impairment (MCI) via a feasibility mixed methods randomized controlled design. Spanish-speaking older Latinos (N = 21, 75.4 [6.3] years old, 16 females/5 males, 22.4 [2.8] Mini-Mental State Examination [MMSE] score) were randomized into a 16-week dance intervention (BAILAMOS) or wait-list control; the control group crossed over at week 17 and received the dance intervention. Feasibility was determined by assessing reach, retention, attendance, dance logs, and postintervention focus groups. Reach was 91.3% of people who were screened and eligible. Program retention was 95.2%. The dropout rate was 42.8% (n = 9), and attendance for all participants was 55.76%. The focus group data revealed 4 themes: enthusiasm for dance, positive aspects of BAILAMOS, unfavorable aspects of BAILAMOS, and physical well-being after BAILAMOS. In conclusion, older Latinos with MCI find Latin dance as an enjoyable and safe mode of physical activity.

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

PubMed

Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

2017-05-15

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

A 12-week interdisciplinary rehabilitation trial in patients with gliomas - a feasibility study.

PubMed

Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek; Jarden, Jens Ole

2018-06-01

This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. We conducted an outpatient two-part rehabilitation intervention that involved six weeks of therapeutic supervised training (part one) and six weeks of unsupervised training in a local gym following a training protocol (part two). Predefined feasibility objectives of safety (100%), consent rate (>80%), drop-out (<20%), adherence (>80%) and patient satisfaction (>80%) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. This study demonstrates that an intensive rehabilitation intervention of physical therapy and occupational therapy in the initial treatment phase of patients with gliomas whose Karnofsky performance status is ≥70 is safe and feasible, if relevant inclusion criteria and precautionary screening are made. With the revised protocol, we are confident that the foundation for conducting a successful randomized controlled trial among these vulnerable patients has been established. Implications for rehabilitation Brain tumors constitute some of the most challenging cancer diagnoses presenting for rehabilitation intervention. Patients with gliomas experiences limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning through interdisciplinary rehabilitation.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Feasibility of ballistic strength training in sub-acute stroke: A randomized, controlled, assessor-blinded pilot study.

PubMed

Hendrey, Genevieve; Clark, Ross A; Holland, Anne E; Mentiplay, Benjamin F; Davis, Carly; Windfeld-Lund, Cristie; Raymond, Melissa J; Williams, Gavin

2018-05-30

To establish the feasibility and effectiveness of a six week ballistic strength training protocol in people with stroke. Randomized, controlled, assessor-blinded study. Sub-acute inpatient rehabilitation. Consecutively admitted inpatients with a primary diagnosis of first ever stroke with lower limb weakness, functional ambulation category score of ≥3, and ability to walk ≥14m were screened for eligibility to recruit 30 participants for randomization. Participants were randomized to standard therapy or ballistic strength training three times per week for six weeks. The primary aim was to evaluate feasibility and outcomes included recruitment rate, participant retention and attrition, feasibility of the exercise protocol, therapist burden and participant safety. Secondary outcomes included measures of mobility, lower limb muscle strength, muscle power and quality of life. Thirty participants (11% of those screened) with mean age of 50 (SD 18) years were randomized. The median number of sessions attended was 15/18 and 17/18 for the ballistic and control groups respectively. Earlier than expected discharge home (n=4) and illness (n=7) were the most common reasons for non-attendance. Participants performed the exercises safely, with no study-related adverse events. There were significant (p<0.05) between-group changes favoring the ballistic group for comfortable gait velocity (mean difference (MD) 0.31m/s, 95% confidence interval CI: 0.08 to 0.52), muscle power, as measured by peak jump height (MD 8cm, 95% CI: 3 to 13) and peak propulsive velocity (MD 64cm/s, 95% CI: 17 to 112). Ballistic training was safe and feasible in select ambulant people with stroke. Similar rates of retention and attrition suggest that ballistic training was acceptable to patients. Secondary outcomes provide promising results that warrant further investigation in a larger trial. Copyright © 2018. Published by Elsevier Inc.

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

Randomized controlled pilot trial of naloxone‐on‐release to prevent post‐prison opioid overdose deaths

PubMed Central

Parmar, Mahesh K. B.; Strang, John; Choo, Louise; Meade, Angela M.

2016-01-01

Abstract Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug‐related death soon after release from prison. The NALoxone InVEstigation (N‐ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone‐on‐release (NOR) to eligible prisoners in England. Design. Parallel‐group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre‐randomization, release due within 3 months and more than 6 months since previous N‐ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single ‘rescue’ injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self‐questionnaires (RPSQs: 207), NOR‐carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70–74%]; 218 RPSQs were received; NOR‐carriage (95% CI = 63–79%) and overdose presence (95% CI = 75–84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one‐third of NOR administrations were to the ex‐prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take‐home emergency naloxone prior to prison release may be a life‐saving interim measure to prevent heroin overdose deaths among ex‐prisoners and the wider population. PMID:27776382

Engaging women with an embodied conversational agent to deliver mindfulness and lifestyle recommendations: A feasibility randomized control trial.

PubMed

Gardiner, Paula M; McCue, Kelly D; Negash, Lily M; Cheng, Teresa; White, Laura F; Yinusa-Nyahkoon, Leanne; Jack, Brian W; Bickmore, Timothy W

2017-09-01

This randomized controlled trial evaluates the feasibility of using an Embodied Conversational Agent (ECA) to teach lifestyle modifications to urban women. Women were randomized to either 1) an ECA (content included: mindfulness, stress management, physical activity, and healthy eating) or 2) patient education sheets mirroring same content plus a meditation CD/MP3 once a day for one month. General outcome measures included: number of stress management techniques used, physical activity levels, and eating patterns. Sixty-one women ages 18 to 50 were enrolled. On average, 51% identified as white, 26% as black, 23% as other races; and 20% as Hispanic. The major stress management techniques reported at baseline were: exercise (69%), listening to music (70%), and social support (66%). After one month, women randomized to the ECA significantly decreased alcohol consumption to reduce stress (p=0.03) and increased daily fruit consumption by an average of 2 servings compared to the control (p=0.04). It is feasible to use an ECA to promote health behaviors on stress management and healthy eating among diverse urban women. Compared to patient information sheets, ECAs provide promise as a way to teach healthy lifestyle behaviors to diverse urban women. Copyright © 2017 Elsevier B.V. All rights reserved.

Mindfulness-based resilience training to reduce health risk, stress reactivity, and aggression among law enforcement officers: A feasibility and preliminary efficacy trial.

PubMed

Christopher, Michael S; Hunsinger, Matthew; Goerling, Lt Richard J; Bowen, Sarah; Rogers, Brant S; Gross, Cynthia R; Dapolonia, Eli; Pruessner, Jens C

2018-06-01

The primary objective of this study was to assess feasibility and gather preliminary outcome data on Mindfulness-Based Resilience Training (MBRT) for law enforcement officers. Participants (n = 61) were randomized to either an 8-week MBRT course or a no intervention control group. Self-report and physiological data were collected at baseline, post-training, and three months following intervention completion. Attendance, adherence, post-training participant feedback, and interventionist fidelity to protocol all demonstrated feasibility of MBRT for law enforcement officers. Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up. This initial randomized trial suggests MBRT is a feasible intervention. Outcome data suggest MBRT targets key physiological, psychological, and health risk factors in law enforcement officers, consistent with the potential to improve officer health and public safety. However, follow-up training or "booster" sessions may be needed to maintain training gains. A fully powered longitudinal randomized trial is warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

A pilot randomized controlled trial of deprescribing.

PubMed

Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

2011-04-01

Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol. PMID:24888266

"FIND Technology": investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial.

PubMed

Bird, M L; Cannell, J; Callisaya, M L; Moles, E; Rathjen, A; Lane, K; Tyson, A; Smith, S

2016-04-16

Stroke results in significant disability, which can be reduced by physical rehabilitation. High levels of repetition and activity are required in rehabilitation, but patients are typically sedentary. Using clinically relevant and fun computer games may be one way to achieve increased activity in rehabilitation. A single-blind randomized controlled trial will be conducted to evaluate the feasibility, efficacy and safety of novel stroke-specific rehabilitation software. This software uses controller-free client interaction and inertial motion sensors. Elements of feasibility include recruitment into the trial, ongoing participation (adherence and dropout), perceived benefit, enjoyment and ease of use of the games. Efficacy will be determined by measuring activity and using upper-limb tasks as well as measures of balance and mobility. The hypothesis that the intervention group will have increased levels of physical activity within rehabilitation and improved physical outcomes compared with the control group will be tested. Results from this study will provide a basis for discussion of feasibility of this interactive video technological solution in an inpatient situation. Differences in activity levels between groups will be the primary measure of efficacy. It will also provide data on measures of upper-limb function, balance and mobility. ACTRN12614000427673 . Prospectively registered 17 April 2014.

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

PubMed

Griffin, D R; Dickenson, E J; Wall, P D H; Realpe, A; Adams, A; Parsons, N; Hobson, R; Achten, J; Costa, M L; Foster, N E; Hutchinson, C E; Petrou, S; Donovan, J L

2016-10-01

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Meals Enhancing Nutrition after Discharge (MEND): Findings from a Pilot Randomized Controlled Trial

PubMed Central

Campbell, Anthony D.; Godfryd, Alice; Flood, Kellie; Kitchin, Elizabeth; Kilgore, Meredith L.; Allocca, Sally; Locher, Julie L.

2016-01-01

Background After older adults experience episodes of poor health or are hospitalized, they may not return to pre-morbid eating behaviors. Furthermore, poor nutrition increases hospital readmission risk, but evidence-based interventions addressing these risks are limited. Objective The pilot study’s objective was to evaluate the feasibility of conducting a randomized controlled trial assessing a post-discharge home-delivered meals program’s impact on older adults’ nutritional intake and hospital readmissions and to assess patient acceptability and satisfaction with the program. The aims of the study were to 1) to evaluate successful recruitment, randomization, and retention of at least 80% of the 24 participants sought; 2) to compare the outcomes of hospital readmission and total daily caloric intake between participants in the intervention and control groups; and 3) to assess patient acceptability and satisfaction with the program. Design This study used a two-arm randomized controlled trial design, and baseline data were collected at enrollment; three 24-hour food recalls were collected during the intervention period; and health services utilization and intervention satisfaction was evaluated 45 days post-discharge. Participants/setting Twenty-four patients from the University of Alabama at Birmingham (UAB) Hospital’s Acute Care for Elders Unit were enrolled from May 2014 to June 2015. They were 65 or older, at risk of malnutrition, cognitively intact, able to communicate, discharged to a place where the patient or family was responsible for preparing meals, and diagnosed with congestive heart failure, chronic obstructive pulmonary disease, acute myocardial infarction, or pneumonia. Final analysis included 21 participants. Intervention The intervention group received 10 days of home-delivered meals and nutrition education; the control group received usual care and nutrition education. Main outcome measures The main outcome was intervention feasibility, measured by recruitment and retention goals. Hospital readmissions, caloric intake, and satisfaction with the intervention were also evaluated. Statistical analyses performed Univariate and bivariate parametric statistics were used to evaluate differences between groups. Goals for success were identified to assess feasibility of conducting a full-scale study, and outcomes were measured against the goals. Results 87.5% of randomized participants were retained for final data collection, indicating that this intervention study is feasible. There were no significant differences between groups for hospital readmissions; however, caloric intake during the intervention period was greater for intervention vs. control participants (1595 vs. 1235, p=.03). Participants were overwhelmingly satisfied (82–100% satisfied or very satisfied) with staff performance, meal quality, and delivery processes. Conclusions Conducting a randomized controlled trial to assess outcomes of providing home-delivered meals to older adults after hospital discharge in partnership with a small nonprofit organization is feasible and warrants future research. PMID:28065635

A randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

Feasibility and effectiveness of an evidence-based asthma service in Australian community pharmacies: a pragmatic cluster randomized trial.

PubMed

Armour, Carol L; Reddel, Helen K; LeMay, Kate S; Saini, Bandana; Smith, Lorraine D; Bosnic-Anticevich, Sinthia Z; Song, Yun Ju Christine; Alles, M Chehani; Burton, Deborah L; Emmerton, Lynne; Stewart, Kay; Krass, Ines

2013-04-01

To test the feasibility, effectiveness, and sustainability of a pharmacy asthma service in primary care. A pragmatic cluster randomized trial in community pharmacies in four Australian states/territories in 2009. Specially trained pharmacists were randomized to deliver an asthma service in two groups, providing three versus four consultations over 6 months. People with poorly controlled asthma or no recent asthma review were included. Follow-up for 12 months after service completion occurred in 30% of randomly selected completing patients. Outcomes included change in asthma control (poor and fair/good) and Asthma Control Questionnaire (ACQ) score, inhaler technique, quality of life, perceived control, adherence, asthma knowledge, and asthma action plan ownership. Ninety-six pharmacists enrolled 570 patients, with 398 (70%) completing. Asthma control significantly improved with both the three- and four-visit service, with no significant difference between groups (good/fair control 29% and 21% at baseline, 61% and 59% at end, p = .791). Significant improvements were also evident in the ACQ (mean change 0.56), inhaler technique (17-33% correct baseline, 57-72% end), asthma action plan ownership (19% baseline, 56% end), quality of life, adherence, perceived control, and asthma knowledge, with no significant difference between groups for any variable. Outcomes were sustained at 12 months post-service. The pharmacy asthma service delivered clinically important improvements in both a three-visit and four-visit service. Pharmacists were able to recruit and deliver the service with minimal intervention, suggesting it is practical to implement in practice. The three-visit service would be feasible and effective to implement, with a review at 12 months.

Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-01-01

Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7…

The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

PubMed

Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

2016-01-01

To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large-scale trial required to confirm these findings would be contingent on addressing the feasibility hurdles identified in this study with respect to recruitment, attrition, compliance, and collection of standardized clinical data. Australia New Zealand Clinical Trials Registry; ACTRN12614000517673 Registered 15 May 2014.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial.

PubMed

Rowe, Sarah L; Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-30

Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG). ©Sarah L Rowe, Krisna Patel, Rebecca S French, Claire Henderson, Dennis Ougrin, Mike Slade, Paul Moran. Originally published in JMIR Mental Health (http://mental.jmir.org), 30.01.2018.

Web-Based Decision Aid to Assist Help-Seeking Choices for Young People Who Self-Harm: Outcomes From a Randomized Controlled Feasibility Trial

PubMed Central

Patel, Krisna; French, Rebecca S; Henderson, Claire; Ougrin, Dennis; Slade, Mike; Moran, Paul

2018-01-01

Background Adolescents who self-harm are often unsure how or where to get help. We developed a Web-based personalized decision aid (DA) designed to support young people in decision making about seeking help for their self-harm. Objective The aim of this study was to evaluate the feasibility and acceptability of the DA intervention and the randomized controlled trial (RCT) in a school setting. Methods We conducted a two-group, single blind, randomized controlled feasibility trial in a school setting. Participants aged 12 to 18 years who reported self-harm in the past 12 months were randomized to either a Web-based DA or to general information about mood and feelings. Feasibility of recruitment, randomization, and follow-up rates were assessed, as was acceptability of the intervention and study procedures. Descriptive data were collected on outcome measures examining decision making and help-seeking behavior. Qualitative interviews were conducted with young people, parents or carers, and staff and subjected to thematic analysis to explore their views of the DA and study processes. Results Parental consent was a significant barrier to young people participating in the trial, with only 17.87% (208/1164) of parents or guardians who were contacted for consent responding to study invitations. Where parental consent was obtained, we were able to recruit 81.7% (170/208) of young people into the study. Of those young people screened, 13.5% (23/170) had self-harmed in the past year. Ten participants were randomized to receiving the DA, and 13 were randomized to the control group. Four-week follow-up assessments were completed with all participants. The DA had good acceptability, but qualitative interviews suggested that a DA that addressed broader mental health problems such as depression, anxiety, and self-harm may be more beneficial. Conclusions A broad-based mental health DA addressing a wide range of psychosocial problems may be useful for young people. The requirement for parental consent is a key barrier to intervention research on self-harm in the school setting. Adaptations to the research design and the intervention are needed before generalizable research about DAs can be successfully conducted in a school setting. Trial Registration International Standard Randomized Controlled Trial registry: ISRCTN11230559; http://www.isrctn.com/ISRCTN11230559 (Archived by WebCite at http://www.webcitation.org/6wqErsYWG) PMID:29382626

A Mixed-Methods, Randomized, Controlled Feasibility Trial to Inform the Design of a Phase III Trial to Test the Effect of the Handheld Fan on Physical Activity and Carer Anxiety in Patients With Refractory Breathlessness.

PubMed

Johnson, Miriam J; Booth, Sara; Currow, David C; Lam, Lawrence T; Phillips, Jane L

2016-05-01

The handheld fan is an inexpensive and safe way to provide facial airflow, which may reduce the sensation of chronic refractory breathlessness, a frequently encountered symptom. To test the feasibility of developing an adequately powered, multicenter, multinational randomized controlled trial comparing the efficacy of a handheld fan and exercise advice with advice alone in increasing activity in people with chronic refractory breathlessness from a variety of medical conditions, measuring recruitment rates; data quality; and potential primary outcome measures. This was a Phase II, multisite, international, parallel, nonblinded, mixed-methods randomized controlled trial. Participants were centrally randomized to fan or control. All received breathlessness self-management/exercise advice and were followed up weekly for four weeks. Participants/carers were invited to participate in a semistructured interview at the study's conclusion. Ninety-seven people were screened, 49 randomized (mean age 68 years; 49% men), and 43 completed the study. Site recruitment varied from 0.25 to 3.3/month and screening:randomization from 1.1:1 to 8.5:1. There were few missing data except for the Chronic Obstructive Pulmonary Disease Self-Efficacy Scale (two-thirds of data missing). No harms were observed. Three interview themes included 1) a fan is a helpful self-management strategy, 2) a fan aids recovery, and 3) a symptom control trial was welcome. A definitive, multisite trial to study the use of the handheld fan as part of self-management of chronic refractory breathlessness is feasible. Participants found the fan useful. However, the value of information for changing practice or policy is unlikely to justify the expense of such a trial, given perceived benefits, the minimal costs, and an absence of harms demonstrated in this study. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial.

PubMed

Harris-Hayes, Marcie; Czuppon, Sylvia; Van Dillen, Linda R; Steger-May, Karen; Sahrmann, Shirley; Schootman, Mario; Salsich, Gretchen B; Clohisy, John C; Mueller, Michael J

2016-06-01

Study Design Feasibility randomized clinical trial. Background Rehabilitation may be an appropriate treatment strategy for patients with chronic hip joint pain; however, the evidence related to the effectiveness of rehabilitation is limited. Objectives To assess feasibility of performing a randomized clinical trial to investigate the effectiveness of movement-pattern training (MPT) to improve function in people with chronic hip joint pain. Methods Thirty-five patients with chronic hip joint pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. The wait-list group received no treatment. Primary outcomes for feasibility were patient retention and adherence. Secondary outcomes to assess treatment effects were patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength. Results Retention rates did not differ between the MPT (89%) and wait-list groups (94%, P = 1.0). Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions. For the home exercise program, 89% of patients reported performing their home program at least once per day. Secondary outcomes support the rationale for conduct of a superiority randomized clinical trial. Conclusion Based on retention and adherence rates, a larger randomized clinical trial appears feasible and warranted to assess treatment effects more precisely. Data from this feasibility study will inform our future clinical trial. Level of Evidence Therapy, level 2b-. J Orthop Sports Phys Ther 2016;46(6):452-461. Epub 26 Apr 2016. doi:10.2519/jospt.2016.6279.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial.

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Clinical Trials NCT01740635.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

PubMed

Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

2015-11-01

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

Efficacy of a Sleep Quality Intervention in People With Low Back Pain: Protocol for a Feasibility Randomized Co-Twin Controlled Trial.

PubMed

Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H

2016-10-01

Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial.

Feasibility of dialectical behavior therapy with suicidal and self-harming adolescents with multi-problems: training, adherence, and retention.

PubMed

Tørmoen, A J; Grøholt, B; Haga, E; Brager-Larsen, A; Miller, A; Walby, F; Stanley, B; Mehlum, L

2014-01-01

We evaluated the feasibility of DBT training, adherence, and retention preparing for a randomized controlled trial of Dialectical Behavior Therapy (DBT) adapted for Norwegian adolescents engaging in self-harming behavior and diagnosed with features of borderline personality disorder. Therapists were intensively trained and evaluated for adherence. Adherence scores, treatment retention, and present and previous self-harm were assessed. Twenty-seven patients were included (mean age 15.7 years), all of them with recent self-harming behaviors and at least 3 features of Borderline Personality Disorder. Therapists were adherent and 21 (78%) patients completed the whole treatment. Three subjects reported self-harm at the end of treatment, and urges to self-harm decreased. At follow up, 7 of 10 subjects reported no self-harm. DBT was found to be well accepted and feasible. Randomized controlled trials are required to test the effectiveness of DBT for adolescents.

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial

PubMed Central

Schneider, Kristin L.; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M.; Waring, Molly E.; Appelhans, Bradley M.; Whited, Matthew C.; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L.

2016-01-01

Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6 months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study. PMID:26956652

Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

PubMed

Schneider, Kristin L; Panza, Emily; Handschin, Barbara; Ma, Yunsheng; Busch, Andrew M; Waring, Molly E; Appelhans, Bradley M; Whited, Matthew C; Keeney, Jacey; Kern, Daniel; Blendea, Mihaela; Ockene, Ira; Pagoto, Sherry L

2016-03-01

Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study. Copyright © 2015. Published by Elsevier Ltd.

Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial.

PubMed

Suttanon, Plaiwan; Hill, Keith D; Said, Catherine M; Williams, Susan B; Byrne, Karin N; LoGiudice, Dina; Lautenschlager, Nicola T; Dodd, Karen J

2013-05-01

To evaluate the feasibility and safety of a home-based exercise programme for people with Alzheimer's disease, and to provide preliminary evidence of programme effectiveness in improving balance and mobility and reducing falls risk. A randomized controlled trial. Community. Forty people with mild to moderate Alzheimer's disease (mean age 81.9, SD 5.72; 62.5% female). Participants were randomized to a six-month home-based individually tailored balance, strengthening and walking exercise programme (physiotherapist) or a six-month home-based education programme (control) (occupational therapist). Both programmes provided six home-visits and five follow-up phone calls. Balance, mobility, falls and falls risk were measured at baseline and programme completion. Intention-to-treat analysis using a generalized linear model with group allocation as a predictor variable was performed to evaluate programme effectiveness. Feasibility and adverse events were systematically recorded at each contact. Fifty-eight per cent of the exercise group finished the programme, completing an average of 83% of prescribed sessions, with no adverse events reported. Functional Reach improved significantly (P = 0.002) in the exercise group (mean (SD), 2.28 (4.36)) compared to the control group (-2.99 (4.87)). Significant improvement was also observed for the Falls Risk for Older People - Community score (P = 0.008) and trends for improvement on several other balance, mobility, falls and falls risk measures for the exercise group compared to the control group. The exercise programme was feasible and safe and may help improve balance and mobility performance and reduce falls risk in people with Alzheimer's disease.

Sham-controlled, randomized, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma

PubMed Central

Meng, Zhiqiang; Garcia, M. Kay; Hu, Chaosu; Chiang, Joseph; Chambers, Mark; Rosenthal, David I.; Peng, Huiting; Wu, Caijun; Zhao, Qi; Zhao, Genming; Liu, Luming; Spelman, Amy; Palmer, J. Lynn; Wei, Qi; Cohen, Lorenzo

2013-01-01

Background Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients. Quality of life (QOL) is impaired, and available treatments are of little benefit. This trial determined the feasibility of conducting a sham-controlled trial of acupuncture and whether acupuncture could prevent xerostomia among head/neck patients undergoing radiotherapy. Methods A sham controlled, feasibility trial was conducted at Fudan University Shanghai Cancer Center, Shanghai, China among patients with nasopharyngeal carcinoma undergoing radiotherapy. To determine feasibility of a sham procedure, 23 patients were randomized to real acupuncture (N = 11) or to sham acupuncture (N = 12). Patients were treated 3 times/week during their course of radiotherapy. Subjective measures were the Xerostomia Questionnaire (XQ) and MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN). Objective measures were unstimulated whole salivary flow rates (UWSFR) and stimulated salivary flow rates (SSFR). Patients were followed for 1 month after radiotherapy. Results XQ scores for acupuncture were significantly lower than sham controls starting in week 3 and lasted through the 1-month follow-up (all P’s < 0.001 except for week 3, which was 0.006), with clinically significant differences as follows: week 6 – RR 0.28 [95% CI, 0.10, 0.79]; week 11- RR 0.17 [95% CI, 0.03, 1.07]. Similar findings were seen for MDASI-HN scores and MDASI-Intrusion scores. Group differences for UWSFR and SSFR were not found. Conclusions In this small pilot study, true acupuncture given concurrently with radiotherapy significantly reduced xerostomia symptoms and improved QOL when compared with sham acupuncture. Large-scale, multi-center, randomized, placebo-controlled trials are now needed. PMID:22285177

No Randomization? No Problem: Experimental Control and Random Assignment in Single Case Research

ERIC Educational Resources Information Center

Ledford, Jennifer R.

2018-01-01

Randomization of large number of participants to different treatment groups is often not a feasible or preferable way to answer questions of immediate interest to professional practice. Single case designs (SCDs) are a class of research designs that are experimental in nature but require only a few participants, all of whom receive the…

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

PubMed

Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

2017-12-01

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

ERIC Educational Resources Information Center

Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

2011-01-01

We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

Influence of General Self-Efficacy on the Effects of a School-Based Universal Primary Prevention Program of Depressive Symptoms in Adolescents: A Randomized and Controlled Follow-up Study

ERIC Educational Resources Information Center

Possel, Patrick; Baldus, Christiane; Horn, Andrea B.; Groen, Gunter; Hautzinger, Martin

2005-01-01

Background: Depressive disorders in adolescents are a widespread and increasing problem. Prevention seems a promising and feasible approach. Methods: We designed a cognitive-behavioral school-based universal primary prevention program and followed 347 eighth-grade students participating in a randomized controlled trial for three months. Results:…

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial.

PubMed

Howarth, Ana; Perkins-Porras, Linda; Smith, Jared G; Subramaniam, Jeevakan; Copland, Claire; Hurley, Mike; Beith, Iain; Riaz, Muhammad; Ussher, Michael

2016-06-02

The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be very acceptable, making a compelling argument for investigating brief, self-management interventions. The aim of this study is two-fold: to assess the immediate effects of a brief self-help mindfulness intervention for coping with chronic pain and to assess the feasibility of conducting a definitive randomized controlled trial to determine the effectiveness of such an intervention. A randomized controlled pilot study will be conducted to evaluate a brief mindfulness intervention for those with chronic pain. Ninety chronic pain patients who attend hospital outpatient clinics will be recruited and allocated randomly to either the control or treatment group on a 1:1 basis using the computer-generated list of random numbers. The treatment group receives mindfulness audios and the control group receives audios of readings from a non-fiction book, all of which are 15 minutes in length. Immediate effects of the intervention are assessed with brief psychological measures immediately before and after audio use. Mindfulness, mood, health-related quality of life, pain catastrophizing and experience of the intervention are assessed with standardized measures, brief ratings and brief telephone follow-ups, at baseline and after one week and one month. Feasibility is assessed by estimation of effect sizes for outcomes, patient adherence and experience, and appraisal of resource allocation in provision of the intervention. This trial will assess whether a brief mindfulness-based intervention is effective for immediately reducing perceived distress and pain with the side effect of increasing relaxation in chronic pain patients and will determine the feasibility of conducting a definitive randomized controlled trial. Patient recruitment began in January 2015 and is due to be completed in June 2016. ISRCTN61538090 Registered 20 April 2015.

Methodological Foundations for the Empirical Evaluation of Non-Experimental Methods in Field Settings

ERIC Educational Resources Information Center

Wong, Vivian C.; Steiner, Peter M.

2015-01-01

Across the disciplines of economics, political science, public policy, and now, education, the randomized controlled trial (RCT) is the preferred methodology for establishing causal inference about program impacts. But randomized experiments are not always feasible because of ethical, political, and/or practical considerations, so non-experimental…

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson's disease: study protocol for a randomized controlled feasibility trial.

PubMed

Silva, Keyte Guedes; De Freitas, Tatiana Beline; Doná, Flávia; Ganança, Fernando Freitas; Ferraz, Henrique Ballalai; Torriani-Pasin, Camila; Pompeu, José Eduardo

2017-01-01

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson's disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial attention deficiencies may contribute to the impairment of motor performance during daily activities. There are strong evidences that physical therapy can prevent physical and cognitive decline in individuals with PD. Recently, the European Physiotherapy Guideline (EPG) was developed based on randomized clinical trials about the effectiveness of the physical therapy to improve the functional deficiencies of individuals with PD. The EPG did not include the use of promising new intervention as virtual reality in PD due the lack of studies about its safety, feasibility and effectiveness. Therefore, this study protocol had as objective to evaluate the feasibility, safety and effectiveness of a physical therapy program-based on the European Physiotherapy Guideline (EPG) compared to Kinect-based training on postural control, gait, cognition, and quality of life (QoL) of Individuals with PD. A single-blind, parallel, randomized, controlled feasibility trial will be conducted with a sample of 32 individuals diagnosed with idiopathic PD. Participants will be allocated into control group (CG) and experimental group (EG). The intervention of the CG will be conventional physical therapy, and the intervention of the EG will be a supervised practice of five Kinect games. Both groups will perform 14 sessions of 1 h each one, twice a week over 7 weeks. Process outcomes will be safety, feasibility, adherence, and acceptability. Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. Feasibility will be assessed through the scores of the games recorded in all training sessions. Adherence will be assessed through the participant's attendance. Acceptability will be the motivation of the participants regarding the interventions. Clinical outcomes will be (1) postural control, (2) cognitive function, (3) balance, (4) gait, and (5) QoL. Individuals will be assessed pre- and post-interventions and after 30 days by a blinded evaluator. This protocol will clarify if an intervention based on Kinect games will be feasible, safe, and acceptable for individuals with PD compared to conventional physical therapy. We will verify whether the proposed interventions can improve clinical outcomes as postural control, gait, cognition, and QoL of individuals with PD. Our hypothesis is that both Kinect games and conventional physical therapy will be feasible, safe, and acceptable for individuals with PD and will promote positive clinical effects. The results of this feasibility study will be used to design a future definitive clinical trial. Unique identification number in WHO Trial Registration: U1111-1171-0371. Brazilian Clinical Trial Registration Number RBR-27kqv5, registration date: February, 2016.

Clinical feasibility of the Nintendo Wii™ for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting.

PubMed

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2014-09-01

To investigate the feasibility and potential efficacy of the Nintendo Wii™ for balance rehabilitation after stroke. Phase II, single-blind, randomized controlled trial. Inpatient rehabilitation facility. Thirty adults (mean age 63.6 (14.7) years) undergoing inpatient rehabilitation who were less than three months post-stroke and able to stand unsupported. Participants were allocated to a Balance Group, using the 'Wii Fit Plus' in standing, or Upper Limb Group, using the 'Wii Sports/Sports Resort' in sitting. Both groups undertook three 45 minute sessions per week over two to four weeks in addition to standard care. The primary focus was feasibility, addressed by recruitment, retention, adherence, acceptability and safety. Efficacy was evaluated by balance, mobility and upper limb outcomes. Twenty-one percent of individuals screened were recruited and 86% (n = 30) of eligible people agreed to participate. Study retention and session adherence was 90% and > 99%, respectively, at two weeks; dropping to 70% and 87% at four weeks due to early discharge. All participants reported enjoying the sessions and most felt they were beneficial. No major adverse events occurred. Wii use by the Balance Group was associated with trends for improved balance, with significantly greater improvement in outcomes including the Step Test and Wii Balance Board-derived centre of pressure scores. The Upper Limb Group had larger, non-significant changes in arm function. A Wii-based approach appears feasible and promising for post-stroke balance rehabilitation. A larger randomized controlled trial is recommended to further investigate efficacy. © The Author(s) 2014.

Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

PubMed

Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

2017-09-01

To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Trial registration Clinical Trials NCT01740635. PMID:24156396

Feasibility and Efficacy of the Nintendo Wii Gaming System to Improve Balance Performance Post-Stroke: Protocol of a Phase II Randomized Controlled Trial in an Inpatient Rehabilitation Setting.

PubMed

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2013-04-01

Balance deficits following stroke are common and debilitating. Commercially available gaming systems, such as the Nintendo(®) (Kyoto, Japan) Wii™, have been widely adopted clinically; however, there is limited evidence supporting their feasibility and efficacy for improving balance performance following stroke. The aim of this trial is to investigate the clinical feasibility and efficacy of using the Nintendo Wii gaming system as an adjunct to standard care to improve balance performance following stroke in an inpatient rehabilitation setting. Thirty participants undergoing inpatient stroke rehabilitation will be recruited into this Phase II, single-blind, randomized controlled trial. Participants will be allocated into a Balance or Upper Limb Group, and both groups will perform activities using the Nintendo Wii in addition to their standard care. Participants will attend three 45-minute sessions per week, for a minimum of 2 and a maximum of 4 weeks. The main focus of the study is to investigate the feasibility of the intervention protocol. This will be evaluated through recruitment, retention, adherence, acceptability, and safety. The Step Test and Functional Reach Test will be the primary efficacy outcomes. Secondary outcomes will include force platform, mobility, and upper limb measures. Assessments will occur at baseline, 2 weeks, and 4 weeks after study entry. To the authors' knowledge, this will be the largest randomized clinical trial to investigate the feasibility and efficacy of the Nintendo Wii gaming system for improving balance performance in a stroke population. The results will inform the design of a Phase III multicenter trial.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer

PubMed Central

Haase, Joan E.; Perkins, Susan M.; Haut, Paul R.; Henley, Amanda K.; Knafl, Kathleen A.; Tong, Yan

2017-01-01

Objectives To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. Methods A pilot two-group randomized trial was conducted with parents/children (ages 3–8 years) receiving AME + P (n  =  9) or attention control (n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Results Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Conclusion Despite child benefit, findings do not support parent delivery of AME + P. PMID:27289068

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Promoting Social Skill Development in Children with Pervasive Developmental Disorders: A Feasibility and Efficacy Study

ERIC Educational Resources Information Center

Koenig, Kathleen; White, Susan Williams; Pachler, Maryellen; Lau, Monika; Lewis, Moira; Klin, Ami; Scahill, Lawrence

2010-01-01

A randomized controlled design was employed to evaluate a social skills intervention for children with pervasive developmental disorders. Aims included evaluating the acceptability of the program and gathering preliminary evidence on efficacy. Forty-four children, ages 8-11 years, were randomly assigned to treatment or wait list. Treatment…

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

PubMed

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

An adapted mindfulness-based stress reduction program for elders in a continuing care retirement community: quantitative and qualitative results from a pilot randomized controlled trial.

PubMed

Moss, Aleezé S; Reibel, Diane K; Greeson, Jeffrey M; Thapar, Anjali; Bubb, Rebecca; Salmon, Jacqueline; Newberg, Andrew B

2015-06-01

The purpose of this study was to test the feasibility and effectiveness of an adapted 8-week Mindfulness-Based Stress Reduction (MBSR) program for elders in a continuing care community. This mixed-methods study used both quantitative and qualitative measures. A randomized waitlist control design was used for the quantitative aspect of the study. Thirty-nine elderly were randomized to MBSR (n = 20) or a waitlist control group (n = 19), mean age was 82 years. Both groups completed pre-post measures of health-related quality of life, acceptance and psychological flexibility, facets of mindfulness, self-compassion, and psychological distress. A subset of MBSR participants completed qualitative interviews. MBSR participants showed significantly greater improvement in acceptance and psychological flexibility and in role limitations due to physical health. In the qualitative interviews, MBSR participants reported increased awareness, less judgment, and greater self-compassion. Study results demonstrate the feasibility and potential effectiveness of an adapted MBSR program in promoting mind-body health for elders. © The Author(s) 2014.

The Feasibility of an E-Mail-Delivered Intervention to Improve Nutrition and Physical Activity Behaviors in African American College Students

ERIC Educational Resources Information Center

Mackey, Eleanor; Schweitzer, Amy; Hurtado, Maria Eugenia; Hathway, Joanne; DiPietro, Loretta; Lei, Kai Y.; Klein, Catherine J.

2015-01-01

Objectives: To evaluate the feasibility and acceptability of an e-mail-delivered program to promote nutrition and physical activity in African American college students. Participants: Forty-seven students (76% female, aged 18-20 years). Methods: Students participated in a 24-week randomized controlled trial, receiving either general health…

Feasibility study design and methods for a home-based, square-stepping exercise program among older adults with multiple sclerosis: The SSE-MS project.

PubMed

Sebastião, Emerson; McAuley, Edward; Shigematsu, Ryosuke; Motl, Robert W

2017-09-01

We propose a randomized controlled trial (RCT) examining the feasibility of square-stepping exercise (SSE) delivered as a home-based program for older adults with multiple sclerosis (MS). We will assess feasibility in the four domains of process, resources, management and scientific outcomes. The trial will recruit older adults (aged 60 years and older) with mild-to-moderate MS-related disability who will be randomized into intervention or attention control conditions. Participants will complete assessments before and after completion of the conditions delivered over a 12-week period. Participants in the intervention group will have biweekly meetings with an exercise trainer in the Exercise Neuroscience Research Laboratory and receive verbal and visual instruction on step patterns for the SSE program. Participants will receive a mat for home-based practice of the step patterns, an instruction manual, and a logbook and pedometer for monitoring compliance. Compliance will be further monitored through weekly scheduled Skype calls. This feasibility study will inform future phase II and III RCTs that determine the actual efficacy and effectiveness of a home-based exercise program for older adults with MS.

Feasibility of Pilates exercise to decrease falls risk: a pilot randomized controlled trial in community-dwelling older people.

PubMed

Barker, Anna L; Talevski, Jason; Bohensky, Megan A; Brand, Caroline A; Cameron, Peter A; Morello, Renata T

2016-10-01

To evaluate the feasibility of Pilates exercise in older people to decrease falls risk and inform a larger trial. Pilot Randomized controlled trial. Community physiotherapy clinic. A total of 53 community-dwelling people aged ⩾60 years (mean age, 69.3 years; age range, 61-84). A 60-minute Pilates class incorporating best practice guidelines for exercise to prevent falls, performed twice weekly for 12 weeks. All participants received a letter to their general practitioner with falls risk information, fall and fracture prevention education and home exercises. Indicators of feasibility included: acceptability (recruitment, retention, intervention adherence and participant experience survey); safety (adverse events); and potential effectiveness (fall, fall injury and injurious fall rates; standing balance; lower limb strength; and flexibility) measured at 12 and 24 weeks. Recruitment was achievable but control group drop-outs were high (23%). Of the 20 participants who completed the intervention, 19 (95%) attended ⩾75% of the classes and reported classes were enjoyable and would recommend them to others. The rate of fall injuries at 24 weeks was 42% lower and injurious fall rates 64% lower in the Pilates group, however, was not statistically significant (P = 0.347 and P = 0.136). Standing balance, lower-limb strength and flexibility improved in the Pilates group relative to the control group (P < 0.05). Estimates suggest a future definitive study would require 804 participants to detect a difference in fall injury rates. A definitive randomized controlled trial analysing the effect of Pilates in older people would be feasible and is warranted given the acceptability and potential positive effects of Pilates on fall injuries and fall risk factors. The protocol for this study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN1262000224820). © The Author(s) 2015.

Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

PubMed Central

White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

2012-01-01

Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial.

PubMed

Platt, Jennica; Baxter, Nancy; Jones, Jennifer; Metcalfe, Kelly; Causarano, Natalie; Hofer, Stefan O P; O'Neill, Anne; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2013-07-06

The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design. The University Health Network, a tertiary care cancer center in Toronto, Canada. Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction. We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient. Usual care includes access to an informational booklet, website, and patient volunteer if desired. Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial. Our pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013. NCT01857882.

Task-Oriented Training with Computer Games for People with Rheumatoid Arthritis or Hand Osteoarthritis: A Feasibility Randomized Controlled Trial.

PubMed

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Szturm, Tony

2016-09-13

To examine the feasibility of a clinical trial on a novel, home-based task-oriented training with conventional hand exercises in people with rheumatoid arthritis or hand osteoarthritis. To explore the experiences of participants who completed their respective home exercise programmes. Thirty volunteer participants aged between 30 and 60 years and diagnosed with rheumatoid arthritis or hand osteoarthritis were proposed for a single-center, assessor-blinded, randomized controlled trial ( ClinicalTrials.gov : NCT01635582). Participants received task-oriented training with interactive computer games and objects of daily life or finger mobility and strengthening exercises. Both programmes were home based and were done four sessions per week with 20 minutes each session for 6 weeks. Major feasibility outcomes were number of volunteers screened, randomized, and retained; completion of blinded assessments, exercise training, and home exercise sessions; equipment and data management; and clinical outcomes of hand function. Reaching the recruitment target in 18 months and achieving exercise compliance >80% were set as success criteria. Concurrent with the trial, focus group interviews explored experiences of those participants who completed their respective programmes. After trial initiation, revisions in inclusion criteria were required to promote recruitment. A total of 17 participants were randomized and 15 were retained. Completion of assessments, exercise training, and home exercise sessions; equipment and data collection and management demonstrated excellent feasibility. Both groups improved in hand function outcomes and exercise compliance was above 85%. Participants perceived both programmes as appropriate and acceptable. Participants who completed task-oriented training also agreed that playing different computer games was enjoyable, engaging, and motivating. Findings demonstrate initial evidence on recruitment, feasibility of trial procedures, and acceptability of task-oriented training in people with rheumatoid arthritis or hand osteoarthritis. Since the pilot trial was unsuccessful in participant recruitment, a large trial will not follow.

Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom.

PubMed

Scott, W; Chilcot, J; Guildford, B; Daly-Eichenhardt, A; McCracken, L M

2018-04-28

Acceptance and Commitment Therapy (ACT) has growing support for chronic pain. However, more accessible treatment delivery is needed. This study evaluated the feasibility of online ACT for patients with complex chronic pain in the United Kingdom to determine whether a larger trial is justified. Participants with chronic pain and clinically meaningful disability and distress were randomly assigned to ACT online plus specialty medical pain management, or specialty medical management alone. Participants completed questionnaires at baseline, and 3- and 9-month post-randomization. Primary feasibility outcomes included recruitment, retention and treatment completion rates. Secondary outcomes were between-groups effects on treatment outcomes and psychological flexibility. Of 139 potential participants, 63 were eligible and randomized (45% recruitment rate). Retention rates were 76-78% for follow-up assessments. Sixty-one per cent of ACT online participants completed treatment. ACT online was less often completed by employed (44%) compared to unemployed (80%) participants. Fifty-six per cent of ACT online participants rated themselves as 'much improved' or better on a global impression of change rating, compared to only 20 per cent of control participants. Three-month effects favouring ACT online were small for functioning, medication and healthcare use, committed action and decentring, medium for mood, and large for acceptance. Small-to-medium effects were maintained for functioning, healthcare use and committed action at 9 months. Online ACT for patients with chronic pain in the United Kingdom appears feasible to study in a larger efficacy trial. Some adjustments to treatment and trial procedures are warranted, particularly to enhance engagement among employed participants. This study supports the feasibility of online Acceptance and Commitment Therapy for chronic pain in the United Kingdom and a larger efficacy trial. Refinements to treatment delivery, particularly to better engage employed patients, may improve treatment completion and outcomes. © 2018 European Pain Federation - EFIC®.

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

PubMed

Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

2013-09-01

To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial.

PubMed

Yang, Xuyang; Wu, Qingbin; Jin, Chengwu; He, Wanbin; Wang, Meng; Yang, Tinghan; Wei, Mingtian; Deng, Xiangbing; Meng, Wenjian; Wang, Ziqiang

2017-07-26

Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total "no-touch" isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total "no-touch" isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial. This is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total "no-touch" isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery). This trial will provide valuable clinical evidence for the feasibility, safety, and potential total "no-touch" isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery. ClinicalTrials.gov, NCT02625272 . Registered on 8 December 2015.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

High-intensity Interval Training and Continuous Aerobic Exercise Interventions to Promote Self-initiated Quit Attempts in Young Adults Who Smoke: Feasibility, Acceptability, and Lessons Learned from a Randomized Pilot Trial.

PubMed

Allen, Alicia; Carlson, Samantha C; Bosch, Tyler A; Eberly, Lynn E; Okuyemi, Kola; Nair, Uma; Gordon, Judith S

2018-05-14

While exercise significantly reduces craving for cigarettes, the effect of exercise on self-initiation of quit attempts is less known. Therefore, this randomized pilot study explored the effect of starting an exercise program on self-initiated quit attempts, and also the feasibility and acceptability of a novel exercise intervention, high-intensity interval training (HIIT), as compared with a more traditional continuous aerobic (CA) exercise intervention. Participants smoked (≥5 cigarettes/d), were aged 18 to 40 years, and wanted to increase their exercise. Participants were randomized into 1 of 3 groups: HIIT, CA, and delayed control. All participants attended follow-up visits at weeks 4, 8, and 12. Outcomes included measures of feasibility (eg, visit attendance) and acceptability (eg, satisfaction), and also changes in smoking behavior (eg, quit attempts during follow-up) and proxies to quit attempts (eg, positive affect). Overall, there were no differences in terms of feasibility and acceptability between the HITT (n = 12) and CA (n = 9) groups. Based on both self-report and objective measurement, the exercise groups (HIIT and CA) increased their physical activity as compared with the delayed treatment group (n = 11). Compared with HIIT and delayed control, CA (n = 9) had significant favorable changes in positive affect (eg, at week 8, HIIT: +0.25 ± 2.21, delayed control: -5.11 ± 2.23, CA: +5.50 ± 2.23; P = 0.0153). These observations suggest that HIIT is as feasible and acceptable as CA, though CA may have a more favorable effect on proxies to quit attempts (eg, positive affect). Fully powered studies are needed to examine the effect of HIIT versus CA on quit attempts.

The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.

PubMed

Klonizakis, M; Tew, G A; Gumber, A; Crank, H; King, B; Middleton, G; Michaels, J A

2018-05-01

Venous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low-cost, low-risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs. To assess the feasibility of a 12-week supervised exercise programme as an adjunct therapy to compression in patients with VLUs. This was a two-centre, two-arm, parallel-group, randomized feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants' experiences. Seventy-two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise-related adverse events (both increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group. The feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported. © 2017 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

Virtual Reality Job Interview Training in Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Smith, Matthew J.; Ginger, Emily J.; Wright, Katherine; Wright, Michael A.; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale E.; Bell, Morris D.; Fleming, Michael F.

2014-01-01

The feasibility and efficacy of virtual reality job interview training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n = 16) or treatment-as-usual (TAU) (n = 10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic…

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

PubMed

Marsac, Meghan L; Kohser, Kristen L; Winston, Flaura K; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed.

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial

PubMed Central

Marsac, Meghan L.; Kohser, Kristen L.; Winston, Flaura K.; Kenardy, Justin; March, Sonja; Kassam-Adams, Nancy

2013-01-01

Background Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. Objectives To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. Method Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8–12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. Results Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). Discussion Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed. PMID:23898396

Controller adherence following hospital discharge in high risk children: A pilot randomized trial of text message reminders.

PubMed

Kenyon, Chén C; Gruschow, Siobhan M; Quarshie, William O; Griffis, Heather; Leach, Michelle C; Zorc, Joseph J; Bryant-Stephens, Tyra C; Miller, Victoria A; Feudtner, Chris

2018-02-13

To assess the feasibility of a mobile health, inhaled corticosteroid (ICS) adherence reminder intervention and to characterize adherence trajectories immediately following severe asthma exacerbation in high-risk urban children with persistent asthma. Children aged 2-13 with persistent asthma were enrolled in this pilot randomized controlled trial during an asthma emergency department (ED) visit or hospitalization. Intervention arm participants received daily text message reminders for 30 days, and both arms received electronic sensors to measure ICS use. Primary outcomes were feasibility of sensor use and text message acceptability. Secondary outcomes included adherence to prescribed ICS regimen and 30-day adherence trajectories. Group-based trajectory modeling was used to examine adherence trajectories. Forty-one participants (mean age 5.9) were randomized to intervention (n = 21) or control (n = 20). Overall, 85% were Black, 88% had public insurance, and 51% of the caregivers had a high school education or less. Thirty-two participant families (78%) transmitted medication adherence data; of caregivers who completed the acceptability survey, 25 (96%) chose to receive daily reminders beyond that study interval. Secondary outcome analyses demonstrated similar average daily adherence between groups (intervention = 36%; control = 32%, P = 0.73). Three adherence trajectories were identified with none ever exceeding 80% adherence. Within a high-risk pediatric cohort, electronic monitoring of ICS use and adherence reminders delivered via text message were feasible for most participants, but there was no signal of effect. Adherence trajectories following severe exacerbation were suboptimal, demonstrating an important opportunity for asthma care improvement.

Treatment of Knee Osteoarthritis With Allogeneic Bone Marrow Mesenchymal Stem Cells: A Randomized Controlled Trial.

PubMed

Vega, Aurelio; Martín-Ferrero, Miguel Angel; Del Canto, Francisco; Alberca, Mercedes; García, Veronica; Munar, Anna; Orozco, Lluis; Soler, Robert; Fuertes, Juan Jose; Huguet, Marina; Sánchez, Ana; García-Sancho, Javier

2015-08-01

Osteoarthritis is the most prevalent joint disease and a common cause of joint pain, functional loss, and disability. Conventional treatments demonstrate only modest clinical benefits without lesion reversal. Autologous mesenchymal stromal cell (MSC) treatments have shown feasibility, safety, and strong indications for clinical efficacy. We performed a randomized, active control trial to assess the feasibility and safety of treating osteoarthritis with allogeneic MSCs, and we obtain information regarding the efficacy of this treatment. We randomized 30 patients with chronic knee pain unresponsive to conservative treatments and showing radiological evidence of osteoarthritis into 2 groups of 15 patients. The test group was treated with allogeneic bone marrow MSCs by intra-articular injection of 40 × 10(6) cells. The control group received intra-articular hyaluronic acid (60 mg, single dose). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping. Feasibility and safety were confirmed and indications of clinical efficacy were identified. The MSC-treated patients displayed significant improvement in algofunctional indices versus the active controls treated with hyaluronic acid. Quantification of cartilage quality by T2 relaxation measurements showed a significant decrease in poor cartilage areas, with cartilage quality improvements in MSC-treated patients. Allogeneic MSC therapy may be a valid alternative for the treatment of chronic knee osteoarthritis that is more logistically convenient than autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves cartilage quality.

Sleep education improves the sleep duration of adolescents: a randomized controlled pilot study.

PubMed

Kira, Geoff; Maddison, Ralph; Hull, Michelle; Blunden, Sarah; Olds, Timothy

2014-07-15

To determine the feasibility and pilot a sleep education program in New Zealand high school students. A parallel, two-arm randomized controlled pilot trial was conducted. High school students (13 to 16 years) were randomly allocated to either a classroom-based sleep education program intervention (n = 15) or to a usual curriculum control group (n = 14). The sleep education program involved four 50-minute classroom-based education sessions with interactive groups. Students completed a 7-day sleep diary, a sleep questionnaire (including sleep hygiene, knowledge and problems) at baseline, post-intervention (4 weeks) and 10 weeks follow-up. An overall treatment effect was observed for weekend sleep duration (F 1,24 = 5.21, p = 0.03). Participants in the intervention group slept longer during weekend nights at 5 weeks (1:37 h:min, p = 0.01) and 10 weeks: (1:32 h:min, p = 0.03) compared to those in the control group. No differences were found between groups for sleep duration on weekday nights. No significant differences were observed between groups for any of the secondary outcomes (sleep hygiene, sleep problems, or sleep knowledge). A sleep education program appears to increase weekend sleep duration in the short term. Although this program was feasible, most schools are under time and resource pressure, thus alternative methods of delivery should be assessed for feasibility and efficacy. Larger trials of longer duration are needed to confirm these findings and determine the sustained effect of sleep education on sleep behavior and its impact on health and psychosocial outcomes. A commentary on this article appears in this issue on page 793.

Surgical timing after chemoradiotherapy for rectal cancer, analysis of technique (STARRCAT): results of a feasibility multi-centre randomized controlled trial.

PubMed

Foster, J D; Ewings, P; Falk, S; Cooper, E J; Roach, H; West, N P; Williams-Yesson, B A; Hanna, G B; Francis, N K

2016-10-01

The optimal time of rectal resection after long-course chemoradiotherapy (CRT) remains unclear. A feasibility study was undertaken for a multi-centre randomized controlled trial evaluating the impact of the interval after chemoradiotherapy on the technical complexity of surgery. Patients with rectal cancer were randomized to either a 6- or 12-week interval between CRT and surgery between June 2012 and May 2014 (ISRCTN registration number: 88843062). For blinded technical complexity assessment, the Observational Clinical Human Reliability Analysis technique was used to quantify technical errors enacted within video recordings of operations. Other measured outcomes included resection completeness, specimen quality, radiological down-staging, tumour cell density down-staging and surgeon-reported technical complexity. Thirty-one patients were enrolled: 15 were randomized to 6 and 16-12 weeks across 7 centres. Fewer eligible patients were identified than had been predicted. Of 23 patients who underwent resection, mean 12.3 errors were observed per case at 6 weeks vs. 10.7 at 12 weeks (p = 0.401). Other measured outcomes were similar between groups. The feasibility of measurement of operative performance of rectal cancer surgery as an endpoint was confirmed in this exploratory study. Recruitment of sufficient numbers of patients represented a challenge, and a proportion of patients did not proceed to resection surgery. These results suggest that interval after CRT may not substantially impact upon surgical technical performance.

Group music therapy for patients with persistent post-traumatic stress disorder--an exploratory randomized controlled trial with mixed methods evaluation.

PubMed

Carr, Catherine; d'Ardenne, Patricia; Sloboda, Ann; Scott, Carleen; Wang, Duolao; Priebe, Stefan

2012-06-01

Not all patients with post-traumatic stress disorder (PTSD) respond to cognitive behavioural therapy (CBT). Literature suggests group music therapy might be beneficial in treating PTSD. However, feasibility and effectiveness have not been assessed. The study objectives were to assess whether group music therapy was feasible for patients who did not respond to CBT, and whether it has an effect on PTSD symptoms and depression. The study employed mixed methods comprising of an exploratory randomized controlled trial, qualitative content analysis of therapy, and patient interviews. Patients with significant PTSD symptoms (n = 17) following completion of CBT were randomly assigned to treatment (n = 9) or control groups (n = 8). The treatment group received 10 weeks of group music therapy after which exit interviews were conducted. Control group patients were offered the intervention at the end of the study. Symptoms were assessed on the Impact of Events Scale-Revised and Beck Depression Inventory II at the beginning and end of treatment. Treatment-group patients experienced a significant reduction in severity of PTSD symptoms (-20.18; 95% confidence interval [CI]: [-31.23, -9.12]) and a marginally significant reduction in depression (-11.92; 95%CI: [-24.05, 0.21]) at 10 weeks from baseline compared to the control. Patients viewed music therapy as helpful and reported experiences concur with current literature. Group music therapy appears feasible and effective for PTSD patients who have not sufficiently responded to CBT. Limitations include the small sample size and lack of blinding. Further research should address these limitations, test sustainability, and identify specific factors that address symptoms in treatment. ©2011 The British Psychological Society.

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Feasibility and Efficacy of an mHealth Game for Managing Anxiety: "Flowy" Randomized Controlled Pilot Trial and Design Evaluation.

PubMed

Pham, Quynh; Khatib, Yasmin; Stansfeld, Stephen; Fox, Simon; Green, Tobias

2016-02-01

Meeting the complex needs of patients with chronic common mental health disorders (CMHDs) may be the greatest challenge facing organized medical practice. On the basis of a well-established and proven theoretical foundation for controlled respiration as a behavioral intervention for CMHDs, as well as preliminary evidence that gamification can improve health outcomes through increasing patient engagement, this randomized controlled pilot study evaluated the feasibility and clinical efficacy of a mobile health game called "Flowy" ( www.flowygame.com ) that digitally delivered breathing retraining exercises for anxiety, panic, and hyperventilation symptom management. We designed an unblinded, Web-based, parallel-group randomized controlled trial focusing on feasibility, clinical efficacy, and design proof of concept. In the intervention condition (n = 31), participants received free access to "Flowy" for 4 weeks. In the control condition (n = 32), participants were placed on a waitlist for 4 weeks before being offered free access to "Flowy." Online measurements using psychological self-report questionnaires were made at 2 and 4 weeks post-baseline. At trial conclusion, participants found "Flowy" acceptable as an anxiety management intervention. "Flowy" engaged participants sufficiently to endorse proactive gameplay. Intent-to-treat analysis revealed a reduction in anxiety, panic, and self-report hyperventilation scores in both trial arms, with the intervention arm experiencing greater quality of life. Participants perceived "Flowy" as a fun and useful intervention, proactively used "Flowy" as part of their care, and would recommend "Flowy" to family and friends. Our results suggest that a digital delivery of breathing retraining exercises through a mobile health game can manage anxiety, panic, and hyperventilation symptoms associated with CMHDs.

Managing mobility outcomes in vulnerable seniors ( MMOVeS): a randomized controlled pilot study.

PubMed

Figueiredo, Sabrina; Morais, Jose A; Mayo, Nancy

2017-12-01

To estimate feasibility and potential for efficacy of an individualized, exercise-focused, self-management program (i.e. Managing Mobility Outcomes In Vulnerable Seniors ( MMOVeS)), in comparison to exercise information in improving mobility after six months among seniors recently discharged from hospital. Randomized pilot study. Two McGill University-teaching hospitals. Community dwelling seniors, aged 70 years and older, recently discharged from either participating hospitals. The physiotherapy-facilitated intervention consisted of (1) evaluation of mobility capacity, (2) setting short- and long-term goals, (3) delineation of an exercise treatment plan, (4) an educational booklet to enhance mobility self-management skills, and (5) six monthly telephone calls. Control group received a booklet with information on exercises targeting mobility limitations in seniors. Mobility, pain, and health status were assessed at baseline and at six months using multiple indicators drawn from Disabilities of the Arm, Shoulder, and Hand (DASH) Score, Lower Extremity Functional Scale (LEFS) and Short-Form (SF)-36. In all, 26 people were randomized to the intervention (mean age: 81 ± 8; 39% women), and 23 were randomized to the control (mean age: 79 ± 7; 33% women). The odds ratio for the mobility outcomes combined was 3.08 and the 95% confidence interval excluded 1 (1.65-5.77). The odds ratio for pain and health perception favored the MMOVeS group, but the 95% confidence interval included the null value. This feasibility study highlights the potential for efficacy of an individualized, exercise-focused, self-management program in comparison to exercise information in improving mobility outcome for seniors. Furthermore, a home-program combining self-management skills and exercise taught with minimal supervision prove to be feasible. Finally, data from this study can be used to estimate sample size for a confirmatory trial.

Chewing gum for the treatment of postoperative nausea and vomiting: a pilot randomized controlled trial.

PubMed

Darvall, J N; Handscombe, M; Leslie, K

2017-01-01

A novel treatment, chewing gum, may be non-inferior to ondansetron in inhibiting postoperative nausea and vomiting (PONV) in female patients after laparoscopic or breast surgery. In this pilot study, we tested the feasibility of a large randomized controlled trial. We randomized 94 female patients undergoing laparoscopic or breast surgery to ondansetron 4 mg i.v. or chewing gum if PONV was experienced in the postanaesthesia care unit (PACU). The primary outcome was full resolution of PONV, with non-inferiority defined as a difference between groups of <15% in a per protocol analysis. Secondary outcomes were PACU stay duration, anti-emetic rescue use, and acceptability of anti-emetic treatment. The feasibility of implementing the protocol in a larger trial was assessed. Postoperative nausea and vomiting in the PACU occurred in 13 (28%) ondansetron patients and 15 (31%) chewing gum patients (P=0.75). Three chewing gum patients could not chew gum when they developed PONV. On a per protocol basis, full resolution of PONV occurred in five of 13 (39%) ondansetron vs nine of 12 (75%) chewing gum patients [risk difference 37% (6.3-67%), P=0.07]. There was no difference in secondary outcomes between groups. Recruitment was satisfactory, the protocol was acceptable to anaesthetists and nurses, and data collection was complete. In this pilot trial, chewing gum was not inferior to ondansetron for treatment of PONV after general anaesthesia for laparoscopic or breast surgery in female patients. Our findings demonstrate the feasibility of a larger, multicentred randomized controlled trial to investigate this novel therapy. Australian New Zealand Clinical Trials Registry: ACTRN12615001327572. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial

PubMed Central

Maas-Van Schaaijk, Nienke M; Sas, Theo C; Clement-de Boers, Agnes; Smallenbroek, Mischa; Nuboer, Roos; Noordam, Cees; Verhaak, Chris M

2017-01-01

Background Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. Objective The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. Methods The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). Results Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents’ frequency of logging on (ρ=.282, P=.03) and page-views (ρ=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F3,101=.49, P=.49). Conclusions The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. Trial Registration Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6) PMID:28830853

Sugarsquare, a Web-Based Patient Portal for Parents of a Child With Type 1 Diabetes: Multicenter Randomized Controlled Feasibility Trial.

PubMed

Boogerd, Emiel; Maas-Van Schaaijk, Nienke M; Sas, Theo C; Clement-de Boers, Agnes; Smallenbroek, Mischa; Nuboer, Roos; Noordam, Cees; Verhaak, Chris M

2017-08-22

Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information. The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice. The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1). Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents' frequency of logging on (ρ=.282, P=.03) and page-views (ρ=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F 3,101 =.49, P=.49). The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested. Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6). ©Emiel Boogerd, Nienke M Maas-Van Schaaijk, Theo C Sas, Agnes Clement-de Boers, Mischa Smallenbroek, Roos Nuboer, Cees Noordam, Chris M Verhaak. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 22.08.2017.

Pilot Randomized Trial of Active Music Engagement Intervention Parent Delivery for Young Children With Cancer.

PubMed

Robb, Sheri L; Haase, Joan E; Perkins, Susan M; Haut, Paul R; Henley, Amanda K; Knafl, Kathleen A; Tong, Yan

2017-03-01

To examine the feasibility/acceptability of a parent-delivered Active Music Engagement (AME + P) intervention for young children with cancer and their parents. Secondary aim to explore changes in AME + P child emotional distress (facial affect) and parent emotional distress (mood; traumatic stress symptoms) relative to controls. A pilot two-group randomized trial was conducted with parents/children (ages 3-8 years) receiving AME + P ( n  =  9) or attention control ( n  =  7). Feasibility of parent delivery was assessed using a delivery checklist and child engagement; acceptability through parent interviews; preliminary outcomes at baseline, postintervention, 30 days postintervention. Parent delivery was feasible, as they successfully delivered AME activities, but interviews indicated parent delivery was not acceptable to parents. Emotional distress was lower for AME + P children, but parents derived no benefit. Despite child benefit, findings do not support parent delivery of AME + P. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Massage therapy for patients with metastatic cancer: a pilot randomized controlled trial.

PubMed

Toth, Maria; Marcantonio, Edward R; Davis, Roger B; Walton, Tracy; Kahn, Janet R; Phillips, Russell S

2013-07-01

The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. This was a randomized controlled trial. Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects were patients with metastatic cancer. There were three interventions: massage therapy, no-touch intervention, and usual care. Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings.

Smoking Cessation Program for Inpatients with Substance Use Disorder: A Quasi-Randomized Controlled Trial of Feasibility and Efficacy.

PubMed

Rüther, Tobias; Ruderer, Amelie; Wirth, Christina; Schuler, Veronika; Lang, Verena; Linhardt, Andrea; Kröger, Christoph B; Pogarell, Oliver

2016-01-01

The present study investigated the feasibility, acceptance and efficacy of a newly developed cognitive behavioral program for smoking cessation/reduction ('Rethink your Smoking' program, RSP) in inpatients with substance use disorder (SUD). One hundred ninety-nine inpatients with SUD were randomly assigned to either the RSP (n = 101) or a minimal intervention (MI) program (n = 98). In addition, participants were offered optional nicotine replacement therapy. Data from a group of patients with SUD without any intervention (control group, n = 78) were included in the analyses for comparison. Assessments were performed at admission, discharge and follow-up after 3 and 6 months. RSP proved to be feasible and was well accepted by participants. Patients in both interventions showed lower scores for physical nicotine dependence and number of cigarettes smoked per day and higher scores for various motivational parameters at discharge and 3 months later. Both interventions were superior to no intervention, but no differences were found between the RSP and MI. A smoking cessation/reduction program is feasible for substance-dependent in-patients undergoing detoxification. Although the RSP appears to be effective in terms of harm reduction in in-patients with SUD, more cost- and time-efficient programs might also be suitable for this population. © 2016 S. Karger AG, Basel.

Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study.

PubMed

Raina, Ketki D; Morse, Jennifer Q; Chisholm, Denise; Leibold, Mary Lou; Shen, Jennifer; Whyte, Ellen

2016-01-01

To evaluate the feasibility of conducting a randomized clinical trial of an Internet-based manualized intervention to teach individuals with traumatic brain injury to manage their fatigue. Community dwelling. Forty-one participants randomized to Maximizing Energy (MAX) intervention group (n = 20) and Health Education group (n = 21). The experimental group (MAX intervention) received an 8-week program that combined education and Problem-Solving Therapy to teach individuals to manage fatigue-related problems. The attention control group received health education. Primary outcome measures pertained to the feasibility of conducting the trial. Secondary outcomes were fatigue impact and fatigue severity assessed at baseline and postintervention. Of the 65 participants referred, 41 were enrolled (63% recruitment rate), of which 3 withdrew (92% retention rate). Participants in the experimental and control groups completed their homework 75% and 85% of the time, respectively, and were equally engaged in the sessions. Participants in the experimental group were able to learn and implement the MAX intervention steps. Effect sizes for all measures ranged from small (-0.17) to medium (-0.58) in favor of the intervention group. Findings from the study suggest that the MAX intervention is feasible to administer to individuals with post-traumatic brain injury fatigue.

Aquatic physical therapy for children with developmental coordination disorder: a pilot randomized controlled trial.

PubMed

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-05-01

Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7 years 1 month; 10 males) with DCD were randomly allocated to receive either six sessions of aquatic therapy (once weekly session of 30 min for 6-8 weeks) or to a wait-list (control group). The intervention and measures were demonstrated to be feasible, but barriers, such as limited appointment times and accessibility, were encountered. Analysis of covariance indicated that at posttest, mean scores on the Movement Assessment Battery were higher for children who received aquatic therapy compared to those on the wait-list (p = .057). Similar trends were noted on the physical competence portion of the Pictorial Scale of Perceived Competence and Social Acceptance (p = .058). Participation levels, as measured by a parent questionnaire, showed improvement for both groups. Potential facilitators and barriers to implementation of an aquatic therapy for children with DCD are discussed.

Video-games used in a group setting is feasible and effective to improve indicators of physical activity in individuals with chronic stroke: a randomized controlled trial.

PubMed

Givon, Noa; Zeilig, Gabi; Weingarden, Harold; Rand, Debbie

2016-04-01

To investigate the feasibility of using video-games in a group setting and to compare the effectiveness of video-games as a group intervention to a traditional group intervention for improving physical activity in individuals with chronic stroke. A single-blind randomized controlled trial with evaluations pre and post a 3-month intervention, and at 3-month follow-up. Compliance (session attendance), satisfaction and adverse effects were feasibility measures. Grip strength and gait speed were measures of physical activity. Hip accelerometers quantified steps/day and the Action Research Arm Test assessed the functional ability of the upper extremity. Forty-seven community-dwelling individuals with chronic stroke (29-78 years) were randomly allocated to receive video-game (N=24) or traditional therapy (N=23) in a group setting. There was high treatment compliance for both interventions (video-games-78%, traditional therapy-66%), but satisfaction was rated higher for the video-game (93%) than the traditional therapy (71%) (χ(2)=4.98, P=0.026). Adverse effects were not reported in either group. Significant improvements were demonstrated in both groups for gait speed (F=3.9, P=0.02), grip strength of the weaker (F=6.67, P=0.002) and stronger hands (F=7.5, P=0.001). Daily steps and functional ability of the weaker hand did not increase in either group. Using video-games in a small group setting is feasible, safe and satisfying. Video-games improve indicators of physical activity of individuals with chronic stroke. © The Author(s) 2015.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Entomological impact and social participation in dengue control: a cluster randomized trial in Fortaleza, Brazil

PubMed Central

Caprara, Andrea; De Oliveira Lima, José Wellington; Rocha Peixoto, Ana Carolina; Vasconcelos Motta, Cyntia Monteiro; Soares Nobre, Joana Mary; Sommerfeld, Johannes; Kroeger, Axel

2015-01-01

Background This study intended to implement a novel intervention strategy, in Brazil, using an ecohealth approach and analyse its effectiveness and costs in reducing Aedes aegypti vector density as well as its acceptance, feasibility and sustainability. The intervention was conducted from 2012 to 2013 in the municipality of Fortaleza, northeast Brazil. Methodology A cluster randomized controlled trial was designed by comparing ten intervention clusters with ten control clusters where routine vector control activities were conducted. The intervention included: community workshops; community involvement in clean-up campaigns; covering the elevated containers and in-house rubbish disposal without larviciding; mobilization of schoolchildren and senior inhabitants; and distribution of information, education and communication (IEC) materials in the community. Results Differences in terms of social participation, commitment and leadership were present in the clusters. The results showed the effectiveness of the intervention package in comparison with the routine control programme. Differences regarding the costs of the intervention were reasonable and could be adopted by public health services. Conclusions Embedding social participation and environmental management for improved dengue vector control was feasible and significantly reduced vector densities. Such a participatory ecohealth approach offers a promising alternative to routine vector control measures. PMID:25604760

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

A new educational film control for use in studies of active mind-body therapies: acceptability and feasibility.

PubMed

Innes, Kim E; Selfe, Terry Kit; Alexander, Gina K; Taylor, Ann Gill

2011-05-01

The study objectives were to ascertain whether a novel educational film class is an acceptable and feasible comparison group for a randomized controlled trial regarding the effects of an active mind-body therapy on cardiovascular disease risk in postmenopausal women. Seventy-five (75) participants attended a baseline assessment visit and were randomly assigned to either a yoga group or an educational film (control) group. Both groups attended two 90-minute classes/week for 8 weeks, followed by a second assessment visit. Those not attending the second assessment were classified as dropouts. Over 60 films covering a range of topics relevant to the study population were evaluated; 15 were selected by consensus of at least 2 researchers and 1 layperson. Each film session followed the same format: an informal greeting period, viewing of the film, and a 15-minute postfilm discussion. To determine acceptability and feasibility of the film class, potential between-group differences in dropout and attendance were examined, and participant feedback given during class and on end-of-study questionnaires were evaluated. The relation between group assignment and dropout was not significant (χ(2) [1, N = 75] = 0.14, p = 0.71). One-way analysis of variance (ANOVA) indicated no significant between-group difference in number of classes attended for the yoga (X = 13.67 ± 3.10) versus film group (13.26 ± 1.97), F(1,63) = 0.39, p = 0.53). Participant feedback regarding the film program was positive. These findings support the feasibility and acceptability of this educational film control. Easy to standardize and tailor to a variety of populations, this film program may offer an attractive alternative to the more traditional educational control.

Development of an Empirically Based Preventive Intervention for Depression in Preadolescent African American Girls.

PubMed

Duffy, Sophia; Brown, Tasha M; Katsonga-Phiri, Tiamo; Bouris, Alida; Grant, Kathryn E; Keenan, Kate

2016-05-01

We describe the development, feasibility, and acceptability of a novel preventive intervention for depression in African American girls living in urban poverty. Our approach targeted individual and interpersonal vulnerabilities that have been shown to confer risk for depression in samples of African American girls living in low-income, urban settings, including suppression of negative emotion and lack of assertiveness with peers, memory for positive emotion, active coping, and family connection. Focus groups and an open trial were conducted to refine the goals and mechanisms for skill building. A randomized controlled trial (RCT) of the new program (Cities Mother-Daughter Project) was conducted with 3rd-5th grade students from Chicago Public Schools (CPS). Three cycles of screening, randomization, and deployment were conducted to assess feasibility, satisfaction, and usability. Results indicate that feasibility was weak; whereas, satisfaction and usability were high. Future directions for testing efficacy are discussed.

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial.

PubMed

McDermott, Kelly A; Rao, Mohan Raghavendra; Nagarathna, Raghuram; Murphy, Elizabeth J; Burke, Adam; Nagendra, Ramarao Hongasandra; Hecht, Frederick M

2014-07-01

Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study. Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being. ClinicalTrials.gov Identified NCT00090506.

Feasibility of a tobacco cessation intervention for pregnant Alaska Native women

PubMed Central

Windsor, Richard A.; Renner, Caroline C.; Enoch, Carrie; Hochreiter, Angela; Nevak, Caroline; Smith, Christina A.; Decker, Paul A.; Bonnema, Sarah; Hughes, Christine A.; Brockman, Tabetha

2010-01-01

Background: Among Alaska Native women residing in the Yukon-Kuskokwim (Y-K) Delta region of Western Alaska, about 79% smoke cigarettes or use smokeless tobacco during pregnancy. Treatment methods developed and evaluated among Alaska Native pregnant tobacco users do not exist. This pilot study used a randomized two-group design to assess the feasibility and acceptability of a targeted cessation intervention for Alaska Native pregnant women. Methods: Recruitment occurred over an 8-month period. Enrolled participants were randomly assigned to the control group (n = 18; brief face-to-face counseling at the first visit and written materials) or to the intervention group (n = 17) consisting of face-to-face counseling at the first visit, four telephone calls, a video highlighting personal stories, and a cessation guide. Interview-based assessments were conducted at baseline and follow-up during pregnancy (≥60 days postrandomization). Feasibility was determined by the recruitment and retention rates. Results: The participation rate was very low with only 12% of eligible women (35/293) enrolled. Among enrolled participants, the study retention rates were high in both the intervention (71%) and control (94%) groups. The biochemically confirmed abstinence rates at follow-up were 0% and 6% for the intervention and control groups, respectively. Discussion: The low enrollment rate suggests that the program was not feasible or acceptable. Alternative approaches are needed to improve the reach and efficacy of cessation interventions for Alaska Native women. PMID:20018946

Six-month exercise training program to treat post-thrombotic syndrome: a randomized controlled two-centre trial

PubMed Central

Kahn, Susan R.; Shrier, Ian; Shapiro, Stan; Houweling, Adrielle H.; Hirsch, Andrew M.; Reid, Robert D.; Kearon, Clive; Rabhi, Khalil; Rodger, Marc A.; Kovacs, Michael J.; Anderson, David R.; Wells, Philip S.

2011-01-01

Background Exercise training may have the potential to improve post-thrombotic syndrome, a frequent, chronic complication of deep venous thrombosis. We conducted a randomized controlled two-centre pilot trial to assess the feasibility of a multicentre-based evaluation of a six-month exercise training program to treat post-thrombotic syndrome and to obtain preliminary data on the effectiveness of such a program. Methods Patients were randomized to receive exercise training (a six-month trainer-supervised program) or control treatment (an education session with monthly phone follow-ups). Levels of eligibility, consent, adherence and retention were used as indicators of study feasibility. Primary outcomes were change from baseline to six months in venous disease-specific quality of life (as measured using the Venous Insufficiency Epidemiological and Economic Study Quality of Life [VEINES-QOL] questionnaire) and severity of post-thrombotic syndrome (as measured by scores on the Villalta scale) in the exercise training group versus the control group, assessed by t tests. Secondary outcomes were change in generic quality of life (as measured using the Short-Form Health Survey-36 [SF-36] questionnaire), category of severity of post-thrombotic syndrome, leg strength, leg flexibility and time on treadmill. Results Of 95 patients with post-thrombotic syndrome, 69 were eligible, 43 consented and were randomized, and 39 completed the study. Exercise training was associated with improvement in VEINES-QOL scores (exercise training mean change 6.0, standard deviation [SD] 5.1 v. control mean change 1.4, SD 7.2; difference 4.6, 95% CI 0.54 to 8.7; p = 0.027) and improvement in scores on the Villalta scale (exercise training mean change −3.6, SD 3.7 v. control mean change −1.6, SD 4.3; difference −2.0, 95% CI −4.6 to 0.6; p = 0.14). Most secondary outcomes also showed greater improvement in the exercise training group. Interpretation Exercise training may improve post-thrombotic syndrome. It would be feasible to definitively evaluate exercise training as a treatment for post-thrombotic syndrome in a large multicentre trial. PMID:21098066

The Family Navigator: A Pilot Intervention to Support Intensive Care Unit Family Surrogates.

PubMed

Torke, Alexia M; Wocial, Lucia D; Johns, Shelley A; Sachs, Greg A; Callahan, Christopher M; Bosslet, Gabriel T; Slaven, James E; Perkins, Susan M; Hickman, Susan E; Montz, Kianna; Burke, Emily S

2016-11-01

Communication problems between family surrogates and intensive care unit (ICU) clinicians have been documented, but few interventions are effective. Nurses have the potential to play an expanded role in ICU communication and decision making. To conduct a pilot randomized controlled trial of the family navigator (FN), a distinct nursing role to address family members' unmet communication needs early in an ICU stay. An interprofessional team developed the FN protocol. A randomized controlled pilot intervention trial of the FN was performed in a tertiary referral hospital's ICU to test the feasibility and acceptability of the intervention. The intervention addressed informational and emotional communication needs through daily contact by using structured clinical updates, emotional and informational support modules, family meeting support, and follow-up phone calls. Twenty-six surrogate/patient pairs (13 per study arm) were enrolled. Surrogates randomized to the intervention had contact with the FN on 90% or more of eligible patient days. All surrogates agreed that they would recom mend the FN to other families. Open-ended comments from both surrogates and clinicians were uniformly positive. Having a fully integrated nurse empowered to facilitate decision making is a feasible intervention in an ICU and is well-received by ICU families and staff. A larger randomized controlled trial is needed to demonstrate impact on important outcomes, such as surrogates' well-being and decision quality. ©2016 American Association of Critical-Care Nurses.

Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study.

PubMed

Vanoglio, Fabio; Bernocchi, Palmira; Mulè, Chiara; Garofali, Francesca; Mora, Chiara; Taveggia, Giovanni; Scalvini, Simonetta; Luisa, Alberto

2017-03-01

The purpose of the study was to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in sub-acute hemiplegic patients. Randomized controlled pilot study. Inpatient rehabilitation centers. Thirty hemiplegic stroke patients (Ashworth spasticity index <3) were recruited and randomly divided into a Treatment group (TG) and Control group (CG). Patients in the TG received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the CG received the same amount of time in terms of conventional hand rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences, (Δ) mean(standard deviation), compared between groups. Results Twenty-seven patients concluded the program: 14 in the TG and 13 in the CG. None of the patients refused the device and only one adverse event of rheumatoid arthritis reactivation was reported. Baseline data did not differ significantly between the two groups. In TG, ΔMI 23(16.4), ΔNHPT 0.16(0.16), ΔGRIP 0.27(0.23) and ΔPINCH 0.07(0.07) were significantly greater than in CG, ΔMI 5.2(9.2), ΔNHPT 0.02(0.07), ΔGRIP 0.03(0.06) and ΔPINCH 0.02(0.03)] ( p=0.002, p=0.009, p=0.003 and p=0.038, respectively). Gloreha Professional is feasible and effective in recovering fine manual dexterity and strength and reducing arm disability in sub-acute hemiplegic patients.

Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke.

PubMed

Baylan, Satu; McGinlay, Meigan; MacDonald, Maxine; Easto, Jake; Cullen, Breda; Haig, Caroline; Mercer, Stewart W; Murray, Heather; Quinn, Terence J; Stott, David; Broomfield, Niall M; Stiles, Ciara; Evans, Jonathan J

2018-05-04

Existing research evidence suggests that both music listening and mindfulness interventions may have beneficial effects on mood and cognition poststroke. This mixed-methods study, nested within a pilot randomized controlled trial investigating the feasibility and acceptability of combining music listening and brief mindfulness training poststroke, explored study participants' experiences of engaging in the interventions. Fifty-six stroke survivors who were randomized to receive an 8-week intervention of mindful music listening (n = 15), music listening (n = 21), or audiobook listening (n = 20, control) using self-selected material participated in a postintervention individual semistructured interview with a researcher not involved in their intervention delivery. Interview questions focused on affective, cognitive, and physical experiences. Data were coded and analyzed using thematic analysis. Across groups, listening was associated with positive distraction from thoughts and worries. Mindful music listening was most strongly associated with relaxation and concentration, improved attentional control, and emotion regulation, as well as enjoyment. Music listening was most strongly associated with increased activity, memory reminiscence, and improved mood. In addition, participants provided valuable feedback on intervention feasibility and acceptability. The findings suggest that the interventions were feasible and enjoyable for people recovering from stroke. © 2018 New York Academy of Sciences.

Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study.

PubMed

Kierkegaard, Marie; Harms-Ringdahl, Karin; Edström, Lars; Widén Holmqvist, Lotta; Tollbäck, Anna

2011-07-01

To investigate the feasibility and effects of a physical exercise programme on functioning and health-related quality of life in adults with myotonic dystrophy type 1. A randomized controlled trial. Thirty-five adults with myotonic dystrophy type 1. After stratification for level of functioning, study participants were assigned by lot to either a training group or a control group. Training-group participants attended a 60-minute comprehensive group-training programme, Friskis&Svettis® Open Doors, twice a week for 14 weeks. The six-minute walk test was the primary outcome measure and the timed-stands test, the timed up-and-go test, the Epworth sleepiness scale and the Short Form-36 health survey were secondary outcome measures. Intention-to-treat analyses revealed no significant differences in any outcome measures, except for an increased between-group difference after intervention in the Short Form-36 mental health subscale and a decrease in the vitality subscale for the control group. The programme was well tolerated and many training-group participants perceived subjective changes for the better. No negative effects were reported. The Friskis&Svettis® Open Doors programme was feasible for adults with myotonic dystrophy type 1 who had been screened for cardiac involvement, had distal or mild-to-moderate proximal muscle impairment, and no severe cognitive impairments. No beneficial or detrimental effects were evident.

Alternatives to the Randomized Controlled Trial

PubMed Central

West, Stephen G.; Duan, Naihua; Pequegnat, Willo; Gaist, Paul; Des Jarlais, Don C.; Holtgrave, David; Szapocznik, José; Fishbein, Martin; Rapkin, Bruce; Clatts, Michael; Mullen, Patricia Dolan

2008-01-01

Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented. PMID:18556609

Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial.

PubMed

Kingston, Dawn; Austin, Marie-Paule; Veldhuyzen van Zanten, Sander; Harvalik, Paula; Giallo, Rebecca; McDonald, Sarah D; MacQueen, Glenda; Vermeyden, Lydia; Lasiuk, Gerri; Sword, Wendy; Biringer, Anne

2017-04-07

Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges. The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns. Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs. Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure. The findings suggest that mental health e-screening is feasible and acceptable to pregnant women. Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb). ©Dawn Kingston, Marie-Paule Austin, Sander Veldhuyzen van Zanten, Paula Harvalik, Rebecca Giallo, Sarah D McDonald, Glenda MacQueen, Lydia Vermeyden, Gerri Lasiuk, Wendy Sword, Anne Biringer. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 07.04.2017.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

The "Interval Walking in Colorectal Cancer" (I-WALK-CRC) study: Design, methods and recruitment results of a randomized controlled feasibility trial.

PubMed

Banck-Petersen, Anna; Olsen, Cecilie K; Djurhuus, Sissal S; Herrstedt, Anita; Thorsen-Streit, Sarah; Ried-Larsen, Mathias; Østerlind, Kell; Osterkamp, Jens; Krarup, Peter-Martin; Vistisen, Kirsten; Mosgaard, Camilla S; Pedersen, Bente K; Højman, Pernille; Christensen, Jesper F

2018-03-01

Low physical activity level is associated with poor prognosis in patients with colorectal cancer (CRC). To increase physical activity, technology-based platforms are emerging and provide intriguing opportunities to prescribe and monitor active lifestyle interventions. The "Interval Walking in Colorectal Cancer"(I-WALK-CRC) study explores the feasibility and efficacy a home-based interval-walking intervention delivered by a smart-phone application in order to improve cardio-metabolic health profile among CRC survivors. The aim of the present report is to describe the design, methods and recruitment results of the I-WALK-CRC study.Methods/Results: The I-WALK-CRC study is a randomized controlled trial designed to evaluate the feasibility and efficacy of a home-based interval walking intervention compared to a waiting-list control group for physiological and patient-reported outcomes. Patients who had completed surgery for local stage disease and patients who had completed surgery and any adjuvant chemotherapy for locally advanced stage disease were eligible for inclusion. Between October 1st , 2015, and February 1st , 2017, 136 inquiries were recorded; 83 patients were eligible for enrollment, and 42 patients accepted participation. Age and employment status were associated with participation, as participants were significantly younger (60.5 vs 70.8 years, P < 0.001) and more likely to be working (OR 5.04; 95%CI 1.96-12.98, P < 0.001) than non-participants. In the present study, recruitment of CRC survivors was feasible but we aim to better the recruitment rate in future studies. Further, the study clearly favored younger participants. The I-WALK-CRC study will provide important information regarding feasibility and efficacy of a home-based walking exercise program in CRC survivors.

Acceptability and Feasibility of a Sexual Health Intervention for Young Adult Black Women.

PubMed

Montgomery, Tiffany M; Mays, Vickie M; Heilemann, MarySue V; Nyamathi, Adey; Bauermeister, Jose A; Koniak-Griffin, Deborah

2018-05-16

To assess the acceptability and feasibility of S2S, a newly adapted behavior intervention to address high-risk sexual behavior. Pilot randomized controlled trial. The Internet and text messages with no in-person interactions. Eighty-eight Black women, ages 18 to 24 years, were randomly assigned to the intervention or control groups and self-enrolled in the respective text message program. Participants in the intervention group were sent text messages about sexual health, whereas those in the control group were sent text messages about diet and/or exercise. Participants in each group received 24 text messages, including text-only messages, memes, and infopics. Participants in the intervention group also received videos links. All text messages were sent three times per week for 8 weeks. Quantitative methods were used to analyze data from the message and video platform reports. Quantitative and qualitative methods were used to analyze participants' responses to an acceptability and feasibility survey. Overall, the delivery of health promotion text messages was viewed as acceptable and feasible by participants in both groups. Most of the short answer responses from participants were favorable, and responses to the acceptability and feasibility survey yielded a total mean score of 4.01 on a 5-point scale. Results from this study support the idea that evidence-based interventions can be adapted for delivery by text message. This delivery modality is acceptable to young adult Black women and may help decrease barriers that would otherwise prevent them from receiving health promotion messages. Copyright © 2018 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

PubMed

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Parenting program versus telephone support for Mexican parents of children with acquired brain injury: A blind randomized controlled trial.

PubMed

Chávez, Clara; Catroppa, Cathy; Hearps, Stephen J C; Yáñez-Téllez, Guillermina; Prieto-Corona, Belén; de León, Miguel A; García, Antonio; Sandoval-Lira, Lucero; Anderson, Vicki

2017-09-01

Acquired brain injury (ABI) during childhood typically causes behavior problems in the child and high levels of stress in the family. The aims of this study are: (1) to investigate the effectiveness and feasibility of a parenting intervention in improving behavior and self-regulation in Mexican children with ABI compared to telephone support; (2) to investigate the effectiveness and feasibility of a parenting intervention in improving parenting skills, parent self-efficacy and decreasing parental stress in parents of children with ABI compared to telephone support. Our secondary aims are (1) to explore the impact that parent characteristics have on the intervention outcomes; (2) to investigate if changes are maintained 3 months after the intervention. The research design is a blind randomized controlled trial (RCT). Eligible participants include children with a diagnosis of ABI, between 6 and 12 years of age, and their parents. Sixty-six children and their parents will be randomly allocated to either a parenting program group or telephone support group. The parenting program involves six face-to-face weekly group sessions of 2.5 h each. Participants in the control group receive an information sheet with behavioral strategies, and six weekly phone calls, in which strategies to improve academic skills are provided. Children and their parents are evaluated by blind assessors before the intervention, immediately after the intervention and 3-months post-intervention. This study will be the first to evaluate the efficacy and feasibility of a parenting program for Mexican parents of children with ABI. ACTRN12617000360314.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

PubMed

Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

2016-01-01

Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95 % confidence intervals for parameters of a priori interest (recruitment, retention, adherence, pain intensity, Neck Disability Index). Results of this study will inform the design of a larger cluster-randomized controlled trial aimed at evaluating the effectiveness of the theory-based tailored intervention and increasing the use of multimodal care by chiropractors managing patients with NSNP. https://clinicaltrials.gov/, NCT02483091.

A research protocol for a pilot randomized controlled trial designed to examine the feasibility of a couple-based mind-body intervention for patients with metastatic lung cancer and their partners.

PubMed

Milbury, Kathrin; Tsao, Anne S; Liao, Zhongxing; Owns, April; Engle, Rosalinda; Gonzalez, Edrea A; Bruera, Eduardo; Cohen, Lorenzo

2018-01-01

Given the generally incurable nature of metastatic non-small cell lung cancer (mNSCLC), patients and their romantic partners are at risk for existential/spiritual distress. Although a handful of dyadic psychosocial interventions for lung cancer patients and their caregivers exist, none of them target spiritual well-being. Informed by the mindfulness-based intervention literature and our pilot work in couples affected by lung cancer, we developed a brief couple-based mind-body (CBMB) intervention. The primary aim of this research protocol is to determine the feasibility of implementing the CBMB intervention versus an active control (AC) or wait list control (WLC) group in patients with mNSCLC and their partners using a randomized controlled trial design. Seventy-five patients with mNSCLC receiving treatment and their partners are randomized to the CBMB intervention, an AC or a WLC group. Those in the CBMB intervention and AC groups receive four intervention sessions of 60 min each over 4 weeks and complete weekly homework assignments. The first session is delivered in person, and the remaining sessions are delivered via videoconference. The dyads in the AC group discuss cancer-related and personal growth concerns with the interventionist but are not taught coping skills. Patients and partners in all groups complete baseline assessments of quality of life (QOL) prior to randomization. Follow-up assessments are performed 4 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 30% of eligible couples consent, ≥ 70% of enrolled couples are retained, and ≥ 50% of all CBMB and AC sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., spiritual well-being and psychological distress) and explore potential intervention mediators (i.e., compassion, communication, mindfulness, and closeness) to inform a larger, future trial. This trial will provide important information regarding the feasibility of a behavioral intervention in a vulnerable yet understudied population using videoconferencing and descriptive data regarding spiritual well-being and other indices of QOL in both mNSCLC patients and their partners. ClinicalTrials.gov NCT02596490.

Semi-Individualized Homeopathy Add-On Versus Usual Care Only for Premenstrual Disorders: A Randomized, Controlled Feasibility Study.

PubMed

Klein-Laansma, Christien T; Jong, Mats; von Hagens, Cornelia; Jansen, Jean Pierre C H; van Wietmarschen, Herman; Jong, Miek C

2018-03-22

Premenstrual syndrome and premenstrual dysphoric disorder (PMS/PMDD) bother a substantial number of women. Homeopathy seems a promising treatment, but it needs investigation using reliable study designs. The feasibility of organizing an international randomized pragmatic trial on a homeopathic add-on treatment (usual care [UC] + HT) compared with UC alone was evaluated. A multicenter, randomized, controlled pragmatic trial with parallel groups. The study was organized in general and private homeopathic practices in the Netherlands and Sweden and in an outpatient university clinic in Germany. Women diagnosed as having PMS/PMDD, based on prospective daily rating by the daily record of severity of problems (DRSP) during a period of 2 months, were included and randomized. Women were to receive UC + HT or UC for 4 months. Homeopathic medicine selection was according to a previously tested prognostic questionnaire and electronic algorithm. Usual care was as provided by the women's general practitioner according to their preferences. Before and after treatment, the women completed diaries (DRSP), the measure yourself concerns and well-being, and other questionnaires. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. In Germany, the study could not proceed because of legal limitations. In Sweden, recruitment proved extremely difficult. In the Netherlands and Sweden, 60 women were randomized (UC + HT: 28; UC: 32), data of 47/46 women were analyzed (ITT/PP). After 4 months, relative mean change of DRSP scores in the UC + HT group was significantly better than in the UC group (p = 0.03). With respect to recruitment and different legal status, it does not seem feasible to perform a larger, international, pragmatic randomized trial on (semi-)individualized homeopathy for PMS/PMDD. Since the added value of HT compared with UC was demonstrated by significant differences in symptom score changes, further studies are warranted.

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

Time-delayed feedback control of diffusion in random walkers.

PubMed

Ando, Hiroyasu; Takehara, Kohta; Kobayashi, Miki U

2017-07-01

Time delay in general leads to instability in some systems, while specific feedback with delay can control fluctuated motion in nonlinear deterministic systems to a stable state. In this paper, we consider a stochastic process, i.e., a random walk, and observe its diffusion phenomenon with time-delayed feedback. As a result, the diffusion coefficient decreases with increasing delay time. We analytically illustrate this suppression of diffusion by using stochastic delay differential equations and justify the feasibility of this suppression by applying time-delayed feedback to a molecular dynamics model.

A pilot randomized controlled trial comparing prenatal yoga to perinatal health education for antenatal depression.

PubMed

Uebelacker, Lisa A; Battle, Cynthia L; Sutton, Kaeli A; Magee, Susanna R; Miller, Ivan W

2016-06-01

We conducted a pilot randomized controlled trial (RCT) comparing a prenatal yoga intervention to perinatal-focused health education in pregnant women with depression. Findings document acceptability and feasibility of the yoga intervention: no yoga-related injuries were observed, instructors showed fidelity to the yoga manual, and women rated interventions as acceptable. Although improvements in depression were not statistically different between groups, they favored yoga. This study provides support for a larger scale RCT examining prenatal yoga to improve mood during pregnancy.

Massage Therapy for Patients with Metastatic Cancer: A Pilot Randomized Controlled Trial

PubMed Central

Toth, Maria; Marcantonio, Edward R.; Davis, Roger B.; Walton, Tracy; Kahn, Janet R.

2013-01-01

Abstract Objectives The study objectives were to determine the feasibility and effects of providing therapeutic massage at home for patients with metastatic cancer. Design This was a randomized controlled trial. Settings/location Patients were enrolled at Oncology Clinics at a large urban academic medical center; massage therapy was provided in patients' homes. Subjects Subjects were patients with metastatic cancer. Interventions There were three interventions: massage therapy, no-touch intervention, and usual care. Outcome measures Primary outcomes were pain, anxiety, and alertness; secondary outcomes were quality of life and sleep. Results In this study, it was possible to provide interventions for all patients at home by professional massage therapists. The mean number of massage therapy sessions per patient was 2.8. A significant improvement was found in the quality of life of the patients who received massage therapy after 1-week follow-up, which was not observed in either the No Touch control or the Usual Care control groups, but the difference was not sustained at 1 month. There were trends toward improvement in pain and sleep of the patients after therapeutic massage but not in patients in the control groups. There were no serious adverse events related to the interventions. Conclusions The study results showed that it is feasible to provide therapeutic massage at home for patients with advanced cancer, and to randomize patients to a no-touch intervention. Providing therapeutic massage improves the quality of life at the end of life for patients and may be associated with further beneficial effects, such as improvement in pain and sleep quality. Larger randomized controlled trials are needed to substantiate these findings. PMID:23368724

Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.

PubMed

Lee, Cindy; Vather, Ryash; O'Callaghan, Anne; Robinson, Jackie; McLeod, Briar; Findlay, Michael; Bissett, Ian

2013-12-01

Malignant bowel obstruction (MBO) is common in patients with advanced cancer. To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.

Job retention vocational rehabilitation for employed people with inflammatory arthritis (WORK-IA): a feasibility randomized controlled trial.

PubMed

Hammond, Alison; O'Brien, Rachel; Woodbridge, Sarah; Bradshaw, Lucy; Prior, Yeliz; Radford, Kate; Culley, June; Whitham, Diane; Ruth Pulikottil-Jacob

2017-07-21

Inflammatory arthritis leads to work disability, absenteeism and presenteeism (i.e. at-work productivity loss) at high cost to individuals, employers and society. A trial of job retention vocational rehabilitation (VR) in the United States identified this helped people keep working. The effectiveness of this VR in countries with different socioeconomic policies and conditions, and its impact on absenteeism, presenteeism and health, are unknown. This feasibility study tested the acceptability of this VR, modified for the United Kingdom, compared to written advice about managing work problems. To help plan a randomized controlled trial, we tested screening, recruitment, intervention delivery, response rates, applicability of the control intervention and identified the relevant primary outcome. A feasibility randomized controlled trial with rheumatoid, psoriatic or inflammatory arthritis patients randomized to receive either job retention VR or written information only (the WORK-IA trial). Following three days VR training, rheumatology occupational therapists provided individualised VR on a one to one basis. VR included work assessment, activity diaries and action planning, and (as applicable) arthritis self-management in the workplace, ergonomics, fatigue and stress management, orthoses, employment rights and support services, assistive technology, work modifications, psychological and disclosure support, workplace visits and employer liaison. Fifty five (10%) people were recruited from 539 screened. Follow-up response rates were acceptable at 80%. VR was delivered with fidelity. VR was more acceptable than written advice only (7.8 versus 6.7). VR took on average 4 h at a cost of £135 per person. Outcome assessment indicated VR was better than written advice in reducing presenteeism (Work Limitations Questionnaire (WLQ) change score mean: VR = -12.4 (SD 13.2); control = -2.5 (SD 15.9), absenteeism, perceived risk of job loss and improving pain and health status, indicating proof of concept. The preferred primary outcome measure was the WLQ, a presenteeism measure. This brief job retention VR is a credible and acceptable intervention for people with inflammatory arthritis with concerns about continuing to work due to arthritis. ISRCTN 76777720 . Registered 21.9.12.

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial.

PubMed

Lambert, Justin; Ghadry-Tavi, Rouzbeh; Knuff, Kate; Jutras, Marc; Siever, Jodi; Mick, Paul; Roque, Carolyn; Jones, Gareth; Little, Jonathan; Miller, Harry; Van Bergen, Colin; Kurtz, Donna; Murphy, Mary Ann; Jones, Charlotte Ann

2017-01-28

Hearing loss (HL) is a disability associated with poorer health-related quality of life including an increased risk for loneliness, isolation, functional fitness declines, falls, hospitalization and premature mortality. The purpose of this pilot trial is to determine the feasibility and acceptability of a novel intervention to reduce loneliness, improve functional fitness, social connectedness, hearing and health-related quality of life in older adults with HL. This 10-week, single-blind, pilot randomized control trial (RCT) will include a convenience sample of ambulatory adults aged 65 years or older with self-reported HL. Following baseline assessments, participants will be randomized to either intervention (exercise, health education, socialization and group auditory rehabilitation (GAR)) or control (GAR only) groups. The intervention group will attend a local YMCA twice a week and the control group once a week. Intervention sessions will include 45 min of strengthening, balance and resistance exercises, 30 min of group walking at a self-selected pace and 60 min of interactive health education or GAR. The control group will attend 60-min GAR sessions. GAR sessions will include education about hearing, hearing technologies, enhancing communication skills, and psychosocial support. Pre-post trial data collection and measures will include: functional fitness (gait speed, 30-s Sit to Stand Test), hearing and health-related quality of life, loneliness, depression, social participation and social support. At trial end, feasibility (recruitment, randomization, retention, acceptability) and GAR will be evaluated. Despite evidence suggesting that HL is associated with declines in functional fitness, there are no studies aimed at addressing functional fitness declines associated with the disability of HL. This pilot trial will provide knowledge about the physical, mental and social impacts on health related to HL as a disability. This will inform the feasibility of a larger RCT and preliminary evidence about the initial effects of a novel, community-based, holistic intervention addressing both the negative psychosocial and functional physical effects of HL among older adults. ClinicalTrials.gov, NCT02662192 . Registered on 14 January 2016.

Preventing family transmission of anxiety: Feasibility RCT of a brief intervention for parents.

PubMed

Cartwright-Hatton, Sam; Ewing, Donna; Dash, Suzanne; Hughes, Zoe; Thompson, Ellen J; Hazell, Cassie M; Field, Andy P; Startup, Helen

2018-03-25

Children of anxious parents are at high risk of anxiety disorders themselves. The evidence suggests that this is due to environmental rather than genetic factors. However, we currently do little to reduce this risk of transmission. There is evidence that supporting parenting in those with mental health difficulties can ameliorate this risk. Therefore, the objective of this study was to test the feasibility of a new one-session, group-based, preventive parenting intervention for parents with anxiety disorders. Feasibility Randomized Controlled Trial. A total of 100 parents with anxiety disorders, recruited from adult mental health services in England (and child aged 3-9 years), were randomized to receive the new intervention (a 1-day, group workshop), or to treatment as usual. Children's anxiety disorder and anxiety symptoms were assessed to 12 months by outcome assessors who were blind to group allocation. Exploratory analyses were conducted on an intention to treat basis, as far as possible. A total of 51 participants were randomized to the intervention condition and 49 to the control condition (82% and 80% followed to 12 months, respectively). The attendance rate was 59%, and the intervention was highly acceptable to parents who received it. The RCT was feasible, and 12-month follow-up attrition rates were low. Children whose parents were in the control condition were 16.5% more likely to have an anxiety disorder at follow-up than those in the intervention group. No adverse events were reported. An inexpensive, light-touch, psycho-educational intervention may be useful in breaking the intergenerational cycle of transmission of anxiety disorders. A substantive trial is warranted. Anxiety disorders run in families, but we currently do little to help anxious parents to raise confident children. A brief group workshop was highly acceptable to such parents and was very inexpensive to run. Children of parents who took part in the brief intervention were 16.5% less likely to have an anxiety disorder, 1 year later, than children whose parents were in the control group. This was a feasibility study, and while it showed that both the intervention and the research were feasible, the study needs replicating with a much larger sample. Many parents faced barriers to attending the workshop, and future efforts should focus on widening accessibility. We were unable to obtain sufficient self-report data from children, so the outcomes are based on parent report only. © 2018 The British Psychological Society.

Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy.

PubMed

Hegel, Mark T; Lyons, Kathleen D; Hull, Jay G; Kaufman, Peter; Urquhart, Laura; Li, Zhongze; Ahles, Tim A

2011-10-01

Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. A pilot RCT of a telephone-delivered Problem-solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n = 15) and usual care (n = 16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 and 12 weeks. Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life, and emotional state favored the PST-OT condition. This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state. 2010 John Wiley & Sons, Ltd.

Problem Solving Skills Training for Parents of Children with Chronic Pain: A Pilot Randomized Controlled Trial

PubMed Central

Palermo, Tonya M.; Law, Emily F.; Bromberg, Maggie; Fales, Jessica; Eccleston, Christopher; Wilson, Anna C.

2016-01-01

This pilot randomized controlled trial aimed to determine the feasibility, acceptability, and preliminary efficacy of parental problem solving skills training (PSST) compared to treatment as usual (TAU) on improving parental mental health symptoms, physical health and well-being, and parenting behaviors. Effects of parent PSST on child outcomes (pain, emotional and physical functioning) were also examined. Participants included 61 parents of children aged 10–17 years with chronic pain randomized to PSST (n = 31) or TAU (n = 30). Parents receiving PSST participated in 4–6 individual sessions of training in problem solving skills. Outcomes were assessed at pre-treatment, immediately post-treatment, and at 3-month follow up. Feasibility was determined by therapy session attendance, therapist ratings, and parent treatment acceptability ratings. Feasibility of PSST delivery in this population was demonstrated by high compliance with therapy attendance, excellent retention, high therapist ratings of treatment engagement, and high parent ratings of treatment acceptability. PSST was associated with post-treatment improvements in parental depression (d = −0.68), general mental health (d = 0.64), and pain catastrophizing (d = −0.48), as well as in child depression (d = −0.49), child general anxiety (d = −0.56), and child pain-specific anxiety (d = −0.82). Several effects were maintained at 3-month follow-up. Findings demonstrate that PSST is feasible and acceptable to parents of youth with chronic pain. Treatment outcome analyses show promising but mixed patterns of effects of PSST on parent and child mental health outcomes. Further rigorous trials of PSST are needed to extend these pilot results. PMID:26845525

Reducing the risk of HIV transmission among men who have sex with men: A feasibility study of the motivational interviewing counseling method.

PubMed

Chen, Jia; Li, Xianhong; Xiong, Yang; Fennie, Kristopher P; Wang, Honghong; Williams, Ann Bartley

2016-09-01

HIV prevalence among Chinese men who have sex with men has rapidly increased in recent years. In this randomized, controlled study, we tested the feasibility and efficacy of motivational interviewing to reduce high-risk sexual behaviors among this population in Changsha, China. Eighty men who have sex with men were randomly assigned to either the intervention group, in which participants received a three-session motivational interviewing intervention over 4 weeks, or the control group, in which participants received usual counseling from peer educators. High-risk behavior indicators and HIV knowledge level were evaluated at baseline and 3 months after the intervention. Motivational interviewing significantly improved consistent anal condom use. However, there was no significant change in consistent condom use for oral sex or in the number of sexual partners over time. HIV knowledge scores improved equally in both groups. This study demonstrated that an intervention using motivational interviewing is feasible and results in increased condom use during anal sex for Chinese men who have sex with men. However, further work must be done to increase the use of condoms during oral sexual encounters. © 2016 John Wiley & Sons Australia, Ltd.

PROMOTING SUPPORTIVE PARENTING IN NEW MOTHERS WITH SUBSTANCE-USE PROBLEMS: A PILOT RANDOMIZED TRIAL OF RESIDENTIAL TREATMENT PLUS AN ATTACHMENT-BASED PARENTING PROGRAM

PubMed Central

BERLIN, LISA J.; SHANAHAN, MEGHAN; CARMODY, KAREN APPLEYARD

2015-01-01

This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier’s Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. PMID:25424409

Training Parents of Youth with Autism Spectrum Disorder to Advocate for Adult Disability Services: Results from a Pilot Randomized Controlled Trial

PubMed Central

Taylor, Julie Lounds; Hodapp, Robert M.; Burke, Meghan M.; Waitz-Kudla, Sydney N.; Rabideau, Carol

2017-01-01

This study presents findings from a pilot randomized controlled trial, testing a 12-week intervention to train parents of youth with autism spectrum disorder (ASD) to advocate for adult disability services—the Volunteer Advocacy Project-Transition (VAP-T). Participants included 41 parents of youth with ASD within two years of high school exit, randomly assigned to a treatment (N = 20) or wait-list control (N = 21) group. Outcomes, collected before and after the intervention, included parental knowledge about adult services, advocacy skills-comfort, and empowerment. The VAP-T had acceptable feasibility, treatment fidelity, and acceptability. After participating in the VAP-T, intervention parents (compared to controls) knew more about the adult service system, were more skilled/comfortable advocating, and felt more empowered. PMID:28070786

Using Mobile Health to Improve Social Support for Low-Income Latino Patients with Diabetes: A Mixed-Methods Analysis of the Feasibility Trial of TExT-MED + FANS.

PubMed

Burner, Elizabeth; Lam, Chun Nok; DeRoss, Rebecca; Kagawa-Singer, Marjorie; Menchine, Michael; Arora, Sanjay

2018-01-01

Social support interventions can improve diabetes self-care, particularly for Latinos, but are time and resource intensive. Mobile health may overcome these barriers by engaging and training supporters remotely. We conducted a randomized controlled feasibility trial of emergency department patients with diabetes to determine the feasibility of enrolling patients and supporters, acceptability of the intervention, and preliminary efficacy results to power a larger trial. All patients received an existing mHealth curriculum (TExT-MED). After identifying a supporter, patients were randomized to intervention: supporters receiving FANS (family and friends network support), a text message support curriculum synchronized to patient messages, or control: supporters receiving a mailed pamphlet of the same information. Participants followed up at 3 months. FANS intervention participants came to postintervention interviews as part of a qualitative analysis. We enrolled 44 patients (22 per arm) and followed up 36 at 3 months. Participants were positive about the program. FANS intervention improved HbA1c (intervention mean decreased from 10.4% to 9.0% vs. from 10.1% to 9.5%, delta -0.8%, confidence interval [CI] -0.4 to 2, P = 0.30), self-monitoring of glucose (intervention increased 1.6 days/week vs. control decreased 2 days/week, delta 2.3 days/week, CI 4-0.6, P = 0.02), and physical activity (mean Godin leisure time activity score improved 16.1 vs. decreased 9.6 for control, delta 25.7, CI 49.2-2.3, P = 0.10). In qualitative analysis, patients reported improved motivation, behaviors, and relationships. Supporters reported making healthier decisions for themselves. mHealth is a feasible, acceptable, and promising avenue to improve social support and diabetes outcomes.

Feasibility, acceptability, and effects of gentle Hatha yoga for women with major depression: Findings from a randomized controlled mixed-methods study

PubMed Central

Kinser, Patricia Anne; Bourguignon, Cheryl; Whaley, Diane; Hauenstein, Emily; Taylor, Ann Gill

2013-01-01

Major depressive disorder (MDD) is a common, debilitating chronic condition in the United States and worldwide. Particularly in women, depressive symptoms are often accompanied by high levels of stress and ruminations, or repetitive self-critical negative thinking. There is a research and clinical imperative to evaluate complementary therapies that are acceptable and feasible for women with depression and that target specific aspects of depression in women, such as ruminations. To begin to address this need, we conducted a randomized, controlled, mixed-methods community-based study comparing an 8-week yoga intervention with an attention-control activity in 27 women with MDD. After controlling for baseline stress, there was a decrease in depression over time in both the yoga group and the attention-control group, with the yoga group having a unique trend in decreased ruminations. Participants in the yoga group reported experiencing increased connectedness and gaining a coping strategy through yoga. The findings provide support for future large scale research to explore the effects of yoga for depressed women and the unique role of yoga in decreasing rumination. PMID:23706890

Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial.

PubMed

Briken, S; Gold, S M; Patra, S; Vettorazzi, E; Harbs, D; Tallner, A; Ketels, G; Schulz, K H; Heesen, C

2014-03-01

Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis (MS). Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans. It may, therefore, be particularly useful for MS patients with pronounced neurodegeneration. To investigate the potential of standardized exercise as a therapeutic intervention for progressive MS, in a randomized-controlled pilot trial. Patients with progressive MS and moderate disability (Expanded Disability Status Scale (EDSS) of 4-6) were randomized to one of three exercise interventions (arm ergometry, rowing, bicycle ergometry) for 8-10 weeks or a waitlist control group. We analyzed the drop-out rate as a measure of feasibility. The primary endpoint of the study was aerobic fitness. Secondary endpoints were walking ability, cognitive function as measured by a neuropsychological test battery, depression and fatigue. A total of 42 patients completed the trial (10.6% drop-out rate). Significant improvements were seen in aerobic fitness. In addition, exercise improved walking ability, depressive symptoms, fatigue and several domains of cognitive function. This study indicated that aerobic training is feasible and could be beneficial for patients with progressive MS. Larger exercise studies are needed to confirm the effect on cognition. ISRCTN (trial number 76467492) http://isrctn.org.

Child Directed Interaction Training for Young Children in Kinship Care: A Pilot Study

PubMed Central

N’zi, Amanda M.; Stevens, Monica L.; Eyberg, Sheila M.

2016-01-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. PMID:27012997

When Wait Lists Are Not Feasible, Nothing Is a Thing That Does Not Need to Be Done

ERIC Educational Resources Information Center

Devilly, Grant J.; McFarlane, Alexander C.

2009-01-01

Clinical psychology practices initially grew through the use of case studies, uncontrolled trials, and eventually through randomized controlled trials (RCTs). The use of a wait-list control group is standard practice in such trials of treatment regimens for psychopathological conditions. However, as knowledge advances regarding the successful…

Family Ties to Health Program: A Randomized Intervention to Improve Vegetable Intake in Children

ERIC Educational Resources Information Center

Tabak, Rachel G.; Tate, Deborah F.; Stevens, June; Siega-Riz, Anna Maria; Ward, Dianne S.

2012-01-01

Objective: Evaluate a home-based intervention targeted toward parents to improve vegetable intake in preschool-aged children. Methods: Four-month feasibility study of home-based intervention consisting of 4 tailored newsletters and 2 motivational phone calls compared to control; 4 children's books for the control group; and measured pre and post…

A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results

PubMed Central

Brown, Justin C.; Troxel, Andrea B.; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S.; Rickels, Michael R.; Rhim, Andrew D.; Rustgi, Anil K.; Courneya, Kerry S.; Schmitz, Kathryn H.

2016-01-01

Background Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the COURAGE trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. Methods/Results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·wk−1) and high-dose (300 min·wk−1) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1,433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (P<0.001) and randomization onto the study protocol (P<0.001). No other demographic, clinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. Discussion The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. PMID:26970181

Feasibility and preliminary efficacy of a web-based smoking cessation intervention for HIV-infected smokers: a randomized controlled trial.

PubMed

Shuter, Jonathan; Morales, Daniela A; Considine-Dunn, Shannon E; An, Lawrence C; Stanton, Cassandra A

2014-09-01

To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV (PLWH). Prospective, randomized controlled trial. HIV-care center in the Bronx, New York. Eligibility criteria included HIV infection, current tobacco usage, interest in quitting, and access to a computer with internet. One hundred thirty-eight subjects enrolled, and 134 completed the study. Positively Smoke Free on the Web (PSFW), an 8-session, 7-week targeted tobacco treatment program for PLWH, was compared with standard care (brief advice to quit and self-help brochure). All subjects were offered nicotine patches. The main feasibility outcomes were number of sessions logged into, number of Web pages visited, number of interactive clicks, and total time logged in. The main efficacy outcome was biochemically verified, 7-day point prevalence abstinence 3 months after intervention. PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages. They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in. Most required reminder phone calls to complete the sessions. Educational level, anxiety score, and home access of the Web site were associated with Web site usage. Ten percent of the PSFW group vs. 4.3% of controls achieved the abstinence end point. Among those who completed all 8 sessions, 17.9% were abstinent, and among women completers, 30.8% were abstinent. Web-based treatment is a feasible strategy for PLWH smokers, and preliminary findings suggest therapeutic efficacy.

Mindfulness meditation for the treatment of chronic low back pain in older adults: A randomized controlled pilot study

PubMed Central

Morone, Natalia E.; Greco, Carol M.; Weiner, Debra K.

2008-01-01

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, attention, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P = .008, P = .004) and SF-36 Physical Function (P = .03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function. PMID:17544212

Feasibility of kangaroo mother care in Mumbai.

PubMed

Kadam, Sandeep; Binoy, S; Kanbur, Wasundhara; Mondkar, J A; Fernandez, Armida

2005-01-01

The purpose of this study was to determine the feasibility and acceptability of kangaroo care in a tertiary care hospital in India. A randomized controlled trial was performed over one year period in which 89 neonates were randomized into two groups kangaroo mother care (KMC) and conventional method of care (CMC). Forty-four babies were randomized into KMC group and 45 to CMC. There was significant reduction in KMC vs CMC group of hypothermia (10/44 vs 21/45, p-value < 0.01), higher oxygen saturations (95.7 vs 94.8%, p-value < 0.01) and decrease in respiratory rates (36.2 vs 40.7, p-value < 0.01). There were no statistically significant differences in the incidence of hyperthermia, sepsis, apnea, onset of breastfeeding and hospital stay in two groups. 79% of mothers felt comfortable during the KMC and 73% felt they would be able to give KMC at home. KMC is feasible, as mothers are already admitted in hospitals and are involved in the care of newborn. KMC is a simple and feasible intervention; acceptable to most mothers admitted in hospitals. There may be benefits in terms of reducing the incidence of hypothermia with no adverse effects of KMC demonstrated in the study. The present study has important implications in the care of LBW infants in the developing countries, where expensive facilities for conventional care may not be available at all place.

Feasibility and Efficacy of a Parent-Focused, Text Message–Delivered Intervention to Reduce Sedentary Behavior in 2- to 4-Year-Old Children (Mini Movers): Pilot Randomized Controlled Trial

PubMed Central

Salmon, Jo; Hinkley, Trina; Hnatiuk, Jill A; Hesketh, Kylie D

2018-01-01

Background Despite public health guidelines to limit sedentary behavior, many young children spend large amounts of time sedentary (eg, screen and sitting time) during waking hours. Objective The objective of this study was to test the feasibility and efficacy of a parent-focused, predominantly text message–delivered intervention to support parents to reduce the amount of time their children spend in sedentary behavior. Methods Mini Movers was a pilot randomized controlled trial delivered to parents of 2- to 4-year-old children in Melbourne, Australia. Participants were recruited through playgroups, social media, and snowball sampling. Eligibility criteria were having an ambulatory child (2-4 years), English literacy, and smartphone ownership. Participants were randomized to intervention or wait-list control on a 1:1 ratio after baseline data collection. The 6-week intervention was predominantly delivered via text messages, using a Web-based bulk text message platform managed by the interventionist. Intervention strategies focused on increasing parental knowledge, building self-efficacy, setting goals, and providing reinforcement, and were underpinned by the Coventry, Aberdeen & London-Refined taxonomy of behavior change techniques and social cognitive theory. The primary outcome was intervention feasibility, measured by recruitment, retention, intervention delivery, and fidelity; process evaluation questionnaires; and qualitative interviews with a subsample of participants. Secondary outcomes were children’s screen and restraint time (parent report), sitting time (parent report, activPAL), and potential mediators (parent report). Linear regression models were used to determine intervention effects on secondary outcomes, controlling for the child’s sex and age and clustering by playgroup; effect sizes (Cohen's d) were calculated. Results A total of 57 participants (30 intervention; 27 wait-list control) were recruited, and retention was high (93%). Process evaluation results showed that the intervention was highly acceptable to parents. The majority of intervention components were reported to be useful and relevant. Compared with children in the control group, children in the intervention group had significantly less screen time postintervention (adjusted difference [95% CI]=−35.0 [−64.1 to −5.9] min/day; Cohen's d=0.82). All other measures of sedentary behavior were in the expected direction, with small to moderate effect sizes. Conclusions Mini Movers was shown to be a feasible, acceptable, and efficacious pilot intervention for parents of young children, warranting a larger-scale randomized control trial. Trial Registration Australian New Zealand Clinical Trials registry: ACTRN12616000628448; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?ACTRN=12616000628448p (Archived by WebCite at http://www.webcitation.org/ 6wZcA3cYM) PMID:29426816

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Conducting pilot and feasibility studies.

PubMed

Cope, Diane G

2015-03-01

Planning a well-designed research study can be tedious and laborious work. However, this process is critical and ultimately can produce valid, reliable study findings. Designing a large-scale randomized, controlled trial (RCT)-the gold standard in quantitative research-can be even more challenging. Even the most well-planned study potentially can result in issues with research procedures and design, such as recruitment, retention, or methodology. One strategy that may facilitate sound study design is the completion of a pilot or feasibility study prior to the initiation of a larger-scale trial. This article will discuss pilot and feasibility studies, their advantages and disadvantages, and implications for oncology nursing research. 
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Evaluation of a train-the-trainer program for stable coronary artery disease management in community settings: A pilot study.

PubMed

Shen, Zhiyun; Jiang, Changying; Chen, Liqun

2018-02-01

To evaluate the feasibility and effectiveness of conducting a train-the-trainer (TTT) program for stable coronary artery disease (SCAD) management in community settings. The study involved two steps: (1) tutors trained community nurses as trainers and (2) the community nurses trained patients. 51 community nurses attended a 2-day TTT program and completed questionnaires assessing knowledge, self-efficacy, and satisfaction. By a feasibility and non-randomized control study, 120 SCAD patients were assigned either to intervention group (which received interventions from trained nurses) or control group (which received routine management). Pre- and post-intervention, patients' self-management behaviors and satisfaction were assessed to determine the program's overall impact. Community nurses' knowledge and self-efficacy improved (P<0.001), as did intervention group patients' self-management behaviors (P<0.001). The satisfaction of community nurses and patients was all very positive after training. The TTT program for SCAD management in community settings in China was generally feasible and effective, but many obstacles remain including patients' noncompliance, nurses' busy work schedules, and lack of policy supports. Finding ways to enhance the motivation of community nurses and patients with SCAD are important in implementing community-based TTT programs for SCAD management; further multicenter and randomized control trials are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

Feasibility of including cellular telephone numbers in random digit dialing for epidemiologic case-control studies.

PubMed

Voigt, Lynda F; Schwartz, Stephen M; Doody, David R; Lee, Spencer C; Li, Christopher I

2011-01-01

The usefulness of landline random digit dialing (RDD) in epidemiologic studies is threatened by the rapid increase in households with only cellular telephone service. This study assessed the feasibility of including cellular telephone numbers in RDD and differences between young adults with landline telephones and those with only cellular telephones. Between 2008 and 2009, a total of 9,023 cellular telephone numbers were called and 43.8% were successfully screened; 248 men and 249 women who resided in 3 Washington State counties, were 20-44 years of age, and used only cellular telephones were interviewed. They were compared with 332 men and 526 women with landline telephones interviewed as controls for 2 case-control studies conducted in parallel with cellular telephone interviewing. Cellular-only users were more likely to be college educated and less likely to have fathered/birthed a child than were their landline counterparts. Male cellular-only users were less likely to be obese and more likely to exercise, to be Hispanic, and to have lower incomes, while female cellular-only users were more likely to be single than landline respondents. Including cellular telephone numbers in RDD is feasible and should be incorporated into epidemiologic studies that rely on this method to ascertain subjects, although low screening rates could hamper the representativeness of such a sample.

Orange interventions for symptoms associated with dimethyl sulfoxide during stem cell reinfusions: a feasibility study.

PubMed

Potter, Pamela; Eisenberg, Seth; Cain, Kevin C; Berry, Donna L

2011-01-01

For over 2 decades, oncology nurses at a regional comprehensive cancer center offered sliced oranges to patients during the reinfusion of autologous hematopoietic progenitor cells (HPCs) to relieve symptoms associated with the preservative dimethyl sulfoxide (DMSO). This randomized pilot study examined feasibility and efficacy of sliced orange intervention (OI), orange aromatherapy intervention (OAI), or deep breathing (control) to address unpleasant adverse effects during HPC infusion. Orange intervention sniffed or tasted a quartered orange, OAI sniffed orange aromatherapy, and control took deep breaths. Perceived "symptom intensity" for tickle/cough urge, nausea, retching, and perceived "relief" were measured on 0- to 10-point numerical scales. Sixty of 72 eligible patients consented to participate and were randomized to OI (n = 19), OAI (n = 23), or control (n = 18). Study personnel successfully administered study procedures. Over the course of 2 bags of cells infused, the OI group reported significantly greater relief with the intervention (P = .032). Among participants less than 90 kg, OI group reported significantly lower symptom intensity (P = .012). Results suggest a feasible protocol and potential efficacy of sliced oranges for treating symptoms associated with DMSO-preserved stem cells. Study procedures provide a tested protocol for future studies. Follow-up study is warranted to confirm these findings and evaluate other treatment options. Oranges offer a simple, noninvasive intervention for relieving symptoms associated with DMSO preservative during autologous HPC infusion.

Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.

PubMed

Moradian, Saeed; Walshe, Catherine; Shahidsales, Soodabeh; Ghavam Nasiri, Mohammad Reza; Pilling, Mark; Molassiotis, Alexander

2015-06-01

Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV. A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial. 99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06). Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting. Copyright © 2014 Elsevier Ltd. All rights reserved.

Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial.

PubMed

Sale, Patrizio; De Pandis, Maria Francesca; Le Pera, Domenica; Sova, Ivan; Cimolin, Veronica; Ancillao, Andrea; Albertini, Giorgio; Galli, Manuela; Stocchi, Fabrizio; Franceschini, Marco

2013-05-24

Over the last years, the introduction of robotic technologies into Parkinson's disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson's disease. Design. Pilot randomized controlled trial. Robot training was feasible, acceptable, safe, and the participants completed 100% of the prescribed training sessions. A statistically significant improvement in gait index was found in favour of the EG (T0 versus T1). In particular, the statistical analysis of primary outcome (gait speed) using the Friedman test showed statistically significant improvements for the EG (p = 0,0195). The statistical analysis performed by Friedman test of Step length left (p = 0,0195) and right (p = 0,0195) and Stride length left (p = 0,0078) and right (p = 0,0195) showed a significant statistical gain. No statistically significant improvements on the CG were found. Robot training is a feasible and safe form of rehabilitative exercise for cognitively intact people with mild PD. This original approach can contribute to increase a short time lower limb motor recovery in idiopathic PD patients. The focus on the gait recovery is a further characteristic that makes this research relevant to clinical practice. On the whole, the simplicity of treatment, the lack of side effects, and the positive results from patients support the recommendation to extend the use of this treatment. Further investigation regarding the long-time effectiveness of robot training is warranted. ClinicalTrials.gov NCT01668407.

Measuring Outcomes of Digital Technology-Assisted Nursing Postpartum: A Randomized Controlled Trial.

PubMed

Mccarter, Deborah E; Demidenko, Eugene; Hegel, Mark T

2018-05-17

To determine if delivering electronic messages from nurses during the first six months postpartum is feasible, acceptable and effective in improving mood and decreasing parenting stress. Competing demands during the postpartum hospitalization make focused time for nurses to provide education and support difficult. Unmet needs following discharge may increase the incidence of postpartum depression. Untreated depression negatively affects families, especially for vulnerable women with limited access to health care. This is a longitudinal cohort study in three phases. Feasibility and acceptability were assessed during Phases 1 & 2. Phase 3 is a randomized controlled trial (RCT) with three conditions. This protocol was approved by the Institutional Review Board of the maternity hospital on 12 May 2015 and reviewed annually. Women are enrolled during the maternity hospitalization, after which randomization occurs. The control group receives usual care. Intervention I participants receive a standardized electronic message four times/week for six months postpartum. Intervention II participants receive the messages and the option to request a call from a nurse. Electronic surveys at 3 weeks, 3 months and 6 months postpartum measure depressive symptoms using the Edinburgh Postnatal Depression Scale and parenting stress using the Parenting Stress Index-Short form. Patient satisfaction, nursing time and expertise required are also measured. Phase 1 and 2 have demonstrated the intervention is feasible and acceptable to women. Phase 3 enrollment is completed, and the last follow-up surveys were emailed to participants in February 2018. Results will help inform efforts to continue nursing care after hospital discharge. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Effects of a Tailored Positive Psychology Intervention on Well-Being and Pain in Individuals With Chronic Pain and a Physical Disability: A Feasibility Trial.

PubMed

Müller, Rachel; Gertz, Kevin J; Molton, Ivan R; Terrill, Alexandra L; Bombardier, Charles H; Ehde, Dawn M; Jensen, Mark P

2016-01-01

To determine the feasibility, acceptability, and efficacy of a computer-based positive psychology intervention in individuals with a physical disability and chronic pain. Individuals with spinal cord injury, multiple sclerosis, neuromuscular disease, or postpolio syndrome and chronic pain were randomly assigned to a positive psychology or a control condition. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises. Participants in the control group were instructed to write about life details for 8 weeks. Participants completed online well-being and pain-related questionnaires at baseline, posttreatment, and at the 2.5-month follow-up, and rated treatment satisfaction at posttreatment. Ninety-six participants were randomized and 68 (70%) completed follow-up assessments. Participants in the positive psychology intervention group reported significant pretreatment to posttreatment improvements in pain intensity, pain control, pain catastrophizing, pain interference, life satisfaction, positive affect, and depression. Improvements in life satisfaction, depression, pain intensity, pain interference, and pain control were maintained to the 2.5-month follow-up. Participants in the control group reported significant pretreatment to posttreatment improvements in life satisfaction, and pretreatment to follow-up improvements in pain intensity and pain control. Significant between-group differences, favoring the treatment group, emerged for pretreatment to posttreatment improvements in pain intensity and pain control. Participants were similarly satisfied with both treatments. The results support the feasibility, acceptability, and potential efficacy of a computer-based positive psychology intervention for improving well-being and pain-related outcomes in individuals with physical disabilities and chronic pain, and indicate that a full trial of the intervention is warranted.

Design and feasibility of a social self-value intervention package to empower people living with HIV.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2016-09-01

Human immunodeficiency virus (HIV) infection affects the quality of life of infected people. It is well known that empowerment is important for appropriate access to health care and quality of care. However, there is currently limited availability of explicit methods to increase the empowerment of HIV-infected people. This study aimed to develop and test the feasibility of a social self-value package as an empowerment intervention method for HIV-infected people. One group included 8-10 participants and each session lasted for one and half hours. Six sessions in total were developed and one session was conducted in one week. A total of 66 participants were randomly selected for participating in the package, assessed its feasibility both quantitatively and qualitatively. Attitudes towards HIV-related issues significantly and positively changed after each session. Client satisfaction and acceptability of the intervention was very high indicating high feasibility with good design. The qualitative findings also supported the quantitative findings where both participants and counselors accepted and were satisfied with the structure and contents of the package. This study revealed that providing an inclusive six-week social self-value package for HIV-infected Nepali people appears to be feasible. Its effect on empowerment intervention will be measured by a randomized controlled trial.

Cognitive Skills Training for Homeless Transition-Age Youth: Feasibility and Pilot Efficacy of a Community Based Randomized Controlled Trial.

PubMed

Medalia, Alice; Saperstein, Alice M; Huang, Yanlan; Lee, Seonjoo; Ronan, Elizabeth J

2017-11-01

Cognitive impairments are common in homeless youth and negatively impact academic and vocational outcomes. We examined the feasibility and efficacy of cognitive interventions provided to 18- to 22-year-old homeless youth living in urban supportive housing. Ninety-one homeless youth were randomized to receive either targeted cognitive training (cognitive remediation) or general cognitive activation (computer skills training). Cognitive and psychological outcomes were assessed at baseline, after 13 and 26 sessions, and 1 month postintervention. A high dropout rate highlighted the feasibility challenges of treating this population. Intent-to-treat analysis found significant improvements across groups in specific and global measures of cognition and psychological distress, with no significant group differences. Transition-age homeless youth show improvements in cognitive and psychological functioning when engaged in interventions that address their cognitive development. This speaks to the malleability of cognitive skills in this cohort and lays the groundwork for future research to address their cognitive health.

A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

PubMed Central

2014-01-01

Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being. Trial registration ClinicalTrials.gov Identified NCT00090506. PMID:24980650

Review and meta-analysis of prospective randomized controlled trials (RCTs) comparing laparo-endoscopic single site and multiport laparoscopy in gynecologic operative procedures.

PubMed

Pontis, Alessandro; Sedda, Federica; Mereu, Liliana; Podda, Mauro; Melis, Gian Benedetto; Pisanu, Adolfo; Angioni, Stefano

2016-09-01

To critically appraise published randomized controlled trials (RCTs) comparing laparo-endoscopic single site (LESS) and multi-port laparoscopic (MPL) in gynecologic operative surgery; the aim was to assess feasibility, safety, and potential benefits of LESS in comparison to MPL. A systematic review and meta-analysis of eleven RCTs. Women undergoing operative LESS and MPL gynecologic procedure (hysterectomy, cystectomy, salpingectomy, salpingo-oophorectomy, myomectomy). Outcomes evaluated were as follows: postoperative overall morbidity, postoperative pain evaluation at 6, 12, 24 and 48 h, cosmetic patient satisfaction, conversion rate, body mass index (BMI), operative time, blood loss, hemoglobin drop, postoperative hospital stay. Eleven RCTs comprising 956 women with gynecologic surgical disease randomized to either LESS (477) or MPL procedures (479) were analyzed systematically. The LESS approach is a surgical procedure with longer operative and better cosmetic results time than MPL but without statistical significance. Operative outcomes, postoperative recovery, postoperative morbidity and patient satisfaction are similar in LESS and MPL. LESS may be considered an alternative to MPL with comparable feasibility and safety in gynecologic operative procedures. However, it does not offer the expected advantages in terms of postoperative pain and cosmetic satisfaction.

The Detroit Young Adult Asthma Project: Pilot of a Technology-Based Medication Adherence Intervention for African-American Emerging Adults.

PubMed

Kolmodin MacDonell, Karen; Naar, Sylvie; Gibson-Scipio, Wanda; Lam, Phebe; Secord, Elizabeth

2016-10-01

To conduct a randomized controlled pilot of a multicomponent, technology-based intervention promoting adherence to controller medication in African-American emerging adults with asthma. The intervention consisted of two computer-delivered sessions based on motivational interviewing combined with text messaged reminders between sessions. Participants (N = 49) were 18-29 years old, African-American, with persistent asthma requiring controller medication. Participants had to report poor medication adherence and asthma control. Youth were randomized to receive the intervention or an attention control. Data were collected through computer-delivered self-report questionnaires at baseline, 1, and 3 months. Ecological Momentary Assessment via two-way text messaging was also used to collect "real-time" data on medication use and asthma control. The intervention was feasible and acceptable to the target population, as evidenced by high retention rates and satisfaction scores. Changes in study outcomes from pre- to postintervention favored the intervention, particularly for decrease in asthma symptoms, t (42) = 2.22, p < .05 (Cohen's d = .071). Results suggest that the intervention is feasible and effective. However, findings are preliminary and should be replicated with a larger sample and more sophisticated data analyses. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

PubMed

Meize-Grochowski, Robin; Shuster, George; Boursaw, Blake; DuVal, Michelle; Murray-Krezan, Cristina; Schrader, Ron; Smith, Bruce W; Herman, Carla J; Prasad, Arti

2015-01-01

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study. Copyright © 2015 Elsevier Inc. All rights reserved.

H∞ control for uncertain linear system over networks with Bernoulli data dropout and actuator saturation.

PubMed

Yu, Jimin; Yang, Chenchen; Tang, Xiaoming; Wang, Ping

2018-03-01

This paper investigates the H ∞ control problems for uncertain linear system over networks with random communication data dropout and actuator saturation. The random data dropout process is modeled by a Bernoulli distributed white sequence with a known conditional probability distribution and the actuator saturation is confined in a convex hull by introducing a group of auxiliary matrices. By constructing a quadratic Lyapunov function, effective conditions for the state feedback-based H ∞ controller and the observer-based H ∞ controller are proposed in the form of non-convex matrix inequalities to take the random data dropout and actuator saturation into consideration simultaneously, and the problem of non-convex feasibility is solved by applying cone complementarity linearization (CCL) procedure. Finally, two simulation examples are given to demonstrate the effectiveness of the proposed new design techniques. Copyright © 2018 ISA. Published by Elsevier Ltd. All rights reserved.

Increasing older adults’ walking through primary care: results of a pilot randomized controlled trial

PubMed Central

Mutrie, Nanette

2012-01-01

Background. Physical activity can positively influence health for older adults. Primary care is a good setting for physical activity promotion. Objective. To assess the feasibility of a pedometer-based walking programme in combination with physical activity consultations. Methods. Design: Two-arm (intervention/control) 12-week randomized controlled trial with a 12-week follow-up for the intervention group. Setting: One general practice in Glasgow, UK. Participants: Participants were aged ≥65 years. The intervention group received two 30-minute physical activity consultations from a trained practice nurse, a pedometer and a walking programme. The control group continued as normal for 12 weeks and then received the intervention. Both groups were followed up at 12 and 24 weeks. Outcome measures: Step counts were measured by sealed pedometers and an activPALTM monitor. Psychosocial variables were assessed and focus groups conducted. Results. The response rate was 66% (187/284), and 90% of those randomized (37/41) completed the study. Qualitative data suggested that the pedometer and nurse were helpful to the intervention. Step counts (activPAL) showed a significant increase from baseline to week 12 for the intervention group, while the control group showed no change. Between weeks 12 and 24, step counts were maintained in the intervention group, and increased for the control group after receiving the intervention. The intervention was associated with improved quality of life and reduced sedentary time. Conclusions. It is feasible to recruit and retain older adults from primary care and help them increase walking. A larger trial is necessary to confirm findings and consider cost-effectiveness. PMID:22843637

Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

PubMed

Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

2014-03-01

To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

PubMed

Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

2014-05-20

Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective. This study highlights the importance of feasibility work prior to a randomized controlled trial to assess recruitment methods and rates, barriers to participation, logistics of scheduling group-based interventions, acceptability of the intervention and piloting resource use questionnaires to improve data available for economic evaluations. This information is of value to researchers and funders in the design and commissioning of future research. Current Controlled Trials ISRCTN52305381.

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial

PubMed Central

2013-01-01

Background There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users’ readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Methods Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. Results The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants’ therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Conclusion Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. Trial registration ClinicalTrials.Gov.UK Identifier - NCT01132976 PMID:23414174

The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial.

PubMed

McMurran, Mary; Cox, W Miles; Whitham, Diane; Hedges, Lucy

2013-02-17

There are high rates of treatment non-completion for personality disorder and those who do not complete treatment have poorer outcomes. A goal-based motivational interview may increase service users' readiness to engage with therapy and so enhance treatment retention. We conducted a feasibility study to inform the design of a randomized controlled trial. The aims were to test the feasibility of recruitment, randomization and follow-up, and to conduct a preliminary evaluation of the effectiveness of the motivational interview. Patients in an outpatient personality disorder service were randomized to receive the Personal Concerns Inventory plus treatment as usual or treatment as usual only. The main randomized controlled trial feasibility criteria were recruitment of 54% of referrals, and 80% of clients and therapists finding the intervention acceptable. Information was collected on treatment attendance, the clarity of therapy goals and treatment engagement. The recruitment rate was 29% (76 of 258). Of 12 interviewed at follow-up, eight (67%) were positive about the Personal Concerns Inventory. Pre-intervention interviews were conducted with 61% (23 out of 38) of the Personal Concerns Inventory group and 74% (28 out of 38) of the treatment as usual group. Participants' therapy goals were blind-rated for clarity on a scale of 0 to 10. The mean score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Over 12 weeks, the median percentage session attendance was 83.33% for the Personal Concerns Inventory group (N = 17) and 66.67% for the treatment as usual group (N = 24). Of 59 eligible participants at follow-up, the Treatment Engagement Rating scale was completed for 40 (68%). The mean Treatment Engagement Rating scale score for the Personal Concerns Inventory group was 6.64 (SD = 2.28) and for the treatment as usual group 2.94 (SD = 1.71). Of the 76 participants, 63 (83%) completed the Client Service Receipt Inventory at baseline and 34 of 59 (58%) at follow-up. Shortfalls in recruitment and follow-up data collection were explained by major changes to the service. However, evidence of a substantial positive impact of the Personal Concerns Inventory on treatment attendance, clarity of therapy goals and treatment engagement, make a full-scale evaluation worth pursuing. Further preparatory work is required for a multisite trial. ClinicalTrials.Gov.UK Identifier - NCT01132976.

Clinical feasibility of interactive motion-controlled games for stroke rehabilitation.

PubMed

Bower, Kelly J; Louie, Julie; Landesrocha, Yoseph; Seedy, Paul; Gorelik, Alexandra; Bernhardt, Julie

2015-08-02

Active gaming technologies, including the Nintendo Wii and Xbox Kinect, have become increasingly popular for use in stroke rehabilitation. However, these systems are not specifically designed for this purpose and have limitations. The aim of this study was to investigate the feasibility of using a suite of motion-controlled games in individuals with stroke undergoing rehabilitation. Four games, which utilised a depth-sensing camera (PrimeSense), were developed and tested. The games could be played in a seated or standing position. Three games were controlled by movement of the torso and one by upper limb movement. Phase 1 involved consecutive recruitment of 40 individuals with stroke who were able to sit unsupported. Participants were randomly assigned to trial one game during a single session. Sixteen individuals from Phase 1 were recruited to Phase 2. These participants were randomly assigned to an intervention or control group. Intervention participants performed an additional eight sessions over four weeks using all four game activities. Feasibility was assessed by examining recruitment, adherence, acceptability and safety in both phases of the study. Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and improvements over time were seen in several functional outcome measures. There were no serious adverse safety events reported in either phase of the study; however, a number of participants reported minor increases in pain. A post-stroke intervention using interactive motion-controlled games shows promise as a feasible and potentially effective treatment approach. This paper presents important recommendations for future game development and research to further explore long-term adherence, acceptability, safety and efficacy. Australian and New Zealand Clinical Trials Registry ( ACTRN12613000220763 ).

A New Educational Film Control for Use in Studies of Active Mind–Body Therapies: Acceptability and Feasibility

PubMed Central

Selfe, Terry Kit; Alexander, Gina K.; Taylor, Ann Gill

2011-01-01

Abstract Objectives The study objectives were to ascertain whether a novel educational film class is an acceptable and feasible comparison group for a randomized controlled trial regarding the effects of an active mind–body therapy on cardiovascular disease risk in postmenopausal women. Methods Seventy-five (75) participants attended a baseline assessment visit and were randomly assigned to either a yoga group or an educational film (control) group. Both groups attended two 90-minute classes/week for 8 weeks, followed by a second assessment visit. Those not attending the second assessment were classified as dropouts. Over 60 films covering a range of topics relevant to the study population were evaluated; 15 were selected by consensus of at least 2 researchers and 1 layperson. Each film session followed the same format: an informal greeting period, viewing of the film, and a 15-minute postfilm discussion. To determine acceptability and feasibility of the film class, potential between-group differences in dropout and attendance were examined, and participant feedback given during class and on end-of-study questionnaires were evaluated. Results The relation between group assignment and dropout was not significant (χ2 [1, N = 75] = 0.14, p = 0.71). One-way analysis of variance (ANOVA) indicated no significant between-group difference in number of classes attended for the yoga (X = 13.67 ± 3.10) versus film group (13.26 ± 1.97), F(1,63) = 0.39, p = 0.53). Participant feedback regarding the film program was positive. Conclusions These findings support the feasibility and acceptability of this educational film control. Easy to standardize and tailor to a variety of populations, this film program may offer an attractive alternative to the more traditional educational control. PMID:21554109

Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study.

PubMed

Morris, Jacqui H; Kelly, Chris; Toma, Madalina; Kroll, Thilo; Joice, Sara; Mead, Gillian; Donnan, Peter; Williams, Brian

2014-09-28

Benefits of art participation after stroke are becoming increasingly recognized. Qualitative studies suggest that participation in visual arts creative engagement interventions (CEIs) during rehabilitation after stroke may improve mood, self-esteem, hope and some aspects of physical recovery. This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness. This trial is a two arm, single-blind, randomized controlled feasibility trial within in-patient stroke rehabilitation. We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland (40 patients in each arm). Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists. Artists will follow an intervention protocol with specific components that enable participants to set, achieve and review artistic goals. Participants will receive up to eight intervention sessions, four within a group and four one-to-one with the artist. Control group participants will receive usual care only.Data collection will occur at baseline, post-intervention and three-month follow-up. Stroke-related health status is the primary outcome; mood, self-esteem, self-efficacy, perceived recovery control and hope are secondary outcomes. Semi-structured interviews will be conducted with purposively selected patients, artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes. Recruitment rates, retention rates and patient preference for art participation will also be collected. Data will indicate, with confidence intervals, the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial. Summary data will indicate potential variability, magnitude and direction of difference between groups. Findings will inform sample size calculations for a definitive trial. Thematic analysis of qualitative data will be managed using the Framework Approach. Framework is an analytical approach for qualitative data, commonly used in policy and medical research. If shown to demonstrate effects, this intervention has the potential to address aspects of stroke recovery previously. Not routinely addressed in rehabilitation. Registered with Clinical Trials.Gov: NCT02085226 on 6th March 2014.

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial

PubMed Central

2013-01-01

Background Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients’ decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. Methods/design A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. Discussion Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. Trial registration ClinicalTrials.gov: NCT01876173 PMID:24148851

Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial.

PubMed

Carroll, Sandra L; McGillion, Michael; Stacey, Dawn; Healey, Jeff S; Browne, Gina; Arthur, Heather M; Thabane, Lehana

2013-10-22

Patients, identified to be at risk for but who have never experienced a potentially lethal cardiac arrhythmia, have the option of receiving an implantable cardioverter defibrillator (ICD) as prophylaxis against sudden cardiac death - a primary prevention indication. In Canada, there is no clear framework to support patients' decision-making for these devices. Decision support, using a decision aid, could moderate treatment-related uncertainty and prepare patients to make well-informed decisions. Patient decision aids provide information on treatment options, risks, and benefits, to help patients clarify their values for outcomes of treatment options. The objectives of this research are: 1) develop a decision aid, 2) evaluate the decision aid, and 3) determine the feasibility of conducting a trial. A development panel comprised of the core investigative team, health service researchers, decision science experts, cardiovascular healthcare practitioners, and ICD patient representatives will collaborate to provide input on the content and format of the aid. To generate probabilities to include in the aid, we will synthesize primary prevention ICD evidence. To obtain anonymous input about the facts and content, we will employ a modified Delphi process. To evaluate the draft decision aid will invite ICD patients and their families (n = 30) to rate its acceptability. After we evaluate the aid, to determine the feasibility, we will conduct a feasibility pilot randomized controlled trial (RCT) in new ICD candidates (n = 80). Participants will be randomized to receive a decision aid prior to specialist consultation versus usual care. Results from the pilot RCT will determine the feasibility of research processes; inform sample size calculation, measure decision quality (knowledge, values, decision conflict) and the influence of health related quality of life on decision-making. Our study seeks to develop a decision aid, for patients offered their first ICD for prophylaxis against sudden cardiac death. This paper outlines the background and methods of a pilot randomized trial which will inform a larger multicenter trial. Ultimately, decision support prior to specialist consultation could enhance the decision-making process between patients, physicians, and families, associated with life-prolonging medical devices like the ICD. ClinicalTrials.gov: NCT01876173.

Randomized controlled trial of asthma risk with paracetamol use in infancy--a feasibility study.

PubMed

Riley, J; Braithwaite, I; Shirtcliffe, P; Caswell-Smith, R; Hunt, A; Bowden, V; Power, S; Stanley, T; Crane, J; Ingham, T; Weatherall, M; Mitchell, E A; Beasley, R

2015-02-01

There is non-experimental evidence that paracetamol (acetaminophen) use may increase the risk of developing asthma. However, numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis. To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator (restricted paracetamol in accordance with WHO guidelines, ibuprofen or placebo), and childhood asthma risk. Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments. Subsequently, infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for 3 months with paracetamol use recorded. Of 120 eligible participants, 72 (60%) parents/guardians completed the questionnaire. Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians, respectively. 36 (30%) infants were randomized to restricted or liberal paracetamol. Paracetamol use was greater for the liberal vs. restricted group for reported [Hodges-Lehmann estimator of difference 0.94 mg/kg/day (95% CI 0.2-3.52), P = 0.02] and measured use [Hodges-Lehmann estimator of difference 2.11 mg/kg/day (95% CI 0.9-4.18), P = 0.004]. The median reported and measured use of paracetamol was 2.0-fold and 3.5-fold greater in the liberal vs. restricted group. Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime, ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood. © 2014 John Wiley & Sons Ltd.

Selecting promising treatments in randomized Phase II cancer trials with an active control.

PubMed

Cheung, Ying Kuen

2009-01-01

The primary objective of Phase II cancer trials is to evaluate the potential efficacy of a new regimen in terms of its antitumor activity in a given type of cancer. Due to advances in oncology therapeutics and heterogeneity in the patient population, such evaluation can be interpreted objectively only in the presence of a prospective control group of an active standard treatment. This paper deals with the design problem of Phase II selection trials in which several experimental regimens are compared to an active control, with an objective to identify an experimental arm that is more effective than the control or to declare futility if no such treatment exists. Conducting a multi-arm randomized selection trial is a useful strategy to prioritize experimental treatments for further testing when many candidates are available, but the sample size required in such a trial with an active control could raise feasibility concerns. In this study, we extend the sequential probability ratio test for normal observations to the multi-arm selection setting. The proposed methods, allowing frequent interim monitoring, offer high likelihood of early trial termination, and as such enhance enrollment feasibility. The termination and selection criteria have closed form solutions and are easy to compute with respect to any given set of error constraints. The proposed methods are applied to design a selection trial in which combinations of sorafenib and erlotinib are compared to a control group in patients with non-small-cell lung cancer using a continuous endpoint of change in tumor size. The operating characteristics of the proposed methods are compared to that of a single-stage design via simulations: The sample size requirement is reduced substantially and is feasible at an early stage of drug development.

Aromatherapy for the treatment of PONV in children: a pilot RCT.

PubMed

Kiberd, Mathew B; Clarke, Suzanne K; Chorney, Jill; d'Eon, Brandon; Wright, Stuart

2016-11-09

Postoperative nausea and vomiting (PONV) is one of the most common postoperative complications of general anesthesia in pediatrics. Aromatherapy has been shown to be effective in treating PONV in adults. Given the encouraging results of the adult studies, we planned to determine feasibility of doing a large-scale study in the pediatric population. Our group conducted a pilot randomized controlled trial examining the effect of aromatherapy on post-operative nausea and vomiting in patients 4-16 undergoing ambulatory surgery at a single center. Nausea was defined as a score of 4/10 on the Baxter Retching Faces Scale (BARF scale). A clinically significant reduction was defined as a two-point reduction in Nausea. Post operatively children were administered the BARF scale in 15 min internals until discharge home or until nausea score of 4/10 or greater. Children with nausea were randomized to saline placebo group or aromatherapy QueaseEase™ (Soothing Scents, Inc, Enterprise, AL: blend of ginger, lavender, mint and spearmint). Nausea scores were recorded post intervention. A total of 162 subjects were screened for inclusion in the study. Randomization occurred in 41 subjects of which 39 were included in the final analysis. For the primary outcome, 14/18 (78 %) of controls reached primary outcome compared to 19/21 (90 %) in the aromatherapy group (p = 0.39, Eta 0.175). Other outcomes included use of antiemetic in PACU (control 44 %, aromatherapy 52 % P = 0.75, Eta 0.08), emesis (Control 11 %, 9 % aromatherapy, P = 0.87, Eta = 0.03). There was a statistically significant difference in whether subjects continued to use the intervention (control 28 %, aromatherapy 66 %, p-value 0.048, Eta 0.33). Aromatherapy had a small non-significant effect size in treating postoperative nausea and vomiting compared with control. A large-scale randomized control trial would not be feasible at our institution and would be of doubtful utility. ClinicalTrials.gov NCT02663154 .

Inorganic nitrate as a treatment for acute heart failure: a protocol for a single center, randomized, double-blind, placebo-controlled pilot and feasibility study.

PubMed

Falls, Roman; Seman, Michael; Braat, Sabine; Sortino, Joshua; Allen, Jason D; Neil, Christopher J

2017-08-08

Acute heart failure (AHF) is a frequent reason for hospitalization worldwide and effective treatment options are limited. It is known that AHF is a condition characterized by impaired vasorelaxation, together with reduced nitric oxide (NO) bioavailability, an endogenous vasodilatory compound. Supplementation of inorganic sodium nitrate (NaNO 3 ) is an indirect dietary source of NO, through bioconversion. It is proposed that oral sodium nitrate will favorably affect levels of circulating NO precursors (nitrate and nitrite) in AHF patients, resulting in reduced systemic vascular resistance, without significant hypotension. We propose a single center, randomized, double-blind, placebo-controlled pilot trial, evaluating the feasibility of sodium nitrate as a treatment for AHF. The primary hypothesis that sodium nitrate treatment will result in increased systemic levels of nitric oxide pre-cursors (nitrate and nitrite) in plasma, in parallel with improved vasorelaxation, as assessed by non-invasively derived systemic vascular resistance index. Additional surrogate measures relevant to the known pathophysiology of AHF will be obtained in order to assess clinical effect on dyspnea and renal function. The results of this study will provide evidence of the feasibility of this novel approach and will be of interest to the heart failure community. This trial may inform a larger study.

A Fitbit and Facebook mHealth intervention for promoting physical activity among adolescent and young adult childhood cancer survivors: A pilot study.

PubMed

Mendoza, Jason A; Baker, K Scott; Moreno, Megan A; Whitlock, Kathryn; Abbey-Lambertz, Mark; Waite, Alan; Colburn, Trina; Chow, Eric J

2017-12-01

Physical activity (PA) may be important for preventing chronic diseases for adolescent and young adult (AYA) childhood cancer survivors. Randomized controlled trials (RCTs) of PA interventions for AYA survivors are sparse, but necessary to determine effective programs for increasing PA among this population. Thus, we conducted a pilot RCT, testing the feasibility of a mobile health (mHealth) intervention to promote PA among AYA survivors. We recruited 14- to 18-year-olds who were ≥1-year post cancer therapy from Seattle Children's Hospital. The 10-week intervention consisted of a wearable PA-tracking device (Fitbit Flex) and a peer-based virtual support group (Facebook group). Research staff helped set step goals and awarded badges weekly. Controls received usual care. Baseline assessments occurred before randomization and follow-up assessments occurred during weeks 8-10 of the intervention period. Feasibility criteria are defined below. Qualitative interviews assessed acceptability. Exploratory outcomes included PA, quality of life, and motivation for PA. All feasibility criteria were met: we recruited 60 survivors, intervention participants wore the Fitbit on the majority (71.5%) of intervention days, and ≥90% of all participants completed questionnaires. Qualitative data confirmed intervention acceptability. Exploratory analyses found no significant adjusted group differences for change in moderate-to-vigorous PA (4.4 vs. 5.0 min/day; P = 0.92) or sedentary time (-4.5 vs. 1.0 min/day; P = 0.73), comparing intervention subjects to controls. Some modest differences were found for select subscales of quality of life and motivation for PA. This mHealth PA intervention was feasible and acceptable to AYA childhood cancer survivors and warrants a fully powered RCT. © 2017 Wiley Periodicals, Inc.

Randomized Controlled Trial of a Home-Based Action Observation Intervention to Improve Walking in Parkinson Disease.

PubMed

Jaywant, Abhishek; Ellis, Terry D; Roy, Serge; Lin, Cheng-Chieh; Neargarder, Sandy; Cronin-Golomb, Alice

2016-05-01

To examine the feasibility and efficacy of a home-based gait observation intervention for improving walking in Parkinson disease (PD). Participants were randomly assigned to an intervention or control condition. A baseline walking assessment, a training period at home, and a posttraining assessment were conducted. The laboratory and participants' home and community environments. Nondemented individuals with PD (N=23) experiencing walking difficulty. In the gait observation (intervention) condition, participants viewed videos of healthy and parkinsonian gait. In the landscape observation (control) condition, participants viewed videos of moving water. These tasks were completed daily for 8 days. Spatiotemporal walking variables were assessed using accelerometers in the laboratory (baseline and posttraining assessments) and continuously at home during the training period. Variables included daily activity, walking speed, stride length, stride frequency, leg swing time, and gait asymmetry. Questionnaires including the 39-item Parkinson Disease Questionnaire (PDQ-39) were administered to determine self-reported change in walking, as well as feasibility. At posttraining assessment, only the gait observation group reported significantly improved mobility (PDQ-39). No improvements were seen in accelerometer-derived walking data. Participants found the at-home training tasks and accelerometer feasible to use. Participants found procedures feasible and reported improved mobility, suggesting that observational training holds promise in the rehabilitation of walking in PD. Observational training alone, however, may not be sufficient to enhance walking in PD. A more challenging and adaptive task, and the use of explicit perceptual learning and practice of actions, may be required to effect change. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Low-Intensity Cognitive Behavioural Therapy-Based Music Group (CBT-Music) for the Treatment of Symptoms of Anxiety and Depression: A Feasibility Study.

PubMed

Trimmer, Chris; Tyo, Richard; Pikard, Jennifer; McKenna, Claire; Naeem, Farooq

2018-03-01

Music has the potential to be an effective and engaging therapeutic intervention in the treatment of mental illness. This research area remains underdeveloped. This paper reports the feasibility of an innovative low-intensity CBT-based music (CBT-Music) group targeted to symptoms of depression and anxiety. A total of 28 participants with symptoms of depression and anxiety who were attending community mental health services were recruited for the study and randomized into TAU (treatment as usual) plus low-intensity CBT-Music (treatment) or to TAU alone (control). The treatment group consisted of a 9-week music group that incorporated various components of CBT material into a musical context. Feasibility was the primary outcome. The secondary outcomes were a reduction in depression, anxiety (Hospital Anxiety and Depression Scale) and disability (WHO Disability Assessment Schedule 2.0) assessed at baseline and 10 weeks. Recruitment proved feasible, retention rates were high, and the participants reported a high level of acceptability. A randomized control study design was successfully implemented as there were no significant differences between treatment and control groups at baseline. Participants in the treatment group showed improvement in disability (p = 0.027). Despite a reduction in depression and anxiety scores, these differences were not statistically significant. A low-intensity CBT-based music group can be successfully administered to clients of community mental health services. There are indications of effectiveness in reducing disability, although there appears to be negligible effect on symptoms of anxiety and depression. This is the first report of a trial of a low-intensity CBT-based music group intervention.

The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

PubMed

Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

2018-04-01

Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence Therapy, level 2b. J Orthop Sports Phys Ther 2018;48(4):307-315. doi:10.2519/jospt.2018.7941.

Physical Activity Self-Management and Coaching Compared to Social Interaction in Huntington Disease: Results From the ENGAGE-HD Randomized, Controlled Pilot Feasibility Trial

PubMed Central

Quinn, Lori; Drew, Cheney; Kelson, Mark; Trubey, Rob; McEwan, Kirsten; Jones, Carys; Townson, Julia; Dawes, Helen; Tudor-Edwards, Rhiannon; Rosser, Anne; Hood, Kerenza

2017-01-01

Abstract Background. Self-management and self-efficacy for physical activity is not routinely considered in neurologic rehabilitation. Objective. This study assessed feasibility and outcomes of a 14-week physical activity self-management and coaching intervention compared with social contact in Huntington disease (HD) to inform the design of a future full-scale trial. Design. Assessor blind, multisite, randomized pilot feasibility trial. Setting. Participants were recruited and assessed at baseline, 16 weeks following randomization, and then again at 26 weeks in HD specialist clinics with intervention delivery by trained coaches in the participants’ homes. Patients and Intervention. People with HD were allocated to the ENGAGE-HD physical activity coaching intervention or a social interaction intervention. Measurements. Eligibility, recruitment, retention, and intervention participation were determined at 16 weeks. Other outcomes of interest included measures of mobility, self-efficacy, physical activity, and disease-specific measures of motor and cognition. Fidelity and costs for both the physical activity and social comparator interventions were established. Results. Forty percent (n = 46) of eligible patients were enrolled; 22 were randomized to the physical intervention and 24 to social intervention. Retention rates in the physical intervention and social intervention were 77% and 92%, respectively. Minimum participation criteria were achieved by 82% of participants in the physical intervention and 100% in the social intervention. There was no indication of between-group treatment effects on function; however, increases in self-efficacy for exercise and self-reported levels of physical activity in the physical intervention lend support to our predefined intervention logic model. Limitations. The use of self-report measures may have introduced bias. Conclusions. An HD physical activity self-management and coaching intervention is feasible and worthy of further investigation. PMID:28371942

Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

PubMed

Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

2015-10-01

To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

Feasibility, design and conduct of a pragmatic randomized controlled trial to reduce overweight and obesity in children: The electronic games to aid motivation to exercise (eGAME) study

PubMed Central

Maddison, Ralph; Foley, Louise; Ni Mhurchu, Cliona; Jull, Andrew; Jiang, Yannan; Prapavessis, Harry; Rodgers, Anthony; Vander Hoorn, Stephen; Hohepa, Maea; Schaaf, David

2009-01-01

Background Childhood obesity has reached epidemic proportions in developed countries. Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity. Active video games, where players physically interact with images onscreen, may have utility as a novel intervention to increase physical activity and improve body composition in children. The aim of the Electronic Games to Aid Motivation to Exercise (eGAME) study is to determine the effects of an active video game intervention over 6 months on: body mass index (BMI), percent body fat, waist circumference, cardio-respiratory fitness, and physical activity levels in overweight children. Methods/Design Three hundred and thirty participants aged 10–14 years will be randomized to receive either an active video game upgrade package or to a control group (no intervention). Discussion An overview of the eGAME study is presented, providing an example of a large, pragmatic randomized controlled trial in a community setting. Reflection is offered on key issues encountered during the course of the study. In particular, investigation into the feasibility of the proposed intervention, as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12607000632493 PMID:19450288

Early rehabilitation exercise program for inpatients during an acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

PubMed

Tang, Clarice Y; Blackstock, Felicity C; Clarence, Michael; Taylor, Nicholas F

2012-01-01

To determine whether an early rehabilitation program was safe and feasible for patients during an acute exacerbation of chronic obstructive pulmonary disease (COPD). In this phase 1 randomized controlled trial, patients with an acute exacerbation of COPD admitted to the hospital were randomly allocated to a low-intensity exercise group, a moderate- to high-intensity exercise group, or a control group, who received routine physical therapy. In addition to routine physical therapy, patients in the exercise group had to participate in an exercise program. The program consisted of twice-daily aerobic and resistance exercise sessions. Primary outcomes were the number and classification of adverse events and program adherence. In 174 exercise sessions, there was 1 serious adverse event of arrhythmia in the low-intensity exercise group that resolved within 1 hour. There were 12 other minor adverse events involving 5 patients with no significant differences between groups. Patients completed an average of 80% of their scheduled sessions with no significant between-group differences. The exercise groups improved significantly in walking distance; however, no significant between-group differences were observed. There was preliminary evidence that it was safe and feasible to implement an exercise program for patients during an acute exacerbation of COPD. Additional studies with larger sample sizes are required to accurately evaluate program effectiveness.

Child Directed Interaction Training for young children in kinship care: A pilot study.

PubMed

N'zi, Amanda M; Stevens, Monica L; Eyberg, Sheila M

2016-05-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Tackling Social Cognition in Schizophrenia: A Randomized Feasibility Trial.

PubMed

Taylor, Rumina; Cella, Matteo; Csipke, Emese; Heriot-Maitland, Charles; Gibbs, Caroline; Wykes, Til

2016-05-01

Social cognition difficulties in schizophrenia are seen as a barrier to recovery. Intervention tackling problems in this domain have the potential to facilitate functioning and recovery. Social Cognition and Interaction Training (SCIT) is a manual-based psychological therapy designed to improve social functioning in schizophrenia. The aim of this study is to evaluate the feasibility and acceptability of a modified version of SCIT for inpatient forensic wards. The potential benefits of the intervention were also assessed. This study is a randomized single blind controlled design, with participants randomized to receive SCIT (N = 21) or treatment as usual (TAU; N = 15). SCIT consisted of 8-week therapy sessions twice per week. Participants were assessed at week 0 and one week after the intervention on measures of social cognition. Feasibility was assessed through group attendance and attrition. Participant acceptability and outcome was evaluated through post-group satisfaction and achievement of social goals. The intervention was well received by all participants and the majority reported their confidence improved. The SCIT group showed a significant improvement in facial affect recognition compared to TAU. Almost all participants agreed they had achieved their social goal as a result of the intervention. It is feasible to deliver SCIT in a forensic ward setting; however, some adaptation to the protocol may need to be considered in order to accommodate for the reduced social contact within forensic wards. Practice of social cognition skills in real life may be necessary to achieve benefits to theory of mind and attributional style.

[On-site quality control of acupuncture randomized controlled trial: design of content and checklist of quality control based on PICOST].

PubMed

Li, Hong-Jiao; He, Li-Yun; Liu, Zhi-Shun; Sun, Ya-Nan; Yan, Shi-Yan; Liu, Jia; Zhao, Ye; Liu, Bao-Yan

2014-02-01

To effectively guarantee quality of randomized controlld trial (RCT) of acupuncture and develop reasonable content and checklist of on-site quality control, influencing factors on quality of acupuncture RCT are analyzed and scientificity of quality control content and feasibility of on-site manipulation are put into overall consideration. Based on content and checklist of on-site quality control in National 11th Five-Year Plan Project Optimization of Comprehensive Treatment Plan for TCM in Prevention and Treatment of Serious Disease and Clinical Assessment on Generic Technology and Quality Control Research, it is proposed that on-site quality control of acupuncture RCT should be conducted with PICOST (patient, intervention, comparison, out come, site and time) as core, especially on quality control of interveners' skills and outcome assessment of blinding, and checklist of on-site quality control is developed to provide references for undertaking groups of the project.

Can Telemedicine Improve Adherence to Resuscitation Guidelines for Critically Ill Children at Community Hospitals? A Randomized Controlled Trial Using High-Fidelity Simulation.

PubMed

Yang, Chris P; Hunt, Elizabeth A; Shilkofski, Nicole; Dudas, Robert; Egbuta, Chinyere; Schwartz, Jamie M

2017-07-01

Children transferred from community hospitals lacking specialized pediatric care are more seriously ill than those presenting to pediatric centers. Pediatric consultation and adherence to management guidelines improve outcomes. The aims of the study were (1) to assess whether telemedicine consultation in critical situations is feasible and (2) to compare the impact of pediatric critical care medicine (PCCM) consultation via telemedicine versus telephone on community hospital adherence to resuscitation guidelines through a randomized controlled telemedicine trial. In situ, high-fidelity simulation scenarios of critically ill children presenting to a community hospital and progressing to cardiopulmonary arrest were performed. Scenarios were randomized to PCCM consultation via telephone (control) or telemedicine (intervention). Primary outcome measure was proportion of teams who successfully defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia. The following 30 scenarios were completed: 15 control and 15 intervention. Only 11 (37%) of 30 teams, defibrillated in 180 seconds or less from presentation of pulseless ventricular tachycardia; control: 6 (40%) of 15 versus intervention: 5 (33%) of 15, P = 0.7. Request for or use of backboard during cardiopulmonary resuscitation occurred in 24 (80%) of 30 scenarios; control: 9 (60%) of 15 versus intervention: 15 (100%) of 15, P = 0.006. Request for or use of stepstool during cardiopulmonary resuscitation occurred in 6 (20%) of 30 scenarios; control: 1 (7%) of 15 versus intervention: 5 (33%) of 15, P = 0.07. This study demonstrates the feasibility of using telemedicine to support acute management of children who present to community hospitals. Neither study arm adhered to current resuscitation guidelines and telemedicine consultation with PCCM experts was not associated with improvement. However, further research on optimizing telemedicine impact on the quality of pediatric care at community hospitals is warranted.

Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial

PubMed Central

Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

2017-01-01

Background Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. Objective To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Design Single-center 3-arm feasibility randomized controlled trial. Setting Urban academic safety-net hospital. Patients Adult inpatients on the Family Medicine ward. Interventions Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Measurements Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting “top box” scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. Results From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Conclusions Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an improved hospital experience, pain management, and connectedness to the massage or music therapist. PMID:29085740

Interactive, culturally sensitive education on colorectal cancer screening.

PubMed

Menon, Usha; Szalacha, Laura A; Belue, Rhonda; Rugen, Kathryn; Martin, Kelly R; Kinney, Anita Y

2008-09-01

Increasing colorectal cancer screening (CRCS) can have a substantial positive impact on morbidity and mortality. The purpose of this report is to describe the development and feasibility testing of a computer-based, theory-guided educational program designed to increase CRCS. This mixed-methods study used focus groups and subsequent randomized controlled trial design. Participants (N = 199) were randomized to an intervention or control group; 75% were African American; mean age was 57.36 (SD = 6.8); 71% were male. Previously validated measures on knowledge, beliefs, and screening test adherence were used to establish pre- and post-intervention perceptions. Feasibility was measured by response and completion rates, and participants' perceptions of the program. Before feasibility testing, the program was presented to 2 focus groups. Changes were made to the program based on discussion, leading to a visually appealing, easy to understand and navigate, self-paced program. In the RCT pilot test that followed, of the participants in the intervention group, 80% said the education helped them decide to get CRCS; 49% agreed it helped them overcome barriers; 91% agreed it was useful, 68% thought it raised new concerns about cancer, but only 30% said it made them worry about CRC; 95% agreed their doctor's office should continue giving such education, and 99% said they would inform family about the program. The response rate of 83% demonstrated feasibility of conducting colorectal cancer education in the primary care setting; overall the program was well received; participants averaged 23 minutes to complete it. Participants sought no help from attending data collectors and navigated the revised touch screen program with ease. Computer-based education is feasible in primary care clinics.

DiAlert: a prevention program for overweight first degree relatives of type 2 diabetes patients: results of a pilot study to test feasibility and acceptability.

PubMed

Heideman, Wieke H; de Wit, Maartje; Middelkoop, Barend J C; Nierkens, Vera; Stronks, Karien; Verhoeff, Arnoud P; Snoek, Frank J

2012-09-27

Prevalence of type 2 diabetes mellitus is increasing due to lifestyle changes, particularly affecting those genetically at risk. We developed DiAlert as a targeted group-based intervention aimed to promote intrinsic motivation and action planning for lifestyle changes and weight loss in first degree relatives of patients with type 2 diabetes mellitus.The main objective of the pilot of the DiAlert intervention was to assess fidelity, feasibility and acceptability prior to starting the randomized controlled trial. Individuals with a family history of type 2 diabetes mellitus were self-identified and screened for eligibility. DiAlert consists of two group sessions. Feasibility, fidelity, acceptability and self-reported perceptions and behavioral determinants were evaluated in a pre-post study using questionnaires and observations. Determinants of behavior change were analyzed using paired-samples t tests and Wilcoxon signed rank tests. DiAlert was delivered to two groups of first degree relatives of patients with type 2 diabetes mellitus (N = 9 and N = 12). Feasibility and fidelity were confirmed. Overall, the DiAlert group sessions were positively evaluated (8.0 on a scale of 1 to 10) by participants. The intervention did not impact perceived susceptibility or worry about personal diabetes risk. Action planning with regard to changing diet and physical activity increased. DiAlert proved feasible and was well-accepted by participants. Positive trends in action planning indicate increased likelihood of actual behavior change following DiAlert. Testing the effectiveness in a randomized controlled trial is imperative. Netherlands National Trial Register (NTR): NTR2036.

Inpatient Massage Therapy Versus Music Therapy Versus Usual Care: A Mixed-methods Feasibility Randomized Controlled Trial.

PubMed

Roseen, Eric J; Cornelio-Flores, Oscar; Lemaster, Chelsey; Hernandez, Maria; Fong, Calvin; Resnick, Kirsten; Wardle, Jon; Hanser, Suzanne; Saper, Robert

2017-01-01

Little is known about the feasibility of providing massage or music therapy to medical inpatients at urban safety-net hospitals or the impact these treatments may have on patient experience. To determine the feasibility of providing massage and music therapy to medical inpatients and to assess the impact of these interventions on patient experience. Single-center 3-arm feasibility randomized controlled trial. Urban academic safety-net hospital. Adult inpatients on the Family Medicine ward. Massage therapy consisted of a standardized protocol adapted from a previous perioperative study. Music therapy involved a preference assessment, personalized compact disc, music-facilitated coping, singing/playing music, and/or songwriting. Credentialed therapists provided the interventions. Patient experience was measured with the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) within 7 days of discharge. We compared the proportion of patients in each study arm reporting "top box" scores for the following a priori HCAHPS domains: pain management, recommendation of hospital, and overall hospital rating. Responses to additional open-ended postdischarge questions were transcribed, coded independently, and analyzed for common themes. From July to December 2014, 90 medical inpatients were enrolled; postdischarge data were collected on 68 (76%) medical inpatients. Participants were 70% females, 43% non-Hispanic black, and 23% Hispanic. No differences between groups were observed on HCAHPS. The qualitative analysis found that massage and music therapy were associated with improved overall hospital experience, pain management, and connectedness to the massage or music therapist. Providing music and massage therapy in an urban safety-net inpatient setting was feasible. There was no quantitative impact on HCAHPS. Qualitative findings suggest benefits related to an improved hospital experience, pain management, and connectedness to the massage or music therapist.

Authoritative feeding behaviors to reduce child BMI through online interventions.

PubMed

Frenn, Marilyn; Pruszynski, Jessica E; Felzer, Holly; Zhang, Jiannan

2013-01-01

PURPOSE.: The purpose of the study was to examine the feasibility and initial efficacies of parent- and/or child-focused online interventions and variables correlated with child body mass index percentile change. DESIGN AND METHODS.: A feasibility and cluster randomized controlled pilot study was used. RESULTS.: Recruitment was more effective at parent-teacher conferences compared with when materials were sent home with fifth- to eighth-grade culturally diverse students. Retention was 90% for students and 62-74% for parents. Authoritative parent feeding behaviors were associated with lower child body mass index. A larger study is warranted. PRACTICE IMPLICATIONS.: Online approaches may provide a feasible option for childhood obesity prevention and amelioration. © 2013, Wiley Periodicals, Inc.

Using Non-experimental Data to Estimate Treatment Effects

PubMed Central

Stuart, Elizabeth A.; Marcus, Sue M.; Horvitz-Lennon, Marcela V.; Gibbons, Robert D.; Normand, Sharon-Lise T.

2009-01-01

While much psychiatric research is based on randomized controlled trials (RCTs), where patients are randomly assigned to treatments, sometimes RCTs are not feasible. This paper describes propensity score approaches, which are increasingly used for estimating treatment effects in non-experimental settings. The primary goal of propensity score methods is to create sets of treated and comparison subjects who look as similar as possible, in essence replicating a randomized experiment, at least with respect to observed patient characteristics. A study to estimate the metabolic effects of antipsychotic medication in a sample of Florida Medicaid beneficiaries with schizophrenia illustrates methods. PMID:20563313

Using Facebook as a Platform to Direct Young Black Men Who Have Sex With Men to a Video-Based HIV Testing Intervention: A Feasibility Study.

PubMed

Washington, Thomas Alex; Applewhite, Sheldon; Glenn, Wendell

2017-01-01

A randomized control pilot study was conducted with Black men who have sex with men (BMSM; N = 42) aged 18-30 years to examine the feasibility of implementing a video intervention delivered using Facebook to motivate HIV testing. At baseline, participants were unaware of their HIV status and had not tested for HIV in the past 6 months, residing in Los Angeles County. The intervention content included topics such as social influence, HIV knowledge, stigma, HIV positive knowledge, and benefits of knowing one's HIV status. Logistic regression revealed that those receiving the video intervention were 7 times more likely to have tested for HIV than those in the control group at 6-week follow-up (odds ratio [ OR ] = 7.00, 95% confidence interval [1.72, 28.33], p = .006). Data suggest that the intervention was feasible for motivating HIV testing.

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

PubMed Central

2010-01-01

Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). Discussion This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. Trial Registration Current controlled trial ISRCTN54009836 PMID:20398349

Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

PubMed Central

Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

2016-01-01

Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

Safety and feasibility of transcranial direct current stimulation in pediatric hemiparesis: randomized controlled preliminary study.

PubMed

Gillick, Bernadette T; Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E

2015-03-01

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. The study was conducted in a university pediatric research laboratory. Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Adverse events/safety assessment and hand function were measured. Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. A limitation of the study was the small sample size, with data available for 11 participants. Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. © 2015 American Physical Therapy Association.

Safety and Feasibility of Transcranial Direct Current Stimulation in Pediatric Hemiparesis: Randomized Controlled Preliminary Study

PubMed Central

Feyma, Tim; Menk, Jeremiah; Usset, Michelle; Vaith, Amy; Wood, Teddi Jean; Worthington, Rebecca; Krach, Linda E.

2015-01-01

Background Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that has shown improved adult stroke outcomes. Applying tDCS in children with congenital hemiparesis has not yet been explored. Objective The primary objective of this study was to explore the safety and feasibility of single-session tDCS through an adverse events profile and symptom assessment within a double-blind, randomized placebo-controlled preliminary study in children with congenital hemiparesis. A secondary objective was to assess the stability of hand and cognitive function. Design A double-blind, randomized placebo-controlled pretest/posttest/follow-up study was conducted. Setting The study was conducted in a university pediatric research laboratory. Participants Thirteen children, ages 7 to 18 years, with congenital hemiparesis participated. Measurements Adverse events/safety assessment and hand function were measured. Intervention Participants were randomly assigned to either an intervention group or a control group, with safety and functional assessments at pretest, at posttest on the same day, and at a 1-week follow-up session. An intervention of 10 minutes of 0.7 mA tDCS was applied to bilateral primary motor cortices. The tDCS intervention was considered safe if there was no individual decline of 25% or group decline of 2 standard deviations for motor evoked potentials (MEPs) and behavioral data and no report of adverse events. Results No major adverse events were found, including no seizures. Two participants did not complete the study due to lack of MEP and discomfort. For the 11 participants who completed the study, group differences in MEPs and behavioral data did not exceed 2 standard deviations in those who received the tDCS (n=5) and those in the control group (n=6). The study was completed without the need for stopping per medical monitor and biostatisticial analysis. Limitations A limitation of the study was the small sample size, with data available for 11 participants. Conclusions Based on the results of this study, tDCS appears to be safe, feasible, and well tolerated in most children with hemiparesis. Future investigations of serial sessions of tDCS in conjunction with rehabilitation in pediatric hemiparesis are indicated to explore the benefit of a synergistic approach to improving hand function. PMID:25413621

Evaluation of a home-based exercise program in the treatment of Alzheimer's disease: the Maximizing Independence in Dementia (MIND) study.

PubMed

Steinberg, Martin; Leoutsakos, Jeannie-Marie Sheppard; Podewils, Laura Jean; Lyketsos, C G

2009-07-01

To determine the feasibility and efficacy of a home-based exercise intervention program to improve the functional performance of patients with Alzheimer's Disease (AD). Twenty-seven home-dwelling patients with AD were randomized to either an exercise intervention program delivered by their caregivers or a home safety assessment control. Measures of functional performance (primary), cognition, neuropsychiatric symptoms, quality of life and caregiver burden (secondary) were obtained at baseline and at 6 and 12 weeks following randomization. For each outcome measure, intent-to-treat analyses using linear random effects models were performed. Feasibility and adverse events were also assessed. Adherence to the exercise program was good. On the primary outcomes (functional performance) patients in the exercise group demonstrated a trend for improved performance on measures of hand function and lower extremity strength. On secondary outcome measures, trends toward worse depression and lower quality of life ratings were noted. The physical exercise intervention developed for the study, delivered by caregivers to home-dwelling patients with AD, was feasible and was associated with a trend for improved functional performance in this group of frail patients. Given the limited efficacy to date of pharmacotherapies for AD, further study of exercise intervention, in a variety of care setting, is warranted.

Monolingual or Bilingual Intervention for Primary Language Impairment? A Randomized Control Trial

ERIC Educational Resources Information Center

Thordardottir, Elin; Cloutier, Geneviève; Ménard, Suzanne; Pelland-Blais, Elaine; Rvachew, Susan

2015-01-01

Purpose: This study investigated the clinical effectiveness of monolingual versus bilingual language intervention, the latter involving speech-language pathologist-parent collaboration. The study focuses on methods that are currently being recommended and that are feasible within current clinical contexts. Method: Bilingual children with primary…

Feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus™ for frail elderly: study protocol for a feasibility trial.

PubMed

Gomes, Gisele Cristine Vieira; Bacha, Jéssica Maria Ribeiro; do Socorro Simões, Maria; Lin, Sumika Mori; Viveiro, Larissa Alamino Pereira; Varise, Eliana Maria; Filho, Wilson Jacob; Pompeu, José Eduardo

2017-01-01

Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases the vulnerability to develop functional dependency and/or death. Studies have shown that the most commonly studied exercise protocol for frail older adults is the multimodal training. Interactive video games (IVGs) involve tasks in virtual environments that combine physical and cognitive demands in an attractive and challenging way. The aim of this study will be to evaluate the feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus TM (NWFP) for frail older adults. The study is a randomized controlled, parallel group, feasibility trial. Participants will be randomly assigned to the experimental group (EG) and control group (CG). The EG will participate in 14 training sessions, each lasting 50 min, twice a week. In each training session, the participants will play five games, with three attempts at each game. The first attempt will be performed with the assistance of a physical therapist to correct the movements and posture of the patients and subsequent attempts will be performed independently. Scores achieved in the games will be recorded. The participants will be evaluated by a blinded physical therapist at three moments: before and after intervention and 30 days after the end of the intervention (follow-up). We will assess the feasibility, acceptability, safety, and clinical outcomes (postural control, gait, cognition, quality of life, mood, and fear of falling). Due to the deficiencies in multiple systems, studies have shown that multimodal interventions including motor-cognitive stimulation can improve the mobility of frail elderly adults. IVGs, among them the NWFP, are considered as a multimodal motor-cognitive intervention that can potentially improve motor and cognitive functions in the frail elderly. However, there is still no evidence in the literature that proves the feasibility, safety, acceptability, and functional outcomes of this intervention in frail elderly individuals. Brazilian Registry of Clinical Trials (RBR-823rst). World Health Organization Trial Registration Data Set (Additional file 1).

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

PubMed Central

2013-01-01

Background Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. Methods We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. Results The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. Conclusions We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions. PMID:24160371

Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.

PubMed

Carson, James W; Carson, Kimberly M; Olsen, Maren K; Sanders, Linda; Porter, Laura S

2017-03-13

Women with metastatic breast cancer (MBC) have average life expectancies of about 2 years, and report high levels of disease-related symptoms including pain, fatigue, sleep disturbance, psychological distress, and functional impairment. There is growing recognition of the limitations of medical approaches to managing such symptoms. Yoga is a mind-body discipline that has demonstrated a positive impact on psychological and functional health in early stage breast cancer patients and survivors, but has not been rigorously studied in advanced cancer samples. This randomized controlled trial examines the feasibility and initial efficacy of a Mindful Yoga program, compared with a social support condition that controls for attention, on measures of disease-related symptoms such as pain and fatigue. The study will be completed by December 2017. Sixty-five women with MBC age ≥ 18 are being identified and randomized with a 2:1 allocation to Mindful Yoga or a support group control intervention. The 120-min intervention sessions take place weekly for 8 weeks. The study is conducted at an urban tertiary care academic medical center located in Durham, North Carolina. The primary feasibility outcome is attendance at intervention sessions. Efficacy outcomes include pain, fatigue, sleep quality, psychological distress, mindfulness and functional capacity at post-intervention, 3-month follow-up, and 6-month follow-up. In this article, we present the challenges of designing a randomized controlled trial with long-term follow-up among women with MBC. These challenges include ensuring adequate recruitment including of minorities, limiting and controlling for selection bias, tailoring of the yoga intervention to address special needs, and maximizing adherence and retention. This project will provide important information regarding yoga as an intervention for women with advanced cancer, including preliminary data on the psychological and functional effects of yoga for MBC patients. This investigation will also establish rigorous methods for future research into yoga as an intervention for this population. ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.

The effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial.

PubMed

Moyle, Wendy; Cooke, Marie; O'Dwyer, Siobhan T; Murfield, Jenny; Johnston, Amy; Sung, Billy

2013-02-18

Caring for a person with dementia can be physically and emotionally demanding, with many long-term care facility staff experiencing increased levels of stress and burnout. Massage has been shown to be one way in which nurses' stress can be reduced. However, no research has been conducted to explore its effectiveness for care staff working with older people with dementia in long-term care facilities. This was a pilot, parallel group, randomized controlled trial aimed at exploring feasibility for a larger randomized controlled trial. Nineteen staff, providing direct care to residents with dementia and regularly working ≥ two day-shifts a week, from one long-term care facility in Queensland (Australia), were randomized into either a foot massage intervention (n=9) or a silent resting control (n=10). Each respective session lasted for 10-min, and participants could receive up to three sessions a week, during their allocated shift, over four-weeks. At pre- and post-intervention, participants were assessed on self-report outcome measures that rated mood state and experiences of working with people with dementia. Immediately before and after each intervention/control session, participants had their blood pressure and anxiety measured. An Intention To Treat framework was applied to the analyses. Individual qualitative interviews were also undertaken to explore participants' perceptions of the intervention. The results indicate the feasibility of undertaking such a study in terms of: recruitment; the intervention; timing of intervention; and completion rates. A change in the intervention indicated the importance of a quiet, restful environment when undertaking a relaxation intervention. For the psychological measures, although there were trends indicating improvement in mood there was no significant difference between groups when comparing their pre- and post- scores. There were significant differences between groups for diastolic blood pressure (p= 0.04, partial η2=0.22) and anxiety (p= 0.02, partial η2=0.31), with the foot massage group experiencing greatest decreases immediately after the session. The qualitative interviews suggest the foot massage was well tolerated and although taking staff away from their work resulted in some participants feeling guilty about taking time out, a 10-min foot massage was feasible during a working shift. This pilot trial provides data to support the feasibility of the study in terms of recruitment and consent, the intervention and completion rates. Although the outcome data should be treated with caution, the pilot demonstrated the foot massage intervention showed trends in improved mood, reduced anxiety and lower blood pressure in long-term care staff working with older people with dementia. A larger study is needed to build on these promising, but preliminary, findings. ACTRN: ACTRN12612000659808.

Feasibility and effects of newly developed balance control trainer for mobility and balance in chronic stroke patients: a randomized controlled trial.

PubMed

Lee, So Hyun; Byun, Seung Deuk; Kim, Chul Hyun; Go, Jin Young; Nam, Hyeon Uk; Huh, Jin Seok; Jung, Tae Du

2012-08-01

To investigate the feasibility and effects of balance training with a newly developed Balance Control Trainer (BCT) that applied the concept of vertical movement for the improvements of mobility and balance in chronic stroke patients. Forty chronic stroke patients were randomly assigned to an experimental or a control group. The experimental group (n=20) underwent training with a BCT for 20 minutes a day, 5 days a week for 4 weeks, in addition to concurrent conventional physical therapy. The control group (n=20) underwent only conventional therapy for 4 weeks. All participants were assessed by: the Functional Ambulation Categories (FAC), 10-meter Walking Test (10mWT), Timed Up and Go test (TUG), Berg Balance Scale (BBS), Korean Modified Barthel Index (MBI), and Manual Muscle Test (MMT) before training, and at 2 and 4 weeks of training. There were statistically significant improvements in all parameters except knee extensor power at 2 weeks of treatment, and in all parameters except MBI which showed further statistically significant progress in the experimental group over the next two weeks (p<0.05). Statistically significant improvements on all measurements were observed in the experimental group after 4 weeks total. Comparing the two groups at 2 and 4 weeks of training respectively, 10mWT, TUG, and BBS showed statistically more significant improvements in the experimental group (p<0.05). Balance training with a newly developed BCT is feasible and may be an effective tool to improve balance and gait in ambulatory chronic stroke patients. Furthermore, it may provide additional benefits when used in conjunction with conventional therapies.

Texting to Increase Adolescent Physical Activity: Feasibility Assessment

PubMed Central

Thompson, Debbe; Cantu, Dora; Ramirez, Betsy; Cullen, Karen W.; Baranowski, Tom; Mendoza, Jason; Anderson, Barbara; Jago, Russell; Rodgers, Wendy; Liu, Yan

2016-01-01

Objective Feasibility trials assess whether a behavior change program warrants a definite trial evaluation. This paper reports the feasibility of an intervention consisting of Self Determination Theory-informed text messages, pedometers, and goal prompts to increase adolescent physical activity. Methods A four-group randomized design with baseline and immediate post-study assessments was used. Groups (pedometer; pedometer + goal prompt; pedometer + goal prompt + theory-informed texts; no-treatment control) were systematically varied to assess the additive effect of intervention components on objectively-measured physical activity (ie, ActiGraph). The primary outcome of the 12-week intervention was program feasibility. Changes in average daily step counts and minutes of moderate-to-vigorous physical activity were also examined. Post-intervention research with a sub-set of participants examined program reactions. Results Participants (N = 160) were evenly split by sex, mostly 14-15 years old, and of diverse race/ethnicity. Feasibility criteria were met. Attrition rate was less than two percent. Modest increases in average daily step counts and moderate-to-vigorous physical activity were observed in all groups except the control group. Participants reported positive reactions to the intervention. Conclusions An intervention consisting of pedometers, theory-informed texts, and goal prompts, is a feasible and acceptable method for promoting physical activity to adolescents. PMID:27338994

National randomized controlled trial of virtual house calls for Parkinson disease.

PubMed

Beck, Christopher A; Beran, Denise B; Biglan, Kevin M; Boyd, Cynthia M; Dorsey, E Ray; Schmidt, Peter N; Simone, Richard; Willis, Allison W; Galifianakis, Nicholas B; Katz, Maya; Tanner, Caroline M; Dodenhoff, Kristen; Aldred, Jason; Carter, Julie; Fraser, Andrew; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Reichwein, Suzanne; Mari, Zoltan; Dunlop, Becky; Morgan, John C; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Mejia, Nicte I; Bwala, Grace; Nance, Martha; Shih, Ludy C; Singer, Carlos; Vargas-Parra, Silvia; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Dhall, Rohit; Hassan, Anhar; DeMello, Steven; Riggare, Sara S; Wicks, Paul; Achey, Meredith A; Elson, Molly J; Goldenthal, Steven; Keenan, H Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E Anna; Zhu, William

2017-09-12

To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable. In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings. A total of 927 individuals indicated interest, 210 were enrolled, and 195 were randomized. Participants had recently seen a specialist (73%) and were largely college-educated (73%) and white (96%). Ninety-five (98% of the intervention group) completed at least one virtual visit, and 91% of 388 virtual visits were completed. Quality of life did not improve in those receiving virtual house calls (0.3 points worse on a 100-point scale; 95% confidence interval [CI] -2.0 to 2.7 points; p = 0.78) nor did quality of care or caregiver burden. Each virtual house call saved patients a median of 88 minutes (95% CI 70-120; p < 0.0001) and 38 miles per visit (95% CI 36-56; p < 0.0001). Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience. NCT02038959. This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type. © 2017 American Academy of Neurology.

Feasibility and acceptability of a child sexual abuse prevention program for childcare professionals: comparison of a web-based and in-person training.

PubMed

Rheingold, Alyssa A; Zajac, Kristyn; Patton, Meghan

2012-01-01

Recent prevention research has established the efficacy of some child sexual abuse prevention programs targeting adults; however, less is known about the feasibility of implementing such programs. The current study examines the feasibility and acceptability of a child sexual abuse prevention program for child care professionals provided in two different formats: in person and Web based. The sample consisted of 188 child care professionals from a large-scale, multisite, randomized controlled trial. Findings indicate that both in-person and online training formats are feasible to implement and acceptable to professionals. When comparing formats, the in-person format was favored in terms of comfort level and likelihood of sharing information with others. These findings have significant implications for dissemination of child sexual abuse prevention programs for child care professionals.

Aquatic Exercise Therapy for People With Parkinson Disease: A Randomized Controlled Trial.

PubMed

Carroll, Louise M; Volpe, Daniele; Morris, Meg E; Saunders, Jean; Clifford, Amanda M

2017-04-01

To evaluate the effects of aquatic exercise therapy on gait variability and disability compared with usual care for people with Parkinson disease (PD). Single-blind randomized controlled trial. Community-based hydrotherapy pool. Individuals with PD (Hoehn-Yahr stages I-III) (N=21). Participants were randomly assigned to either an aquatic exercise therapy group (45min, twice a week for 6wk) or a group that received usual care. The primary outcome measure was gait variability as measured using a motion capture system. Secondary outcomes were quality of life measured on the Parkinson's Disease Questionnaire-39 and freezing of gait and motor disability quantified by the Unified Parkinson's Disease Rating Scale. Feasibility was evaluated by measuring safety, adverse events, and participant satisfaction. People in the aquatic therapy group and usual care group showed similar small improvements in gait variability. The aquatic therapy group showed greater improvements in disability than the usual care group (P<.01). No differences between groups or over time were identified for freezing of gait or quality of life. Aquatic therapy sessions were safe and enjoyable with no adverse events. Aquatic therapy appears feasible and safe for some people in the early stages of PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Feasibility and acceptability of two incentive-based implementation strategies for mental health therapists implementing cognitive-behavioral therapy: a pilot study to inform a randomized controlled trial.

PubMed

Beidas, Rinad S; Becker-Haimes, Emily M; Adams, Danielle R; Skriner, Laura; Stewart, Rebecca E; Wolk, Courtney Benjamin; Buttenheim, Alison M; Williams, Nathaniel J; Inacker, Patricia; Richey, Elizabeth; Marcus, Steven C

2017-12-15

Informed by our prior work indicating that therapists do not feel recognized or rewarded for implementation of evidence-based practices, we tested the feasibility and acceptability of two incentive-based implementation strategies that seek to improve therapist adherence to cognitive-behavioral therapy for youth, an evidence-based practice. This study was conducted over 6 weeks in two community mental health agencies with therapists (n = 11) and leaders (n = 4). Therapists were randomized to receive either a financial or social incentive if they achieved a predetermined criterion on adherence to cognitive-behavioral therapy. In the first intervention period (block 1; 2 weeks), therapists received the reward they were initially randomized to if they achieved criterion. In the second intervention period (block 2; 2 weeks), therapists received both rewards if they achieved criterion. Therapists recorded 41 sessions across 15 unique clients over the project period. Primary outcomes included feasibility and acceptability. Feasibility was assessed quantitatively. Fifteen semi-structured interviews were conducted with therapists and leaders to assess acceptability. Difference in therapist adherence by condition was examined as an exploratory outcome. Adherence ratings were ascertained using an established and validated observational coding system of cognitive-behavioral therapy. Both implementation strategies were feasible and acceptable-however, modifications to study design for the larger trial will be necessary based on participant feedback. With respect to our exploratory analysis, we found a trend suggesting the financial reward may have had a more robust effect on therapist adherence than the social reward. Incentive-based implementation strategies can be feasibly administered in community mental health agencies with good acceptability, although iterative pilot work is essential. Larger, fully powered trials are needed to compare the effectiveness of implementation strategies to incentivize and enhance therapists' adherence to evidence-based practices such as cognitive-behavioral therapy.

Mentalization-based therapy for parents in entrenched conflict: A random allocation feasibility study.

PubMed

Hertzmann, Leezah; Target, Mary; Hewison, David; Casey, Polly; Fearon, Pasco; Lassri, Dana

2016-12-01

To explore the effectiveness of a mentalization-based therapeutic intervention specifically developed for parents in entrenched conflict over their children. To the best of our knowledge, this is the first randomized controlled intervention study in the United Kingdom to work with both parents postseparation, and the first to focus on mentalization in this situation. Using a mixed-methods study design, 30 parents were randomly allocated to either mentalization-based therapy for parental conflict-Parenting Together, or the Parents' Group, a psycho-educational intervention for separated parents based on elements of the Separated Parents Information Program-part of the U.K. Family Justice System and approximating to treatment as usual. Given the challenges of recruiting parents in these difficult circumstances, the sample size was small and permitted only the detection of large differences between conditions. The data, involving repeated measures of related individuals, was explored statistically, using hierarchical linear modeling, and qualitatively. Significant findings were reported on the main predicted outcomes, with clinically important trends on other measures. Qualitative findings further contributed to the understanding of parents' subjective experience, pre- and posttreatment. Findings indicate that a larger scale randomized controlled trial would be worthwhile. These encouraging findings shed light on the dynamics maintaining these high-conflict situations known to be damaging to children. We established that both forms of intervention were acceptable to most parents, and we were able to operate a random allocation design with extensive quantitative and qualitative assessments of the kind that would make a larger-scale trial feasible and productive. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial

PubMed Central

Atukunda, Esther C; Tumuhimbise, Wilson; Pisarski, Emily E; Tam, Melanie; Wyatt, Monique A; Ware, Norma C; Haberer, Jessica E

2018-01-01

Background Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. Objective The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. Methods Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. Results A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility—the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. Conclusions Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. Trial Registration ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa) PMID:29773527

A feasibility study of a psychoeducational intervention program for gynecological cancer patients.

PubMed

Chow, Ka Ming; Chan, Carmen W H; Chan, Joanne C Y; Choi, Kai K C; Siu, K Y

2014-08-01

This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients. A single-blinded randomized controlled trial and mixed-method design were used. Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment. They were randomly assigned to the intervention group, in which a psychoeducational intervention program based on a thematic counseling model was offered, or to the attention control group. Quantitative data on sexual functioning, quality of life, uncertainty, anxiety, depression and social support were collected at recruitment, post-operative and during the in-hospital period, and eight weeks after the operation. Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews. Of the 30 eligible subjects, 26 were successfully recruited into the study. Following the psychoeducational intervention program, there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group. In addition, trends towards improvement were demonstrated in quality of life, uncertainty, depression and perceived social support with the provision of the interventions. Qualitative data indicated the interventions were desired and appreciated by the participants, as well as being feasible and practical to implement in Hong Kong clinical settings. The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients. A full-scale study is warranted to confirm the results. Copyright © 2014 Elsevier Ltd. All rights reserved.

A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial.

PubMed

Mansell, Warren; Tai, Sara; Clark, Alexandra; Akgonul, Savas; Dunn, Graham; Davies, Linda; Law, Heather; Morriss, Richard; Tinning, Neil; Morrison, Anthony P

2014-10-24

Existing psychological therapies for bipolar disorders have been found to have mixed results, with a consensus that they provide a significant, but modest, effect on clinical outcomes. Typically, these approaches have focused on promoting strategies to prevent future relapse. An alternative treatment approach, termed 'Think Effectively About Mood Swings' (TEAMS) addresses current symptoms, including subclinical hypomania, depression and anxiety, and promotes long-term recovery. Following the publication of a theoretical model, a range of research studies testing the model and a case series have demonstrated positive results. The current study reports the protocol of a feasibility randomized controlled trial to inform a future multi-centre trial. A target number of 84 patients with a diagnosis of bipolar I or II disorder, or bipolar disorder not-otherwise-specified are screened, allocated to a baseline assessment and randomized to either 16 sessions of TEAMS therapy plus treatment-as-usual (TAU) or TAU. Patients complete self-report inventories of depression, anxiety, recovery status and bipolar cognitions targeted by TEAMS. Assessments of diagnosis, bipolar symptoms, medication, access to services and quality of life are conducted by assessors blind to treatment condition at 3, 6, 12 and 18 months post-randomization. The main aim is to evaluate recruitment and retention of participants into both arms of the study, as well as adherence to therapy, to determine feasibility and acceptability. It is predicted that TEAMS plus TAU will reduce self-reported depression in comparison to TAU alone at six months post-randomization. The secondary hypotheses are that TEAMS will reduce the severity of hypomanic symptoms and anxiety, reduce bipolar cognitions, improve social functioning and promote recovery compared to TAU alone at post-treatment and follow-up. The study also incorporates semi-structured interviews about the experiences of previous treatment and the experience of TEAMS therapy that will be subject to qualitative analyses to inform future developments of the approach. The design will provide preliminary evidence of efficacy, feasibility, acceptability, uptake, attrition and barriers to treatment to design a definitive trial of this novel intervention compared to treatment as usual. This trial was registered with Current Controlled Trials (ISRCTN83928726) on registered 25 July 2014.

Feasibility and Acceptability of Internet-delivered Cognitive Behavioral Therapy for Chronic Pain in Adolescents With Sickle Cell Disease and Their Parents.

PubMed

Palermo, Tonya M; Dudeney, Joanne; Santanelli, James P; Carletti, Alexie; Zempsky, William T

2018-03-01

Pain is a clinical hallmark of sickle cell disease (SCD), and is rarely optimally managed. Cognitive-behavioral therapy (CBT) for pain has been effectively delivered through the Internet in other pediatric populations. We tested feasibility and acceptability of an Internet-delivered CBT intervention in 25 adolescents with SCD (64% female, mean age=14.8 y) and their parents randomized to Internet CBT (n=15) or Internet Pain Education (n=10). Participants completed pretreatment/posttreatment measures. Eight dyads completed semistructured interviews to evaluate treatment acceptability. Feasibility indicators included recruitment and participation rates, engagement and adherence to intervention, and completion of outcome measures. In total, 87 referrals were received from 9 study sites; our recruitment rate was 60% from those families approached for screening. Among participants, high levels of initial intervention engagement (>90%), and adherence (>70%) were demonstrated. Most participants completed posttreatment outcome and diary measures (>75%). Retention at posttreatment was 80%. High treatment acceptability was reported in interviews. Our findings suggest that Internet-delivered CBT for SCD pain is feasible and acceptable to adolescents with SCD and their parents. Engagement and adherence were good. Next steps are to modify recruitment plans to enhance enrollment and determine efficacy of Internet CBT for SCD pain in a large multisite randomized controlled trial.

Effects of tai chi qigong on psychosocial well-being among hidden elderly, using elderly neighborhood volunteer approach: a pilot randomized controlled trial.

PubMed

Chan, Aileen Wk; Yu, Doris Sf; Choi, K C

2017-01-01

To test the feasibility and preliminary effectiveness of a tai chi qigong program with the assistance of elderly neighborhood volunteers in strengthening social networks and enhancing the psychosocial well-being of hidden elderly. "Hidden elderly" is a term used to describe older adults who are socially isolated and refuse social participation. This pilot randomized controlled trial recruited 48 older adults aged 60 or above who did not engage in any social activity. They were randomized into tai chi qigong (n=24) and standard care control (n=24) groups. The former group underwent a three-month program of two 60-minute sessions each week, with the socially active volunteers paired up with them during practice. Standard care included regular home visits by social workers. Primary outcomes were assessed by means of the Lubben social network and De Jong Gieveld loneliness scales, and by a revised social support questionnaire. Secondary outcomes were covered by a mental health inventory and the Rosenberg self-esteem scale, and quality of life by using the 12-Item Short Form Health Survey. Data was collected at baseline, and at three and six months thereafter. The generalized estimating equations model revealed general improvement in outcomes among participants on the tai chi qigong program. In particular, participants reported a significantly greater improvement on the loneliness scale ( B =-1.32, 95% confidence interval [CI] -2.54 to -0.11, P =0.033) and the satisfaction component of the social support questionnaire ( B =3.43, 95% CI 0.10-6.76, P =0.044) than the control group. The pilot study confirmed that tai chi qigong with elderly neighborhood volunteers is a safe and feasible social intervention for hidden elderly. Its potential benefits in improving social and psychological health suggest the need for a full-scale randomized controlled trial to reveal its empirical effects.

A Randomized Controlled Trial of the Child Anxiety Multi-Day Program (CAMP) for Separation Anxiety Disorder

ERIC Educational Resources Information Center

Santucci, Lauren C.; Ehrenreich-May, Jill

2013-01-01

While the efficacy of cognitive behavior therapy for childhood anxiety disorders, including separation anxiety disorder (SAD), has been established, tailoring such treatments to particular interests and needs may enhance uptake of evidence-based interventions. The current investigation evaluates the feasibility and preliminary efficacy of an…

MAP Markers: Research and Evaluation of the Mutual Agreement Program. Resource Document No. 5.

ERIC Educational Resources Information Center

Robison, James O.

This report is an evaluation, using randomized experimental/control design, of a program involving negotiated contractual agreements (MAP) between prisoners and parole boards for specific parole dates contingent on performance in work, training and treatment activities. Contracts were generally for less than six months. Both feasibility and…

Motivational Enhancement Therapy for Adolescent Marijuana Users: A Preliminary Randomized Controlled Trial

ERIC Educational Resources Information Center

Walker, Denise D.; Roffman, Roger A.; Stephens, Robert S.; Wakana, Kim; Berghuis, James

2006-01-01

This study's aims were (a) to investigate the feasibility of a school-based motivational enhancement therapy (MET) intervention in voluntarily attracting adolescents who smoke marijuana regularly but who are not seeking formal treatment and (b) to evaluate the efficacy of the intervention in reducing marijuana use. Ninety-seven adolescents who had…

Creating Mandalas for the Management of Acute Pain Symptoms in Pediatric Patients

ERIC Educational Resources Information Center

Stinley, Nora E.; Norris, Deborah O.; Hinds, Pamela S.

2015-01-01

This randomized controlled clinical trial explored the feasibility of implementing a fast-acting mandala intervention to reduce physical pain and psychological anxiety experienced during needle sticks. Forty pediatric patients participated in this two-group study: 20 participants created a mandala on an iPad (Treatment Group) and 20 participants…

Influencing Alcohol Control Policies and Practices at Community Festivals

ERIC Educational Resources Information Center

Toomey, Traci L.; Fabian, Lindsey A.; Erickson, Darin J.; Wagenaar, Alexander C.; Fletcher, Linda; Lenk, Kathleen M.

2006-01-01

The goal of this study was to assess the feasibility and effectiveness of two interventions aimed at reducing alcohol-related risks at community festivals--a training program for festival planners and a community organizing campaign. We randomly selected four festivals for each intervention and had 24 comparison festivals. Our assessment included…

PROMOTING GROSS MOTOR SKILLS IN TODDLERS: THE ACTIVE BEGINNINGS PILOT CLUSTER RANDOMIZED TRIAL.

PubMed

Veldman, Sanne L C; Okely, Anthony D; Jones, Rachel A

2015-12-01

This study examined the feasibility, acceptability, and potential efficacy of a gross motor skill program for toddlers. An 8-wk. skills program in which children practiced three skills was implemented for 10 min. daily in two randomly designated childcare centers. Two other centers served as the control group. Recruitment and retention rates were collected for feasibility. Data on professional development, children's participation, program duration, and appropriateness of the lessons were collected for acceptability, and the Test of Gross Motor Development-2 and Get Skilled, Get Active (total of 28 points) were used to look at the potential efficacy. The participants were 60 toddlers (M age=2.5 yr., SD=0.4; n=29 boys), and the retention rate was 95%. Overall participation was 76%, and educators rated 98% of the lessons as appropriate. Compared with the control group, the intervention group showed significantly greater improvements in motor skills (p<.05, Cohen's d=1.13). This study shows that a brief intervention, which is easy to integrate on a daily basis in childcare settings, can improve motor skills among toddlers.

Feasibility, Acceptability, and Preliminary Effects of the COPE Online Cognitive-Behavioral Skill-Building Program on Mental Health Outcomes and Academic Performance in Freshmen College Students: A Randomized Controlled Pilot Study.

PubMed

Melnyk, Bernadette Mazurek; Amaya, Megan; Szalacha, Laura A; Hoying, Jacqueline; Taylor, Tiffany; Bowersox, Kristen

2015-08-01

Despite the increasing prevalence of mental health disorders in university students, few receive needed evidence-based treatment. The purpose of this study was to assess the feasibility and preliminary effects of a seven-session online cognitive-behavioral skill-building intervention (i.e., COPE, Creating Opportunities for Personal Empowerment) versus a comparison group on their anxiety, depressive symptoms, and grade performance. A randomized controlled pilot study was conducted from September 2012 to May 2013 with 121 college freshmen enrolled in a required one credit survey course. Although there were no significant differences in anxiety and depressive symptoms between the groups, only COPE students with an elevated level of anxiety at baseline had a significant decline in symptoms. Grade point average was higher in COPE versus comparison students. Evaluations indicated that COPE was a positive experience for students. COPE is a promising brief intervention that can be integrated effectively into a required freshman course. © 2015 Wiley Periodicals, Inc.

Adipose-derived mesenchymal stem cells (AdMSC) for the treatment of secondary-progressive multiple sclerosis: A triple blinded, placebo controlled, randomized phase I/II safety and feasibility study.

PubMed

Fernández, Oscar; Izquierdo, Guillermo; Fernández, Victoria; Leyva, Laura; Reyes, Virginia; Guerrero, Miguel; León, Antonio; Arnaiz, Carlos; Navarro, Guillermo; Páramo, Maria Dolores; Cuesta, Antonio De la; Soria, Bernat; Hmadcha, Abdelkrim; Pozo, David; Fernandez-Montesinos, Rafael; Leal, Maria; Ochotorena, Itziar; Gálvez, Patricia; Geniz, Maria Angeles; Barón, Francisco Javier; Mata, Rosario; Medina, Cristina; Caparrós-Escudero, Carlos; Cardesa, Ana; Cuende, Natividad

2018-01-01

Currently available treatments for secondary progressive multiple sclerosis(SPMS) have limited efficacy and/or safety concerns. Adipose-mesenchymal derived stem cells(AdMSCs) represent a promising option and can be readily obtained using minimally invasive procedures. In this triple-blind, placebo-controlled study, cell samples were obtained from consenting patients by lipectomy and subsequently expanded. Patients were randomized to a single infusion of placebo, low-dose(1x106cells/kg) or high-dose(4x106cells/kg) autologous AdMSC product and followed for 12 months. Safety was monitored recording adverse events, laboratory parameters, vital signs and spirometry. Expanded disability status score (EDSS), magnetic-resonance-imaging, and other measures of possible treatment effects were also recorded. Thirty-four patients underwent lipectomy for AdMSCs collection, were randomized and thirty were infused (11 placebo, 10 low-dose and 9 high-dose); 4 randomized patients were not infused because of karyotype abnormalities in the cell product. Only one serious adverse event was observed in the treatment arms (urinary infection, considered not related to study treatment). No other safety parameters showed changes. Measures of treatment effect showed an inconclusive trend of efficacy. Infusion of autologous AdMSCs is safe and feasible in patients with SPMS. Larger studies and probably treatment at earlier phases would be needed to investigate the potential therapeutic benefit of this technique.

The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study.

PubMed

Sturkenboom, Ingrid H; Graff, Maud J; Borm, George F; Veenhuizen, Yvonne; Bloem, Bastiaan R; Munneke, Marten; Nijhuis-van der Sanden, Maria W

2013-02-01

To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at three months. Forty-three community-dwelling patients with Parkinson's disease and difficulties in daily activities, their primary caregivers and seven occupational therapists. Ten weeks of home-based occupational therapy according to the Dutch guidelines of occupational therapy in Parkinson's disease versus no occupational therapy in the control group. Process evaluation measured accrual, drop-out, intervention delivery and protocol adherence. Primary outcome measures of patients assessed daily functioning: Canadian Occupational Performance Measure (COPM) and Assessment of Motor and Process Skills. Primary outcome for caregivers was caregiver burden: Zarit Burden Inventory. Participants' perspectives of the intervention were explored using questionnaires and in-depth interviews. Inclusion was 23% (43/189), drop-out 7% (3/43) and unblinding of assessors 33% (13/40). Full intervention protocol adherence was 74% (20/27), but only 60% (71/119) of baseline Canadian Occupational Performance Measure priorities were addressed in the intervention. The outcome measures revealed negligible to small effects in favour of the intervention group. Almost all patients and caregivers of the intervention group were satisfied with the results. They perceived: 'more grip on the situation' and used 'practical advices that make life easier'. Therapists were satisfied, but wished for a longer intervention period. The positive perceived impact of occupational therapy warrants a large-scale trial. Adaptations in instructions and training are needed to use the Canadian Occupational Performance Measure as primary outcome measure.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

An interactive health communication application for supporting parents managing childhood long-term conditions: outcomes of a randomized controlled feasibility trial.

PubMed

Swallow, Veronica M; Knafl, Kathleen; Santacroce, Sheila; Campbell, Malcolm; Hall, Andrew G; Smith, Trish; Carolan, Ian

2014-12-03

Families living with chronic or long-term conditions such as chronic kidney disease (CKD), stages 3-5, face multiple challenges and respond to these challenges in various ways. Some families adapt well while others struggle, and family response to a condition is closely related to outcome. With families and professionals, we developed a novel condition-specific interactive health communication app to improve parents' management ability-the online parent information and support (OPIS) program. OPIS consists of a comprehensive mix of clinical caregiving and psychosocial information and support. The purpose of this study was to (1) assess feasibility of a future full-scale randomized controlled trial (RCT) of OPIS in terms of recruitment and retention, data collection procedures, and psychometric performance of the study measures in the target population, and (2) investigate trends in change in outcome measures in a small-scale RCT in parents of children with CKD stages 3-5. Parents were recruited from a pediatric nephrology clinic and randomly assigned to one of two treatment groups: usual support for home-based clinical caregiving (control) or usual support plus password-protected access to OPIS for 20 weeks (intervention). Both groups completed study measures at study entry and exit. We assessed feasibility descriptively in terms of recruitment and retention rates overall; assessed recruitment, retention, and uptake of the intervention between groups; and compared family condition management, empowerment to deliver care, and fathers' involvement between groups. We recruited 55 parents of 39 children (42% of eligible families). Of those, about three-quarters of intervention group parents (19/26, 73%) and control group parents (22/29, 76%) were retained through completion of 20-week data collection. The overall retention rate was 41/55 (75%). The 41 parents completing the trial were asked to respond to the same 10 questionnaire scales at both baseline and 20 weeks later; 10 scores were missing at baseline and nine were missing at 20 weeks. Site user statistics provided evidence that all intervention group parents accessed OPIS. Analysis found that intervention group parents showed a greater improvement in perceived competence to manage their child's condition compared to control group parents: adjusted mean Family Management Measure (FaMM) Condition Management Ability Scale intervention group 44.5 versus control group 41.9, difference 2.6, 95% CI -1.6 to 6.7. Differences between the groups in the FaMM Family Life Difficulty Scale (39.9 vs 36.3, difference 3.7, 95% CI -4.9 to 12.2) appeared to agree with a qualitative observation that OPIS helped parents achieve understanding and maintain awareness of the impact of their child's condition. A full-scale RCT of the effectiveness of OPIS is feasible. OPIS has the potential to beneficially affect self-reported outcomes, including parents' perceived competence to manage home-based clinical care for children with CKD stage 3-5. Our design and methodology can be transferred to the management of other childhood conditions. International Standard Randomized Controlled Trial Number (ISRCTN): 84283190; http://www.controlled-trials.com/ISRCTN84283190 (Archived by WebCite at http://www.webcitation.org/6TuPdrXTF).

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

PubMed

Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

Early vibration assisted physiotherapy in toddlers with cerebral palsy - a randomized controlled pilot trial.

PubMed

Stark, C; Herkenrath, P; Hollmann, H; Waltz, S; Becker, I; Hoebing, L; Semler, O; Hoyer-Kuhn, H; Duran, I; Hero, B; Hadders-Algra, M; Schoenau, E

2016-09-07

to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function.

Early vibration assisted physiotherapy in toddlers with cerebral palsy – a randomized controlled pilot trial

PubMed Central

Stark, C.; Herkenrath, P.; Hollmann, H.; Waltz, S.; Becker, I.; Hoebing, L.; Semler, O.; Hoyer-Kuhn, H.; Duran, I.; Hero, B.; Hadders-Algra, M.; Schoenau, E.

2016-01-01

Objectives: to investigate feasibility, safety and efficacy of home-based side-alternating whole body vibration (sWBV) to improve motor function in toddlers with cerebral palsy (CP). Methods: Randomized controlled trial including 24 toddlers with CP (mean age 19 months (SD±3.1); 13 boys). Intervention: 14 weeks sWBV with ten 9-minute sessions weekly (non-individualized). Group A started with sWBV, followed by 14 weeks without; in group B this order was reversed. Feasibility (≥70% adherence) and adverse events were recorded; efficacy evaluated with the Gross Motor Function Measure (GMFM-66), Pediatric Evaluation of Disability Inventory (PEDI), at baseline (T0), 14 (T1) and 28 weeks (T2). Results: Developmental change between T0 and T1 was similar in both groups; change scores in group A and B: GMFM-66 2.4 (SD±2.1) and 3.3 (SD±2.9) (p=0.412); PEDI mobility 8.4 (SD±6.6) and 3.5 (SD±9.2) (p=0.148), respectively. In two children muscle tone increased post-sWBV. 24 children received between 67 and 140 sWBV sessions, rate of completed sessions ranged from 48 to 100% and no dropouts were observed. Conclusion: A 14-week home-based sWBV intervention was feasible and safe in toddlers with CP, but was not associated with improvement in gross motor function. PMID:27609033

Feasibility of a Grocery Store Tour for Parents and Their Adolescents: A Randomized Controlled Pilot Study.

PubMed

Nikolaus, Cassandra J; Graziose, Matthew M; Nickols-Richardson, Sharon M

To evaluate the feasibility of a grocery store tour for parents and their adolescents being led by adults or adolescent peers. Randomized controlled pilot study with surveys at baseline and post-program, and at 3- and 6-month follow-up. Midwestern midsized grocery stores. Sixty-one parents and their 71 11- to 14-year-old adolescents. Nutrition education during 1 90-minute grocery store tour. Process observations and participants' tour perceptions provided fidelity outcomes. Questionnaires quantitatively assessed participants' knowledge, self-efficacy, and tour strategy use. Chi-square and McNemar tests were used to analyze categorical data, and Kruskal-Wallis, Wilcoxon signed-rank, and Mann-Whitney U tests were employed for continuous variables (significance at P < .05). Over 90% of tour tasks were rated as completed well for adult and peer leaders. Participants had positive tour perceptions but noted deficiencies in teen leaders' knowledge and leadership skills. Overall, parents and adolescents retained increased self-efficacy from pre-tour to post-tour intervals. Despite limited knowledge retention, parents reported they had increased (6.5 ± 4.19) healthful grocery shopping behaviors in the 6 months after the intervention. Peers may feasibly lead grocery store tours but they may need additional resources and support to be highly effective. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Feasibility and effectiveness of adding object-related bilateral symmetrical training to mirror therapy in chronic stroke: A randomized controlled pilot study.

PubMed

Rodrigues, Letícia Cardoso; Farias, Nayara Correa; Gomes, Raquel Pinheiro; Michaelsen, Stella Maris

2016-01-01

To evaluate the feasibility and effectiveness of adding object-related bilateral symmetrical training to mirror therapy (MT) to improve upper limb (UL) activity in chronic stroke patients. Sixteen patients with moderate UL impairment were randomly allocated to either the experimental (EG) or control (CG) group. Both groups performed 1 hour sessions, 3 days/week for 4 weeks, involving object-related bilateral symmetrical training. EG performed the tasks observing their nonparetic UL reflected in the mirror, while CG observed the paretic UL directly. The primary outcome measure was unilateral and bilateral UL activity according to the Test d'Évaluation des Membres Supérieurs de Personnes Âgées (TEMPA). All measurements were taken at baseline, post-training, and follow-up (2 weeks). TEMPA total score showed the main effect of time. Significant improvement was found for bilateral but not unilateral tasks. Both groups showed gains after training, with no differences between them. This study showed the feasibility of adding object-related bilateral training to MT. Both types of training improved UL bilateral activity; however, a larger sample is required for a definitive study. Other studies need to be carried out to evaluate the effectiveness of combining more distal-oriented movements and object-related unilateral training to improve these effects in chronic stroke patients.

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

PubMed Central

Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

2013-01-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: postintervention results.

PubMed

Fitzgibbon, Marian L; Stolley, Melinda R; Schiffer, Linda A; Braunschweig, Carol L; Gomez, Sandra L; Van Horn, Linda; Dyer, Alan R

2011-05-01

The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the nine schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the nine control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and postintervention. At postintervention, children in the intervention schools engaged in more moderate-to-vigorous physical activity (MVPA) than children in the control schools (difference between adjusted group means = 7.46 min/day, P = 0.02). Also, children in the intervention group had less total screen time (-27.8 min/day, P = 0.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not on diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision.

A single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol.

PubMed

Wyndow, Narelle; Crossley, Kay M; Vicenzino, Bill; Tucker, Kylie; Collins, Natalie J

2017-01-01

Patellofemoral joint osteoarthritis is a common condition, yet information regarding conservative management is lacking. Foot orthoses are an effective intervention for improving pain and function in younger individuals with patellofemoral pain and may be effective in those with patellofemoral osteoarthritis. This pilot study will seek to establish the feasibility of a phase III randomised controlled trial to investigate whether foot orthoses worn in prescribed motion controlled footwear are superior to prescribed motion control footwear alone in the management of patellofemoral osteoarthritis. This phase II pilot clinical trial is designed as a randomized, single-blind, parallel group, two arm, superiority trial. The trial will recruit 44 participants from Queensland and Tasmania, Australia. Volunteers aged 40 years and over must have clinical symptoms and radiographic evidence of patellofemoral osteoarthritis to be eligible for inclusion. Those eligible will be randomized to receive either foot orthoses and prescribed motion control shoes, or prescribed motion control shoes alone, to be worn for a period of 4 months. The feasibility of a phase III clinical trial will be evaluated by assessing factors such as recruitment rate, number of eligible participants, participant compliance with the study protocol, adverse events, and drop-out rate. A secondary aim of the study will be to determine completion rates and calculate effect sizes for patient reported outcome measures such as knee-related symptoms, function, quality of life, kinesiophobia, self-efficacy, general and mental health, and physical activity at 2 and 4 months. Primary outcomes will be reported descriptively while effect sizes and 95% confidence intervals will be calculated for the secondary outcome measures. Data will be analysed using an intention-to-treat principle. The results of this pilot trial will help determine the feasibility of a phase III clinical trial investigating whether foot orthoses plus motion control footwear are superior to motion control footwear alone in individuals with patellofemoral osteoarthritis. A Phase III clinical trial will help guide footwear and foot orthoses recommendations in the clinical management of this disorder. Retrospectively registered with the Australian New Zealand Clinical Trials Registry: ACTRN12615000002583. Date registered: 07/01/15.

Effectiveness of a fluid chart in outpatient management of suspected dengue fever: A pilot study.

PubMed

Nasir, Nazrila Hairin; Mohamad, Mohazmi; Lum, Lucy Chai See; Ng, Chirk Jenn

2017-01-01

Dengue infection is the fastest spreading mosquito-borne viral disease in the world. One of the complications of dengue is dehydration which, if not carefully monitored and treated, may lead to shock, particularly in those with dengue haemorrhagic fever. WHO has recommended oral fluid intake of five glasses or more for adults who are suspected to have dengue fever. However, there have been no published studies looking at self-care intervention measures to improve oral fluid intake among patients suspected of dengue fever. To assess the feasibility and effectiveness of using a fluid chart to improve oral fluid intake in patients with suspected dengue fever in a primary care setting. This feasibility study used a randomized controlled study design. The data was collected over two months at a primary care clinic in a teaching hospital. The inclusion criteria were: age > 12 years, patients who were suspected to have dengue fever based on the assessment by the primary healthcare clinician, fever for > three days, and thrombocytopenia (platelets < 150 x 109/L). Both groups received a dengue home care card. The intervention group received the fluid chart and a cup (200ml). Baseline clinical and laboratory data, 24-hour fluid recall (control group), and fluid chart were collected. The main outcomes were: hospitalization rates, intravenous fluid requirement and total oral fluid intake. Among the 138 participants who were included in the final analysis, there were fewer hospital admissions in the intervention group (n = 7, 10.0%) than the control group (n = 12, 17.6%) (p = 0.192). Similarly, fewer patients (n = 9, 12.9%) in the intervention group required intravenous fluid compared to the control group (n = 15, 22.1%), (p = 0.154). There was an increase in the amount of daily oral fluid intake in the intervention group (about 3,000 ml) compared to the control group (about 2,500 ml, p = 0.521). However, these differences did not reach statistical significance. This is a feasible and acceptable study to perform in a primary care setting. The fluid chart is a simple, inexpensive tool that may reduce hospitalization and intravenous fluid requirement in suspected dengue patients. A randomized controlled trial with larger sample size is needed to determine this conclusively. International Standard Randomized Controlled Trial Number (ISRCTN) Registry ISRCTN25394628 http://www.isrctn.com/ISRCTN25394628.

A Pilot Randomized Controlled Trial of a Guided Self-Help Intervention to Manage Chronic Orofacial Pain.

PubMed

Goldthorpe, Joanna; Lovell, Karina; Peters, Sarah; McGowan, Linda; Nemeth, Imola; Roberts, Christopher; Aggarwal, Vishal R

2017-01-01

To conduct a pilot trial to test the feasibility of a guided self-help intervention for chronic orofacial pain. A pilot randomized controlled trial was conducted to compare the intervention with usual treatment. A total of 37 patients with chronic orofacial pain were randomized into either the intervention group (n = 19) or the usual treatment (control) group (n = 18). Validated outcome measures were used to measure the potential effectiveness of the intervention over a number of domains: physical and mental functioning (Short Form 36 [SF-36]); anxiety and depression (Hospital Anxiety and Depression Scale [HADS]); pain intensity and interference with life (Brief Pain Inventory [BPI]); disability (Manchester Orofacial Pain Disability Scale [MOPDS]); and illness behavior (Revised Illness Perceptions Questionnaire [IPQr]). Bootstrap confidence intervals were computed for the treatment effect (ES) posttreatment and at 3 months follow-up and adjusted for baseline values of the outcome measure by using analysis of covariance. At posttreatment and the 3-month follow-up, 11 participants in the intervention group and 7 in the control group failed to complete outcome measures. The intervention was acceptable and could be feasibly delivered face to face or over the telephone. Although the pilot trial was not powered to draw conclusions about the effectiveness, it showed significant (P < .05) effects of the intervention on physical and mental functioning and treatment control. The self-help intervention was acceptable to patients and allowed them to better understand and self-manage chronic orofacial pain. It showed potential effectiveness on outcome domains related to functioning and illness perception. Further research is needed to understand the cost effectiveness of the intervention for chronic orofacial pain.

Randomized Trial of a Physical Activity and Meditation Intervention for Young Adult Cancer Survivors.

PubMed

Rabin, Carolyn; Pinto, Bernardine; Fava, Joseph

2016-03-01

Young adult cancer survivors have a number of increased health and psychosocial risks. To minimize these risks, they must address any modifiable risk factors, for example increase their physical activity (PA) and reduce stress. Unfortunately, more than half of young survivors remain sedentary, and few participate in a structured form of relaxation. This study evaluated the feasibility, acceptability, and effects of a theory-based PA and meditation intervention for young survivors. Young adult cancer survivors (age 18-39 years) were randomized to receive the 12-week "RElaxation aNd Exercise for Wellness" (RENEW) intervention right away (intervention group) or after a 12-week wait (control group). Participants were assessed at baseline, 12 weeks, and 24 weeks. Thirty-five survivors were enrolled and randomized. Results indicate that 89% of intervention calls were delivered, and most participants felt that intervention goals and the number and duration of intervention calls were appropriate. Satisfaction ratings indicate that the intervention was acceptable, and 100% of participants would recommend it to others. Comparison of the intervention and control groups at the 12-week assessment (i.e., before controls received the intervention) revealed that the intervention group was performing more minutes of at least moderate intensity PA/week (p = 0.002; M = 113.8, SE = 23.5 vs. M = -8.7, SE = 27.1) and outperformed controls on a test of cardiovascular fitness (p = 0.008; M = -1.76, SE = 0.41 vs. M = -0.03, SE = 0.45). When data from the intervention and control groups were pooled, pre- to post-intervention analyses indicated a trend toward improved mood. This theory-based intervention for young adult cancer survivors was feasible and acceptable, and may have helped survivors increase PA, improve fitness, and enhance mood.

Behavioral Weight Loss for the Management of Menopausal Hot Flashes: A Pilot Study

PubMed Central

Thurston, Rebecca C.; Ewing, Linda J.; Low, Carissa A.; Christie, Aimee J.; Levine, Michele D.

2014-01-01

Objective Although adiposity has been considered protective against hot flashes, newer data suggest positive relations between flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss to reduce hot flashes. Methods Forty overweight/obese women with hot flashes (≥4/day) were randomized to a behavioral weight loss intervention or to wait list control. Hot flashes were assessed pre- and post-intervention via physiologic monitor, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were tested via Wilcoxon tests. Results Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a main motivator to lose weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg, p<.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-week hot flashes: −63.0) than did women in the control (−28.0, p=.03), a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (e.g., r=.47, p=.006). Conclusions This pilot study showed a behavioral weight loss program to be feasible, acceptable, and effective in producing weight loss among overweight/obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior. PMID:24977456

Behavioral weight loss for the management of menopausal hot flashes: a pilot study.

PubMed

Thurston, Rebecca C; Ewing, Linda J; Low, Carissa A; Christie, Aimee J; Levine, Michele D

2015-01-01

Although adiposity has been considered to be protective against hot flashes, newer data suggest positive relationships between hot flashes and adiposity. No studies have been specifically designed to test whether weight loss reduces hot flashes. This pilot study aimed to evaluate the feasibility, acceptability, and initial efficacy of behavioral weight loss in reducing hot flashes. Forty overweight or obese women with hot flashes (≥ 4 hot flashes/d) were randomized to either behavioral weight loss intervention or wait-list control. Hot flashes were assessed before and after intervention via physiologic monitoring, diary, and questionnaire. Comparisons of changes in hot flashes and anthropometrics between conditions were performed via Wilcoxon tests. Study retention (83%) and intervention satisfaction (93.8%) were high. Most women (74.1%) reported that hot flash reduction was a major motivator for losing weight. Women randomized to the weight loss intervention lost more weight (-8.86 kg) than did women randomized to control (+0.23 kg; P < 0.0001). Women randomized to weight loss also showed greater reductions in questionnaire-reported hot flashes (2-wk hot flashes, -63.0) than did women in the control group (-28.0; P = 0.03)-a difference not demonstrated in other hot flash measures. Reductions in weight and hot flashes were significantly correlated (eg, r = 0.47, P = 0.006). This pilot study shows a behavioral weight loss program that is feasible, acceptable, and effective in producing weight loss among overweight or obese women with hot flashes. Findings indicate the importance of a larger study designed to test behavioral weight loss for hot flash reduction. Hot flash management could motivate women to engage in this health-promoting behavior.

Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial.

PubMed

Graetz, Ilana; Anderson, Janeane N; McKillop, Caitlin N; Stepanski, Edward J; Paladino, Andrew J; Tillmanns, Todd D

2018-06-11

Nearly 1 in 5 patients hospitalized for ovarian cancer surgery are readmitted for complications that may have been prevented with monitoring. We conducted a randomized controlled feasibility trial to evaluate a postoperative web-based app intervention to provide real-time symptom monitoring among patients diagnosed or with suspected gynecological cancer who had open bilateral salpingo-oophorectomy surgery. Participants were randomized into two groups: (1) App + Reminder: had access to the app, and use was encouraged with daily and/or weekly reminders; (2) app: had access to the app but received no reminders. The app displayed discharge instructions and queried symptoms. Patients' self-reported health information was integrated into their electronic health records. Outcomes above a predetermined threshold triggered alerts that indicated a patient may need medical intervention. Participants completed a questionnaire at baseline and 30-day follow-up. They were also invited to provide qualitative, post-intervention feedback. We screened 35 patients, with high rates of recruitment (74%, N = 26) and completion (93%, N = 24). Participants in the App + Reminder group had more frequent app use relative to the app group (p = 0.05). Using differences-in-differences (DID) analysis for quality of life, the App + Reminder group had relative increase in the mental health score (DID = 7.51, p = 0.15) but decrease in the physical health score (DID = -7.49, p = 0.13). Participant feedback suggested the relative decrease in physical quality of life was attributable to the app activating patients' focus on physical symptoms, not the intervention. The pilot established feasibility, acceptability, and some potential benefits of a new web-based app intervention for gynecological oncology postoperative care. Copyright © 2018 Elsevier Inc. All rights reserved.

Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial.

PubMed

Causarano, Natalie; Platt, Jennica; Baxter, Nancy N; Bagher, Shaghayegh; Jones, Jennifer M; Metcalfe, Kelly A; Hofer, Stefan O P; O'Neill, Anne C; Cheng, Terry; Starenkyj, Elizabeth; Zhong, Toni

2015-05-01

Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction. We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT. Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen's d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02-1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = -0.60-0.71) and satisfaction with information (0.11, 95 % CI = -0.53-0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06. A pre-consultation educational group intervention improves patients' shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy.

PubMed

Lawrence, J A; Griffin, L; Balcueva, E P; Groteluschen, D L; Samuel, T A; Lesser, G J; Naughton, M J; Case, L D; Shaw, E G; Rapp, S R

2016-02-01

Some breast cancer survivors report cognitive difficulties greater than 1 year after chemotherapy. Acetylcholinesterase inhibitors (AChEI) may improve cognitive impairment. We conducted a randomized, placebo-controlled, pilot study to assess the feasibility of using the AChEI, donepezil, to improve subjective and objective measures of cognitive function in breast cancer survivors. Women who received adjuvant chemotherapy 1-5 years prior with current cognitive dysfunction symptoms were randomized to 5 mg of donepezil/day vs placebo for 6 weeks and if tolerated 10 mg/day for 18 weeks for a total of 24 weeks. A battery of validated measures of attention, memory, language, visuomotor skills, processing speed, executive function, and motor dexterity and speed was administered at baseline and at 24 and 36 weeks. Subjective cognitive function, fatigue, sleep, mood, and health-related quality of life were evaluated at baseline and at 12, 24, and 36 weeks. Sixty-two patients were enrolled, 76 % completed the study, self-reported compliance was 98 %, and toxicities were minimal. At the end of treatment, the donepezil group performed significantly better than the control group on two parameters of memory-the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall (p = 0.033) and HVLT-R Discrimination (p = 0.036). There were no significant differences on other cognitive variables or in subjective cognitive function or quality of life. Accrual to this feasibility trial was robust, retention was good, compliance was excellent, and toxicities were minimal. Randomized clinical trials in breast cancer survivors to improve cognitive dysfunction are feasible. A phase III trial testing the efficacy of donepezil is warranted given these pilot results.

Yo Puedo - a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in San Francisco

PubMed Central

Minnis, Alexandra M.; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S.

2014-01-01

Purpose We designed and evaluated for feasibility an intervention - Yo Puedo - that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing. Methods Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions, and targeted youth 16 to 21 years old and same-aged members of their social network. We conducted a 2-arm study with social networks randomized to the intervention or a standard services control arm. We evaluated intervention uptake, adherence and safety; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and STI risk. Results Seventy-two social networks comprised of 162 youth enrolled, with 92% retention over six months. Seventy-two percent of youth randomized to the intervention participated in intervention activities: 53% received at least one CCT payment; and 66% came to at least one life skills session. We found no evidence that cash payments financed illicit or high-risk behavior. At six months, intervention participants, compared to controls, had a lower odds of hanging out on the street frequently (OR = 0.54, p = 0.10) and a lower odds of reporting their close friends had been incarcerated (OR = 0.6, p=0.12). They reported less regular alcohol use (OR = 0.54, p=0.04) and a lower odds of having sex (OR = 0.50, p = 0.04). Conclusions The feasibility evaluation of Yo Puedo demonstrated its promise; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted. PMID:24518532

Yo Puedo--a conditional cash transfer and life skills intervention to promote adolescent sexual health: results of a randomized feasibility study in san francisco.

PubMed

Minnis, Alexandra M; vanDommelen-Gonzalez, Evan; Luecke, Ellen; Dow, William; Bautista-Arredondo, Sergio; Padian, Nancy S

2014-07-01

We designed and evaluated for feasibility an intervention-Yo Puedo-that addresses social network influences and socioeconomic opportunities in a neighborhood with substantial gang exposure and early childbearing. Yo Puedo combined conditional cash transfers for completion of educational and reproductive health wellness goals with life skills sessions, and targeted youth 16-21 years of age and same-aged members of their social network. We conducted a two-arm study with social networks randomized to the intervention or a standard services control arm. We evaluated intervention uptake, adherence, and safety; and assessed evidence of effects on behavioral outcomes associated with unintended pregnancy and sexually transmitted infection risk. A total of 72 social networks composed of 162 youth enrolled, with 92% retention over 6 months. Seventy-two percent of youth randomized to the intervention participated in intervention activities: 53% received at least one conditional cash transfer payment and 66% came to at least one life skills session. We found no evidence that cash payments financed illicit or high-risk behavior. At 6 months, compared with controls, intervention participants had a lower odds of hanging out on the street frequently (odds ratio [OR], .54; p = .10) and a lower odds of reporting that their close friends had been incarcerated (OR, .6; p = .12). They reported less regular alcohol use (OR, .54; p = .04) and a lower odds of having sex (OR, .50; p = .04). The feasibility evaluation of Yo Puedo demonstrated its promise; a larger evaluation of effects on pregnancy and sustained behavioral changes is warranted. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Developing leadership capacity for guideline use: a pilot cluster randomized control trial.

PubMed

Gifford, Wendy A; Davies, Barbara L; Graham, Ian D; Tourangeau, Ann; Woodend, A Kirsten; Lefebre, Nancy

2013-02-01

The importance of leadership to influence nurses' use of clinical guidelines has been well documented. However, little is known about how to develop and evaluate leadership interventions for guideline use. The purpose of this study was to pilot a leadership intervention designed to influence nurses' use of guideline recommendations when caring for patients with diabetic foot ulcers in home care nursing. This paper reports on the feasibility of implementing the study protocol, the trial findings related to nursing process outcomes, and leadership behaviors. A mixed methods pilot study was conducted with a post-only cluster randomized controlled trial and descriptive qualitative interviews. Four units were randomized to control or experimental groups. Clinical and management leadership teams participated in a 12-week leadership intervention (workshop, teleconferences). Participants received summarized chart audit data, identified goals for change, and created a team leadership action. Criteria to assess feasibility of the protocol included: design, intervention, measures, and data collection procedures. For the trial, chart audits compared differences in nursing process outcomes. 8-item nursing assessments score. Secondary outcome: 5-item score of nursing care based on goals for change identified by intervention participants. Qualitative interviews described leadership behaviors that influenced guideline use. Conducting this pilot showed some aspects of the study protocol were feasible, while others require further development. Trial findings observed no significant difference in the primary outcome. A significant increase was observed in the 5-item score chosen by intervention participants (p = 0.02). In the experimental group more relations-oriented leadership behaviors, audit and feedback and reminders were described as leadership strategies. Findings suggest that a leadership intervention has the potential to influence nurses' use of guideline recommendations, but further work is required to refine the intervention and outcome measures. A taxonomy of leadership behaviors is proposed to inform future research. © 2012 The authors. World Views on Evidence-Based Nursing © Sigma Theta Tau International.

Feasibility, acceptability, and preliminary effectiveness of patient advocates for improving adult asthma outcomes

PubMed Central

Apter, Andrea J.; Wan, Fei; Reisine, Susan; Bogen, Daniel K.; Rand, Cynthia; Bender, Bruce; Bennett, Ian M.; Gonzalez, Rodalyn; Priolo, Chantel; Sonnad, Seema S.; Bryant-Stephens, Tyra; Ferguson, Monica; Boyd, Rhonda C.; Have, Thomas Ten; Roy, Jason

2014-01-01

Background Asthmatic adults from low-income urban neighborhoods have inferior health outcomes which in part may be due to barriers accessing care and with patient-provider communication. We adapted a patient advocate (PA) intervention to overcome these barriers. Objective To conduct a pilot study to assess feasibility, acceptability, and preliminary evidence of effectiveness. Methods A prospective randomized design was employed with mixed methods evaluation. Adults with moderate or severe asthma were randomized to 16 weeks of PA or a minimal intervention (MI) comparison condition. The PA, a nonprofessional, modeled preparations for a medical visit, attended the visit, and confirmed understanding. The PA facilitated scheduling, obtaining insurance coverage, and overcoming barriers to implementing medical advice. Outcomes included electronically-monitored inhaled corticosteroid adherence, asthma control, quality of life, FEV1, ED visits, and hospitalizations. Mixed-effects models guided an intention-to-treat analysis. Results 100 adults participated: age 47±14 years, 75% female, 71% African American, 16% white, baseline FEV1 69% ± 18%, 36% experiencing hospitalizations and 56% ED visits for asthma in the prior year. Ninety-three subjects completed all visits; 36 of 53 PA-assigned had a PA visit. Adherence declined significantly in the control (p= 0.001) but not significantly in the PA group (p=.30). Both PA and MI groups demonstrated improved asthma control (p=0.01 in both) and quality of life (p=0.001, p=0.004). Hospitalizations and ED visits for asthma did not differ between groups. The observed changes over time tended to favor the PA group, but this study was underpowered to detect differences between groups. Conclusion The PA intervention was feasible and acceptable and demonstrated potential for improving asthma control and quality of life. PMID:23800333

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes

PubMed Central

Walker, Gemma M; Armstrong, Sarah; Gordon, Adam L; Gladman, John; Robertson, Kate; Ward, Marie; Conroy, Simon; Arnold, Gail; Darby, Janet; Frowd, Nadia; Williams, Wynne; Knowles, Sue; Logan, Pip A

2015-01-01

Objective: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. Design: Two-centre, cluster feasibility randomized controlled trial and process evaluation. Setting: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. Subjects: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. Interventions: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. Outcomes: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. Results: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. Conclusions: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records. PMID:26385358

Feasibility and effects of home-based smartphone-delivered automated feedback training for gait in people with Parkinson's disease: A pilot randomized controlled trial.

PubMed

Ginis, Pieter; Nieuwboer, Alice; Dorfman, Moran; Ferrari, Alberto; Gazit, Eran; Canning, Colleen G; Rocchi, Laura; Chiari, Lorenzo; Hausdorff, Jeffrey M; Mirelman, Anat

2016-01-01

Inertial measurement units combined with a smartphone application (CuPiD-system) were developed to provide people with Parkinson's disease (PD) real-time feedback on gait performance. This study investigated the CuPiD-system's feasibility and effectiveness compared with conventional gait training when applied in the home environment. Forty persons with PD undertook gait training for 30 min, three times per week for six weeks. Participants were randomly assigned to i) CuPiD, in which a smartphone application offered positive and corrective feedback on gait, or ii) an active control, in which personalized gait advice was provided. Gait, balance, endurance and quality of life were assessed before and after training and at four weeks follow-up using standardized tests. Both groups improved significantly on the primary outcomes (single and dual task gait speed) at post-test and follow-up. The CuPiD group improved significantly more on balance (MiniBESTest) at post-test (from 24.8 to 26.1, SD ∼ 5) and maintained quality of life (SF-36 physical health) at follow-up whereas the control group deteriorated (from 50.4 to 48.3, SD ∼ 16). No other statistically significant differences were found between the two groups. The CuPiD system was well-tolerated and participants found the tool user-friendly. CuPiD was feasible, well-accepted and seemed to be an effective approach to promote gait training, as participants improved equally to controls. This benefit may be ascribed to the real-time feedback, stimulating corrective actions and promoting self-efficacy to achieve optimal performance. Further optimization of the system and adequately-powered studies are warranted to corroborate these findings and determine cost-effectiveness.

Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol.

PubMed

Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

2015-03-01

In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article.

Virtual Reality Job Interview Training in Adults with Autism Spectrum Disorder

PubMed Central

Smith, Matthew J.; Ginger, Emily; Wright, Katherine; Wright, Michael; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D.; Fleming, Michael F.

2014-01-01

The feasibility and efficacy of Virtual Reality Job Interview Training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n=16) or treatment as usual (TAU) (n=10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic training. Participants attended 90% of lab-based training sessions and found VR-JIT easy-to-use, enjoyable, and they felt prepared for future interviews. VR-JIT participants had greater improvement during live standardized job interview role-play performances than TAU participants (p=0.046). A similar pattern was observed for self-reported self-confidence at a trend level (p=0.060). VR-JIT simulation performance scores increased over time (R-Squared=0.83). Results indicate preliminary support for the feasibility and efficacy of VR-JIT, which can be administered using computer software or via the internet. PMID:24803366

Virtual reality job interview training in adults with autism spectrum disorder.

PubMed

Smith, Matthew J; Ginger, Emily J; Wright, Katherine; Wright, Michael A; Taylor, Julie Lounds; Humm, Laura Boteler; Olsen, Dale E; Bell, Morris D; Fleming, Michael F

2014-10-01

The feasibility and efficacy of virtual reality job interview training (VR-JIT) was assessed in a single-blinded randomized controlled trial. Adults with autism spectrum disorder were randomized to VR-JIT (n = 16) or treatment-as-usual (TAU) (n = 10) groups. VR-JIT consisted of simulated job interviews with a virtual character and didactic training. Participants attended 90 % of laboratory-based training sessions, found VR-JIT easy to use and enjoyable, and they felt prepared for future interviews. VR-JIT participants had greater improvement during live standardized job interview role-play performances than TAU participants (p = 0.046). A similar pattern was observed for self-reported self-confidence at a trend level (p = 0.060). VR-JIT simulation performance scores increased over time (R(2) = 0.83). Results indicate preliminary support for the feasibility and efficacy of VR-JIT, which can be administered using computer software or via the internet.

The PHLAME firefighters' study: feasibility and findings.

PubMed

Elliot, Diane L; Goldberg, Linn; Duncan, Terry E; Kuehl, Kerry S; Moe, Esther L; Breger, Rosemary K R; DeFrancesco, Carol L; Ernst, Denise B; Stevens, Victor J

2004-01-01

To assess efficacy of 2 worksite health promotion interventions. Randomly assign 3 fire stations to (a) team-based curriculum, (b) individual counselor meetings, and (c) control. Both interventions were feasible and acceptable, and they resulted in significant reductions in LDL cholesterol. The team approach significantly increased coworker cohesion, personal exercise habits, and coworkers' healthy behaviors. The one-on-one strategy significantly increased dietary self-monitoring, decreased fat intake, and reduced depressed feelings. Although both interventions promoted healthy behaviors, specific outcomes differed and reflected their conceptual underpinnings. The team-based curriculum is innovative and may enlist influences not accessed with individual formats.

Short-term balance training with computer-based feedback in children with cerebral palsy: A feasibility and pilot randomized trial.

PubMed

Saxena, Shikha; Rao, Bhamini K; Senthil, Kumaran D

2017-04-01

To assess the feasibility of using short-term balance training with computer-based visual feedback (BTVF) and its effect on standing balance in children with bilateral spastic cerebral palsy (BSCP). Out of the fourteen children with BSCP (mean age = 10.31 years), seven children received four sessions of BTVF (two such sessions/day, each session = 15 min) in comparison to the control group that received standard care. Feasibility was measured as percentages of recruitment, retention and safety and balance was measured using a posturography machine as sway velocity (m/s) and velocity moment (m/s 2 ) during quiet standing. No serious adverse events occurred in either group. There were no differences in the retention percentages and in any clinical outcome measure between both groups. Use of BTVF is feasible in children with BSCP but further investigation is required to estimate a dose-effect relationship.

Therapist-Designed Adaptive Riding in Children With Cerebral Palsy: Results of a Feasibility Study.

PubMed

Angsupaisal, Mattana; Visser, Baudina; Alkema, Anne; Meinsma-van der Tuin, Marja; Maathuis, Carel G B; Reinders-Messelink, Heleen; Hadders-Algra, Mijna

2015-08-01

It is debatable whether adaptive riding (AR) in children with cerebral palsy (CP) improves postural control and gross motor development. The study aim was to explore the feasibility of an extensive assessment protocol for a randomized controlled trial of therapist-designed adaptive riding (TDAR) in children with CP, with the goals of assessing the effect on child outcomes and evaluating working mechanisms of sitting postural control. A pretest-posttest group design with 2 baseline measurements was used. Six children (1 girl, 5 boys; age range=6-12 years, median age=8 years 9 months) with bilateral spastic CP (Gross Motor Function Classification System level III) participated. Outcomes were evaluated 3 times (T0, T1, and T2) at 6-week intervals. T0 and T1 were baseline measurements; between T1 and T2, a TDAR intervention including an integrated program of postural challenge exercises (2 times per week for 1 hour) was applied. The complex protocol included the 88-item Gross Motor Function Measure (GMFM-88) and electromyographic (EMG) recording of postural muscle activity during reaching while sitting (EMG recording at T1 and T2 only). The protocol was feasible. Median GMFM-88 scores changed from 64.4 at T0 to 66.7 at T1 and from 66.7 at T1 to 73.2 at T2. The change scores for all children exceeded the minimal clinically important difference of the GMFM-88. Five of 6 children showed a decrease in stereotyped top-down recruitment between T1 and T2. Study limitations included the lack of a control group, small sample size, and potential assessor bias for all but the EMG parameters. The feasibility of the complex protocol was established. The data suggested that a 6-week TDAR intervention may improve gross motor function and may reduce stereotyped postural adjustments in children with CP. The limited results warrant replication in a well-powered randomized controlled trial. © 2015 American Physical Therapy Association.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Combining Motivational and Physical Intervention Components to Promote Fall-Reducing Physical Activity Among Community-Dwelling Older Adults: A Feasibility Study.

PubMed

McMahon, Siobhan Kathleen; Wyman, Jean F; Belyea, Michael J; Shearer, Nelma; Hekler, Eric B; Fleury, Julie

2016-11-01

To assess the feasibility of a new intervention, Ready~Steady, in terms of demand, acceptability, implementation, and limited efficacy. Randomized controlled trial; repeated measures. Two rural communities in Itasca County, Minnesota. Thirty participants were randomized to an intervention (n = 16) or attention-control (n = 14) group. Ready~Steady combined two components: (1) motivational (motivational support, social network support, empowering education), and (2) fall-reducing physical activities (PAs; guidance to practice leg-strengthening, balance, and flexibility activities and walking). Acceptability questionnaire and Indices of Procedural Consistency (investigator developed), Community Health Activity Model Program for Seniors Questionnaire (confirmed with accelerometry), Short Physical Performance Battery, Perceived Environmental Support Scale, Social Support for Exercise Questionnaire, Goal Attainment Scale, Index of Readiness, and Index of Self-Regulation. Descriptive statistics and a marginal approach to repeated-measures analysis of variance, using mixed-model procedures. Attrition was 7% and mean attendance was 7.2 of 8 sessions, participants evaluated Ready~Steady as acceptable, and implementation fidelity was good. The intervention group improved significantly more than the attention-control group in PA behavior, F 1,27 = 11.92, p = .002; fall risk (functional balance and strength), F 1,27 = 14.89, p = .001; support for exercise from friends, F 1,27 = 11.44, p = .002; and self-regulation, F 1,26 = 38.82, p < .005. The Ready~Steady intervention was feasible as evidenced by low attrition and good attendance and implementation, as well as positive effects on targeted outcomes and theoretical mechanisms of change. © 2016 by American Journal of Health Promotion, Inc.

Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study.

PubMed

Blonstein, Andrea C; Lv, Nan; Camargo, Carlos A; Wilson, Sandra R; Buist, A Sonia; Rosas, Lisa G; Strub, Peg; Ma, Jun

2016-08-01

'DASH for Asthma' (n 90) was a 6-month randomized controlled trial that demonstrated potential benefits of a DASH (Dietary Approaches to Stop Hypertension) behavioural intervention for improving diet quality and asthma control by comparing intervention to usual care in adults with uncontrolled asthma. The present study examined acceptability and feasibility of the intervention from the perspective of intervention participants and lifestyle coaches. Grounded in Social Cognitive Theory, the 3-month intensive stage, including three individual and eight group sessions, focused on diet modifications and behavioural self-regulation. The 3-month maintenance stage contained telephone consultations. Participants and lifestyle coaches completed surveys including 5-point Likert scales and open-ended questions. We analysed data using descriptive and inductive content analyses. Forty-six intervention participants (survey response rate was 65-72 %) and two lifestyle coaches. Participants and lifestyle coaches were highly satisfied (all mean ratings >4) with individual and group sessions. Participants identified mastery of knowledge and skills (awareness, goal setting, self-monitoring, problem solving), social learning (class members sharing experiences and ideas) and good coaching skills (reflective listening, empathy, motivational counselling) as important contributors to self-efficacy and programme satisfaction. Participants also valued personalized feedback received in individual sessions. Lifestyle coaches viewed participant engagement as a facilitator to effective sessions. Finally, participants and lifestyle coaches identified food tasting as beneficial for observational learning and facilitation of participant engagement. High class attendance and self-monitoring rate also reflected the high engagement among participants. The DASH behavioural intervention was feasible and highly acceptable to participants with uncontrolled asthma and lifestyle coaches.

Tablet-Based Intervention for Reducing Children's Preoperative Anxiety: A Pilot Study.

PubMed

Chow, Cheryl H T; Van Lieshout, Ryan J; Schmidt, Louis A; Buckley, Norman

To examine the feasibility, acceptability, and effects of a novel tablet-based application, Story-Telling Medicine (STM), in reducing children's preoperative anxiety. Children (N = 100) aged 7 to 13 years who were undergoing outpatient surgery were recruited from a local children's hospital. This study comprised 3 waves: Waves 1 (n = 30) and 2 (n = 30) examined feasibility, and Wave 3 (n = 40) examined the acceptability of STM and compared its effect on preoperative anxiety to Usual Care (UC). In Wave 3, children were randomly allocated to receive STM+UC or UC. A change in preoperative anxiety was measured using the Children's Perioperative Multidimensional Anxiety Scale (CPMAS) 7 to 14 days before surgery (T1), on the day of surgery (T2), and 1 month postoperatively (T3). Wave 1 demonstrated the feasibility of participant recruitment and data collection procedures but identified challenges with attrition at T2 and T3. Wave 2 piloted a modified protocol that addressed attrition and increased the feasibility of follow-up. In Wave 3, children in the STM+UC demonstrated greater reductions in CPMAS compared with the UC group (ΔM = 119.90, SE = 46.36, t(27) = 2.59, p = .015; 95% confidence interval = 24.78-215.02). This pilot study provides preliminary evidence that STM is a feasible and acceptable intervention for reducing children's preoperative anxiety in a busy pediatric operative setting and supports the investigation of a full-scale randomized controlled trial.

Using Facebook as a Platform to Direct Young Black Men Who Have Sex With Men to a Video-Based HIV Testing Intervention: A Feasibility Study

PubMed Central

Washington, Thomas Alex; Applewhite, Sheldon; Glenn, Wendell

2017-01-01

Objective A randomized control pilot study was conducted with Black men who have sex with men (BMSM; N = 42) aged 18–30 years to examine the feasibility of implementing a video intervention delivered using Facebook to motivate HIV testing. Methods At baseline, participants were unaware of their HIV status and had not tested for HIV in the past 6 months, residing in Los Angeles County. The intervention content included topics such as social influence, HIV knowledge, stigma, HIV positive knowledge, and benefits of knowing one’s HIV status. Findings Logistic regression revealed that those receiving the video intervention were 7 times more likely to have tested for HIV than those in the control group at 6-week follow-up (odds ratio [OR] = 7.00, 95% confidence interval [1.72, 28.33], p = .006). Conclusion Data suggest that the intervention was feasible for motivating HIV testing. PMID:29276800

Feasibility and Safety of Substituting Lung Ultrasonography for Chest Radiography When Diagnosing Pneumonia in Children: A Randomized Controlled Trial.

PubMed

Jones, Brittany Pardue; Tay, Ee Tein; Elikashvili, Inna; Sanders, Jennifer E; Paul, Audrey Z; Nelson, Bret P; Spina, Louis A; Tsung, James W

2016-07-01

Chest radiography (CXR) is the test of choice for diagnosing pneumonia. Lung ultrasonography (LUS) has been shown to be accurate for diagnosing pneumonia in children and may be an alternative to CXR. Our objective was to determine the feasibility and safety of substituting LUS for CXR when evaluating children suspected of having pneumonia. We conducted a randomized control trial comparing LUS with CXR in 191 children from birth to 21 years of age suspected of having pneumonia in an ED. Patients in the investigational arm underwent LUS. If there was clinical uncertainty after ultrasonography, physicians had the option to perform CXR. Patients in the control arm underwent sequential imaging with CXR followed by LUS. The primary outcome was the rate of CXR reduction; secondary outcomes were missed pneumonia, subsequent unscheduled health-care visits, and adverse events between the investigational and control arms. There was a 38.8% reduction (95% CI, 30.0%-48.9%) in CXR among investigational subjects compared with no reduction (95% CI, 0.0%-3.6%) in the control group. Novice and experienced physician-sonologists achieved 30.0% and 60.6% reduction in CXR use, respectively. There were no cases of missed pneumonia among all study participants (investigational arm, 0.0%: 95% CI, 0.0%-2.9%; control arm, 0.0%: 95% CI, 0.0%-3.0%), or differences in adverse events, or subsequent unscheduled health-care visits between arms. It may be feasible and safe to substitute LUS for CXR when evaluating children suspected of having pneumonia with no missed cases of pneumonia or increase in rates of adverse events. ClinicalTrials.gov; No.: NCT01654887; URL: www.clinicaltrials.gov. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Impact of School-Based HIV Prevention Program in Post-Conflict Liberia

ERIC Educational Resources Information Center

Atwood, Katharine A.; Kennedy, Stephen B.; Shamblen, Steve; Tegli, Jemee; Garber, Salome; Fahnbulleh, Pearl W.; Korvah, Prince M.; Kolubah, Moses; Mulbah-Kamara, Comfort; Fulton, Shannon

2012-01-01

This paper presents findings of a feasibility study to adapt and evaluate the impact of an evidence-based HIV prevention intervention on sexual risk behaviors of in-school 6th grade youth in post-conflict Liberia (n = 812). The study used an attention-matched, group randomized controlled trial. Four matched pairs of elementary/middle schools in…

Evaluation of a Sexual Abuse Prevention Education for Chinese Preschoolers

ERIC Educational Resources Information Center

Zhang, Wenjing; Chen, Jingqi; Feng, Yanan; Li, Jingyi; Liu, Chengfeng; Zhao, Xiaoxia

2014-01-01

Objectives: The purpose of this study was to test the feasibility of a sexual abuse prevention education in a sample of Chinese preschool children in Beijing, China. Method: One hundred and fifty preschool children were randomly assigned to either the intervention group (N = 78) or the wait-list control group (N = 72). Children were posttested on…

Causal Inference and the Comparative Interrupted Time Series Design: Findings from Within-Study Comparisons

ERIC Educational Resources Information Center

St. Clair, Travis; Hallberg, Kelly; Cook, Thomas D.

2014-01-01

Researchers are increasingly using comparative interrupted time series (CITS) designs to estimate the effects of programs and policies when randomized controlled trials are not feasible. In a simple interrupted time series design, researchers compare the pre-treatment values of a treatment group time series to post-treatment values in order to…

Promoting Healthy Transition to College through Mindfulness Training with First-Year College Students: Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Dvoráková, Kamila; Kishida, Moé; Li, Jacinda; Elavsky, Steriani; Broderick, Patricia C.; Agrusti, Mark R.; Greenberg, Mark T.

2017-01-01

Objective: Given the importance of developmental transitions on young adults' lives and the high rates of mental health issues among U.S. college students, first-year college students can be particularly vulnerable to stress and adversity. This pilot study evaluated the effectiveness and feasibility of mindfulness training aiming to promote…

Postpartum Depression Prevention for Reservation-Based American Indians: Results from a Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ginsburg, Golda S.; Barlow, Allison; Goklish, Novalene; Hastings, Ranelda; Baker, Elena Varipatis; Mullany, Britta; Tein, Jenn-Yun; Walkup, John

2012-01-01

Background: Postpartum depression is a devastating condition that affects a significant number of women and their offspring. Few preventive interventions have targeted high risk youth, such as American Indians (AIs). Objective: To evaluate the feasibility of a depression prevention program for AI adolescents and young adults. Methods: Expectant AI…

Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety.

PubMed

Welch, Martha G; Hofer, Myron A; Stark, Raymond I; Andrews, Howard F; Austin, Judy; Glickstein, Sara B; Ludwig, Robert J; Myers, Michael M

2013-09-24

While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU. The FNI trial is a single center, parallel-group, randomized controlled trial at Morgan Stanley Children's Hospital for mothers and their singleton or twin infants of 26-34 weeks gestation. Families were randomized to standard care (SC) or (FNI). FNI was implemented by nurture specialists trained to facilitate affective communication between mother and infant during specified calming interactions. These interactions included scent cloth exchange, sustained touch, vocal soothing and eye contact, wrapped or skin-to-skin holding, plus family-based support interactions. A total of 826 infants born between 26 and 34 weeks during the 3.5 year study period were admitted to the NICU. After infant and mother screening plus exclusion due to circumstances that prevented the family from participating, 373 infants were eligible for the study. Of these, we were unable to schedule a consent meeting with 56, and consent was withheld by 165. Consent was obtained for 150 infants from 115 families. The infants were block randomized to groups of N = 78, FNI and N = 72, SC. Sixteen (9.6%) of the randomized infants did not complete the study to home discharge, 7% of those randomized to SC and 12% of FNI infants. Mothers in the intervention group engaged in 3 to 4 facilitated one- to two-hour sessions/week. Intent to treat analyses revealed no significant difference between groups in medical complications. The mean length of stay was not significantly affected by the intervention. There was no significant effect demonstrated with this intervention amount on the primary short-term outcome, length of stay. FNI can be safely and feasibly implemented within a level IV NICU. Clinicaltrials.gov: NCT01439269.

A study protocol of a three-group randomized feasibility trial of an online yoga intervention for mothers after stillbirth (The Mindful Health Study).

PubMed

Huberty, Jennifer; Matthews, Jeni; Leiferman, Jenn; Cacciatore, Joanne; Gold, Katherine J

2018-01-01

In the USA, stillbirth (in utero fetal death ≥20 weeks gestation) is a major public health issue. Women who experience stillbirth, compared to women with live birth, have a nearly sevenfold increased risk of a positive screen for post-traumatic stress disorder (PTSD) and a fourfold increased risk of depressive symptoms. Because the majority of women who have experienced the death of their baby become pregnant within 12-18 months and the lack of intervention studies conducted within this population, novel approaches targeting physical and mental health, specific to the needs of this population, are critical. Evidence suggests that yoga is efficacious, safe, acceptable, and cost-effective for improving mental health in a variety of populations, including pregnant and postpartum women. To date, there are no known studies examining online-streaming yoga as a strategy to help mothers cope with PTSD symptoms after stillbirth. The present study is a two-phase randomized controlled trial. Phase 1 will involve (1) an iterative design process to develop the online yoga prescription for phase 2 and (2) qualitative interviews to identify cultural barriers to recruitment in non-Caucasian women (i.e., predominately Hispanic and/or African American) who have experienced stillbirth ( N  = 5). Phase 2 is a three-group randomized feasibility trial with assessments at baseline, and at 12 and 20 weeks post-intervention. Ninety women who have experienced a stillbirth within 6 weeks to 24 months will be randomized into one of the following three arms for 12 weeks: (1) intervention low dose (LD) = 60 min/week online-streaming yoga ( n  = 30), (2) intervention moderate dose (MD) = 150 min/week online-streaming yoga ( n  = 30), or (3) stretch and tone control (STC) group = 60 min/week of stretching/toning exercises ( n  = 30). This study will explore the feasibility and acceptability of a 12-week, home-based, online-streamed yoga intervention, with varying doses among mothers after a stillbirth. If feasible, the findings from this study will inform a full-scale trial to determine the effectiveness of home-based online-streamed yoga to improve PTSD. Long-term, health care providers could use online yoga as a non-pharmaceutical, inexpensive resource for stillbirth aftercare. NCT02925481.

Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial

PubMed Central

Johnson, Cynthia R.; Turner, Kylan S.; Foldes, Emily; Brooks, Maria M.; Kronk, Rebecca; Wiggs, Luci

2013-01-01

Objectives A large percentage of children with autism spectrum disorders (ASD) have bedtime and sleep disturbances. However, the treatment of these disturbances has been understudied. The purpose of our study was to develop a manualized behavioral parent training (BPT) program for parents of young children with ASD and sleep disturbances and to test the feasibility, fidelity, and initial efficacy of the treatment in a small randomized controlled trial (RCT). Participants and methods Parents of a sample of 40 young children diagnosed with ASD with an average age of 3.5 years were enrolled in our study. Participants were randomized to either the BPT program group or a comparison group who were given nonsleep-related parent education. Each was individually administered a 5-session program delivered over the 8-week study. Outcome measures of feasibility, fidelity, and efficacy were collected at weeks 4 and 8 after the baseline time point. Children’s sleep was assessed by parent report and objectively by actigraphy. Results Of the 20 participants in each group, data were available for 15 participants randomized to BPT and 18 participants randomized to the comparison condition. Results supported the feasibility of the manualized parent training program and the comparison program. Treatment fidelity was high for both groups. The BPT program group significantly improved more than the comparison group based on the primary sleep outcome of parent report. There were no objective changes in sleep detected by actigraphy. Conclusions Our study is one of few RCTs of a BPT program to specifically target sleep disturbances in a well-characterized sample of young children with ASD and to demonstrate the feasibility of the approach. Initial efficacy favored the BPT program over the comparison group and suggested that this manualized parent training approach is worthy of further examination of the efficacy within a larger RCT. PMID:23993773

Behavioral parent training to address sleep disturbances in young children with autism spectrum disorder: a pilot trial.

PubMed

Johnson, Cynthia R; Turner, Kylan S; Foldes, Emily; Brooks, Maria M; Kronk, Rebecca; Wiggs, Luci

2013-10-01

A large percentage of children with autism spectrum disorders (ASD) have bedtime and sleep disturbances. However, the treatment of these disturbances has been understudied. The purpose of our study was to develop a manualized behavioral parent training (BPT) program for parents of young children with ASD and sleep disturbances and to test the feasibility, fidelity, and initial efficacy of the treatment in a small randomized controlled trial (RCT). Parents of a sample of 40 young children diagnosed with ASD with an average age of 3.5years were enrolled in our study. Participants were randomized to either the BPT program group or a comparison group who were given nonsleep-related parent education. Each participant was individually administered a 5-session program delivered over the 8-week study. Outcome measures of feasibility, fidelity, and efficacy were collected at weeks 4 and 8 after the baseline time point. Children's sleep was assessed by parent report and objectively by actigraphy. Of the 20 participants in each group, data were available for 15 participants randomized to BPT and 18 participants randomized to the comparison condition. Results supported the feasibility of the manualized parent training program and the comparison program. Treatment fidelity was high for both groups. The BPT program group significantly improved more than the comparison group based on the primary sleep outcome of parent report. There were no objective changes in sleep detected by actigraphy. Our study is one of few RCTs of a BPT program to specifically target sleep disturbances in a well-characterized sample of young children with ASD and to demonstrate the feasibility of the approach. Initial efficacy favored the BPT program over the comparison group and suggested that this manualized parent training approach is worthy of further examination of the efficacy within a larger RCT. Copyright © 2013 Elsevier B.V. All rights reserved.

Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood.

PubMed

Kohn, Julia E; Simons, Hannah R; Della Badia, Lisa; Draper, Elissa; Morfesis, Johanna; Talmont, Elizabeth; Beasley, Anitra; McDonald, Melanie; Westhoff, Carolyn L

2018-03-01

Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. We randomized 401 females ages 15-44 requesting DMPA at clinics in Texas and New Jersey to self-administration or clinic administration in a 1:1 allocation. Clinic staff taught participants randomized to self-administration to self-inject and observed the first injection; participants received instructions, a sharps container, and three doses for home use. Participants randomized to clinic administration received usual care. All participants received DMPA-sc at no cost and injection reminders via text message or email. We conducted follow-up surveys at six and 12 months. Three hundred thirty-six participants (84%) completed the 12-month survey; 316 completed both follow-up surveys (an 80% response rate excluding eight withdrawals). Participants ranged in age from 16-44. One-year DMPA continuous use was 69% in the self-administration group and 54% in the clinic group (p=.005). There were three self-reported pregnancies during the study period, all occurred in the clinic group; all three women had discontinued DMPA and one reported her pregnancy as intended. Among the self-administration group, 97% reported that self-administration was very or somewhat easy; 87% would recommend self-administration of DMPA-sc to a friend. Among the clinic group, 52% reported interest in self-administration in the future. Satisfaction was similar between groups. No serious adverse events were reported. DMPA self-administration improves contraceptive continuation and is a feasible and acceptable option for women and adolescents. Self-administration of subcutaneous DMPA can improve contraceptive access, autonomy, and continuation, and is a feasible and acceptable option for women and adolescents. It should be made widely available as an option for women and adolescents. Copyright © 2017 Elsevier Inc. All rights reserved.

The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.

PubMed

Eldabe, Sam; Thomson, Simon; Duarte, Rui; Brookes, Morag; deBelder, Mark; Raphael, Jon; Davies, Ed; Taylor, Rod

2016-01-01

Patients with "refractory angina" (RA) unsuitable for coronary revascularization experience high levels of hospitalization and poor health-related quality of life. Randomized trials have shown spinal cord stimulation (SCS) to be a promising treatment for chronic stable angina and RA; however, none has compared SCS with usual care (UC). The aim of this pilot study was to address the key uncertainties of conducting a definitive multicenter trial to assess the clinical and cost-effectiveness of SCS in RA patients, i.e., recruitment and retention of patients, burden of outcome measures, our ability to standardize UC in a UK NHS setting. RA patients deemed suitable were randomized in a 1:1 ratio to SCS plus UC (SCS group) or UC alone (UC group). We sought to assess: recruitment, uptake, and retention of patients; feasibility and acceptability of SCS treatment; the feasibility and acceptability of standardizing UC; and the feasibility and acceptability of the proposed trial outcome measures. Patient outcomes were assessed at baseline (prerandomization) and three and six months postrandomization. We failed to meet our planned recruitment target (45 patients) and randomized 29 patients (15 SCS group, 14 UC group) over a 42-month period across four sites. None of the study participants chose to withdraw following consent and randomization. With exception of two deaths, all completed evaluation at baseline and follow-up. Although the study was not formally powered to compare outcomes between groups, we saw a trend toward larger improvements in both primary and secondary outcomes in the SCS group. While patient recruitment was found to be challenging, levels of participant retention, outcome completion, and acceptability of SCS therapy were high. A number of lessons are presented in order to take forward a future definitive pragmatic randomized trial. © 2015 The Authors. Neuromodulation: Technology at the Neural Interface published by Wiley Periodicals, Inc. on behalf of International Neuromodulation Society.

Effects of a group-based exercise and self-regulatory intervention on obese adolescents' physical activity, social cognitions, body composition and strength: a randomized feasibility study.

PubMed

Wilson, A Justine; Jung, Mary E; Cramp, Anita; Simatovic, Jacqueline; Prapavessis, Harry; Clarson, Cheril

2012-11-01

This feasibility study assessed the effects of an exercise plus group-based self-regulatory skills intervention on obese youths' physical activity, social cognitions, body composition and strength. Forty-three obese youth (male = 13, BMI > 95th percentile; 10-16 yrs) completed this 12-week intervention. Assessments were taken at baseline, week 6, 13 and 12 weeks post-intervention (week 24). Although no attention control group (i.e. exercise only) was included in this study, participants engaged in significantly more self-reported physical activity at weeks 13 and 24 as compared to baseline. Social cognitions, body composition and strength were also positively impacted suggesting this intervention technique may be feasible for treating obese adolescents.

A randomized pilot trial of a full subsidy vs. a partial subsidy for obesity treatment.

PubMed

Tsai, Adam G; Felton, Sue; Hill, James O; Atherly, Adam J

2012-09-01

Intensive obesity treatment is mandated by federal health care reform but is costly. A partial subsidy for obesity treatment could lower the cost of treatment, without reducing its efficacy. This study sought to test whether a partial subsidy for obesity treatment would be feasible, as compared to a fully subsidized intervention. The study was a pilot randomized trial. Participants (n = 50) were primary care patients with obesity and at least one comorbid condition (diabetes, hypertension, dyslipidemia, or obstructive sleep apnea). Each participant received eight weight loss counseling visits as well as portion-controlled foods for weight loss. Participants were randomized to full subsidy or partial subsidy (2 vs. 1 meal per day provided). The primary outcome was weight change after 4 months. Secondary outcomes included changes in blood pressure, waist circumference, and health-related quality of life. Participants in the full and partial subsidy groups lost 5.9 and 5.3 kg, equivalent to 5.3% and 5.1% of initial weight, respectively (P = 0.71). Changes in secondary outcomes were similar in the two groups. A partial subsidy was feasible and induced a clinically similar amount of weight loss, compared to a full subsidy. Large-scale testing of economic incentives for weight control is merited given the federal mandate to offer weight loss counseling to obese patients.

Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial.

PubMed

Evans, Mark; Kellett, Stephen; Heyland, Simon; Hall, Jo; Majid, Shazmin

2017-01-01

The evidence base for treatment of bipolar affective disorder (BD) demands the evaluation of new psychotherapies in order to broaden patient choice. This study reports on the feasibility, safety, helpfulness and effectiveness of cognitive analytic therapy (CAT). In a pilot randomized controlled trial, BD patients in remission were randomized to either receiving 24 sessions of CAT (n = 9) or treatment as usual (n = 9) and were assessed in terms of symptoms, functioning and service usage over time. In the CAT arm no adverse events occurred, 8/9 completed treatment, 5/8 attended all 24 sessions and 2/8 were categorized as recovered. The most common helpful event during CAT was recognition of patterns in mood variability, with helpfulness themes changing according to phase of therapy. No major differences were found when comparing the arms over time in terms of service usage or psychometric outcomes. The study suggests that conducting further research into the effectiveness of CAT in treating BD is warranted and guidance regarding future trials is provided. Copyright © 2016 John Wiley & Sons, Ltd. Treating BD with CAT appears feasible and safe. Retaining fidelity to the reformulation, recognition and revision structure of CAT appears useful. Participants stated that across the phases of CAT, focussing on patterns of mood variability was consistently helpful. Copyright © 2016 John Wiley & Sons, Ltd.

Hypothermia for Traumatic Brain Injury in Children-A Phase II Randomized Controlled Trial.

PubMed

Beca, John; McSharry, Brent; Erickson, Simon; Yung, Michael; Schibler, Andreas; Slater, Anthony; Wilkins, Barry; Singhal, Ash; Williams, Gary; Sherring, Claire; Butt, Warwick

2015-07-01

To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury. Multicenter prospective randomized controlled phase II trial. All eight of the PICUs in Australia and New Zealand and one in Canada. Children 1-15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury. The control group had strict normothermia to a temperature of 36-37°C for 72 hours. The intervention group had therapeutic hypothermia to a temperature of 32-33°C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure. Of 764 children admitted to PICU with traumatic brain injury, 92 (12%) were eligible and 55 (7.2%) were recruited. There were five major protocol violations (9%): three related to recruitment and consent processes and two to incorrect temperature management. Rewarming took a median of 21.5 hours (16-35 hr) and was performed without compromise in the cerebral perfusion pressure. There was no increase in any complications, including infections, bleeding, and arrhythmias. There was no difference in outcomes 12 months after injury; in the therapeutic hypothermia group, four (17%) had a bad outcome (pediatric cerebral performance category, 4-6) and three (13%) died, whereas in the normothermia group, three (12%) had a bad outcome and one (4%) died. Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial. Recruitment rates were lower and outcomes were better than expected. Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible. A large international trials group and alternative approaches to trial design will be required to further inform practice.

Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

PubMed

Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

2016-01-30

This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. Copyright © 2016. Published by Elsevier Ireland Ltd.

Findings of the Chronic Obstructive Pulmonary Disease-Sitting and Exacerbations Trial (COPD-SEAT) in Reducing Sedentary Time Using Wearable and Mobile Technologies With Educational Support: Randomized Controlled Feasibility Trial.

PubMed

Orme, Mark W; Weedon, Amie E; Saukko, Paula M; Esliger, Dale W; Morgan, Mike D; Steiner, Michael C; Downey, John W; Sherar, Lauren B; Singh, Sally J

2018-04-11

Targeting sedentary time post exacerbation may be more relevant than targeting structured exercise for individuals with chronic obstructive pulmonary disease. Focusing interventions on sitting less and moving more after an exacerbation may act as a stepping stone to increase uptake to pulmonary rehabilitation. The aim of this paper was to conduct a randomized trial examining trial feasibility and the acceptability of an education and self-monitoring intervention using wearable technology to reduce sedentary behavior for individuals with chronic obstructive pulmonary disease admitted to hospital for an acute exacerbation. Participants were recruited and randomized in hospital into 3 groups, with the intervention lasting 2 weeks post discharge. The Education group received verbal and written information about reducing their time in sedentary behavior, sitting face-to-face with a study researcher. The Education+Feedback group received the same education component along with real-time feedback on their sitting time, stand-ups, and steps at home through a waist-worn inclinometer linked to an app. Patients were shown how to use the technology by the same study researcher. The inclinometer also provided vibration prompts to encourage movement at patient-defined intervals of time. Patients and health care professionals involved in chronic obstructive pulmonary disease exacerbation care were interviewed to investigate trial feasibility and acceptability of trial design and methods. Main quantitative outcomes of trial feasibility were eligibility, uptake, and retention, and for acceptability, were behavioral responses to the vibration prompts. In total, 111 patients were approached with 33 patients recruited (11 Control, 10 Education, and 12 Education+Feedback). Retention at 2-week follow-up was 52% (17/33; n=6 for Control, n=3 for Education, and n=8 for Education+Feedback). No study-related adverse events occurred. Collectively, patients responded to 106 out of 325 vibration prompts from the waist-worn inclinometer (32.62%). Within 5 min of the prompt, 41% of responses occurred, with patients standing for a mean 1.4 (SD 0.8) min and walking for 0.4 (SD 0.3) min (21, SD 11, steps). Interviews indicated that being unwell and overwhelmed after an exacerbation was the main reason for not engaging with the intervention. Health care staff considered reducing sedentary behavior potentially attractive for patients but suggested starting the intervention as an inpatient. Although the data support that it was feasible to conduct the trial, modifications are needed to improve participant retention. The intervention was acceptable to most patients and health care professionals. International Standard Randomized Controlled Trial Number (ISRCTN) 13790881; http://www.isrctn.com/ISRCTN13790881 (Archived by WebCite at http://www.webcitation.org/6xmnRGjFf). ©Mark W Orme, Amie E Weedon, Paula M Saukko, Dale W Esliger, Mike D Morgan, Michael C Steiner, John W Downey, Lauren B Sherar, Sally J Singh. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 11.04.2018.

Home-based hand rehabilitation with a robotic glove in hemiplegic patients after stroke: a pilot feasibility study.

PubMed

Bernocchi, Palmira; Mulè, Chiara; Vanoglio, Fabio; Taveggia, Giovanni; Luisa, Alberto; Scalvini, Simonetta

2018-03-01

To evaluate the feasibility and safety of home rehabilitation of the hand using a robotic glove, and, in addition, its effectiveness, in hemiplegic patients after stroke. In this non-randomized pilot study, 21 hemiplegic stroke patients (Ashworth spasticity index ≤ 3) were prescribed, after in-hospital rehabilitation, a 2-month home-program of intensive hand training using the Gloreha Lite glove that provides computer-controlled passive mobilization of the fingers. Feasibility was measured by: number of patients who completed the home-program, minutes of exercise and number of sessions/patient performed. Safety was assessed by: hand pain with a visual analog scale (VAS), Ashworth spasticity index for finger flexors, opponents of the thumb and wrist flexors, and hand edema (circumference of forearm, wrist and fingers), measured at start (T0) and end (T1) of rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip test) were also measured at T0 and T1. Patients performed, over a mean period 56 (49-63) days, a total of 1699 (1353-2045) min/patient of exercise with Gloreha Lite, 5.1 (4.3-5.8) days/week. Seventeen patients (81%) completed the full program. The mean VAS score of hand pain, Ashworth spasticity index and hand edema did not change significantly at T1 compared to T0. The MI, NHPT and Grip test improved significantly (p = 0.0020, 0.0156 and 0.0024, respectively) compared to baseline. Gloreha Lite is feasible and safe for use in home rehabilitation. The efficacy data show a therapeutic effect which need to be confirmed by a randomized controlled study.

A Pilot Feasibility Intervention to Increase Advance Care Planning among African Americans in the Deep South.

PubMed

Huang, Chao-Hui Sylvia; Crowther, Martha; Allen, Rebecca S; DeCoster, Jamie; Kim, Giyeon; Azuero, Casey; Ang, Xinying; Kvale, Elizabeth

2016-02-01

Despite growing efforts to facilitate advance care planning (ACP) to decrease health disparities in palliative care, low completion rates of advance directives (AD) have been consistently found among African Americans. The objective was to examine the feasibility of a multicomponent ACP intervention program that integrates motivational interviewing, evidence-based ACP facilitation program (Respecting Choices(®)), and health-literacy adjusted AD. This pilot study aims to address the unique barriers to ACP engagement among African Americans in the Deep South. The design was a mixed-method randomized controlled trial design. Analysis of covariance (ANCOVA) and thematic content analysis (TCA) were conducted to identify barriers and facilitators for ACP engagement and to assess feasibility, knowledge, and intention to complete an AD. Thirty community-dwelling African Americans (mean age M = 55.43, SD = 6.71, range = 47-73) were recruited from the Deep South and randomly assigned to receive intervention (n = 15) or educational material (n = 15) at a local university medical center. All participants (n = 30) reported high satisfaction (M = 4.81, SD = 0.44, max score = 5) and increased intent to complete an AD at postintervention. A significant increase in knowledge on AD from baseline to postintervention was observed in the intervention group-t(14) = -3.06, p = 0.01, d = 1.67); no significant change was found for control. Lack of information, mistrust of doctors, and avoidance of discussing death were primary barriers to ACP discussions. Facilitators include ACP education, decreased mistrust, and proactive initiation of ongoing ACP discussions. Feasibility data revealed successful implementation of a brief intervention to increase ACP engagement and willingness to complete an AD among southern African Americans.

Introducing supported self-management for depression to primary care in Vietnam: A feasibility study in preparation for a randomized controlled trial.

PubMed

Murphy, Jill; Oanh, Pham Thi; Goldsmith, Charles H; Jones, Wayne; Nguyen, Vu Cong

2018-06-01

Although depression is a major contributor to the global burden of disease, services remain scarce in many low- and middle-income countries. In Vietnam, depression services are limited, and the government has recently prioritized primary care and community-based service integration. We conducted a pilot study in 2 districts of Hanoi to test the feasibility of (a) introducing a supported self-management (SSM) intervention for adult depression in primary care in Vietnam, and (b) conducting a randomized controlled trial (RCT) to test the effectiveness of the intervention. We conducted focus groups with providers (n = 16) and community members (n = 32) to assess the appropriateness of an Antidepressant Skills Workbook for use in Vietnam. We trained providers (n = 23) to screen patients using the Self-Reporting Questionnaire-20 (SRQ-20) depression scale and to deliver SSM for a 2-month period. A total of 71 patients were eligible to participate in the study, with depression (SRQ-20) and disability (World Health Organization Disability Assessment Schedule 2.0) scores assessed at baseline and 1 and 2 months. Study results demonstrate the feasibility of conducting a full RCT in Vietnam and suggest that SSM is an appropriate care model for the Vietnamese context. There was a statistically significant decrease in depression symptoms on the SRQ-20 and in functional disability in all domains for the World Health Organization Disability Assessment Schedule 2.). Feasibility study results suggested that a full RCT was warranted. An unanticipated outcome of the study was the uptake of the model by the Ministry of Labor, Invalids, and Social Affairs in 2 additional provinces. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial.

PubMed

Jensen, Bente Thoft; Laustsen, Sussie; Jensen, Jørgen Bjerggaard; Borre, Michael; Petersen, Annemette Krintel

2016-08-01

Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC). A parent prospective randomized controlled clinical trial investigated efficacy of a multidisciplinary rehabilitation program on length of stay following RC. A total of 107 patients were included in the intension-to-treat population revealing 50 patients in the intervention group and 57 patients in the standard group. Pre-operatively, the intervention group was instructed to a standardized exercise program consisting of both muscle strength exercises and endurance training. The number of training sessions and exercise repetitions was patient-reported. Feasibility was expressed as adherence to the program and efficacy as the differences in muscle power within and between treatment groups at time for surgery. A total of 66 % (95 % confidence interval (CI) 51; 78) adhered more than 75 % of the recommended progressive standardized exercise program. In the intervention group, a significant improvement in muscle power of 18 % (p < 0.002) was found at time for surgery. Moreover, muscle power was significantly improved compared to that in the standard group with 0.3 W/kg (95 % CI 0.08; 0.5 %) (p < 0.006). Adherence was not associated with pre-operative BMI, nutritional risk, comorbidity, pain, gender, or age. In patients awaiting RC, a short-term exercise-based pre-habilitation intervention is feasible and effective and should be considered in future survivorship strategies.

Feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke: a randomized controlled pilot study.

PubMed

Lin, Li-Fong; Lin, Yi-Jia; Lin, Zi-Hao; Chuang, Li-Yun; Hsu, Wei-Chun; Lin, Yuan-Hsiang

2017-06-19

Wearable devices based on inertial measurement units through wireless sensor networks have many applications such as real-time motion monitoring and functional outcome assessment of stroke rehabilitation. However, additional investigations are warranted to validate their clinical value, particularly in detecting the synergy patterns of movements after stroke. To explore the feasibility and efficacy of wearable devices for upper limb rehabilitation in patients with chronic stroke and to compare the intervention effects (e.g., neurological recovery, active range of motion, and deviation angle) with those in a control group. A single-blind, randomized-controlled pilot study. Rehabilitation ward. A total of 18 patients with chronic stroke were randomly distributed into a device group and control group. Both groups received conventional rehabilitation; nevertheless, the device group was additionally subjected to 15 daily sessions at least three times a week for 5 weeks. The outcome measures included the upper extremity subscores of the Fugl-Meyer assessment, active range of motion, and deviation angle. These measurements were performed pre- and post-treatment. All five Fugl-Meyer assessment subscores improved in both the device and control groups after intervention; in particular, the "shoulder/elbow/forearm" subscore (p = 0.02, 0.03) and "total score" (p = 0.03, 0.03) substantially improved. The active range of motion of shoulder flexion and abduction substantially improved at pre-post treatment in both the device (p = 0.02, 0.03) and control (p = 0.02, 0.03) groups. The deviation angle of shoulder external rotation during shoulder abduction substantially improved in the device group (p = 0.02), but not in the control group. The designed wearable devices are practical and efficient for use in chronic patients with stroke. Wearable devices are expected to be useful for future internet-of-things rehabilitation clinical trials at home and in long-term care institutions.

A Randomized Controlled Trial to Increase Navy Bean or Rice Bran Consumption in Colorectal Cancer Survivors.

PubMed

Borresen, Erica C; Brown, Dustin G; Harbison, Greg; Taylor, Lynn; Fairbanks, Amanda; O'Malia, Joanne; Bazan, Marlon; Rao, Sangeeta; Bailey, Susan M; Wdowik, Melissa; Weir, Tiffany L; Brown, Regina J; Ryan, Elizabeth P

2016-01-01

Consumption of navy beans (NB) and rice bran (RB) have been shown to inhibit colon carcinogenesis. Given the overall poor diet quality in colorectal cancer (CRC) survivors and low reported intake of whole grains and legumes, practical strategies to increase consumption merit attention. This study determined feasibility of increasing NB or RB intake in CRC survivors to increase dietary fiber and examined serum inflammatory biomarkers and telomere lengths. Twenty-nine subjects completed a randomized controlled trial with foods that included cooked NB powder (35 g/day), heat-stabilized RB (30 g/day), or no additional ingredient. Fasting blood, food logs, and gastrointestinal health questionnaires were collected. The amount of NB or RB consumed equated to 4-9% of subjects' daily caloric intake and no major gastrointestinal issues were reported with increased consumption. Dietary fiber amounts increased in NB and RB groups at Weeks 2 and 4 compared to baseline and to control (P ≤ 0.01). Telomere length correlated with age and HDL cholesterol at baseline, and with improved serum amyloid A (SAA) levels at Week 4 (P ≤ 0.05). This study concludes feasibility of increased dietary NB and RB consumption to levels associated with CRC chemoprevention and warrants longer-term investigations with both foods in high-risk populations that include cancer prevention and control outcomes.

A randomized-controlled trial to increase navy bean or rice bran consumption in colorectal cancer survivors

PubMed Central

Borresen, Erica C.; Brown, Dustin G.; Harbison, Greg; Taylor, Lynn; Fairbanks, Amanda; O’Malia, Joanne; Bazan, Marlon; Rao, Sangeeta; Bailey, Susan M.; Wdowik, Melissa; Weir, Tiffany L.; Brown, Regina J.; Ryan, Elizabeth P.

2016-01-01

Consumption of navy beans (NB) and rice bran (RB) have been shown to inhibit colon carcinogenesis. Given the overall poor diet quality in colorectal cancer (CRC) survivors and low reported intake of whole grains and legumes, practical strategies to increase consumption merit attention. This study determined feasibility of increasing NB or RB intake in CRC survivors to increase dietary fiber and examined serum inflammatory biomarkers and telomere lengths. Twenty-nine participants completed a randomized-controlled trial with foods that included cooked NB powder (35g/day), heat-stabilized RB (30g/day), or no additional ingredient. Fasting blood, food logs, and gastrointestinal health questionnaires were collected. The amount of NB or RB consumed equated to 4–9% of participants daily caloric intake and no major gastrointestinal issues were reported with increased consumption. Dietary fiber amounts increased in NB and RB groups at weeks 2 and 4 compared to baseline and to control (p≤0.01). Telomere length correlated with age and HDL-cholesterol at baseline, and with improved serum amyloid A (SAA) levels at week 4 (p≤0.05). This study concludes feasibility of increased dietary NB and RB consumption to levels associated with CRC chemoprevention and warrants longer-term investigations with both foods in high-risk populations that include cancer prevention and control outcomes. PMID:27689688

Bridges self-management program for people with stroke in the community: A feasibility randomized controlled trial.

PubMed

McKenna, Suzanne; Jones, Fiona; Glenfield, Pauline; Lennon, Sheila

2015-07-01

Enabling self-management behaviors is considered important in order to develop coping strategies and confidence for managing life with a long-term condition. However, there is limited research into stroke-specific self-management interventions. The aim of this randomized controlled trial was to evaluate the feasibility of delivering the Bridges stroke self-management program in addition to usual stroke rehabilitation compared with usual rehabilitation only. Participants recruited from the referrals to a community stroke team were randomly allocated to the Bridges stroke self-management program, receiving either one session of up to one-hour per week over a six-week period in addition to usual stroke rehabilitation, or usual rehabilitation only. Feasibility was measured using a range of methods to determine recruitment and retention; adherence to the program; suitability and variability of outcome measures used; application and fidelity of the program; and acceptability of the program to patients, carers and professionals. Twenty-five people were recruited to the study over a 13-month period. Eight out of the 12 participants in the Bridges stroke self-management program received all six sessions; there was one withdrawal from the study. There were changes in outcomes between the two groups. Participants who received the Bridges stroke self-management program appeared to have a greater change in self-efficacy, functional activity, social integration and quality of life over the six-week intervention period and showed less decline in mood and quality of life at the three-month follow-up. Professionals found the program acceptable to use in practice, and feedback from participants was broadly positive. The findings from this study appear promising, but questions remain regarding the feasibility of delivering the Bridges stroke self-management program in addition to usual rehabilitation. The dose response of receiving the program cannot be ruled out, and the next stage of research should explore the feasibility of an integrated program. Exploration of the reasons behind relatively low recruitment and of the sensitivity of outcome measures to detect a change are also required. Additional investigation of intervention fidelity is required to monitor if the program is being delivered as intended. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

A community health worker-led lifestyle behavior intervention for Latina (Hispanic) women: feasibility and outcomes of a randomized controlled trial.

PubMed

Koniak-Griffin, Deborah; Brecht, Mary-Lynn; Takayanagi, Sumiko; Villegas, Juan; Melendrez, Marylee; Balcázar, Héctor

2015-01-01

Low-income Latinas (Hispanics) face risk for cardiovascular disease due to high rates of overweight/obesity, sedentary lifestyle, and other factors. Limited access to health care and language barriers may prevent delivery of health promotion messages. Targeted approaches, including the integration of community health workers, may be required to promote healthy lifestyle and prevent chronic disease in underserved ethnic minority groups. The term commonly used to refer to female community health workers in Latino communities is "promotora(s)." This study evaluates the outcomes and feasibility of a promotora-led lifestyle behavior intervention for overweight, immigrant Latinas. A community prevention model was employed in planning and implementing this study. A randomized controlled trial design was used. A Community Advisory Board provided expertise in evaluating feasibility of study implementation in the community and other important guidance. The sample was comprised of 223 women aged 35-64 years, predominantly with low income and ≤8th grade education. The culturally tailored Lifestyle Behavior Intervention included group education (8 classes based upon Su Corazon, Su Vida), followed by 4 months of individual teaching and coaching (home visits and telephone calls). The control group received a comparable length educational program and follow-up contacts. Evaluations were conducted at baseline and at 6 and 9 months using a dietary habits questionnaire, accelerometer readings of physical activity, and clinical measures (body mass index, weight, waist circumference, blood pressure, lipids, blood glucose). Data were collected between January 2010 and August 2012. Women in the intervention group improved significantly in dietary habits, waist circumference, and physical activity in comparison to those in the control group. A treatment dosage effect was observed for weight and waist circumference. Knowledge about heart disease increased. High attendance at classes and participation in the individual teaching and counseling sessions and high retention rates support the feasibility and acceptability of the promotora-led lifestyle behavior intervention. Our findings demonstrate that lifestyle behaviors and other risk factors of overweight Latina women may be improved through a promotora-led lifestyle behavior intervention. Feasibility of implementing this intervention in community settings and engaging promotoras as facilitators is supported. Copyright © 2014 Elsevier Ltd. All rights reserved.

Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity.

PubMed

Demark-Wahnefried, Wendy; Cases, Mallory G; Cantor, Alan B; Frugé, Andrew D; Smith, Kerry P; Locher, Julie; Cohen, Harvey J; Tsuruta, Yuko; Daniel, Michael; Kala, Rishabh; De Los Santos, Jennifer F

2018-04-01

Holistic approaches are sought to improve lifestyle behaviors and health of cancer survivors long term. Our aim was to explore whether a home-based vegetable gardening intervention is feasible and whether it improves diet and other health-related outcomes among older cancer survivors. We conducted a feasibility trial in which cancer survivors were randomized to receive a year-long gardening intervention immediately or to a wait-list control arm. Home visits at baseline and 1 year assessed physical performance, anthropometric indices, behavioral and psychosocial outcomes, and biomarkers. Participants included 46 older (aged 60+ years) survivors of locoregionally staged cancers across Alabama from 2014 to 2016. Forty-two completed 1-year follow-up. Cooperative extension master gardeners delivered guidance to establish three seasonal vegetable gardens at survivors' homes. Plants, seeds, and gardening supplies were provided. Primary outcomes were feasibility targets of 80% accrual and retention, and an absence of serious adverse events; other outcomes were secondary and explored potential benefits. Baseline to follow-up changes were assessed within and between arms using paired t, McNemar's, and χ 2 tests. This trial proved to be safe and demonstrated 91.3% retention; 70% of intervention participants rated their experience as "excellent," and 85% would "do it again." Data suggest significantly increased reassurance of worth (+0.49 vs -0.45) and attenuated increases in waist circumference (+2.30 cm vs +7.96 cm) in the gardening vs control arms (P=0.02). Vegetable and fruit consumption increased by approximately 1 serving/day within the gardening arm from baseline to follow-up (mean [standard error]=1.34 [1.2] to 2.25 [1.9] servings/day; P=0.02)] compared to controls (1.22 [1.1] to 1.12 [0.7]; P=0.77; between-arm P=0.06). The home vegetable gardening intervention among older cancer survivors was feasible and suggested improvements in vegetable and fruit consumption and reassurance of worth; data also suggest attenuated increases in waist circumference. Continued study of vegetable gardening interventions is warranted to improve health, health behaviors, and well-being of older cancer survivors. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

A randomized phase II feasibility trial of a multimodal intervention for the management of cachexia in lung and pancreatic cancer.

PubMed

Solheim, Tora S; Laird, Barry J A; Balstad, Trude Rakel; Stene, Guro B; Bye, Asta; Johns, Neil; Pettersen, Caroline H; Fallon, Marie; Fayers, Peter; Fearon, Kenneth; Kaasa, Stein

2017-10-01

Cancer cachexia is a syndrome of weight loss (including muscle and fat), anorexia, and decreased physical function. It has been suggested that the optimal treatment for cachexia should be a multimodal intervention. The primary aim of this study was to examine the feasibility and safety of a multimodal intervention (n-3 polyunsaturated fatty acid nutritional supplements, exercise, and anti-inflammatory medication: celecoxib) for cancer cachexia in patients with incurable lung or pancreatic cancer, undergoing chemotherapy. Patients receiving two cycles of standard chemotherapy were randomized to either the multimodal cachexia intervention or standard care. Primary outcome measures were feasibility assessed by recruitment, attrition, and compliance with intervention (>50% of components in >50% of patients). Key secondary outcomes were change in weight, muscle mass, physical activity, safety, and survival. Three hundred and ninety-nine were screened resulting in 46 patients recruited (11.5%). Twenty five patients were randomized to the treatment and 21 as controls. Forty-one completed the study (attrition rate 11%). Compliance to the individual components of the intervention was 76% for celecoxib, 60% for exercise, and 48% for nutritional supplements. As expected from the sample size, there was no statistically significant effect on physical activity or muscle mass. There were no intervention-related Serious Adverse Events and survival was similar between the groups. A multimodal cachexia intervention is feasible and safe in patients with incurable lung or pancreatic cancer; however, compliance to nutritional supplements was suboptimal. A phase III study is now underway to assess fully the effect of the intervention. © 2017 The Authors. Journal of Cachexia, Sarcopenia and Muscle published by John Wiley & Sons Ltd on behalf of the Society on Sarcopenia, Cachexia and Wasting Disorders.

Blood pressure, salivary cortisol, and inflammatory cytokine outcomes in senior female cancer survivors enrolled in a tai chi chih randomized controlled trial.

PubMed

Campo, Rebecca A; Light, Kathleen C; O'Connor, Kathleen; Nakamura, Yoshio; Lipschitz, David; LaStayo, Paul C; Pappas, Lisa M; Boucher, Kenneth M; Irwin, Michael R; Hill, Harry R; Martins, Thomas B; Agarwal, Neeraj; Kinney, Anita Y

2015-03-01

Older cancer survivors are a vulnerable population due to an increased risk for chronic diseases (e.g., cardiovascular disease) compounded with treatment late-effects and declines in physical functioning. Therefore, interventions that reduce chronic disease risk factors (i.e., blood pressure, chronic inflammation, and cortisol) are important in this population. Tai chi chih (TCC) is a mind-body exercise associated with reductions in chronic disease risk factors, but has not been examined with older cancer survivors. In a feasibility randomized controlled trial of TCC, we examined secondary outcomes of blood pressure, salivary cortisol, and inflammatory cytokines (interleukin (IL)-6, IL-12, tumor necrosis factor-α, IL-10, IL-4) due to their implications in chronic diseases. Sixty-three senior female cancer survivors (M age = 67 years, SD = 7.15) with physical functioning limitations (SF-12 physical functioning ≤80 or role-physical ≤72) were randomized to 12-weeks (60-min, three times a week) of TCC or Health Education control (HEC) classes. Resting blood pressure, 1-day salivary cortisol samples, and fasting plasma samples for cytokine multiplex assays were collected at baseline and 1-week post-intervention. Controlling for baseline values, the TCC group had significantly lower systolic blood pressure (SBP, p = 0.002) and cortisol area-under-curve (AUC, p = 0.02) at post-intervention than the HEC group. There was no intervention effect on inflammatory cytokines (p's > 0.05). This TCC feasibility trial was associated with significant reductions in SBP and cortisol AUC in senior female cancer survivors. Larger, definitive trials are needed to confirm these findings. Senior survivors' have an increased risk for chronic diseases; however, TCC interventions may help reduce associated risk factors.

Preliminary efficacy and feasibility of embedding high intensity interval training into the school day: A pilot randomized controlled trial.

PubMed

Costigan, S A; Eather, N; Plotnikoff, R C; Taaffe, D R; Pollock, E; Kennedy, S G; Lubans, D R

2015-01-01

Current physical activity and fitness levels among adolescents are low, increasing the risk of chronic disease. Although the efficacy of high intensity interval training (HIIT) for improving metabolic health is now well established, it is not known if this type of activity can be effective to improve adolescent health. The primary aim of this study is to assess the effectiveness and feasibility of embedding HIIT into the school day. A 3-arm pilot randomized controlled trial was conducted in one secondary school in Newcastle, Australia. Participants (n = 65; mean age = 15.8(0.6) years) were randomized into one of three conditions: aerobic exercise program (AEP) (n = 21), resistance and aerobic exercise program (RAP) (n = 22) and control (n = 22). The 8-week intervention consisted of three HIIT sessions per week (8-10 min/session), delivered during physical education (PE) lessons or at lunchtime. Assessments were conducted at baseline and post-intervention to detect changes in cardiorespiratory fitness (multi-stage shuttle-run), muscular fitness (push-up, standing long jump tests), body composition (Body Mass Index (BMI), BMI-z scores, waist circumference) and physical activity motivation (questionnaire), by researchers blinded to treatment allocation. Intervention effects for outcomes were examined using linear mixed models, and Cohen's d effect sizes were reported. Participants in the AEP and RAP groups had moderate intervention effects for waist circumference (p = 0.024), BMI-z (p = 0.037) and BMI (not significant) in comparison to the control group. A small intervention effect was also evident for cardiorespiratory fitness in the RAP group.

A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study.

PubMed

Sharma, Anup; Barrett, Marna S; Cucchiara, Andrew J; Gooneratne, Nalaka S; Thase, Michael E

2017-01-01

To evaluate feasibility, efficacy, and tolerability of Sudarshan Kriya yoga (SKY) as an adjunctive intervention in patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment. Patients with MDD (defined by DSM-IV-TR) who were depressed despite ≥ 8 weeks of antidepressant treatment were randomized to SKY or a waitlist control (delayed yoga) arm for 8 weeks. The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to 2 months. The key secondary efficacy end points were change in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) total scores. Analyses of the intent-to-treat (ITT) and completer sample were performed. The study was conducted at the University of Pennsylvania between October 2014 and December 2015. In the ITT sample (n = 25), the SKY arm (n = 13) showed a greater improvement in HDRS-17 total score compared to waitlist control (n = 12) (-9.77 vs 0.50, P = .0032). SKY also showed greater reduction in BDI total score versus waitlist control (-17.23 vs -1.75, P = .0101). Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist (ITT mean difference: -5.19; 95% CI, -0.93 to -9.34; P = .0097; completer mean difference: -6.23; 95% CI, -1.39 to -11.07; P = .0005). No adverse events were reported. Results of this randomized, waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants. ClinicalTrials.gov identifier: NCT02616549. © Copyright 2016 Physicians Postgraduate Press, Inc.

Parent Education for Migrant Mothers of Left-Behind Children in China: A Pilot Randomized Controlled Trial.

PubMed

To, Siu-Ming; Kwok, Ching-Man; So, Yuk-Yan; Yan, Ming-Wai

2018-06-13

Although numerous studies have indicated the significance of parental support and parent-child communication in alleviating the adverse effects of parental departure on left-behind children, researchers have rarely addressed the impact of parent education on migrant parents. On the basis of the results of a pilot randomized controlled trial, the study reported here involved examining the possible outcomes and feasibility of a parent education program for rural-to-urban migrant mothers of left-behind children in China. Informed by an existential-narrative approach to parent education, the program was composed of six 2.5-hour sessions. The sample included 56 migrant mothers recruited from a social service center in Shenzhen, China, who were randomly assigned to either the immediate group (n = 28, M = 34.82 years, SD = 4.12, aged 23-43) or the waitlist control group (n = 28, M = 34.68 years, SD = 4.53, aged 28-43). The hypotheses of the trial were twofold: that the program would positively affect participants' parental identity and that it would improve mother-child relationships and parenting practices. The results revealed no significant difference in parental identity between the intervention group and the waitlist control group at the post-test assessment after ruling out the effects of pretest survey scores. However, significant differences did emerge in parent-child relationships and parenting practices. Overall, the results corroborate the feasibility of examining the current program for migrant mothers in China in a full trial. The findings also offer insights into developing empirically supported parent education programs for migrant parents. © 2018 Family Process Institute.

Remote magnetic control of a wireless capsule endoscope in the esophagus is safe and feasible: results of a randomized, clinical trial in healthy volunteers.

PubMed

Keller, Jutta; Fibbe, Christiane; Volke, Frank; Gerber, Jeremy; Mosse, Alexander C; Reimann-Zawadzki, Meike; Rabinovitz, Elisha; Layer, Peter; Swain, Paul

2010-11-01

Remote control of esophageal capsule endoscopes could enhance diagnostic accuracy. To assess the safety and efficacy of remote magnetic manipulation of a modified capsule endoscope (magnetic maneuverable capsule [MMC]; Given Imaging Ltd, Yoqneam, Israel) in the esophagus of healthy humans. Randomized, controlled trial. Academic hospital. This study involved 10 healthy volunteers. All participants swallowed a conventional capsule (ESO2; Given Imaging) and a capsule endoscope with magnetic material, the MMC, which is activated by a thermal switch, in random order (1 week apart). An external magnetic paddle (EMP; Given Imaging) was used to manipulate the MMC within the esophageal lumen. MMC responsiveness was evaluated on a screen showing the MMC film in real time. Safety and tolerability of the procedure (questionnaire), responsiveness of the MMC to the EMP, esophageal transit time, and visualization of the Z-line. No adverse events occurred apart from mild retrosternal pressure (n = 5). The ability to rotate the MMC around its longitudinal axis and to tilt it by defined movements of the EMP was clearly demonstrated in 9 volunteers. Esophageal transit time was highly variable for both capsules (MMC, 111-1514 seconds; ESO2, 47-1474 seconds), but the MMC stayed longer in the esophagus in 8 participants (P < .01). Visualization of the Z-line was more efficient with the ESO2 (inspection of 73% ± 18% of the circumference vs 33% ± 27%, P = .01). Magnetic forces were not strong enough to hold the MMC against peristalsis when the capsule approached the gastroesophageal junction. Remote control of the MMC in the esophagus of healthy volunteers is safe and feasible, but higher magnetic forces may be needed. Copyright © 2010 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Feasibility of Using Cranial Electrotherapy Stimulation for Pain in Persons with Parkinson's Disease

PubMed Central

Rintala, Diana H.; Tan, Gabriel; Willson, Pamela; Bryant, Mon S.; Lai, Eugene C. H.

2010-01-01

Objectives. To assess the feasibility of treating musculoskeletal pain in the lower back and/or lower extremities in persons with Parkinson's disease (PD) with cranial electrotherapy stimulation (CES). Design. Randomized, controlled, double-blind trial. Setting. Veterans Affairs Medical Center, Community. Participants. Nineteen persons with PD and pain in the lower back and/or lower extremities. Thirteen provided daily pain rating data. Intervention. Of the thirteen participants who provided daily pain data, 6 were randomly provided with active CES devices and 7 with sham devices to use at home 40 minutes per day for six weeks. They recorded their pain ratings on a 0-to-10 scale immediately before and after each session. Main Outcome Measure. Average daily change in pain intensity. Results. Persons receiving active CES had, on average, a 1.14-point decrease in pain compared with a 0.23-point decrease for those receiving sham CES (Wilcoxon Z = −2.20, P = .028). Conclusion. Use of CES at home by persons with PD is feasible and may be somewhat helpful in decreasing pain. A larger study is needed to determine the characteristics of persons who may experience meaningful pain reduction with CES. Guidelines for future studies are provided. PMID:20976091

Motivational interviewing and screening colonoscopy in high-risk individuals. A randomized controlled trial.

PubMed

Salimzadeh, Hamideh; Khabiri, Roghaye; Khazaee-Pool, Maryam; Salimzadeh, Somayeh; Delavari, Alireza

2018-06-01

To measure the impact of motivational interviewing (MI) on cancer knowledge and screening practice among first degree relatives (FDRs) of patients with colon cancer. This randomized controlled trial targeted patients with colon cancer first to recruit their possible FDRs. Digit randomization of the eligible index patients into intervention or control groups resulted in allocating their belonging FDRs to the same study arm. FDRs (n = 120) in intervention arm received MI counseling on phone by a trained oncology nurse and FDRs (n = 120) in control group received standard generic information by a physician on phone. Primary outcome was the rate of documented colonoscopy in FDRs within six months after the baseline. A total of 227 FDRs were followed up, 115 in the intervention and 112 in the control group. At follow-up, the uptake of screening colonoscopy in the intervention group was 83.5% versus 48.2% in controls (crude odds ratio, 5.4; 95% confidence interval, 2.9-10.0, P < .001). This was the first randomized controlled trial in Iran that confirmed the efficaciousness of a phone-based MI counseling in improving colonoscopy uptake among family members of patients with colon cancer. Phone-based motivational counseling that involves trained nurses or health providers seems to be feasible approach in Iran health system and enhances screening for colon cancer. Copyright © 2018 Elsevier B.V. All rights reserved.

Quasi-experimental study designs series-paper 2: complementary approaches to advancing global health knowledge.

PubMed

Geldsetzer, Pascal; Fawzi, Wafaie

2017-09-01

Quasi-experiments have been infrequently used in the health sciences. Focusing on health systems implementation research, this article details key advantages of quasi-experiments and argues that they can complement (but not replace) randomized evaluations. Specifically, it may be possible to use a quasi-experiment to study the causal effect of an intervention that cannot feasibly be randomized or that would be unethical (e.g., because the intervention has become the standard of care) to test in a randomized controlled trial (RCT). In addition, because they usually take advantage of routinely collected data, quasi-experiments may be feasible when it is too costly (either financially or in terms of the required time) to carry out a RCT - an important advantage in research on health systems, which vary widely between settings. Nonetheless, we argue that RCTs will continue to be indispensable for implementation research because i) the assumptions needed to establish causality with a quasi-experiment are often unverifiable, ii) available data frequently do not allow for a rigorous quasi-experiment, and iii) randomized designs tend to lend themselves more to informing policy makers of causal effects prior to (or during) the full-scale rollout of an intervention than quasi-experiments. Copyright © 2017 Elsevier Inc. All rights reserved.

Feasibility of a Trial on Improvisational Music Therapy for Children with Autism Spectrum Disorder.

PubMed

Geretsegger, Monika; Holck, Ulla; Bieleninik, Łucja; Gold, Christian

2016-01-01

To conduct generalizable, rigorously designed, adequately powered trials investigating music therapy and other complex interventions, it is essential that study procedures are feasible and acceptable for participants. To date, only limited evidence on feasibility of trial designs and strategies to facilitate study implementation is available in the music therapy literature. Using data from a subsample of a multi-center RCT on improvisational music therapy (IMT) for autism spectrum disorder (ASD), this study aims to evaluate feasibility of study procedures, evaluate safety, document concomitant treatment, and report consistency of individuals' trends over time in chosen outcome measures. Children with ASD aged between 4 years, 0 months, and 6 years, 11 months, were randomly assigned to one of three conditions: one (low intensity) vs. three weekly IMT sessions (high intensity) for five months vs. standard care. Feasibility was evaluated by examining recruitment, implementation of study conditions, assessment procedures, blinding, and retention; we also evaluated safety, concomitant treatment, and consistency of changes in standardized scales completed by blinded assessors and parents before and 5 months after randomization. Within this subsample (n = 15), recruitment rates, session attendance in the high-intensity condition, and consistency between outcome measures were lower than expected. Session attendance in the low-intensity and control conditions, treatment fidelity, measurement completion, blinding, retention, and safety met a priori thresholds for feasibility. By discussing strategies to improve recruitment and to minimize potential burden on study participants, referrers, and researchers, this study helps build knowledge about designing and implementing trials successfully. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Efficacy of a workplace-based weight loss program for overweight male shift workers: the Workplace POWER (Preventing Obesity Without Eating like a Rabbit) randomized controlled trial.

PubMed

Morgan, Philip J; Collins, Clare E; Plotnikoff, Ronald C; Cook, Alyce T; Berthon, Bronwyn; Mitchell, Simon; Callister, Robin

2011-05-01

To evaluate the feasibility and efficacy of a workplace-based weight loss program (Workplace POWER-WP) for male shift workers. A prospective, two-armed randomized controlled trial of 110 overweight/obese (BMI 25-40) (mean [SD] age = 44.4 [8.6] years; BMI = 30.5 [3.6]) male employees at Tomago Aluminium aged 18-65. In October (2009) men were randomized to either (i) WP program (n=65) or (ii) a 14-week wait-list control group (n=45). The 3-month program involved one information session, program booklets, group-based financial incentives and an online component. Men were assessed at baseline and at 14-week follow-up for weight (primary outcome), waist circumference, BMI, blood pressure, resting heart rate, self-reported physical activity and dietary variables, and physical activity and dietary cognitions. Intention-to-treat analysis using linear mixed models revealed significant between group differences for weight loss after 14 weeks (P < .001, Cohen's d = 0.34). Significant intervention effects were also found for waist circumference (P < .001, d = 0.63), BMI (P < .001, d = 0.41), systolic blood pressure (P = .02, d = 0.48), resting heart rate (P < .001, d = 0.81), physical activity (P = .03, d = 0.77), sweetened beverages (P < .02, d = 0.5-0.6) and physical activity-related cognitions (P < .02, d=0.6). The WP program was feasible and efficacious and resulted in significant weight loss and improved health-related outcomes and behaviours in overweight male shift workers. Copyright © 2011 Elsevier Inc. All rights reserved.

Hyperthermia and fever control in brain injury.

PubMed

Badjatia, Neeraj

2009-07-01

Fever in the neurocritical care setting is common and has a negative impact on outcome of all disease types. Meta-analyses have demonstrated that fever at onset and in the acute setting after ischemic brain injury, intracerebral hemorrhage, and cardiac arrest has a negative impact on morbidity and mortality. Data support that the impact of fever is sustained for longer durations after subarachnoid hemorrhage and traumatic brain injury. Recent advances have made eliminating fever and maintaining normothermia feasible. However, there are no prospective randomized trials demonstrating the benefit of fever control in these patient populations, and important questions regarding indications and timing remain. The purpose of this review is to analyze the data surrounding the impact of fever across a range of neurologic injuries to better understand the optimal timing and duration of fever control. Prospective randomized trials are needed to determine whether the beneficial impact of secondary injury prevention is outweighed by the potential risks of prolonged fever control.

Effectiveness and feasibility of early physical rehabilitation programs for geriatric hospitalized patients: a systematic review

PubMed Central

2013-01-01

Background Old adults admitted to the hospital are at severe risk of functional loss during hospitalization. Early in-hospital physical rehabilitation programs appear to prevent functional loss in geriatric patients. The first aim of this review was to investigate the effect of early physical rehabilitation programs on physical functioning among geriatric patients acutely admitted to the hospital. The second aim was to evaluate the feasibility of early physical rehabilitation programs. Methods Two searches, one for physical functioning and one for feasibility, were conducted in PubMed, CINAHL, and EMBASE. Additional studies were identified through reference and citation tracking. To be included articles had to report on in-hospital early physical rehabilitation of patients aged 65 years and older with an outcome measure of physical functioning. Studies were excluded when the treatment was performed on specialized units other than geriatric units. Randomized controlled trials were included to examine the effect of early physical rehabilitation on physical functioning, length of stay and discharge destination. To investigate feasibility also non randomized controlled trials were added. Results Fifteen articles, reporting on 13 studies, described the effect on physical functioning. The early physical rehabilitation programs were classified in multidisciplinary programs with an exercise component and usual care with an exercise component. Multidisciplinary programs focussed more on facilitating discharge home and independent ADL, whereas exercise programs aimed at improving functional outcomes. At time of discharge patients who had participated in a multidisciplinary program or exercise program improved more on physical functional tests and were less likely to be discharged to a nursing home compared to patients receiving only usual care. In addition, multidisciplinary programs reduced the length of hospital stay significantly. Follow-up interventions improved physical functioning after discharge. The feasibility search yielded four articles. The feasibility results showed that early physical rehabilitation for acutely hospitalized old adults was safe. Adherence rates differed between studies and the recruitment of patients was sometimes challenging. Conclusions Early physical rehabilitation care for acutely hospitalized old adults leads to functional benefits and can be safely executed. Further research is needed to specifically quantify the physical component in early physical rehabilitation programs. PMID:24112948

Effectiveness and feasibility of early physical rehabilitation programs for geriatric hospitalized patients: a systematic review.

PubMed

Kosse, Nienke M; Dutmer, Alisa L; Dasenbrock, Lena; Bauer, Jürgen M; Lamoth, Claudine J C

2013-10-10

Old adults admitted to the hospital are at severe risk of functional loss during hospitalization. Early in-hospital physical rehabilitation programs appear to prevent functional loss in geriatric patients. The first aim of this review was to investigate the effect of early physical rehabilitation programs on physical functioning among geriatric patients acutely admitted to the hospital. The second aim was to evaluate the feasibility of early physical rehabilitation programs. Two searches, one for physical functioning and one for feasibility, were conducted in PubMed, CINAHL, and EMBASE. Additional studies were identified through reference and citation tracking. To be included articles had to report on in-hospital early physical rehabilitation of patients aged 65 years and older with an outcome measure of physical functioning. Studies were excluded when the treatment was performed on specialized units other than geriatric units. Randomized controlled trials were included to examine the effect of early physical rehabilitation on physical functioning, length of stay and discharge destination. To investigate feasibility also non randomized controlled trials were added. Fifteen articles, reporting on 13 studies, described the effect on physical functioning. The early physical rehabilitation programs were classified in multidisciplinary programs with an exercise component and usual care with an exercise component. Multidisciplinary programs focussed more on facilitating discharge home and independent ADL, whereas exercise programs aimed at improving functional outcomes. At time of discharge patients who had participated in a multidisciplinary program or exercise program improved more on physical functional tests and were less likely to be discharged to a nursing home compared to patients receiving only usual care. In addition, multidisciplinary programs reduced the length of hospital stay significantly. Follow-up interventions improved physical functioning after discharge. The feasibility search yielded four articles. The feasibility results showed that early physical rehabilitation for acutely hospitalized old adults was safe. Adherence rates differed between studies and the recruitment of patients was sometimes challenging. Early physical rehabilitation care for acutely hospitalized old adults leads to functional benefits and can be safely executed. Further research is needed to specifically quantify the physical component in early physical rehabilitation programs.

The effectiveness of solution-focused brief therapy for psychological distress among Chinese parents of children with a cancer diagnosis: a pilot randomized controlled trial.

PubMed

Zhang, Anao; Ji, QingYing; Currin-McCulloch, Jennifer; Solomon, Phyllis; Chen, YuTing; Li, Yaxi; Jones, Barbara; Franklin, Cynthia; Nowicki, Jack

2018-08-01

Given the critical role of parental care for pediatric cancer patients, this pilot study evaluated the feasibility and effectiveness of a hospital-based solution-focused brief therapy (SFBT) intervention for reducing psychological distress among parents of pediatric cancer patients in China. Differences between treatment and active control (AC) groups were assessed on dimensions of psychological distress. Parents' level of hope was also assessed. Participants (N = 44) were randomly assigned to SFBT or AC. Parents received four sessions of SFBT twice a week delivered by graduate-level hospital social workers. Pre- and post-intervention assessments measured change in distress (depression, anxiety, and somatization symptoms) of parents as well as their level of hope. Analysis of covariance (ANCOVA) indicated the SFBT group had better outcomes than the AC group on overall distress of somatic, anxiety, depression symptoms and level of hope. Within- and between-group treatment effects reported significantly greater effect of the SFBT group than of the AC group. Considering the inherent limits of a pilot feasibility study, results suggest that SFBT is a feasible, culturally compatible, and promising intervention for alleviating distress among Chinese parents of children with cancer. Additional comprehensive trials are needed to draw more definitive conclusions. SFBT may be beneficial for improving the critical support systems of parents of pediatric cancer patients. Thus, SFBT may have the potential to enhance children's well-being during cancer treatment and recovery.

Teaching surgical skills using video internet communication in a resource-limited setting.

PubMed

Autry, Amy M; Knight, Sharon; Lester, Felicia; Dubowitz, Gerald; Byamugisha, Josaphat; Nsubuga, Yosam; Muyingo, Mark; Korn, Abner

2013-07-01

To study the feasibility and acceptability of using video Internet communication to teach and evaluate surgical skills in a low-resource setting. This case-controlled study used video Internet communication for surgical skills teaching and evaluation. We randomized intern physicians rotating in the Obstetrics and Gynecology Department at Mulago Hospital at Makerere University in Kampala, Uganda, to the control arm (usual practice) or intervention arm (three video teaching sessions with University of California, San Francisco faculty). We made preintervention and postintervention videos of all interns tying knots using a small video camera and uploaded the files to a file hosting service that offers cloud storage. A blinded faculty member graded all of the videos. Both groups completed a survey at the end of the study. We randomized 18 interns with complete data for eight in the intervention group and seven in the control group. We found score improvement of 50% or more in six of eight (75%) interns in the intervention group compared with one of seven (14%) in the control group (P=.04). Scores declined in five of the seven (71%) controls but in none in the intervention group. Both intervention and control groups used attendings, colleagues, and the Internet as sources for learning about knot-tying. The control group was less likely to practice knot-tying than the intervention group. The trainees and the instructors felt this method of training was enjoyable and helpful. Remote teaching in low-resource settings, where faculty time is limited and access to visiting faculty is sporadic, is feasible, effective, and well-accepted by both learner and teacher. II.

Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial.

PubMed

Kimani-Murage, Elizabeth W; Kimiywe, Judith; Kabue, Mark; Wekesah, Frederick; Matiri, Evelyn; Muhia, Nelson; Wanjohi, Milka; Muriuki, Peterrock; Samburu, Betty; Kanyuira, James N; Young, Sera L; Griffiths, Paula L; Madise, Nyovani J; McGarvey, Stephen T

2015-09-28

Interventions promoting optimal infant and young child nutrition could prevent a fifth of under-5 deaths in countries with high mortality. Poor infant and young child feeding practices are widely documented in Kenya, with potential detrimental effects on child growth, health and survival. Effective strategies to improve these practices are needed. This study aims to pilot implementation of the Baby Friendly Community Initiative (BFCI), a global initiative aimed at promoting optimal infant and young child feeding practices, to determine its feasibility and effectiveness with regards to infant feeding practices, nutrition and health outcomes in a rural setting in Kenya. The study, employing a cluster-randomized trial design, will be conducted in rural Kenya. A total of 12 clusters, constituting community units within the government's Community Health Strategy, will be randomized, with half allocated to the intervention and the other half to the control arm. A total of 812 pregnant women and their respective children will be recruited into the study. The mother-child pairs will be followed up until the child is 6 months old. Recruitment will last approximately 1 year from January 2015, and the study will run for 3 years, from 2014 to 2016. The intervention will involve regular counseling and support of mothers by trained community health workers and health professionals on maternal, infant and young child nutrition. Regular assessment of knowledge, attitudes and practices on maternal, infant and young child nutrition will be done, coupled with assessment of nutritional status of the mother-child pairs and morbidity for the children. Statistical methods will include analysis of covariance, multinomial logistic regression and multilevel modeling. The study is funded by the NIH and USAID through the Program for Enhanced Research (PEER) Health. Findings from the study outlined in this protocol will inform potential feasibility and effectiveness of a community-based intervention aimed at promoting optimal breastfeeding and other infant feeding practices. The intervention, if proved feasible and effective, will inform policy and practice in Kenya and similar settings, particularly regarding implementation of the baby friendly community initiative. ISRCTN03467700 ; Date of Registration: 24 September 2014.

National randomized controlled trial of virtual house calls for Parkinson disease

PubMed Central

Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Aldred, Jason; Carter, Julie; Fraser, Andrew; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Reichwein, Suzanne; Mari, Zoltan; Dunlop, Becky; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy C.; Singer, Carlos; Vargas-Parra, Silvia; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Dhall, Rohit; Hassan, Anhar; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Achey, Meredith A.; Elson, Molly J.; Goldenthal, Steven; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2017-01-01

Objective: To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable. Methods: In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire–39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings. Results: A total of 927 individuals indicated interest, 210 were enrolled, and 195 were randomized. Participants had recently seen a specialist (73%) and were largely college-educated (73%) and white (96%). Ninety-five (98% of the intervention group) completed at least one virtual visit, and 91% of 388 virtual visits were completed. Quality of life did not improve in those receiving virtual house calls (0.3 points worse on a 100-point scale; 95% confidence interval [CI] −2.0 to 2.7 points; p = 0.78) nor did quality of care or caregiver burden. Each virtual house call saved patients a median of 88 minutes (95% CI 70–120; p < 0.0001) and 38 miles per visit (95% CI 36–56; p < 0.0001). Conclusions: Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience. ClinicalTrials.gov identifier: NCT02038959. Classification of evidence: This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type. PMID:28814455

Feasibility and effects of preventive home visits for at-risk older people: design of a randomized controlled trial.

PubMed

Cutchin, Malcolm P; Coppola, Susan; Talley, Vibeke; Svihula, Judie; Catellier, Diane; Shank, Kendra Heatwole

2009-12-03

The search for preventive methods to mitigate functional decline and unwanted relocation by older adults living in the community is important. Preventive home visit (PHV) models use infrequent but regular visits to older adults by trained practitioners with the goal of maintaining function and quality of life. Evidence about PHV efficacy is mixed but generally supportive. Yet interventions have rarely combined a comprehensive (biopsychosocial) occupational therapy intervention protocol with a home visit to older adults. There is a particular need in the USA to create and examine such a protocol. The study is a single-blind randomized controlled pilot trial designed to assess the feasibility, and to obtain preliminary efficacy estimates, of an intervention consisting of preventive home visits to community-dwelling older adults. An occupational therapy-based preventive home visit (PHV) intervention was developed and is being implemented and evaluated using a repeated measures design. We recruited a sample of 110 from a population of older adults (75+) who were screened and found to be at-risk for functional decline. Participants are currently living in the community (not in assisted living or a skilled nursing facility) in one of three central North Carolina counties. After consent, participants were randomly assigned into experimental and comparison groups. The experimental group receives the intervention 4 times over a 12 month follow-up period while the comparison group receives a minimal intervention of mailed printed materials. Pre- and post-intervention measures are being gathered by questionnaires administered face-to-face by a treatment-blinded research associate. Key outcome measures include functional ability, participation, life satisfaction, self-rated health, and depression. Additional information is collected from participants in the experimental group during the intervention to assess the feasibility of the intervention and potential modifiers. Fidelity is being addressed and measured across several domains. Feasibility indications to date are positive. Although the protocol has some limitations, we expect to learn enough about the intervention, delivery and effects to support a larger trial with a more stringent design and enhanced statistical power. ClinicalTrials.gov ID NCT00985283.

The feasibility, time savings and economic impact of a designated time appointment system at a busy HIV care clinic in Kenya: a randomized controlled trial.

PubMed

Kwena, Zachary A; Njoroge, Betty W; Cohen, Craig R; Oyaro, Patrick; Shikari, Rosemary; Kibaara, Charles K; Bukusi, Elizabeth A

2015-01-01

As efforts are made to reach universal access to ART in Kenya, the problem of congestion at HIV care clinics is likely to worsen. We evaluated the feasibility and the economic benefits of a designated time appointment system as a solution to decongest HIV care clinics. This was an explanatory two-arm open-label randomized controlled trial that enrolled 354 consenting participants during their normal clinic days and followed-up at subsequent clinic appointments for up to nine months. Intervention arm participants were given specific dates and times to arrive at the clinic for their next appointment while those in the control arm were only given the date and had the discretion to decide on the time to arrive as is the standard practice. At follow-up visits, we recorded arrival and departure times and asked the monetary value of work participants engaged in before and after clinic. We conducted multiple imputation to replace missing data in our primary outcome variables to allow for intention-to-treat analysis; and analyzed the data using Mann-Whitney U test. Overall, 72.1% of the intervention participants arrived on time, 13.3% arrived ahead of time and 14.6% arrived past scheduled time. Intervention arm participants spent a median of 65 [interquartile range (IQR), 52-87] minutes at the clinic compared to 197 (IQR, 173-225) minutes for control participants (p<0.01). Furthermore, intervention arm participants were more productively engaged on their clinic days valuing their cumulative work at a median of USD 10.5 (IQR, 60.0-16.8) compared to participants enrolled in the control arm who valued their work at USD 8.3 (IQR, 5.5-12.9; p=0.02). A designated time appointment system is feasible and provides substantial time savings associated with greater economic productivity for HIV patients attending a busy HIV care clinic.

A Comparative Study on the Teaching Effects of TRIZ Courses for the Humanities

ERIC Educational Resources Information Center

Luo, Lingling; Li, Peng; Zhang, Ping

2017-01-01

In order to test the feasibility of the curriculum system of TRIZ used in humanities and social science majors, this study will test whether it is effective to cultivate students' creativity and to train their ability to solve problems. This study designs the randomly experimental targets in the two control groups for pretest and post-test. This…

Empirical Benchmarks of Hidden Bias in Educational Research: Implication for Assessing How well Propensity Score Methods Approximate Experiments and Conducting Sensitivity Analysis

ERIC Educational Resources Information Center

Dong, Nianbo; Lipsey, Mark

2014-01-01

When randomized control trials (RCT) are not feasible, researchers seek other methods to make causal inference, e.g., propensity score methods. One of the underlined assumptions for the propensity score methods to obtain unbiased treatment effect estimates is the ignorability assumption, that is, conditional on the propensity score, treatment…

Making Time for Instructional Leadership. Volume 2: The Feasibility of a Randomized Control Trial of the SAM Process

ERIC Educational Resources Information Center

Goldring, Ellen; Grissom, Jason A.; Neumerski, Christine M.; Murphy, Joseph; Blissett, Richard; Porter, Andy

2015-01-01

This three-volume report describes the "SAM (School Administration Manager) process," an approach that about 700 schools around the nation are using to direct more of principals' time and effort to improve teaching and learning in classrooms. Research has shown that a principal's instructional leadership is second only to teaching among…

Parents' Opinions about an Intervention to Manage Repetitive Behaviours in Young Children with Autism Spectrum Disorder: A Qualitative Study

ERIC Educational Resources Information Center

Hodgson, Anna R.; Grahame, Victoria; Garland, Deborah; Gaultier, Fiona; Lecouturier, Jan; Le Couteur, Ann

2018-01-01

Background: Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social communication skills. We report data collected via focus group discussions as part of a feasibility and acceptability pilot randomized controlled trial (RCT) about a new parent group intervention to manage restricted and repetitive behaviours (RRB)…

Duodenal Electric Stimulation: Results of a First-in-Man Study.

PubMed

Aberle, Jens; Busch, Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver

2016-02-01

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Children Learning About Second-Hand Smoking: A Feasibility Cluster Randomized Controlled Trial.

PubMed

Huque, Rumana; Dogar, Omara; Cameron, Ian; Thomson, Heather; Amos, Amanda; Siddiqi, Kamran

2015-12-01

Exposure to second-hand smoke is a threat to children's health. We developed a school-based smoke-free intervention (SFI) to support families in implementing smoke-free homes in Bangladesh, and gathered preliminary evidence of its effectiveness. A feasibility cluster randomized controlled trial of SFI was conducted in 24 schools in Mirpur, an urban area within Dhaka. Using simple stratified randomization, schools were allocated to: Arm A (SFI only), Arm B (SFI plus reminders), and Arm C (the control group). A total of 781 year-5 children (10-12 years old) in the consenting schools, participated in the study. Outcomes including "smoke-free homes" and "social visibility" that is, not smoking in front of children at home were assessed through questionnaire-based children's surveys, administered by researchers, at baseline and at weeks 1, 12, 27, and 52 in all arms. "Smoke-free homes" were significantly higher in Arm A (odds ratio [OR] = 4.8; 95% CI = 2.6-9.0) and in Arm B (OR = 3.9; 95% CI = 2.0-7.5) than in Arm C, when controlled for the baseline levels, at year 1. Similarly, "social visibility" was significantly reduced in Arm A (OR = 5.8; 95% CI = 2.8-11.7) and in Arm B (OR = 7.2; 95% CI = 3.3-15.9) than Arm C, when controlled for the baseline levels, at year 1. We observed an increasing trend (Cochrane Armitage test statistic [Z] = 3.8; p < .0001) in homes becoming smoke-free with increasing intensity of the intervention (control < Arm A < Arm B), and a decreasing trend (Z = -5.13; p < .0001) in social visibility at homes. SFI has the potential to encourage children to negotiate a smoke-free environment in their homes. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India.

PubMed

Mimiaga, Matthew J; Thomas, Beena; Biello, Katie; Johnson, Blake E; Swaminathan, Soumya; Navakodi, Pandiyaraja; Balaguru, S; Dhanalakshmi, A; Closson, Elizabeth F; Menon, Sunil; O'Cleirigh, Conall; Mayer, Kenneth H; Safren, Steven A

2017-11-01

Men who have sex with men (MSM) are at increased risk for HIV infection in India, particularly those who engage in transactional sex with other men (i.e., male sex workers; MSW). Despite the need, HIV prevention efforts for Indian MSW are lacking. As in other settings, MSW in India increasingly rely on the use of mobile phones for sex work solicitation. Integrating mobile phone technology into an HIV prevention intervention for Indian MSW may mitigate some of the challenges associated with face-to face approaches, such as implementation, lack of anonymity, and time consumption, while at the same time proving to be both feasible and useful. This is a pilot randomized controlled trial to examine participant acceptability, feasibility of study procedures, and preliminary efficacy for reducing sexual risk for HIV. MSW (N = 100) were equally randomized to: (1) a behavioral HIV prevention intervention integrating in-person and mobile phone delivered HIV risk reduction counseling, and daily, personalized text or voice messages as motivating "cognitive restructuring" cues for reducing condomless anal sex (CAS); or (2) a standard of care (SOC) comparison condition. Both groups received HIV counseling and testing at baseline and 6-months, and completed ACASI-based, behavioral and psychosocial assessments at baseline, 3, and 6 months. Mixed-effects regression procedures specifying a Poisson distribution and log link with a random intercept and slope for month of follow-up was estimated to assess the intervention effect on the primary outcomes: (1) CAS acts with male clients who paid them for sex, and (2) CAS acts with male non-paying sexual partners-both outcomes assessed over the past month. The intervention was both feasible (98% retention at 6-months) and acceptable (>96% of all intervention sessions attended); all intervention participants rated the intervention as "acceptable" or "very acceptable." A reduction in the reported number of CAS acts with male clients who paid them for sex in the past month was seen in both study conditions. MSW in the intervention condition reported a faster rate of decline in the number of CAS acts with male clients in the past month from the baseline to both the 3-month (B = -1.20; 95% CI -1.68, -0.73; p < 0.0001) and 6-month (B = -2.44; 95% CI -3.35, -1.53; p < 0.00001) assessment visits compared to the SOC condition. Post-hoc contrasts indicated that, at 3 months, participants in the intervention condition reported 1.43 (SD = 0.29) CAS acts with male clients in the past month compared to 4.85 (SD = 0.87) in the control condition (p = 0.0003). Furthermore, at 6 months, the intervention condition participants reported 0.24 (SD = 0.09) CAS acts with male clients in the past month compared to 2.79 (SD = 0.79) in the control condition (p < 0.0001). Findings are encouraging and provide evidence of feasibility and acceptability, and demonstrate initial efficacy (for reducing sexual risk for HIV) of a behavioral HIV prevention intervention for Indian MSW that combines daily, personalized text or voice messages with mobile phone-delivered sexual risk reduction counseling and skills building. Future testing of the intervention in a fully powered randomized controlled efficacy trial is warranted.

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness.

PubMed

Serfaty, Marc; Ridgewell, Anna; Drennan, Vari; Kessel, Anthony; Brewin, Chris R; Leavey, Gerard; Wright, Anwen; Laycock, Gloria; Blanchard, Martin

2016-03-01

Limited data suggest that crime may have a devastating impact on older people. Although identification and treatment may be beneficial, no well-designed studies have investigated the prevalence of mental disorder and the potential benefits of individual manualized CBT in older victims of crime. To identify mental health problems in older victims of common crime, provide preliminary data on its prevalence, and conduct a feasibility randomized controlled trial (RCT) using mixed methods. Older victims, identified through police teams, were screened for symptoms of anxiety, depression or post-traumatic stress disorder (PTSD) one (n = 581) and 3 months (n = 486) after experiencing a crime. Screen positive participants were offered diagnostic interviews. Of these, 26 participants with DSM-IV diagnoses agreed to be randomized to Treatment As Usual (TAU) or TAU plus our manualized CBT informed Victim Improvement Package (VIP). The latter provided feedback on the VIP. Recruitment, assessment and intervention are feasible and acceptable. At 3 months 120/486 screened as cases, 33 had DSM-IV criteria for a psychiatric disorder; 26 agreed to be randomized to a pilot trial. There were trends in favour of the VIP in all measures except PTSD at 6 months post crime. This feasibility RCT is the first step towards improving the lives of older victims of common crime. Without intervention, distress at 3 and 6 months after a crime remains high. However, the well-received VIP appeared promising for depressive and anxiety symptoms, but possibly not posttraumatic stress disorder.

Design of the Blood Pressure Goals in Dialysis pilot study.

PubMed

Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer; Harford, Antonia; Horowitz, Bruce; Chen, Joline; Paine, Susan; Bedrick, Edward; Kusek, John W; Unruh, Mark; Zager, Philip

2014-02-01

Cardiovascular disease (CVD) is markedly increased among hemodialysis (HD) patients. Optimizing blood pressure (BP) among HD patients may present an important opportunity to reduce the disparity in CVD rates between HD patients and the general population. The optimal target predialysis systolic BP (SBP) among HD patients is unknown. Current international guidelines, calling for a predialysis SBP < 140 mm Hg, are based on the opinion and extrapolation from the general population. Existing randomized controlled trials (RCTs) were small and did not include prespecified BP targets. The authors described the design of the Blood Pressure in Dialysis (BID) Study, a pilot, multicenter RCT where HD patients are randomized to either a target-standardized predialysis SBP of 110 to 140 mm Hg or 155 to 165 mm Hg. This is the first study to randomize HD patients to 2 different SBP targets. Primary outcomes are feasibility and safety. Feasibility parameters include recruitment and retention rates, adherence with prescribed BP measurements and achievement and maintenance of selected BP targets. Safety parameters include rates of hypotension and other adverse and serious adverse events. The authors obtained preliminary data on changes in left ventricular mass, aortic pulse wave velocity, vascular access thromboses and health-related quality of life across study arms, which may be the secondary outcomes in the full-scale study. The data acquired in the pilot RCT will determine the feasibility and safety and inform the design of a full-scale trial, powered for hard outcomes, which may require 2000 participants.

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS. ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.

PubMed

Walsh, Fiona J; Bärnighausen, Till; Delva, Wim; Fleming, Yvette; Khumalo, Gavin; Lejeune, Charlotte L; Mazibuko, Sikhathele; Mlambo, Charmaine Khudzie; Reis, Ria; Spiegelman, Donna; Zwane, Mandisa; Okello, Velephi

2017-08-18

There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system. This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling. A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa. ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016.

Improving symptom communication through personal digital assistants: the CHAT (Communicating Health Assisted by Technology) project.

PubMed

Post, Douglas M; Shapiro, Charles L; Cegala, Donald J; David, Prabu; Katz, Mira L; Krok, Jessica L; Phillips, Gary S; McAlearney, Ann Sheck; Lehman, Jennifer S; Hicks, William; Paskett, Electra D

2013-12-01

Communication problems impede effective symptom management during chemotherapy. The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant-delivered communication intervention on pain, depression, and fatigue symptoms among breast cancer patients undergoing chemotherapy. Secondary aims included assessment of 1) study feasibility, 2) patient and clinician responses to study participation, and 3) intervention effects on health-related quality of life (HRQoL) and communication self-efficacy. Intervention group participants (n = 27) completed symptom inventories at baseline, once per week during treatment, and at posttreatment. Depending on symptom severity, they viewed race-concordant videos on how to communicate about pain, depression and/or fatigue, using the personal digital assistant. Symptom records were tracked and shared with clinicians. Control group participants (n = 23) received usual care. Longitudinal random effects modeling assessed the changes in average symptom scores over time. Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy. Postintervention focus groups, interviews, and surveys assessed responses to study participation. Mean age of the participants was 51.0 years; 42 participants (84%) were white. In comparison with control, intervention group participants reported lower average pain severity over time (P = .015). Mean pain interference scores over time were marginally different between groups (P = .07); mean depression and fatigue scores over time were statistically nonsignificant. Feasibility outcomes and perspectives about study participation were positive. Mean pre-post decreases in HRQoL were generally higher among intervention group participants; pre-post changes in communication self-efficacy were equivalent. Mixed findings of the study indicate the need for future research.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Improving Symptom Communication Through Personal Digital Assistants: The CHAT (Communicating Health Assisted by Technology) Project

PubMed Central

2013-01-01

Background Communication problems impede effective symptom management during chemotherapy. The primary aim of this pilot randomized controlled trial was to test the effects of a personal digital assistant–delivered communication intervention on pain, depression, and fatigue symptoms among breast cancer patients undergoing chemotherapy. Secondary aims included assessment of 1) study feasibility, 2) patient and clinician responses to study participation, and 3) intervention effects on health-related quality of life (HRQoL) and communication self-efficacy. Methods Intervention group participants (n = 27) completed symptom inventories at baseline, once per week during treatment, and at posttreatment. Depending on symptom severity, they viewed race-concordant videos on how to communicate about pain, depression and/or fatigue, using the personal digital assistant. Symptom records were tracked and shared with clinicians. Control group participants (n = 23) received usual care. Longitudinal random effects modeling assessed the changes in average symptom scores over time. Descriptive statistics assessed study feasibility and intervention effects on HRQoL and communication self-efficacy. Postintervention focus groups, interviews, and surveys assessed responses to study participation. Results Mean age of the participants was 51.0 years; 42 participants (84%) were white. In comparison with control, intervention group participants reported lower average pain severity over time (P = .015). Mean pain interference scores over time were marginally different between groups (P = .07); mean depression and fatigue scores over time were statistically nonsignificant. Feasibility outcomes and perspectives about study participation were positive. Mean pre–post decreases in HRQoL were generally higher among intervention group participants; pre–post changes in communication self-efficacy were equivalent. Conclusion Mixed findings of the study indicate the need for future research. PMID:24395985

A Pilot Trial of Early Specialty Palliative Care for Patients with Advanced Pancreatic Cancer: Challenges Encountered and Lessons Learned.

PubMed

Schenker, Yael; Bahary, Nathan; Claxton, Rene; Childers, Julie; Chu, Edward; Kavalieratos, Dio; King, Linda; Lembersky, Barry; Tiver, Greer; Arnold, Robert M

2018-01-01

Patients with advanced pancreatic cancer suffer from high morbidity and mortality. Specialty palliative care may improve quality of life. Assess the feasibility, acceptability, and perceived effectiveness of early specialty physician-led palliative care for patients with advanced pancreatic cancer and their caregivers. A mixed-methods pilot randomized controlled trial in which patient-caregiver pairs were randomized (2:1) to receive specialty palliative care, in addition to standard oncology care versus standard oncology care alone. At a National Cancer Institute-designated comprehensive cancer center in Western Pennsylvania, 30 patients with advanced pancreatic adenocarcinoma and their caregivers (N = 30), oncologists (N = 4), and palliative care physicians (N = 3) participated. Feasibility (enrollment, three-month outcome-assessment, and intervention completion rates), acceptability, and perceived effectiveness (process interviews with patients, caregivers, and physicians). Consent:approach rate was 49%, randomized:consent rate 55%, and three-month outcome assessment rate 75%. Two patients and three caregivers withdrew early. The three-month mortality rate was 13%. Patients attended a mean of 1.3 (standard deviation 1.1) palliative care visits during the three-month period. Positive experiences with palliative care included receiving emotional support and symptom management. Negative experiences included inconvenience, long travel times, spending too much time at the cancer center, and no perceived palliative care needs. Physicians suggested embedding palliative care within oncology clinics, tailoring services to patient needs, and facilitating face-to-face communication between oncologists and palliative physicians. A randomized trial of early palliative care for advanced pancreatic cancer did not achieve feasibility goals. Integrating palliative care within oncology clinics may increase acceptability and perceived effectiveness.

A central storage facility to reduce pesticide suicides--a feasibility study from India.

PubMed

Vijayakumar, Lakshmi; Jeyaseelan, Lakshmanan; Kumar, Shuba; Mohanraj, Rani; Devika, Shanmugasundaram; Manikandan, Sarojini

2013-09-16

Pesticide suicides are considered the single most important means of suicide worldwide. Centralized pesticide storage facilities have the possible advantage of delaying access to pesticides thereby reducing suicides. We undertook this study to examine the feasibility and acceptability of a centralized pesticide storage facility as a preventive intervention strategy in reducing pesticide suicides. A community randomized controlled feasibility study using a mixed methods approach involving a household survey; focus group discussions (FGDs) and surveillance were undertaken. The study was carried out in a district in southern India. Eight villages that engaged in floriculture were identified. Using the lottery method two were randomized to be the intervention sites and two villages constituted the control site. Two centralized storage facilities were constructed with local involvement and lockable storage boxes were constructed. The household survey conducted at baseline and one and a half years later documented information on sociodemographic data, pesticide usage, storage and suicides. At baseline 4446 individuals (1097 households) in the intervention and 3307 individuals (782 households) in the control sites were recruited while at follow up there were 4308 individuals (1063 households) in the intervention and 2673 individuals (632 households) in the control sites. There were differences in baseline characteristics and imbalances in the prevalence of suicides between intervention and control sites as this was a small feasibility study.The results from the FGDs revealed that most participants found the storage facility to be both useful and acceptable. In addition to protecting against wastage, they felt that it had also helped prevent pesticide suicides as the pesticides stored here were not as easily and readily accessible. The primary analyses were done on an Intention to Treat basis. Following the intervention, the differences between sites in changes in combined, completed and attempted suicide rates per 100,000 person-years were 295 (95% CI: 154.7, 434.8; p < 0.001) for pesticide suicide and 339 (95% CI: 165.3, 513.2, p < 0.001) for suicide of all methods. Suicide by pesticides poisoning is a major public health problem and needs innovative interventions to address it. This study, the first of its kind in the world, examined the feasibility of a central storage facility as a means of limiting access to pesticides and, has provided preliminary results on its usefulness. These results need to be interpreted with caution in view of the imbalances between sites. The facility was found to be acceptable, thereby underscoring the need for larger studies for a longer duration. ISRCTN04912407.

Remote just-in-time telementored trauma ultrasound: a double-factorial randomized controlled trial examining fluid detection and remote knobology control through an ultrasound graphic user interface display.

PubMed

Kirkpatrick, Andrew W; McKee, Ian; McKee, Jessica L; Ma, Irene; McBeth, Paul B; Roberts, Derek J; Wurster, Charles L; Parfitt, Robbie; Ball, Chad G; Oberg, Scott; Sevcik, William; Hamilton, Douglas R

2016-05-01

Remote-telementored ultrasound involves novice examiners being remotely guided by experts using informatic-technologies. However, requiring a novice to perform ultrasound is a cognitively demanding task exacerbated by unfamiliarity with ultrasound-machine controls. We incorporated a randomized evaluation of using remote control of the ultrasound functionality (knobology) within a study in which the images generated by distant naive examiners were viewed on an ultrasound graphic user interface (GUI) display viewed on laptop computers by mentors in different cities. Fire-fighters in Edmonton (101) were remotely mentored from Calgary (n = 65), Nanaimo (n = 19), and Memphis (n = 17) to examine an ultrasound phantom randomized to contain free fluid or not. Remote mentors (2 surgeons, 1 internist, and 1 ED physician) were randomly assigned to use GUI knobology control during mentoring (GUIK+/GUIK-). Remote-telementored ultrasound was feasible in all cases. Overall accuracy for fluid detection was 97% (confidence interval = 91 to 99%) with 3 false negatives (FNs). Positive/negative likelihood ratios were infinity/0.0625. One FN occurred with the GUIK+ and 2 without (GUIK-). There were no statistical test performance differences in either group (GUIK+ and GUIK-). Ultrasound-naive 1st responders can be remotely mentored with high accuracy, although providing basic remote control of the knobology did not affect outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Feasibility of group intervention for bereaved siblings after pediatric cancer death.

PubMed

Greenwald, Naomi; Barrera, Maru; Neville, Alexandra; Hancock, Kelly

2017-01-01

This study evaluated the feasibility (acceptability, recruitment, retention rates, treatment fidelity, and outcome measures) of implementing a manualized group intervention for bereaved siblings after pediatric cancer death. A convenience sample of 10 siblings participated. The intervention consisted of eight 2-hour sessions that focused on strategies for coping with grief, relationships, and emotional growth. Positive outcomes were obtained with respect to acceptability, recruitment, retention rates, and treatment fidelity. Preliminary outcomes were mixed. Parent pre- and post-intervention outcomes suggested improvements in siblings' overall emotional and social quality of life. Siblings' self-reports reflected no improvements. These data support the feasibility of conducting this intervention and suggest beneficial outcomes based on parental reports. Further research is recommended to evaluate the group intervention efficacy with a large sample using a randomized controlled trial to address the needs of bereaved siblings.

The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial.

PubMed

Holt, Jane; Lord, Jonathan; Acharya, Umesh; White, Adrian; O'Neill, Nyree; Shaw, Steve; Barton, Andy

2009-06-01

To determine whether foot reflexology, a complementary therapy, has an effect greater than sham reflexology on induction of ovulation. Sham-controlled randomized trial with patients and statistician blinded. Infertility clinic in Plymouth, United Kingdom. Forty-eight women attending the clinic with anovulation. Women were randomized to receive eight sessions of either genuine foot reflexology or sham reflexology with gentle massage over 10 weeks. The primary outcome was ovulation detected by serum progesterone level of >30 nmol/L during the study period. Twenty-six patients were randomized to genuine reflexology and 22 to sham (one randomized patient was withdrawn). Patients remained blinded throughout the trial. The rate of ovulation during true reflexology was 11 out of 26 (42%), and during sham reflexology it was 10 out of 22 (46%). Pregnancy rates were 4 out of 26 in the true group and 2 out of 22 in the control group. Because of recruitment difficulties, the required sample size of 104 women was not achieved. Patient blinding of reflexology studies is feasible. Although this study was too small to reach a definitive conclusion on the specific effect of foot reflexology, the results suggest that any effect on ovulation would not be clinically relevant. Sham reflexology may have a beneficial general effect, which this study was not designed to detect.

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial

PubMed Central

Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

2016-01-01

Background Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. Method In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Main Outcome Measures Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. Results We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. Conclusion The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible. Trial Registration UMIN Clinical Trials Registry UMIN000012994 PMID:26930191

Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial.

PubMed

Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

2016-01-01

Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. The results suggest that occupational therapy using the ADOC for older residents might be effective and cost-effective. We also found that conducting an RCT in the occupational therapy setting is feasible. UMIN Clinical Trials Registry UMIN000012994.

Feasibility of a Sensory-Adapted Dental Environment for Children With Autism

PubMed Central

Stein Duker, Leah I.; Williams, Marian E.; Lane, Christianne Joy; Dawson, Michael E.; Borreson, Ann E.; Polido, José C.

2015-01-01

OBJECTIVE. To provide an example of an occupational therapy feasibility study and evaluate the implementation of a randomized controlled pilot and feasibility trial examining the impact of a sensory-adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorder (ASD). METHOD. Twenty-two children with ASD and 22 typically developing children, ages 6–12 yr, attended a dental clinic in an urban hospital. Participants completed two dental cleanings, 3–4 mo apart, one in a regular environment and one in a SADE. Feasibility outcome measures were recruitment, retention, accrual, dropout, and protocol adherence. Intervention outcome measures were physiological stress, behavioral distress, pain, and cost. RESULTS. We successfully recruited and retained participants. Parents expressed satisfaction with research study participation. Dentists stated that the intervention could be incorporated in normal practice. Intervention outcome measures favored the SADE condition. CONCLUSION. Preliminary positive benefit of SADE in children with ASD warrants moving forward with a large-scale clinical trial. PMID:25871593

A Feasibility Study of Virtual Reality-Based Coping Skills Training for Nicotine Dependence

PubMed Central

Bordnick, Patrick S.; Traylor, Amy C.; Carter, Brian L.; Graap, Ken M.

2014-01-01

Objective Virtual reality (VR)-based cue reactivity has been successfully used for the assessment of drug craving. Going beyond assessment of cue reactivity, a novel VR-based treatment approach for smoking cessation was developed and tested for feasibility. Method In a randomized experiment, 10-week treatment feasibility trial, 46 nicotine-dependent adults, completed the10-week program. Virtual reality skills training (VRST) combined with nicotine replacement therapy (NRT) was compared to NRT alone. Participants were assessed for smoking behavior and coping skills during, at end of treatment, and at posttreatment follow-up. Results Smoking rates and craving for nicotine were significantly lower for the VRST group compared to NRT-only group at the end of treatment. Self-confidence and coping skills were also significantly higher for the VRST group, and number of cigarettes smoked was significantly lower, compared to the control group at follow-up. Conclusions Feasibility of VRST was supported in the current study. PMID:25484549

Is clarithromycin a potential treatment for cachexia in people with lung cancer? A feasibility study.

PubMed

Awan, Sarah; Crosby, Vincent; Potter, Vanessa; Hennig, Ivo; Baldwin, David; Ndlovu, Mehluli; Paradine, Sharon; Wilcock, Andrew

2017-02-01

Clarithromycin may improve cachexia and survival in non-small cell lung cancer (NSCLC), but adequately controlled data are lacking. This study was undertaken primarily to inform the feasibility and scale of a phase III trial. Eligible consenting patients with stage IV NSCLC and cachexia were to be randomized to receive either clarithromycin 250mg twice daily or placebo for eight weeks. Aspects of trial feasibility recorded included numbers eligible, approached and recruited, together with adherence and completion of treatment and assessments. Over 6 months, none of 125 patients identified fulfilled the entry criteria. The commonest reasons for ineligibility were the use of an excluded concurrent drug (45, 36%), brain metastases (22, 18%), poor performance status (21, 17%) and current chemotherapy (15, 12%). A phase III trial of clarithromycin using these entry criteria is not feasible in this setting. Other macrolides that have a lower risk of a drug-drug interaction may be more practical to pursue. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Evaluation of multisystemic therapy pilot services in Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B): study protocol for a randomized controlled trial.

PubMed

Fonagy, Peter; Butler, Stephen; Baruch, Geoffrey; Byford, Sarah; Seto, Michael C; Wason, James; Wells, Charles; Greisbach, Jessie; Ellison, Rachel; Simes, Elizabeth

2015-11-02

Clinically effective and cost-effective methods for managing problematic sexual behaviour in adolescents are urgently needed. Adolescents who show problematic sexual behaviour have a range of negative psychosocial outcomes, and they and their parents can experience stigma, hostility and rejection from their community. Multisystemic therapy (MST) shows some evidence for helping to reduce adolescent sexual reoffending and is one of the few promising interventions available to young people who show problematic sexual behaviour. This paper describes the protocol for Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B), a feasibility trial of MST for problem sexual behaviour (MST-PSB) in antisocial adolescents at high risk of out-of-home placement due to problematic sexual behaviour. Eighty participants and their families recruited from five London boroughs will be randomized to MST-PSB or management as usual with follow-up to 20 months post-randomization. The primary outcome is out-of-home placement at 20 months. Secondary outcomes include sexual and non-sexual offending rates and antisocial behaviours, participant well-being, educational outcomes and total service and criminal justice sector costs. Feasibility outcomes include mapping the clinical service pathways needed to recruit adolescents displaying problematic sexual behaviour, acceptability of a randomized controlled trial to the key systems involved in managing these adolescents, and acceptability of the research protocol to young people and their families. Data will be gathered from police computer records, the National Pupil Database and interviews and self-report measures administered to adolescents and parents and will be analysed on an intention-to-treat basis. The STEPS-B feasibility trial aims to inform policymakers, commissioners of services and professionals about the potential for implementing MST-PSB as an intervention for adolescents showing problem sexual behaviour. Should MST-PSB show potential, STEPS-B will determine what would be necessary to implement the programme more fully and at a scale that would warrant a full trial. ISRCTN28441235 (registered 25 January 2012).

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study

PubMed Central

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A.; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18–25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system (n = 7) or a self-paced review of materials about job-interviewing skills (n = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning. PMID:28955254

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study.

PubMed

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18-25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system ( n  = 7) or a self-paced review of materials about job-interviewing skills ( n  = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning.

A randomized controlled trial of yoga for pregnant women with symptoms of depression and anxiety.

PubMed

Davis, Kyle; Goodman, Sherryl H; Leiferman, Jenn; Taylor, Mary; Dimidjian, Sona

2015-08-01

Yoga may be well suited for depressed and anxious pregnant women, given reported benefits of meditation and physical activity and pregnant women's preference for nonpharmacological treatments. We randomly assigned 46 pregnant women with symptoms of depression and anxiety to an 8-week yoga intervention or treatment-as-usual (TAU) in order to examine feasibility and preliminary outcomes. Yoga was associated with high levels of credibility and satisfaction as an intervention for depression and anxiety during pregnancy. Participants in both conditions reported significant improvement in symptoms of depression and anxiety over time; and yoga was associated with significantly greater reduction in negative affect as compared to TAU (β = -0.53, SE = 0.20, p = .011). Prenatal yoga was found to be a feasible and acceptable intervention and was associated with reductions in symptoms of anxiety and depression; however, prenatal yoga only significantly outperformed TAU on reduction of negative affect. Published by Elsevier Ltd.

A double-blind randomized pilot trial comparing computerized cognitive exercises to Tetris in adolescents with attention-deficit/hyperactivity disorder.

PubMed

Bikic, Aida; Christensen, Torben Østergaard; Leckman, James F; Bilenberg, Niels; Dalsgaard, Søren

2017-08-01

The purpose of this trial was to examine the feasibility and efficacy of computerized cognitive exercises from Scientific Brain Training (SBT), compared to the computer game Tetris as an active placebo, in a pilot study of adolescents with attention-deficit/hyperactivity disorder (ADHD). Eighteen adolescents with ADHD were randomized to treatment or control intervention for 7 weeks. Outcome measures were cognitive test, symptom, and motivation questionnaires. SBT and Tetris were feasible as home-based interventions, and participants' compliance was high, but participants perceived both interventions as not very interesting or helpful. There were no significant group differences on cognitive and ADHD-symptom measures after intervention. Pre-post intra-group measurement showed that the SBT had a significant beneficial effect on sustained attention, while the active placebo had significant beneficial effects on working memory, both with large effect sizes. Although no significant differences were found between groups on any measure, there were significant intra-group changes for each group.

A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

PubMed

Koffel, Erin; Kuhn, Eric; Petsoulis, Napoleon; Erbes, Christopher R; Anders, Samantha; Hoffman, Julia E; Ruzek, Josef I; Polusny, Melissa A

2018-03-01

There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study ( n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment.

Feasibility of the "Bring Your Own Device" Model in Clinical Research: Results from a Randomized Controlled Pilot Study of a Mobile Patient Engagement Tool.

PubMed

Pugliese, Laura; Woodriff, Molly; Crowley, Olga; Lam, Vivian; Sohn, Jeremy; Bradley, Scott

2016-03-16

Rising rates of smartphone ownership highlight opportunities for improved mobile application usage in clinical trials. While current methods call for device provisioning, the "bring your own device" (BYOD) model permits participants to use personal phones allowing for improved patient engagement and lowered operational costs. However, more evidence is needed to demonstrate the BYOD model's feasibility in research settings. To assess if CentrosHealth, a mobile application designed to support trial compliance, produces different outcomes in medication adherence and application engagement when distributed through study-provisioned devices compared to the BYOD model. 87 participants were randomly selected to use the mobile application or no intervention for a 28-day pilot study at a 2:1 randomization ratio (2 intervention: 1 control) and asked to consume a twice-daily probiotic supplement. The application users were further randomized into two groups: receiving the application on a personal "BYOD" or study-provided smartphone. In-depth interviews were performed in a randomly-selected subset of the intervention group (five BYOD and five study-provided smartphone users). The BYOD subgroup showed significantly greater engagement than study-provided phone users, as shown by higher application use frequency and duration over the study period. The BYOD subgroup also demonstrated a significant effect of engagement on medication adherence for number of application sessions (unstandardized regression coefficient beta=0.0006, p=0.02) and time spent therein (beta=0.00001, p=0.03). Study-provided phone users showed higher initial adherence rates, but greater decline (5.7%) than BYOD users (0.9%) over the study period. In-depth interviews revealed that participants preferred the BYOD model over using study-provided devices. Results indicate that the BYOD model is feasible in health research settings and improves participant experience, calling for further BYOD model validity assessment. Although group differences in medication adherence decline were insignificant, the greater trend of decline in provisioned device users warrants further investigation to determine if trends reach significance over time. Significantly higher application engagement rates and effect of engagement on medication adherence in the BYOD subgroup similarly imply that greater application engagement may correlate to better medication adherence over time.

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

PubMed

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario and McMaster Universities Osteoarthritis Index scale[WOMAC] and the Lequesne Index) as well as the timed up and go, sit to stand, preferred gait speed, and body composition. This pilot study appears to be the first study assessing the feasibility and safety of a home-based HIIT training program for middle-aged and older adults with knee OA. As HIIT has been demonstrated to be more effective than MICT for improving aspects of health status, body composition, and/or muscular function in other chronic disease groups, the current study has the potential to improve patient outcomes and inform the design of future randomized controlled trials.

Interpersonal art psychotherapy for the treatment of aggression in people with learning disabilities in secure care: a protocol for a randomised controlled feasibility study.

PubMed

Hackett, Simon S; Taylor, John L; Freeston, Mark; Jahoda, Andrew; McColl, Elaine; Pennington, Lindsay; Kaner, Eileen

2017-01-01

Art psychotherapy has greater potential for use with adults with mild to moderate learning disabilities as it places less of a burden on verbal interaction to achieve positive therapeutic, psychological, and behavioural goals. The feasibility study objectives include testing procedures, outcomes, validated tools, recruitment and attrition rates, acceptability, and treatment fidelity for manualised interpersonal art psychotherapy. Adult males and females with mild to moderate learning disabilities will be recruited from four NHS secure hospitals. Twenty patients will be recruited and randomly assigned to one of two treatment groups: fifteen 1-h individual sessions of manualised interpersonal art psychotherapy, or a treatment as usual waiting list control group. The Modified Overt Aggression Scale will be administered to both treatment arms. Four patients will be recruited to a single-case design component of the study exploring the acceptability of an attentional condition. This multi-site study will assist in future trial planning and inform feasibility including, procedures, treatment acceptability, therapist adherence, and estimation of samples size for a definitive RCT.

An Implementation Study of Two Evidence-Based Exercise and Health Education Programmes for Older Adults with Osteoarthritis of the Knee and Hip

ERIC Educational Resources Information Center

de Jong, O. R. W.; Hopman-Rock, M.; Tak, E. C. M. P.; Klazinga, N. S.

2004-01-01

Implementation studies are recommended to assess the feasibility and effectiveness in real-life of programmes which have been tested in randomized controlled trials (RCTs). We report on an implementation study of two evidence-based exercise and health education programmes for older adults with osteoarthritis (OA) of the knee or hip. Three types of…

The Impact of Dialogic Book-Sharing Training on Infant Language and Attention: A Randomized Controlled Trial in a Deprived South African Community

ERIC Educational Resources Information Center

Vally, Zahir; Murray, Lynne; Tomlinson, Mark; Cooper, Peter J.

2015-01-01

Background: Dialogic book-sharing is an interactive form of shared reading. It has been shown in high income countries (HICs) to be of significant benefit to child cognitive development. Evidence for such benefit in low and middle income countries (LMICs) is scarce, although a feasibility study of our own produced encouraging findings.…

Effectiveness of a smart phone app on improving immunization of children in rural Sichuan Province, China: study protocol for a paired cluster randomized controlled trial.

PubMed

Chen, Li; Wang, Wei; Du, Xiaozhen; Rao, Xiuqin; van Velthoven, Michelle Helena; Yang, Ruikan; Zhang, Lin; Koepsell, Jeanne Catherine; Li, Ye; Wu, Qiong; Zhang, Yanfeng

2014-03-20

Although good progress has been achieved in expanding immunization of children in China, disparities exist across different provinces. Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas. The rapid development of mobile health technology (mHealth) provides unprecedented opportunities for improving health services and reaching underserved populations. However, there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications (apps). This study aims to assess the effectiveness of a smart phone-based app (Expanded Program on Immunization app, or EPI app) on improving the coverage of children's immunization. This cluster randomized trial will take place in Xuanhan County, Sichuan Province, China. Functionalities of the app include the following: to make appointments automatically, record and update children's immunization information, generate a list of children who missed their vaccination appointments, and send health education information to village doctors. After pairing, 36 villages will be randomly allocated to the intervention arm (n=18) and control arm (n=18). The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas. A household survey will be used at baseline and at endline (8 months of implementation). The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine, Rotavirus vaccine and Pneumococcal conjugate vaccine. Multidimensional evaluation of the app will also be conducted to assess usability and feasibility. This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China. This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings. Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960.

Transfer of obturator nerve for femoral nerve injury: an experiment study in rats.

PubMed

Meng, Depeng; Zhou, Jun; Lin, Yaofa; Xie, Zheng; Chen, Huihao; Yu, Ronghua; Lin, Haodong; Hou, Chunlin

2018-07-01

Quadriceps palsy is mainly caused by proximal lesions in the femoral nerve. The obturator nerve has been previously used to repair the femoral nerve, although only a few reports have described the procedure, and the outcomes have varied. In the present study, we aimed to confirm the feasibility and effectiveness of this treatment in a rodent model using the randomized control method. Sixty Sprague-Dawley rats were randomized into two groups: the experimental group, wherein rats underwent femoral neurectomy and obturator nerve transfer to the femoral nerve motor branch; and the control group, wherein rats underwent femoral neurectomy without nerve transfer. Functional outcomes were measured using the BBB score, muscle mass, and histological assessment. At 12 and 16 weeks postoperatively, the rats in the experimental group exhibited recovery to a stronger stretch force of the knee and higher BBB score, as compared to the control group (p < 0.05). The muscle mass and myofiber cross-sectional area of the quadriceps were heavier and larger than those in the control group (p < 0.05). A regenerated nerve with myelinated and unmyelinated fibers was observed in the experimental group. No significant differences were observed between groups at 8 weeks postoperatively (p > 0.05). Obturator nerve transfer for repairing femoral nerve injury was feasible and effective in a rat model, and can hence be considered as an option for the treatment of femoral nerve injury.

Reduce chest pain using modified silicone fluted drain tube for chest drainage after video-assisted thoracic surgery (VATS) lung resection.

PubMed

Li, Xin; Hu, Bin; Miao, Jinbai; Li, Hui

2016-02-01

The aim of this study was to assess the feasibility, efficacy and safety of a modified silicone fluted drain tube after video-assisted thoracic surgery (VATS) lung resection. The prospective randomized study included 50 patients who underwent VATS lung resection between March 2015 and June 2015. Eligible patients were randomized into two groups: experimental group (using the silicone fluted drain tubes for chest drainage) and control group (using standard drain tubes for chest drainage). The volume and characteristics of drainage, postoperative (PO) pain scores and hospital stay were recorded. All patients received standard care during hospital admission. In accordance with the exit criteria, three patients were excluded from study. The remaining 47 patients included in the final analysis were divided into two groups: experiment group (N=24) and control group (N=23). There was no significant difference between the two groups in terms of age, sex, height, weight, clinical diagnosis and type of surgical procedure. There was a trend toward less PO pain in experimental group on postoperative day (POD) 1, with a statistically significant difference. Patients in experimental group had a reduced occurrence of fever [temperature (T) >37.4 °C] compared to the control group. The silicone fluted drain tube is feasible and safe and may relieve patient PO pain and reduce occurrence of fever without the added risk of PO complications.

A reanalysis of cluster randomized trials showed interrupted time-series studies were valuable in health system evaluation.

PubMed

Fretheim, Atle; Zhang, Fang; Ross-Degnan, Dennis; Oxman, Andrew D; Cheyne, Helen; Foy, Robbie; Goodacre, Steve; Herrin, Jeph; Kerse, Ngaire; McKinlay, R James; Wright, Adam; Soumerai, Stephen B

2015-03-01

There is often substantial uncertainty about the impacts of health system and policy interventions. Despite that, randomized controlled trials (RCTs) are uncommon in this field, partly because experiments can be difficult to carry out. An alternative method for impact evaluation is the interrupted time-series (ITS) design. Little is known, however, about how results from the two methods compare. Our aim was to explore whether ITS studies yield results that differ from those of randomized trials. We conducted single-arm ITS analyses (segmented regression) based on data from the intervention arm of cluster randomized trials (C-RCTs), that is, discarding control arm data. Secondarily, we included the control group data in the analyses, by subtracting control group data points from intervention group data points, thereby constructing a time series representing the difference between the intervention and control groups. We compared the results from the single-arm and controlled ITS analyses with results based on conventional aggregated analyses of trial data. The findings were largely concordant, yielding effect estimates with overlapping 95% confidence intervals (CI) across different analytical methods. However, our analyses revealed the importance of a concurrent control group and of taking baseline and follow-up trends into account in the analysis of C-RCTs. The ITS design is valuable for evaluation of health systems interventions, both when RCTs are not feasible and in the analysis and interpretation of data from C-RCTs. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial.

PubMed

Gasparini, Maurizio; Galimberti, Paola; Bragato, Renato; Ghio, Stefano; Raineri, Claudia; Landolina, Maurizio; Chieffo, Enrico; Lunati, Maurizio; Mulargia, Ederina; Proclemer, Alessandro; Facchin, Domenico; Rordorf, Roberto; Vicentini, Alessandro; Marcantoni, Lina; Zanon, Francesco; Klersy, Catherine

2016-12-03

Despite an intensive search for predictors of the response to cardiac resynchronization therapy (CRT), the QRS duration remains the simplest and most robust predictor of a positive response. QRS duration of ≥ 130 ms is considered to be a prerequisite for CRT; however, some studies have shown that CRT may also be effective in heart failure (HF) patients with a narrow QRS (<130 ms). Since CRT can now be performed by pacing the left ventricle from multiple vectors via a single quadripolar lead, it is possible that multipoint pacing (MPP) might be effective in HF patients with a narrow QRS. This article reports the design of the MPP Narrow QRS trial, a prospective, randomized, multicenter, controlled feasibility study to investigate the efficacy of MPP using two LV pacing vectors in patients with a narrow QRS complex (100-130 ms). Fifty patients with a standard ICD indication will be enrolled and randomized (1:1) to either an MPP group or a Standard ICD group. All patients will undergo a low-dose dobutamine stress echo test and only those with contractile reserve will be included in the study and randomized. The primary endpoint will be the percentage of patients in each group that have reverse remodeling at 12 months, defined as a reduction in left ventricular end-systolic volume (LVESV) of >15% from the baseline. This feasibility study will determine whether MPP improves reverse remodeling, as compared with standard ICD, in HF patients who have a narrow QRS complex (100-130 ms). ClinicalTrials.gov, NCT02402816 . Registered on 25 March 2015.

Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial.

PubMed

Jibb, Lindsay A; Birnie, Kathryn A; Nathan, Paul C; Beran, Tanya N; Hum, Vanessa; Victor, J Charles; Stinson, Jennifer N

2018-06-12

Subcutaneous port needle insertions are painful and distressing for children with cancer. The interactive MEDiPORT robot has been programmed to implement psychological strategies to decrease pain and distress during this procedure. This study assessed the feasibility of a future MEDiPORT trial. The secondary aim was to determine the preliminary effectiveness of MEDiPORT in reducing child pain and distress during subcutaneous port accesses. This 5-month pilot randomized controlled trial used a web-based service to randomize 4- to 9-year-olds with cancer to the MEDiPORT cognitive-behavioral arm (robot using evidence-based cognitive-behavioral interventions) or active distraction arm (robot dancing and singing) while a nurse conducted a needle insertion. We assessed accrual and retention; technical difficulties; outcome measure completion by children, parents, and nurses; time taken to complete the study and clinical procedure; and child-, parent-, and nurse-rated acceptability. Descriptive analyses, with exploratory inferential testing of child pain and distress data, were used to address study aims. Forty children were randomized across study arms. Most (85%) eligible children participated and no children withdrew. Technical difficulties were more common in the cognitive-behavioral arm. Completion times for the study and needle insertion were acceptable and >96% of outcome measure items were completed. Overall, MEDiPORT and the study were acceptable to participants. There was no difference in pain between arms, but distress during the procedure was less pronounced in the active distraction arm. The MEDiPORT study appears feasible to implement as an adequately-powered effectiveness-assessing trial following modifications to the intervention and study protocol. ClinicalTrials.gov NCT02611739. © 2018 Wiley Periodicals, Inc.

Population-Level Cost-Effectiveness of Implementing Evidence-Based Practices into Routine Care

PubMed Central

Fortney, John C; Pyne, Jeffrey M; Burgess, James F

2014-01-01

Objective The objective of this research was to apply a new methodology (population-level cost-effectiveness analysis) to determine the value of implementing an evidence-based practice in routine care. Data Sources/Study Setting Data are from sequentially conducted studies: a randomized controlled trial and an implementation trial of collaborative care for depression. Both trials were conducted in the same practice setting and population (primary care patients prescribed antidepressants). Study Design The study combined results from a randomized controlled trial and a pre-post-quasi-experimental implementation trial. Data Collection/Extraction Methods The randomized controlled trial collected quality-adjusted life years (QALYs) from survey and medication possession ratios (MPRs) from administrative data. The implementation trial collected MPRs and intervention costs from administrative data and implementation costs from survey. Principal Findings In the randomized controlled trial, MPRs were significantly correlated with QALYs (p = .03). In the implementation trial, patients at implementation sites had significantly higher MPRs (p = .01) than patients at control sites, and by extrapolation higher QALYs (0.00188). Total costs (implementation, intervention) were nonsignificantly higher ($63.76) at implementation sites. The incremental population-level cost-effectiveness ratio was $33,905.92/QALY (bootstrap interquartile range −$45,343.10/QALY to $99,260.90/QALY). Conclusions The methodology was feasible to operationalize and gave reasonable estimates of implementation value. PMID:25328029

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study

PubMed Central

John, Bindu; Bellipady, Sumanth Shetty; Bhat, Shrinivasa Undaru

2016-01-01

Aims. The purpose of this pilot trial was to determine the efficacy of sleep promotion program to adapt it for the use of adolescents studying in various schools of Mangalore, India, and evaluate the feasibility issues before conducting a randomized controlled trial in a larger sample of adolescents. Methods. A randomized controlled trial design with stratified random sampling method was used. Fifty-eight adolescents were selected (mean age: 14.02 ± 2.15 years; intervention group, n = 34; control group, n = 24). Self-report questionnaires, including sociodemographic questionnaire with some additional questions on sleep and activities, Sleep Hygiene Index, Pittsburgh Sleep Quality Index, The Cleveland Adolescent Sleepiness Questionnaire, and PedsQL™ Present Functioning Visual Analogue Scale, were used. Results. Insufficient weekday-weekend sleep duration with increasing age of adolescents was observed. The program revealed a significant effect in the experimental group over the control group in overall sleep quality, sleep onset latency, sleep duration, daytime sleepiness, and emotional and overall distress. No significant effect was observed in sleep hygiene and other sleep parameters. All target variables showed significant correlations with each other. Conclusion. The intervention holds a promise for improving the sleep behaviors in healthy adolescents. However, the effect of the sleep promotion program treatment has yet to be proven through a future research. This trial is registered with ISRCTN13083118. PMID:27088040

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

PubMed

Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

2017-01-23

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

Feasibility of exercising adults with asthma: a randomized pilot study.

PubMed

Boyd, Amy; Yang, Celeste T; Estell, Kim; Ms, Craig Tuggle; Gerald, Lynn B; Dransfield, Mark; Bamman, Marcas; Bonner, James; Atkinson, T Prescott; Schwiebert, Lisa M

2012-08-03

Aerobic exercise appears to have clinical benefits for many asthmatics, yet a complete understanding of the mechanisms underlying these benefits has not been elucidated at this time. The objective of this study was to determine feasibility for a larger, future study that will define the effect of aerobic exercise on cellular, molecular, and functional measures in adults with mild-moderate asthma. Recruited subjects were randomized into usual care (sedentary) or usual care with moderate intensity aerobic exercise treatment groups. Nineteen adults with mild-moderate asthma but without a recent history of exercise were recruited at the UAB Lung Health Center, Birmingham, AL. The exercise group underwent a 12 week walking program exercising at 60 - 75% of maximum heart rate (HRmax). Subjects self-monitored HRmax levels using heart rate monitors; exercise diaries and recreation center sign-in logs were also used. Functional measures, including lung function and asthma control scores, were evaluated for all subjects at pre- and post-study time-points; fitness measures were also assessed for subjects in the exercise group. Peripheral blood and nasal lavage fluid were collected from all subjects at pre- and post-study visits in order to evaluate cellular and molecular measures, including cell differentials and eosinophilic cationic protein (ECP). Sixteen subjects completed the prescribed protocol. Results show that subjects randomized to the exercise group adhered well (80%) to the exercise prescription and exhibited a trend toward improved fitness levels upon study completion. Both groups exhibited improvements in ACQ scores. No changes were observed in lung function (FEV1, FEV1/FVC), cell differentials, or ECP between groups. Results indicate that a moderate intensity aerobic exercise training program may improve asthma control and fitness levels without causing asthma deterioration in adult asthmatics. As such, these findings demonstrate the feasibility of the study protocol in preparation for a larger, clinical trial that will elucidate the functional consequences of aerobic exercise on asthmatic cellular and molecular responses.

Pilot randomized controlled trial of a mindfulness-based group intervention in adolescent girls at risk for type 2 diabetes with depressive symptoms.

PubMed

Shomaker, Lauren B; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-06-01

(1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Parallel-group, randomized controlled pilot trial conducted at a university. Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Most adolescents attended ≥80% sessions (mindfulness: 92% versus cognitive-behavioral: 87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. ClinicalTrials.gov identifier: NCT02218138 clinicaltrials.gov. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial.

PubMed

Pichler, Gerhard; Urlesberger, Berndt; Baik, Nariae; Schwaberger, Bernhard; Binder-Heschl, Corinna; Avian, Alexander; Pansy, Jasmin; Cheung, Po-Yin; Schmölzer, Georg Marcus

2016-03-01

To assess if monitoring of cerebral regional tissue oxygen saturation (crSO2) using near-infrared spectroscopy (NIRS) to guide respiratory and supplemental oxygen support reduces burden of cerebral hypoxia and hyperoxia in preterm neonates during resuscitation after birth. Preterm neonates <34(+0) weeks of gestation were included in a prospective randomized controlled pilot feasibility study at 2 tertiary level neonatal intensive care units. In a NIRS-visible group, crSO2 monitoring in addition to pulse oximetry was used to guide respiratory and supplemental oxygen support during the first 15 minutes after birth. In a NIRS-not-visible group, only pulse oximetry was used. The primary outcomes were burden of cerebral hypoxia (<10th percentile) or hyperoxia (>90th percentile) measured in %minutes crSO2 during the first 15 minutes after birth. Secondary outcomes were all cause of mortality and/or cerebral injury and neurologic outcome at term age. Allocation sequence was 1:1 with block-randomization of 30 preterm neonates at each site. In the NIRS-visible group burden of cerebral hypoxia in %minutes, crSO2 was halved, and the relative reduction was 55.4% (95% CI 37.6-73.2%; P = .028). Cerebral hyperoxia was observed in NIRS-visible group in 3 neonates with supplemental oxygen and in NIRS-not-visible group in 2. Cerebral injury rate and neurologic outcome at term age was similar in both groups. Two neonates died in the NIRS-not-visible group and none in the NIRS-visible group. No severe adverse reactions were observed. Reduction of burden of cerebral hypoxia during immediate transition and resuscitation after birth is feasible by crSO2 monitoring to guide respiratory and supplemental oxygen support. ClinicalTrials.gov: NCT02017691. Copyright © 2016 Elsevier Inc. All rights reserved.

Coach to cope: feasibility of a life coaching program for young adults with cystic fibrosis.

PubMed

Knudsen, Karin Bæk; Pressler, Tacjana; Mortensen, Laust Hvas; Jarden, Mary; Boisen, Kirsten Arntz; Skov, Marianne; Quittner, Alexandra L; Katzenstein, Terese Lea

2017-01-01

Over the last two decades, lifespan has increased significantly for people living with cystic fibrosis (CF). However, several studies have demonstrated that many young adults with CF report mental health problems and poor adherence to their prescribed treatments, challenging their long-term physical health. Treatment guidelines recommend interventions to improve adherence and self-management. The aim of this study was to test the feasibility of a life coaching intervention for young adults with CF. A randomized, controlled feasibility study was conducted at the CF Center at Copenhagen University Hospital, Rigshospitalet. Participants were young adults with CF, aged 18-30 years without severe intellectual impairments. Participants were randomized to either life coaching or standard care. The intervention consisted of up to 10 individual, face-to-face or telephone coaching sessions over a period of 1 year. Primary outcomes were recruitment success, acceptability, adherence to the intervention, and retention rates. Secondary outcome measures included health-related quality of life, adherence to treatment, self-efficacy, pulmonary function, body mass index, and blood glucose values. Among the 85 eligible patients approached, 40 (47%) were enrolled and randomized to the intervention or control group; two patients subsequently withdrew consent. Retention rates after 5 and 10 coaching sessions were 67% and 50%, respectively. Reasons for stopping the intervention included lack of time, poor health, perceiving coaching as not helpful, lack of motivation, and no need for further coaching. Coaching was primarily face-to-face (68%). No significant differences were found between the groups on any of the secondary outcomes. Both telephone and face-to-face coaching were convenient for participants, with 50% receiving the maximum offered coaching sessions. However, the dropout rate early in the intervention was a concern. In future studies, eligible participants should be screened for their interest and perceived need for support and life coaching before enrollment.

Pilot Randomized Controlled Trial of a Mindfulness-Based Group Intervention in Adolescent Girls at Risk for Type 2 Diabetes with Depressive Symptoms

PubMed Central

Shomaker, Lauren B.; Bruggink, Stephanie; Pivarunas, Bernadette; Skoranski, Amanda; Foss, Jillian; Chaffin, Ella; Dalager, Stephanie; Annameier, Shelly; Quaglia, Jordan; Brown, Kirk Warren; Broderick, Patricia; Bell, Christopher

2017-01-01

Objective (1) Evaluate feasibility and acceptability of a mindfulness-based group in adolescent girls at-risk for type 2 diabetes (T2D) with depressive symptoms, and (2) compare efficacy of a mindfulness-based versus cognitive-behavioral group for decreasing depressive symptoms and improving insulin resistance. Design and setting Parallel-group, randomized controlled pilot trial conducted at a university. Participants Thirty-three girls 12-17y with overweight/obesity, family history of diabetes, and elevated depressive symptoms were randomized to a six-week mindfulness-based (n=17) or cognitive-behavioral program (n=16). Interventions Both interventions included six, one-hour weekly group sessions. The mindfulness-based program included guided mindfulness awareness practices. The cognitive-behavioral program involved cognitive restructuring and behavioral activation. Main outcome measures Adolescents were evaluated at baseline, post-intervention, and six-months. Feasibility/acceptability were measured by attendance and program ratings. Depressive symptoms were assessed by validated survey. Insulin resistance was determined from fasting insulin and glucose, and dual energy x-ray absorptiometry was used to assess body composition. Results Most adolescents attended ≥80% sessions (mindfulness:92% versus cognitive-behavioral:87%, p=1.00). Acceptability ratings were strong. At post-treatment and six-months, adolescents in the mindfulness condition had greater decreases in depressive symptoms than adolescents in the cognitive-behavioral condition (ps<.05). Compared to the cognitive-behavioral condition, adolescents in the mindfulness-based intervention also had greater decreases in insulin resistance and fasting insulin at post-treatment, adjusting for fat mass and other covariates (ps<.05). Conclusions A mindfulness-based intervention shows feasibility and acceptability in girls at-risk for T2D with depressive symptoms. Compared to a cognitive-behavioral program, after the intervention, adolescents who received mindfulness showed greater reductions in depressive symptoms and better insulin resistance. PMID:28619307

Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings.

PubMed

Cattaneo, A; Davanzo, R; Worku, B; Surjono, A; Echeverria, M; Bedri, A; Haksari, E; Osorno, L; Gudetta, B; Setyowireni, D; Quintero, S; Tamburlini, G

1998-09-01

A randomized controlled trial was carried out for 1 y in three tertiary and teaching hospitals, in Addis Ababa (Ethiopia), Yogyakarta (Indonesia) and Merida (Mexico), to study the effectiveness, feasibility, acceptability and cost of kangaroo mother care (KMC) when compared to conventional methods of care (CMC). About 29% of 649 low birthweight infants (LBWI; 1000-1999 g) died before eligibility. Of the survivors, 38% were excluded for various reasons, 149 were randomly assigned to KMC (almost exclusive skin-to-skin care after stabilization), and 136 to CMC (warm room or incubator care). There were three deaths in each group and no difference in the incidence of severe disease. Hypothermia was significantly less common in KMC infants in Merida (13.5 vs 31.5 episodes/100 infants/d) and overall (10.8 vs 14.6). Exclusive breastfeeding at discharge was more common in KMC infants in Merida (80% vs 16%) and overall (88% vs 70%). KMC infants had a higher mean daily weight gain (21.3 g vs 17.7 g) and were discharged earlier (13.4 vs 16.3 d after enrolment). KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment. Mothers expressed a clear preference for KMC and health workers found it safe and convenient. KMC was cheaper than CMC in terms of salaries (US$ 11,788 vs US$ 29,888) and other running costs (US$ 7501 vs US$ 9876). This study confirms that hospital KMC for stabilized LBWI 1000-1999 g is at least as effective and safe as CMC, and shows that it is feasible in different settings, acceptable to mothers of different cultures, and less expensive. Where exclusive breastfeeding is uncommon among LBWI, KMC may bring about an increase in its prevalence and duration, with consequent benefits for health and growth. For hospitals in low-income countries KMC may represent an appropriate use of scarce resources.

Emollient enhancement of the skin barrier from birth offers effective atopic dermatitis prevention

PubMed Central

Simpson, Eric L.; Chalmers, Joanne R.; Hanifin, Jon M.; Thomas, Kim S.; Cork, Michael J.; McLean, W.H. Irwin; Brown, Sara J.; Chen, Zunqiu; Chen, Yiyi; Williams, Hywel C.

2014-01-01

Background Atopic dermatitis (atopic eczema) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence. Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on disease prevention, with limited success. Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization. Objective Our objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates. Methods We performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis. Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth. Parents in the control arm were asked to use no emollients. The primary feasibility outcome was the percentage of families willing to be randomized. The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months, as assessed by a trained investigator. Results Forty-two percent of eligible families agreed to be randomized into the trial. All participating families in the intervention arm found the intervention acceptable. A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50% (relative risk, 0.50; 95% CI, 0.28-0.9; P = .017). There were no emollient-related adverse events and no differences in adverse events between groups. Conclusion The results of this trial demonstrate that emollient therapy from birth represents a feasible, safe, and effective approach for atopic dermatitis prevention. If confirmed in larger trials, emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases. PMID:25282563

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

PubMed

Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

2014-11-27

Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions. This trial was registered on clinicaltrials.gov on January 8, 2014 [NCT02038959].

Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability.

PubMed

Wozniak, Jeffrey R; Fuglestad, Anita J; Eckerle, Judith K; Kroupina, Maria G; Miller, Neely C; Boys, Christopher J; Brearley, Ann M; Fink, Birgit A; Hoecker, Heather L; Zeisel, Steven H; Georgieff, Michael K

2013-11-01

There are no biological treatments for fetal alcohol spectrum disorders (FASDs), lifelong conditions associated with physical anomalies, brain damage, and neurocognitive abnormalities. In preclinical studies, choline partially ameliorates memory and learning deficits from prenatal alcohol exposure. This phase I pilot study evaluated the feasibility, tolerability, and potential adverse effects of choline supplementation in children with FASD. We hypothesized that choline would be well tolerated with minimal adverse events. The study design was a double-blind, randomized, placebo-controlled trial. Participants included 20 children aged 2.5 to 4.9 years with prenatal alcohol exposure and FASD diagnoses. Participants were randomly assigned to 500 mg choline or placebo daily for 9 months (10 active, 10 placebo). Primary outcome measures included feasibility, tolerability, adverse effects, and serum choline levels. Seventeen participants completed the study. Compliance was 82% to 87%, as evidenced by parent-completed log sheets and dose counts. Periodic 24-hour dietary recalls showed no evidence of dietary confounding. Adverse events were minimal and were equivalent in the active and placebo arms with the exception of fishy body odor, which occurred only in the active group. There were no serious adverse events to research participants. This phase I pilot study demonstrates that choline supplementation at 500 mg/d for 9 months in children aged 2 to 5 years is feasible and has high tolerability. Further examination of the efficacy of choline supplementation in FASD is currently underway. © 2013.

Developing and pilot-testing a Finding Balance Intervention for older adult bereaved family caregivers: A randomized feasibility trial.

PubMed

Holtslander, Lorraine; Duggleby, Wendy; Teucher, Ulrich; Cooper, Dan; Bally, Jill M G; Solar, Jessica; Steeves, Megan

2016-04-01

This study aimed to test the feasibility of a psychosocially supportive writing intervention focused on finding balance for older adult bereaved family caregivers of advanced cancer patients. The Finding Balance Intervention (FBI) was tested for feasibility, acceptability and potential influence on increasing hope, coping and balance through a multi-method pilot study employing a randomized trial design with 19 older adults with an average age of 72 years. The intervention group received the FBI and a follow up visit from an RN-RA. The control group received the FBI at a second visit. The FBI, a theory-based intervention was developed from grounded theory qualitative data, applying Delphi methods to design a self-administered, psychosocially supportive, writing intervention for older adults who had lost a spouse after caregiving. Feasibility was assessed and specific modifications identified. The FBI was easy to use, acceptable and of benefit. The FBI offered validation of emotions and ways to discover new ideas to find balance, which may enable bereaved caregivers to move forward on a unique journey through grief. The treatment group showed a statistically significant increase in restoration-oriented coping and higher oscillation activity. The results suggest the FBI was easy to use, acceptable and of benefit. A full scale study, with specific modifications to the design, is needed to test the effectiveness of this innovative intervention. Copyright © 2016 Elsevier Ltd. All rights reserved.

Choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD) has high feasibility and tolerability

PubMed Central

Wozniak, Jeffrey R.; Fuglestad, Anita J.; Eckerle, Judith K.; Kroupina, Maria G.; Miller, Neely C.; Boys, Christopher J.; Brearley, Ann M.; Fink, Birgit A.; Hoecker, Heather L.; Zeisel, Steven H.; Georgieff, Michael K.

2013-01-01

There are no biological treatments for fetal alcohol spectrum disorders (FASD), lifelong conditions associated with physical anomalies, brain damage, and neurocognitive abnormalities. In pre-clinical studies, choline partially ameliorates memory and learning deficits from prenatal alcohol exposure. This Phase I pilot study evaluated the feasibility, tolerability, and potential adverse effects of choline supplementation in children with FASD. We hypothesized that choline would be well-tolerated with minimal adverse events. The study design was a double-blind, randomized, placebo-controlled trial. Participants included 20 children, ages 2.5–4.9y, with prenatal alcohol exposure and FASD diagnoses. Participants were randomly assigned to 500 mg. choline or placebo daily for nine months (10 active; 10 placebo). Primary outcome measures included feasibility, tolerability, adverse effects, and serum choline levels. Seventeen participants completed the study. Compliance was 82–87% as evidenced by parent-completed logsheets and dose counts. Periodic 24-hour dietary recalls showed no evidence of dietary confounding. Adverse events were minimal and were equivalent in the active and placebo arms with the exception of fishy body odor, which occurred only in the active group. There were no serious adverse events to research participants. This Phase I pilot study demonstrates that choline supplementation at 500 mg per day for nine months in children ages 2–5 is feasible and has high tolerability. Further examination of the efficacy of choline supplementation in FASD is currently underway. PMID:24176229

Weight management for overweight and obese men delivered through professional football clubs: a pilot randomized trial

PubMed Central

2013-01-01

Background The prevalence of male obesity is increasing, but men are less likely than women to attend existing weight management programmes. We have taken a novel approach to reducing perceived barriers to weight loss for men by using professional football (soccer) clubs to encourage participation in a weight management group programme, gender-sensitised in content and style of delivery. Football Fans in Training (FFIT) provides 12 weeks of weight loss, physical activity and healthy eating advice at top professional football clubs in Scotland. This pilot randomized trial explored the feasibility of using these clubs as a setting for a randomized controlled trial of 12 month weight loss following men’s participation in FFIT. Methods A two-arm pilot trial at two Scottish Premier League football clubs (one large, one smaller), with 103 men (aged 35–65, body mass index (BMI) ≥27 kg/m2) individually randomized to the intervention (n=51, received the pilot programme (p-FFIT) immediately) and waitlist comparison (n=52, received p-FFIT after four months) groups. Feasibility of recruitment, randomization, data collection and retention were assessed. Objective physical measurements (weight, waist circumference, blood pressure, body composition) and questionnaires (self-reported physical activity, diet, alcohol consumption, psychological outcomes) were obtained from both groups by fieldworkers trained to standard protocols at baseline and 12 weeks, and from the intervention group at 6 and 12 months. Qualitative methods elicited men’s experiences of participation in the pilot trial. Results Following a short recruitment period, the recruitment target was achieved at the large, but not smaller, club. Participants’ mean age was 47.1±8.4 years; mean BMI 34.5±5.0 kg/m2. Retention through the trial was good (>80% at 12 weeks and 6 months; >75% at 12 months), and 76% attended at least 80% of available programme delivery sessions. At 12 weeks, the intervention group lost significantly more weight than the comparison group (4.6% c.f. -0.6%, p<.001) and many maintained this to 12 months (intervention group baseline-12 month weight loss: 3.5%, p<.001). There were also improvements in self-reported physical activity and diet, many sustained long term. Conclusions The results demonstrated the feasibility of trial procedures and the potential of FFIT to engage men in sustained weight loss and positive lifestyle change. They supported the conduct of a fully-powered randomized controlled trial. PMID:24171842

Efficacy and side-effect profiles of lactulose, docusate sodium, and sennosides compared to PEG in opioid-induced constipation: a systematic review.

PubMed

Ruston, Teresa; Hunter, Kathleen; Cummings, Greta; Lazarescu, Adriana

2013-01-01

Opioid-induced constipation (OIC) is a side effect of opioid therapy that can affect quality of life, adherence to treatment, and morbidity and possibly mortality. To investigate whether docusate sodium, sennosides, and lactulose have equal efficacy and side effect profiles compared to PEG in the management of OIC in adults. A systematic review was undertaken. Randomized controlled trials of adults taking opioids for cancer or non-cancer pain were considered if they met inclusion criteria. Statistical pooling was not possible as no studies met inclusion criteria. Large, well-powered, randomized controlled trials are feasible. Standard definitions of OIC would assist with the execution of these studies and contribute to their internal and external validity. Further research is strongly encouraged.

The feasibility and stability of large complex biological networks: a random matrix approach.

PubMed

Stone, Lewi

2018-05-29

In the 70's, Robert May demonstrated that complexity creates instability in generic models of ecological networks having random interaction matrices A. Similar random matrix models have since been applied in many disciplines. Central to assessing stability is the "circular law" since it describes the eigenvalue distribution for an important class of random matrices A. However, despite widespread adoption, the "circular law" does not apply for ecological systems in which density-dependence operates (i.e., where a species growth is determined by its density). Instead one needs to study the far more complicated eigenvalue distribution of the community matrix S = DA, where D is a diagonal matrix of population equilibrium values. Here we obtain this eigenvalue distribution. We show that if the random matrix A is locally stable, the community matrix S = DA will also be locally stable, providing the system is feasible (i.e., all species have positive equilibria D > 0). This helps explain why, unusually, nearly all feasible systems studied here are locally stable. Large complex systems may thus be even more fragile than May predicted, given the difficulty of assembling a feasible system. It was also found that the degree of stability, or resilience of a system, depended on the minimum equilibrium population.

A randomized trial to measure the impact of a community-based cognitive training intervention on balance and gait in cognitively intact Black older adults.

PubMed

Smith-Ray, Renae L; Makowski-Woidan, Beth; Hughes, Susan L

2014-10-01

Fall prevention is important for maintaining mobility and independence into old age. Approaches for reducing falls include exercise, tai chi, and home modifications; however, causes of falling are multifactorial and include not just physical but cognitive factors. Cognitive decline occurs with age, but older adults with the greatest declines in executive function experience more falls. The purpose of this study was twofold: to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population. This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group. Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks. Classes were held at senior/community centers. Primary outcomes included balance as measured by the Berg Balance Scale (BBS), 10-meter gait speed, and 10-meter gait speed under visuospatial dual-task condition. All measures were assessed at baseline and immediately post-intervention. Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls (N = 45). Compared to controls, intervention participants experienced statistically significant improvements in BBS and gait speed. Mean performance on distracted gait speed also improved more for intervention participants compared to controls. Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention. They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls. © 2014 Society for Public Health Education.

A worksite prevention program for construction workers: design of a randomized controlled trial.

PubMed

Oude Hengel, Karen M; Joling, Catelijne I; Proper, Karin I; Blatter, Birgitte M; Bongers, Paulien M

2010-06-14

A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. NTR1278.

App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial.

PubMed

Bonn, Stephanie E; Alexandrou, Christina; Hjörleifsdottir Steiner, Kristin; Wiklander, Klara; Östenson, Claes-Göran; Löf, Marie; Trolle Lagerros, Ylva

2018-01-10

Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2. The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months. Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2. ClinicalTrials.gov Identifier: NCT03053336 ; 7 Feb, 2017.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

PubMed

Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

2015-12-01

Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

A web-based multidomain lifestyle intervention with connected devices for older adults: research protocol of the eMIND pilot randomized controlled trial.

PubMed

Pothier, Kristell; Soriano, G; Lussier, M; Naudin, A; Costa, N; Guyonnet, S; Piau, A; Ousset, P J; Nourhashemi, F; Vellas, B; de Souto Barreto, P

2018-01-24

Multidomain interventions composed of nutritional counseling, exercise and cognitive trainings have shown encouraging results as effective preventive strategies delaying age-related declines. However, these interventions are time- and resource-consuming. The use of Information and Communication Technologies (ICT) might facilitate the translation from research into real-world practice and reach a massive number of people. This article describes the protocol of the eMIND study, a randomized controlled trial (RCT) using a web-based multidomain intervention for older adults. One hundred and twenty older adults (≥ 65 years), with a spontaneous memory complaint, will be randomly assigned to a six-month web-based multidomain (nutritional counseling, physical and cognitive trainings) intervention group with a connected accelerometer (number of steps, energy expenditure), or to a control group with access to general information on healthy aging plus the accelerometer, but no access to the multidomain intervention. The main outcome is the feasibility/acceptability of the web-based intervention. Secondary clinical outcomes include: cognitive functions, physical performance, nutritional status and cost-effectiveness. We expect a high amount of adherers (ie, > 75% compliance to the protocol) to reflect the feasibility. Acceptability, assessed through interviews, should allow us to understand motivators and barriers to this ICT intervention. We also expect to provide data on its effects on various clinical outcomes and efficiency. The eMIND study will provide crucial information to help developing a future and larger web-based multidomain lifestyle RCT, which should facilitate the translation of this ICT intervention from the research world into real-life clinical practice for the healthcare of older adults.

Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

PubMed

Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

2016-03-01

Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

Acceptability of Family-Centered Advanced Care Planning for Adolescents With HIV

PubMed Central

Kimmel, Allison; Wilkins, Megan L.; Rana, Sohail; Garcia, Ana; Cheng, Yao I.; Wang, Jichuan; Lyon, Maureen E.

2016-01-01

BACKGROUND AND OBJECTIVE: Small pilot studies support the appropriateness of engaging adolescents with chronic or life-limiting illnesses in pediatric advance care planning (pACP). We do not yet know if pACP is acceptable, feasible, and worthwhile, even if emotionally intense, in a fully powered randomized controlled trial. METHODS: We conducted a prospective 2-arm randomized controlled trial at 6 US urban hospitals. Adolescent/family member dyads were randomized to receive the 1-session-a-week 3-session FAmily-CEntered Advance Care Planning (FACE) pACP intervention (1, ACP Survey; 2, Goals of Care Conversation/Treatment Preferences; 3, Completion of Advance Directive) or active comparator (1, Developmental History; 2, Safety Tips; 3, Nutrition/Exercise). The Satisfaction Questionnaire was administered to participants independently after each session by a blinded research assistant. RESULTS: We enrolled 53% of eligible participants and intervened with 97 adolescent/family dyads. Adolescents ranged in age from 14 to 21 years; 54% were male individuals; 93% African American; and 73% perinatally infected. Attendance was 99% for all 3 sessions in each arm. At session 3, FACE adolescents and family dyad members, respectively, found the session useful (98%, 98%) and helpful (98%, 100%), despite feelings of sadness (25%, 17%). FACE adolescents’ improvement in the total subscale A score (useful, helpful, like a load off my mind, satisfied, something I needed to do, courageous, worthwhile) was better than control adolescents at session 3 (β = 1.16, P = .02). There were no adverse events. CONCLUSIONS: FACE enabled worthwhile conversations, while simultaneously eliciting intense emotions. No participants withdrew, 99% of those enrolled completed each session, and there were no adverse events, evidence of pACP’s feasibility, acceptability, and safety. PMID:27940700

Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

PubMed

Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

2017-12-01

Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

A worksite prevention program for construction workers: design of a randomized controlled trial

PubMed Central

2010-01-01

Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278 PMID:20546568

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

PubMed

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score <10 seconds on the One-Leg Stance Test (eyes open). All participants received 50-minutes individualised traditional physiotherapy sessions three times a week for seven weeks. In addition, the intervention group (N = 8) performed an individualised dual-task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

A pilot cluster randomized controlled trial of structured goal-setting following stroke.

PubMed

Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

2012-04-01

To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers

PubMed Central

Achey, Meredith A.; Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Ziman, Nathan; Aldred, Jason; Carter, Julie; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Mari, Zoltan; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Bull, Michael T.; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy; Anderson, Lauren; Singer, Carlos; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Cooper, Jessica; Webb, Sydney; Dhall, Rohit; Hassan, Anhar; Weis, Delana; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Smith, Joseph; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2016-01-01

Abstract Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. PMID:26886406

Alleviating Parenting Stress in Parents with Intellectual Disabilities: A Randomized Controlled Trial of a Video-feedback Intervention to Promote Positive Parenting.

PubMed

Hodes, Marja W; Meppelder, Marieke; de Moor, Marleen; Kef, Sabina; Schuengel, Carlo

2017-05-01

Adapted parenting support may alleviate the high levels of parenting stress experienced by many parents with intellectual disabilities. Parents with mild intellectual disabilities or borderline intellectual functioning were randomized to experimental (n = 43) and control (n = 42) conditions. Parents in both groups received care-as-usual. The experimental group also received an adapted version of video-feedback intervention for positive parenting and learning difficulties (VIPP-LD). Measures of parenting stress were obtained pre-test, post-test and 3-month follow-up. Randomization to the experimental group led to a steeper decline in parenting stress related to the child compared to the control group (d = 0.46). No statistically significant effect on stress related to the parent's own functioning or situation was found. The results of the study suggest the feasibility of reducing parenting stress in parents with mild intellectual disability (MID) through parenting support, to the possible benefit of their children. © 2016 John Wiley & Sons Ltd.

Staying Connected: A Feasibility Study Linking American Indian and Alaska Native Trauma Survivors to their Tribal Communities

PubMed Central

Tsosie, Ursula; Nannauck, Sweetwater; Buchwald, Dedra; Russo, Joan; Geiss Trusz, Sarah; Foy, Hugh; Zatzick, Douglas

2013-01-01

The objective of this investigation was to assess the feasibility of a culturally tailored care management intervention for physically injured American Indian/Alaska Native (AI/AN) patients. The intervention was initiated at a Level I trauma center and aimed to link AI/AN patients to their distant tribal communities. Thirty AI/AN patients were randomized to the intervention or to usual care. Assessments at baseline, 3 months, and 6 months included self-reported lifetime cumulative trauma burden, Native healing requests, and symptoms of posttraumatic stress, depression, and alcohol use. Generalized estimating equations ascertained differences between groups over time. Ninety-four percent of eligible patients participated; follow-up at 3 and 6 months was 83%. Participants had high numbers of lifetime traumas (mean = 5.1, standard deviation = 2.6). No differences between the intervention and control groups were observed in posttraumatic stress symptoms, depression symptoms, or alcohol use at baseline or follow-up time points. Among intervention patients, 60% either requested or participated in traditional Native healing practices and 75% reported that the intervention was helpful. This effectiveness trial demonstrated the feasibility of recruiting and randomizing injured AI/AN patients. Future efforts could integrate evidence-based interventions and traditional Native healing into stepped collaborative care treatment programs. PMID:22168295

Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

ERIC Educational Resources Information Center

Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

2014-01-01

Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

Feasibility of a randomized controlled trial to evaluate the impact of decision boxes on shared decision-making processes.

PubMed

Giguere, Anik Mc; Labrecque, Michel; Légaré, France; Grad, Roland; Cauchon, Michel; Greenway, Matthew; Haynes, R Brian; Pluye, Pierre; Syed, Iqra; Banerjee, Debi; Carmichael, Pierre-Hugues; Martin, Mélanie

2015-02-25

Decision boxes (DBoxes) are two-page evidence summaries to prepare clinicians for shared decision making (SDM). We sought to assess the feasibility of a clustered Randomized Controlled Trial (RCT) to evaluate their impact. A convenience sample of clinicians (nurses, physicians and residents) from six primary healthcare clinics who received eight DBoxes and rated their interest in the topic and satisfaction. After consultations, their patients rated their involvement in decision-making processes (SDM-Q-9 instrument). We measured clinic and clinician recruitment rates, questionnaire completion rates, patient eligibility rates, and estimated the RCT needed sample size. Among the 20 family medicine clinics invited to participate in this study, four agreed to participate, giving an overall recruitment rate of 20%. Of 148 clinicians invited to the study, 93 participated (63%). Clinicians rated an interest in the topics ranging 6.4-8.2 out of 10 (with 10 highest) and a satisfaction with DBoxes of 4 or 5 out of 5 (with 5 highest) for 81% DBoxes. For the future RCT, we estimated that a sample size of 320 patients would allow detecting a 9% mean difference in the SDM-Q-9 ratings between our two arms (0.02 ICC; 0.05 significance level; 80% power). Clinicians' recruitment and questionnaire completion rates support the feasibility of the planned RCT. The level of interest of participants for the DBox topics, and their level of satisfaction with the Dboxes demonstrate the acceptability of the intervention. Processes to recruit clinics and patients should be optimized.

Phase II Pragmatic Randomized Controlled Trial of Patient-Led Therapies (Mirror Therapy and Lower-Limb Exercises) During Inpatient Stroke Rehabilitation.

PubMed

Tyson, Sarah; Wilkinson, Jack; Thomas, Nessa; Selles, Ruud; McCabe, Candy; Tyrrell, Pippa; Vail, Andy

2015-10-01

Patient-led therapy has the potential to increase the amount of therapy patients undertake during stroke rehabilitation and to enhance recovery. Our objective was to assess the feasibility and acceptability of 2 patient-led therapies during the acute stages of stroke care: mirror therapy for the upper limb and lower-limb exercises for the lower limb. This was a blind assessed, multicenter, pragmatic randomized controlled trial of patient-led upper-limb mirror therapy and patient-led lower leg exercises. Stroke survivors with upper and lower limb limitations, undergoing inpatient rehabilitation and able to consent were recruited at least 1 week poststroke. Both interventions proved feasible, with >90% retention. No serious adverse events were reported. Both groups did less therapy than recommended; typically 5 to 15 minutes for 7 days or less. Participants receiving mirror therapy (n = 63) tended to do less practice than those doing lower-limb exercises (n = 31). Those with neglect did 69% less mirror therapy than those without (P = .02), which was not observed in the exercise group. Observed between-group differences were modest but neglect, upper-limb strength, and dexterity showed some improvement in the mirror therapy group. No changes were seen in the lower-limb group. Both patient-led mirror therapy and lower-limb exercises during inpatient stroke care are safe, feasible, and acceptable and warrant further investigation. Practice for 5 to 15 minutes for 7 days is a realistic prescription unless strategies to enhance adherence are included. © The Author(s) 2015.

Feasibility of a personal health technology-based psychological intervention for men with stress and mood problems: randomized controlled pilot trial.

PubMed

Lappalainen, Päivi; Kaipainen, Kirsikka; Lappalainen, Raimo; Hoffrén, Henna; Myllymäki, Tero; Kinnunen, Marja-Liisa; Mattila, Elina; Happonen, Antti P; Rusko, Heikki; Korhonen, Ilkka

2013-01-09

Work-related stress is a significant problem for both people and organizations. It may lead to mental illnesses such as anxiety and depression, resulting in increased work absences and disabilities. Scalable interventions to prevent and manage harmful stress can be delivered with the help of technology tools to support self-observations and skills training. The aim of this study was to assess the feasibility of the P4Well intervention in treatment of stress-related psychological problems. P4Well is a novel intervention which combines modern psychotherapy (the cognitive behavioral therapy and the acceptance and commitment therapy) with personal health technologies to deliver the intervention via multiple channels, includinggroup meetings, Internet/Web portal, mobile phone applications, and personal monitoring devices. This pilot study design was a small-scale randomized controlled trial that compared the P4Well intervention with a waiting list control group. In addition to personal health technologies for self-assessment, the intervention consisted of 3 psychologist-assisted group meetings. Self-assessed psychological measures through questionnaires were collected offline pre- and post-intervention, and 6 months after the intervention for the intervention group. Acceptance and usage of technology tools were measured with user experience questionnaires and usage logs. A total of 24 subjects were randomized: 11 participants were followed up in the intervention group (1 was lost to follow-up) and 12 participants did not receive any intervention (control group). Depressive and psychological symptoms decreased and self-rated health and working ability increased. All participants reported they had benefited from the intervention. All technology tools had active users and 10/11 participants used at least 1 tool actively. Physiological measurements with personal feedback were considered the most useful intervention component. Our results confirm the feasibility of the intervention and suggest that it had positive effects on psychological symptoms, self-rated health, and self-rated working ability. The intervention seemed to have a positive impact on certain aspects of burnout and job strain, such as cynicism and over-commitment. Future studies need to investigate the effectiveness, benefits, and possible problems of psychological interventions which incorporate new technologies. The Finnish Funding Agency for Technology and Innovation (TEKES), Project number 40011/08.

Understanding Physical Activity Motivation and Behaviour Through Self-Determination and Servant Leadership Theories in a Feasibility Study.

PubMed

Gray, Samantha M; Wharf Higgins, Joan; Rhodes, Ryan E

2017-09-27

Despite its well-established benefits, physical activity (PA) engagement is low in the adult population; evidence suggests that this is especially a concern for women > 60 years. The purpose of this mixed methods study was to explore the feasibility of a six-week randomized control trial of Self-Determination Theory-based dance and walking programs for older women. Primary outcomes were feasibility measures: recruitment, retention, and satisfaction. Secondary outcomes included self-reported PA, behavioural regulations, and psychological needs. Thirty-five women completed the study (M = 62.8 ± 4.8 years), representing 39% recruitment and 95% retention rate. Both programs were highly attended. Exploratory effect sizes for secondary measures were promising. Emergent themes highlighted the importance of servant leadership concepts in the group setting for motivating PA. Our findings provide support for expanding this trial to a full-scale study.

An Interactive Web-Based Intervention to Achieve Healthy Weight in Young Children.

PubMed

Wald, Ellen R; Ewing, Linda J; Moyer, Stacey C L; Eickhoff, Jens C

2018-05-01

This prospective, randomized, controlled trial for parents of overweight and obese 3- to 7-year-olds was performed to assess the feasibility of a program promoting healthy eating and lifestyle by targeting parents as agents of change. The intervention was composed of 6-in-person group sessions and a customized website over 12 months. The control group received customary care. The primary outcome was feasibility of the intervention to promote healthy behavior change measured by attendance. The secondary outcome was effectiveness assessed by attaining reduced body mass index (BMI) z scores, healthy behavior changes and increased parent self-efficacy. Seventy-three child-parent dyads were enrolled; 14 parents never attended any sessions. Participation in follow-up assessments did not meet the hypothesized level. Ultimate BMI z scores did not differ between control and intervention groups. Parenting skills did not improve in the intervention group. This intervention to achieve healthy lifestyle changes in children via their parents as "change agents" was unsuccessful.

Feasibility study of cytokine removal by hemoadsorption in brain-dead humans.

PubMed

Kellum, John A; Venkataraman, Ramesh; Powner, David; Elder, Michele; Hergenroeder, Georgene; Carter, Melinda

2008-01-01

Inflammatory cytokines occur in the circulation and in the tissues after brain death and have been associated with dysfunction of donor organs before and after transplantation. To determine the feasibility of removing cytokines using a hemoadsorption device. Two-center, randomized, open-label, feasibility study in which brain-dead subjects were randomized to two treatment groups. Two U.S. academic hospitals. Eight brain-dead subjects deemed unsuitable for organ donation by respective organ procurement organizations. After obtaining consent from families, subjects were treated with hemoadsorption for 4 hrs using CytoSorb. Effects on cytokines (tumor necrosis factor, interleukin [IL]-6, and IL-10) were assessed both across the device and in the plasma over time. Feasibility for cytokine removal was assessed using objective criteria. Cytokine removal across the CytoSorb device ranged from 4% to 30% and was not significantly different from 1 hr to 4 hrs. Overall removal was greatest for IL-6, 28% (p = .006), and least for tumor necrosis factor, 8.5% (p = .13). Plasma concentrations of both IL-6 and tumor necrosis factor, but not IL-10, were significantly reduced after the first hour of therapy; mean differences were -13% +/- 7% for IL-6 (p = .039), -23% +/- 9% for tumor necrosis factor (p = .02), and -2% +/- 7% of IL-10 (p = 23). However, plasma concentrations for all three cytokines increased over time and were above baseline by the end of the intervention. No adverse effects of therapy were observed. However, removal of cortisol and triiodothyronine was similar to removal of cytokines. Hemoadsorption for removal of cytokines in brain-dead subjects is feasible. Evaluation of possible clinical benefit will require controlled trials in actual donors. However, the significant capacity for cytokine removal and absence of adverse events suggest that such trials are warranted.

Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair - A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Safety and Feasibility.

PubMed

Greiner, Stefan; Ide, Junji; Van Noort, Arthur; Mochizuki, Yu; Ochi, Hiroshi; Marraffino, Shannon; Sridharan, Sudhakar; Rudicel, Sally; Itoi, Eiji

2015-08-01

Recombinant human bone morphogenetic protein-12 (rhBMP-12) has been shown to induce tendon and ligament formation in rats and to improve tendon healing; however, the safety and feasibility of implanting rhBMP-12/absorbable collagen sponge (ACS) in humans are not known. To investigate the safety and feasibility of rhBMP-12 on an ACS as an adjuvant therapy in open rotator cuff repair. Randomized controlled trial; Level of evidence, 2. This study consisted of 20 patients with full-thickness rotator cuff tears. Patients were randomized either to standard of care (SOC) treatment (open rotator cuff repair) or to receive 0.015 mg/mL rhBMP-12/ACS and SOC treatment during their open rotator cuff repair (rhBMP-12/ACS group) at a rate of 1/4 SOC/rhBMP-12/ACS. The feasibility of implanting the product and the safety of the product were evaluated during the 1-year follow-up period. The evaluation involved up to 10 postoperative visits, which included physical examinations, radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans with an emphasis on heterotopic ossification (HO), pharmacokinetics, immunogenicity, laboratory evaluations, and local and systemic adverse events at specified time points. Small amounts of HO were seen on follow-up CT scans in 10 of 16 patients in the rhBMP-12/ACS group and in 2 of 3 patients in the SOC group. HO did not increase at 26 weeks and was not associated with any adverse events or unsatisfactory clinical outcomes. Pharmacokinetics demonstrated that circulating levels of rhBMP-12 were not detectable after administration. Five of 16 patients showed a postoperative immunogenic response but did not show any correlating adverse events. Complete healing of the rotator cuff was observed in 14 of 16 patients; 2 of 16 imaging results could not be analyzed because of artifacts in the rhBMP-12 group on MRI scans. In the SOC group, 1 of 4 patients showed a retear at 12 weeks after surgery. The use of rhBMP-12/ACS has been shown to be feasible and safe in a concentration of 0.015 mg/mL when used in open rotator cuff repair. Higher dose concentrations of rhBMP-12 should be evaluated in the future to evaluate their safety and potential to increase rotator cuff healing after open surgical repair. © 2015 The Author(s).

Robot-assisted walking training for individuals with Parkinson’s disease: a pilot randomized controlled trial

PubMed Central

2013-01-01

Background Over the last years, the introduction of robotic technologies into Parkinson’s disease rehabilitation settings has progressed from concept to reality. However, the benefit of robotic training remains elusive. This pilot randomized controlled observer trial is aimed at investigating the feasibility, the effectiveness and the efficacy of new end-effector robot training in people with mild Parkinson’s disease. Methods Design. Pilot randomized controlled trial. Setting. Robot assisted gait training (EG) compared to treadmill training (CG). Participants. Twenty cognitively intact participants with mild Parkinson’s disease and gait disturbance. Interventions. The EG underwent a rehabilitation programme of robot assisted walking for 40 minutes, 5 times a week for 4 weeks. The CG received a treadmill training programme for 40 minutes, 5 times a week for 4 weeks. Main outcome measures. The outcome measure of efficacy was recorded by gait analysis laboratory. The assessments were performed at the beginning (T0) and at the end of the treatment (T1). The main outcome was the change in velocity. The feasibility of the intervention was assessed by recording exercise adherence and acceptability by specific test. Results Robot training was feasible, acceptable, safe, and the participants completed 100% of the prescribed training sessions. A statistically significant improvement in gait index was found in favour of the EG (T0 versus T1). In particular, the statistical analysis of primary outcome (gait speed) using the Friedman test showed statistically significant improvements for the EG (p = 0,0195). The statistical analysis performed by Friedman test of Step length left (p = 0,0195) and right (p = 0,0195) and Stride length left (p = 0,0078) and right (p = 0,0195) showed a significant statistical gain. No statistically significant improvements on the CG were found. Conclusions Robot training is a feasible and safe form of rehabilitative exercise for cognitively intact people with mild PD. This original approach can contribute to increase a short time lower limb motor recovery in idiopathic PD patients. The focus on the gait recovery is a further characteristic that makes this research relevant to clinical practice. On the whole, the simplicity of treatment, the lack of side effects, and the positive results from patients support the recommendation to extend the use of this treatment. Further investigation regarding the long-time effectiveness of robot training is warranted. Trial registration ClinicalTrials.gov NCT01668407 PMID:23706025

Early Mobilization in Ischemic Stroke: A Pilot Randomized Trial of Safety and Feasibility in a Public Hospital in Brazil

PubMed Central

Poletto, Simone Rosa; Rebello, Letícia Costa; Valença, Maria Júlia Monteiro; Rossato, Daniele; Almeida, Andrea Garcia; Brondani, Rosane; Chaves, Márcia Lorena Fagundes; Nasi, Luiz Antônio; Martins, Sheila Cristina Ouriques

2015-01-01

Background The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals. PMID:26034487

Feasibility of a Preventive Parenting Intervention for Very Preterm Children at 18 Months Corrected Age: A Randomized Pilot Trial.

PubMed

Flierman, Monique; Koldewijn, Karen; Meijssen, Dominique; van Wassenaer-Leemhuis, Aleid; Aarnoudse-Moens, Cornelieke; van Schie, Petra; Jeukens-Visser, Martine

2016-09-01

To evaluate the feasibility and potential efficacy of an age-appropriate additional parenting intervention for very preterm born toddlers. In a randomized controlled pilot study, 60 of 94 eligible very preterm born children who had received a responsive parenting intervention in their first year were randomized to usual care or the additional intervention, consisting of 4-6 home visits between 18 and 22 months' corrected gestational age (CA). Parents were supported to responsively interact during increasingly complex daily activities and play. Parental satisfaction with the intervention was evaluated with a questionnaire. At baseline and 24 months CA, parents completed the Infant Toddler Social and Emotional Assessment, the Ages and Stages Questionnaire, and the Dutch Schlichting Lexilist for receptive language. At 24 months CA, motor, and cognitive development was measured by the Bayley Scales of Infant and Toddler Development, Third Edition Dutch version, and parent-child interaction was evaluated by the Emotional Availability Scales. Parental compliance and satisfaction with the intervention was high. Effect sizes (after correction for baseline variables) were small for internalizing and competence behavior, receptive language, and problem solving; medium for cognitive development and parent-child interaction; and large for externalizing and dysregulation behavior and motor development. After a postdischarge intervention during the first year, an additional responsive parenting support at toddler-age is feasible and associated with positive outcomes in a broad array of parental and child outcome measures. www.toetsingonline.nl: NL40208.018.12. Copyright © 2016 Elsevier Inc. All rights reserved.

Lifestyle interventions to reduce risk of diabetes among women with prior gestational diabetes mellitus.

PubMed

Chasan-Taber, Lisa

2015-01-01

While lifestyle interventions involving exercise and a healthy diet in high-risk adults have been found to reduce progression to type 2 diabetes by >50%, little attention has been given to the potential benefits of such strategies in women with a history of gestational diabetes mellitus (GDM). We conducted a literature search of PubMed for English language studies of randomized controlled trials of lifestyle interventions among women with a history of GDM. In total, nine studies were identified which fulfilled the eligibility criteria. The majority of randomized trials of lifestyle interventions in women with GDM have been limited to pilot or feasibility studies. However, preliminary findings suggest that such interventions can improve diabetes risk factors in women with a history of GDM. Larger, well-designed controlled randomized trials are needed to assess the effects of lifestyle interventions on preventing subsequent progression to type 2 diabetes among women with GDM. Copyright © 2014 Elsevier Ltd. All rights reserved.

Nurse-Facilitated Health Checks for Persons With Severe Mental Illness: A Cluster-Randomized Controlled Trial.

PubMed

White, Jacquie; Lucas, Joanne; Swift, Louise; Barton, Garry R; Johnson, Harriet; Irvine, Lisa; Abotsie, Gabriel; Jones, Martin; Gray, Richard J

2018-05-01

This study tested the effectiveness of a nurse-delivered health check with the Health Improvement Profile (HIP), which takes approximately 1.5 hours to complete and code, for persons with severe mental illness. A single-blind, cluster-randomized controlled trial was conducted in England to test whether health checks improved the general medical well-being of persons with severe mental illness at 12-month follow-up. Sixty nurses were randomly assigned to the HIP group or the treatment-as-usual group. From their case lists, 173 patients agreed to participate. HIP group nurses completed health checks for 38 of their 90 patients (42%) at baseline and 22 (24%) at follow-up. No significant between-group differences were noted in patients' general medical well-being at follow-up. Nurses who had volunteered for a clinical trial administered health checks only to a minority of participating patients, suggesting that it may not be feasible to undertake such lengthy structured health checks in routine practice.

Pilot Feasibility Study of Therapeutic Hypothermia for Moderate to Severe Acute Respiratory Distress Syndrome.

PubMed

Slack, Donald F; Corwin, Douglas S; Shah, Nirav G; Shanholtz, Carl B; Verceles, Avelino C; Netzer, Giora; Jones, Kevin M; Brown, Clayton H; Terrin, Michael L; Hasday, Jeffrey D

2017-07-01

Prior studies suggest hypothermia may be beneficial in acute respiratory distress syndrome, but cooling causes shivering and increases metabolism. The objective of this study was to assess the feasibility of performing a randomized clinical trial of hypothermia in patients with acute respiratory distress syndrome receiving treatment with neuromuscular blockade because they cannot shiver. Retrospective study and pilot, prospective, open-label, feasibility study. Medical ICU. Retrospective review of 58 patients with acute respiratory distress syndrome based on Berlin criteria and PaO2/FIO2 less than 150 who received neuromuscular blockade. Prospective hypothermia treatment in eight acute respiratory distress syndrome patients with PaO2/FIO2 less than 150 receiving neuromuscular blockade. Cooling to 34-36°C for 48 hours. Core temperature, hemodynamics, serum glucose and electrolytes, and P/F were sequentially measured, and medians (interquartile ranges) presented, 28-day ventilator-free days, and hospital mortality were calculated in historical controls and eight cooled patients. Average patient core temperature was 36.7°C (36-37.3°C), and fever occurred during neuromuscular blockade in 30 of 58 retrospective patients. In the prospectively cooled patients, core temperature reached target range less than or equal to 4 hours of initiating cooling, remained less than 36°C for 92% of the 48 hours cooling period without adverse events, and was lower than the controls (34.35°C [34-34.8°C]; p < 0.0001). Compared with historical controls, the cooled patients tended to have lower hospital mortality (75% vs 53.4%; p = 0.26), more ventilator-free days (9 [0-21.5] vs 0 [0-12]; p = 0.16), and higher day 3 P/F (255 [160-270] vs 171 [120-214]; p = 0.024). Neuromuscular blockade alone does not cause hypothermia but allowed acute respiratory distress syndrome patients to be effectively cooled. Results support conducting a randomized clinical trial of hypothermia in acute respiratory distress syndrome and the feasibility of studying acute respiratory distress syndrome patients receiving neuromuscular blockade.

Sensory Adapted Dental Environments to Enhance Oral Care for Children with Autism Spectrum Disorders: A Randomized Controlled Pilot Study

ERIC Educational Resources Information Center

Cermak, Sharon A.; Stein Duker, Leah I.; Williams, Marian E.; Dawson, Michael E.; Lane, Christianne J.; Polido, José C.

2015-01-01

This pilot and feasibility study examined the impact of a sensory adapted dental environment (SADE) to reduce distress, sensory discomfort, and perception of pain during oral prophylaxis for children with autism spectrum disorder (ASD). Participants were 44 children ages 6-12 (n = 22 typical, n = 22 ASD). In an experimental crossover design, each…

Integrated Behavior Therapy for Selective Mutism: a randomized controlled pilot study.

PubMed

Bergman, R Lindsey; Gonzalez, Araceli; Piacentini, John; Keller, Melody L

2013-10-01

To evaluate the feasibility, acceptability, and preliminary efficacy of a novel behavioral intervention for reducing symptoms of selective mutism and increasing functional speech. A total of 21 children ages 4 to 8 with primary selective mutism were randomized to 24 weeks of Integrated Behavior Therapy for Selective Mutism (IBTSM) or a 12-week Waitlist control. Clinical outcomes were assessed using blind independent evaluators, parent-, and teacher-report, and an objective behavioral measure. Treatment recipients completed a three-month follow-up to assess durability of treatment gains. Data indicated increased functional speaking behavior post-treatment as rated by parents and teachers, with a high rate of treatment responders as rated by blind independent evaluators (75%). Conversely, children in the Waitlist comparison group did not experience significant improvements in speaking behaviors. Children who received IBTSM also demonstrated significant improvements in number of words spoken at school compared to baseline, however, significant group differences did not emerge. Treatment recipients also experienced significant reductions in social anxiety per parent, but not teacher, report. Clinical gains were maintained over 3 month follow-up. IBTSM appears to be a promising new intervention that is efficacious in increasing functional speaking behaviors, feasible, and acceptable to parents and teachers. Copyright © 2013 Elsevier Ltd. All rights reserved.

Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes.

PubMed

Rohlman, Diane S; Parish, Megan; Elliot, Diane L; Hanson, Ginger; Perrin, Nancy

2016-08-10

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14-24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen's d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior.

Addressing Younger Workers’ Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes

PubMed Central

Rohlman, Diane S.; Parish, Megan; Elliot, Diane L.; Hanson, Ginger; Perrin, Nancy

2016-01-01

Most younger workers, less than 25 years old, receive no training in worker safety. We report the feasibility and outcomes of a randomized controlled trial of an electronically delivered safety and health curriculum for younger workers entitled, PUSH (Promoting U through Safety and Health). All younger workers (14–24 years old) hired for summer work at a large parks and recreation organization were invited to participate in an evaluation of an online training and randomized into an intervention or control condition. Baseline and end-of-summer online instruments assessed acceptability, knowledge, and self-reported attitudes and behaviors. One-hundred and forty participants (mean age 17.9 years) completed the study. The innovative training was feasible and acceptable to participants and the organization. Durable increases in safety and health knowledge were achieved by intervention workers (p < 0.001, effect size (Cohen’s d) 0.4). However, self-reported safety and health attitudes did not improve with this one-time training. These results indicate the potential utility of online training for younger workers and underscore the limitations of a single training interaction to change behaviors. Interventions may need to be delivered over a longer period of time and/or include environmental components to effectively alter behavior. PMID:27517968

A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study.

PubMed

Sallés, Laia; Martín-Casas, Patricia; Gironès, Xavier; Durà, María José; Lafuente, José Vicente; Perfetti, Carlo

2017-04-01

[Purpose] This study aims to describe a protocol based on neurocognitive therapeutic exercises and determine its feasibility and usefulness for upper extremity functionality when compared with a conventional protocol. [Subjects and Methods] Eight subacute stroke patients were randomly assigned to a conventional (control group) or neurocognitive (experimental group) treatment protocol. Both lasted 30 minutes, 3 times a week for 10 weeks and assessments were blinded. Outcome measures included: Motor Evaluation Scale for Upper Extremity in Stroke Patients, Motricity Index, Revised Nottingham Sensory Assessment and Kinesthetic and Visual Imagery Questionnaire. Descriptive measures and nonparametric statistical tests were used for analysis. [Results] The results indicate a more favorable clinical progression in the neurocognitive group regarding upper extremity functional capacity with achievement of the minimal detectable change. The functionality results are related with improvements on muscle strength and sensory discrimination (tactile and kinesthetic). [Conclusion] Despite not showing significant group differences between pre and post-treatment, the neurocognitive approach could be a safe and useful strategy for recovering upper extremity movement following stroke, especially regarding affected hands, with better and longer lasting results. Although this work shows this protocol's feasibility with the panel of scales proposed, larger studies are required to demonstrate its effectiveness.

A neurocognitive approach for recovering upper extremity movement following subacute stroke: a randomized controlled pilot study

PubMed Central

Sallés, Laia; Martín-Casas, Patricia; Gironès, Xavier; Durà, María José; Lafuente, José Vicente; Perfetti, Carlo

2017-01-01

[Purpose] This study aims to describe a protocol based on neurocognitive therapeutic exercises and determine its feasibility and usefulness for upper extremity functionality when compared with a conventional protocol. [Subjects and Methods] Eight subacute stroke patients were randomly assigned to a conventional (control group) or neurocognitive (experimental group) treatment protocol. Both lasted 30 minutes, 3 times a week for 10 weeks and assessments were blinded. Outcome measures included: Motor Evaluation Scale for Upper Extremity in Stroke Patients, Motricity Index, Revised Nottingham Sensory Assessment and Kinesthetic and Visual Imagery Questionnaire. Descriptive measures and nonparametric statistical tests were used for analysis. [Results] The results indicate a more favorable clinical progression in the neurocognitive group regarding upper extremity functional capacity with achievement of the minimal detectable change. The functionality results are related with improvements on muscle strength and sensory discrimination (tactile and kinesthetic). [Conclusion] Despite not showing significant group differences between pre and post-treatment, the neurocognitive approach could be a safe and useful strategy for recovering upper extremity movement following stroke, especially regarding affected hands, with better and longer lasting results. Although this work shows this protocol’s feasibility with the panel of scales proposed, larger studies are required to demonstrate its effectiveness. PMID:28533607

Evaluating the use of friend or family controls in epidemiologic case-control studies.

PubMed

Zhong, Charlie; Cockburn, Myles; Cozen, Wendy; Voutsinas, Jenna; Lacey, James V; Luo, Jianning; Sullivan-Halley, Jane; Bernstein, Leslie; Wang, Sophia S

2017-02-01

Traditional methodologies for identifying and recruiting controls in epidemiologic case-control studies, such as random digit dialing or neighborhood walk, suffer from declining response rates. Here, we revisit the feasibility and comparability of using alternative sources of controls, specifically friend and family controls. We recruited from a recently completed case-control study of non-Hodgkin lymphoma (NHL) among women in Los Angeles County where controls from the parent study were ascertained by neighborhood walk. We calculated participation rates and compared questionnaire responses between the friend/family controls and the original matched controls from the parent study. Of the 182 NHL case patients contacted, 111 (61%) agreed to participate in our feasibility study. 70 (63%) provided contact information for potential friend and/or family member controls. We were able to successfully contact and recruit a friend/family member for 92% of the case patients. This represented 46 friend controls and 54 family controls. Family controls significantly differed from original matched controls by sex and household income. Other characteristics were similar between friend controls and the original study's neighborhood controls. The apparent comparability of neighborhood controls to friend and family controls among respondents in this study suggests that these alternative methods of control identification can serve as a complementary source of eligible controls in epidemiologic case-control studies. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Concurrent design of quasi-random photonic nanostructures

PubMed Central

Lee, Won-Kyu; Yu, Shuangcheng; Engel, Clifford J.; Reese, Thaddeus; Rhee, Dongjoon; Chen, Wei

2017-01-01

Nanostructured surfaces with quasi-random geometries can manipulate light over broadband wavelengths and wide ranges of angles. Optimization and realization of stochastic patterns have typically relied on serial, direct-write fabrication methods combined with real-space design. However, this approach is not suitable for customizable features or scalable nanomanufacturing. Moreover, trial-and-error processing cannot guarantee fabrication feasibility because processing–structure relations are not included in conventional designs. Here, we report wrinkle lithography integrated with concurrent design to produce quasi-random nanostructures in amorphous silicon at wafer scales that achieved over 160% light absorption enhancement from 800 to 1,200 nm. The quasi-periodicity of patterns, materials filling ratio, and feature depths could be independently controlled. We statistically represented the quasi-random patterns by Fourier spectral density functions (SDFs) that could bridge the processing–structure and structure–performance relations. Iterative search of the optimal structure via the SDF representation enabled concurrent design of nanostructures and processing. PMID:28760975

The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial.

PubMed

Karstoft, Kristian; Winding, Kamilla; Knudsen, Sine H; Nielsen, Jens S; Thomsen, Carsten; Pedersen, Bente K; Solomon, Thomas P J

2013-02-01

To evaluate the feasibility of free-living walking training in type 2 diabetic patients and to investigate the effects of interval-walking training versus continuous-walking training upon physical fitness, body composition, and glycemic control. Subjects with type 2 diabetes were randomized to a control (n = 8), continuous-walking (n = 12), or interval-walking group (n = 12). Training groups were prescribed five sessions per week (60 min/session) and were controlled with an accelerometer and a heart-rate monitor. Continuous walkers performed all training at moderate intensity, whereas interval walkers alternated 3-min repetitions at low and high intensity. Before and after the 4-month intervention, the following variables were measured: VO(2)max, body composition, and glycemic control (fasting glucose, HbA(1c), oral glucose tolerance test, and continuous glucose monitoring [CGM]). Training adherence was high (89 ± 4%), and training energy expenditure and mean intensity were comparable. VO(2)max increased 16.1 ± 3.7% in the interval-walking group (P < 0.05), whereas no changes were observed in the continuous-walking or control group. Body mass and adiposity (fat mass and visceral fat) decreased in the interval-walking group only (P < 0.05). Glycemic control (elevated mean CGM glucose levels and increased fasting insulin) worsened in the control group (P < 0.05), whereas mean (P = 0.05) and maximum (P < 0.05) CGM glucose levels decreased in the interval-walking group. The continuous walkers showed no changes in glycemic control. Free-living walking training is feasible in type 2 diabetic patients. Continuous walking offsets the deterioration in glycemia seen in the control group, and interval walking is superior to energy expenditure-matched continuous walking for improving physical fitness, body composition, and glycemic control.

Natural science modules with SETS approach to improve students’ critical thinking ability

NASA Astrophysics Data System (ADS)

Budi, A. P. S.; Sunarno, W.; Sugiyarto

2018-05-01

SETS (Science, Environment, Technology and Society) approach for learning is important to be developed for middle school, since it can improve students’ critical thinking ability. This research aimed to determine feasibility and the effectiveness of Natural Science Module with SETS approach to increase their critical thinking ability. The module development was done by invitation, exploration, explanation, concept fortifying, and assessment. Questionnaire and test performed including pretest and posttest with control group design were used as data collection technique in this research. Two classes were selected randomly as samples and consisted of 32 students in each group. Descriptive data analysis was used to analyze the module feasibility and t-test was used to analyze their critical thinking ability. The results showed that the feasibility of the module development has a very good results based on assessment of the experts, practitioners and peers. Based on the t-test results, there was significant difference between control class and experiment class (0.004), with n-gain score of control and the experiment class respectively 0.270 (low) and 0.470 (medium). It showed that the module was more effective than the textbook. It was able to improve students’ critical thinking ability and appropriate to be used in learning process.

Pilot trial of a dissonance-based cognitive-behavioral group depression prevention with college students.

PubMed

Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M

2016-07-01

Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = 0.64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

Pilot Trial of a Dissonance-Based Cognitive-Behavioral Group Depression Prevention with College Students

PubMed Central

Rohde, Paul; Stice, Eric; Shaw, Heather; Gau, Jeff M.

2016-01-01

Objective Conduct a pilot trial testing whether a new cognitive-behavioral (CB) group prevention program that incorporated cognitive-dissonance change principles was feasible and appeared effective in reducing depressive symptoms and major depressive disorder onset relative to a brochure control condition in college students with elevated depressive symptoms. Method 59 college students (M age = 21.8, SD = 2.3; 68% female, 70% White) were randomized to the 6-session Change Ahead group or educational brochure control condition, completing assessments at pretest, posttest, and 3-month follow-up. Results Recruitment and screening methods were effective and intervention attendance was high (86% attended all 6 sessions). Change Ahead participants showed medium-large reductions in depressive symptoms at posttest (M d = .64), though the effect attenuated by 3-month follow-up. Incidence of major depression onset at 3-month follow-up was 4% for Change Ahead participants versus 13% (difference ns). Conclusions Change Ahead appears highly feasible and showed positive indications of reduced acute phase depressive symptoms and MDD onset relative to a minimal intervention control in this initial pilot. Given the brevity of the intervention, its apparent feasibility, and the lack of evidence-based depression prevention programs for college students, continued evaluation of Change Ahead appears warranted. PMID:27176493

PPAR-gamma agonist pioglitazone modifies craving intensity and brain white matter integrity in patients with primary cocaine use disorder: a double-blind randomized controlled pilot trial.

PubMed

Schmitz, Joy M; Green, Charles E; Hasan, Khader M; Vincent, Jessica; Suchting, Robert; Weaver, Michael F; Moeller, F Gerard; Narayana, Ponnada A; Cunningham, Kathryn A; Dineley, Kelly T; Lane, Scott D

2017-10-01

Pioglitazone (PIO), a potent agonist of PPAR-gamma, is a promising candidate treatment for cocaine use disorder (CUD). We tested the effects of PIO on targeted mechanisms relevant to CUD: cocaine craving and brain white matter (WM) integrity. Feasibility, medication compliance and tolerability were evaluated. Two-arm double-blind randomized controlled proof-of-concept pilot trial of PIO or placebo (PLC). Single-site out-patient treatment research clinic in Houston, TX, USA. Thirty treatment-seeking adults, 18 to 60 years old, with CUD. Eighteen participants (8 = PIO; 10 = PLC) completed diffusion tensor imaging (DTI) of WM integrity at pre-/post-treatment. Study medication was dispensed at thrice weekly visits along with once-weekly cognitive behavioral therapy for 12 weeks. Measures of target engagement mechanisms of interest included cocaine craving assessed by the Brief Substance Craving Scale (BSCS), the Obsessive Compulsive Drug Use Scale (OCDUS), a visual analog scale (VAS) and change in WM integrity. Feasibility measures included number completing treatment, medication compliance (riboflavin detection) and tolerability (side effects, serious adverse events). Target engagement change in mechanisms of interest, defined as a ≥ 0.75 Bayesian posterior probability of an interaction existing favoring PIO over PLC, was demonstrated on measures of craving (BSCS, VAS) and WM integrity indexed by fractional anisotropy (FA) values. Outcomes indicated greater decrease in craving and greater increase in FA values in the PIO group. Feasibility was demonstrated by high completion rates among those starting treatment (21/26 = 80%) and medication compliance (≥ 80%). There were no reported serious adverse events for PIO. Compared with placebo, patients receiving pioglitazone show a higher likelihood of reduced cocaine craving and improved brain white matter integrity as a function of time in treatment. Pioglitazone shows good feasibility as a treatment for cocaine use disorder. © 2017 Society for the Study of Addiction.

Preliminary findings describing participant experience with iSTEP, an mHealth intervention to increase physical activity and improve neurocognitive function in people living with HIV

PubMed Central

Henry, Brook L.; Moore, David J.

2016-01-01

We assessed the feasibility and acceptability of using text messages to monitor and encourage physical activity in the first 21 participants enrolled in an ongoing randomized controlled trial evaluating a 16-week Short Message Service/Multimedia Message Service (SMS/MMS) intervention (iSTEP) designed to increase moderate physical activity and improve neurocognition in persons with HIV-associated neurocognitive disorders (HAND; iSTEP, n = 11; control group, n = 10). Data were collected during the intervention and from interviews conducted at the 16-week post-intervention visits. Text message response rates for both iSTEP and control participants were high (89% and 85%, respectively). Pedometer self-monitoring, step count goals, and milestone achievement texts were reported to facilitate physical activity. All iSTEP participants (100%) and 70% of control participants indicated that they would recommend the study to other people living with HIV. The results indicate that it is feasible to administer an SMS/MMS physical activity intervention to persons with HAND. PMID:26847379

Healthy Beyond Pregnancy, a Web-Based Intervention to Improve Adherence to Postpartum Care: Randomized Controlled Feasibility Trial

PubMed Central

Donovan, Heidi; Wang, Stephanie; Weaver, Carrie; Grove, Jillian Rae; Facco, Francesca Lucia

2017-01-01

Background During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. Objectives The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. Methods We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. Results The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users’ experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06). Conclusions We have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system. Trial Registration Clinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk) PMID:29017990

Opinions of researchers based in the UK on recruiting subjects from developing countries into randomized controlled trials.

PubMed

Newton, Sam K; Appiah-Poku, John

2007-12-01

Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Recorded in-depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty.

A pilot randomized controlled trial evaluating motivationally matched pedometer feedback to increase physical activity behavior in older adults.

PubMed

Strath, Scott J; Swartz, Ann M; Parker, Sarah J; Miller, Nora E; Grimm, Elizabeth K; Cashin, Susan E

2011-09-01

Increasing physical activity (PA) levels in older adults represents an important public health challenge. The purpose of this study was to evaluate the feasibility of combining individualized motivational messaging with pedometer walking step targets to increase PA in previously inactive and insufficiently active older adults. In this 12-week intervention study older adults were randomized to 1 of 4 study arms: Group 1--control; Group 2--pedometer 10,000 step goal; Group 3--pedometer step goal plus individualized motivational feedback; or Group 4--everything in Group 3 augmented with biweekly telephone feedback. 81 participants were randomized into the study, 61 participants completed the study with an average age of 63.8 ± 6.0 years. Group 1 did not differ in accumulated steps/day following the 12-week intervention compared with participants in Group 2. Participants in Groups 3 and 4 took on average 2159 (P < .001) and 2488 (P < .001) more steps/day, respectively, than those in Group 1 after the 12-week intervention. In this 12-week pilot randomized control trial, a pedometer feedback intervention partnered with individually matched motivational messaging was an effective intervention strategy to significantly increase PA behavior in previously inactive and insufficiently active older adults.

The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study.

PubMed

de Jong, Lex D; Peters, Andy; Hooper, Julie; Chalmers, Nina; Henderson, Claire; Laventure, Robert Me; Skelton, Dawn A

2016-06-20

Increasing physical activity (PA) brings many health benefits, but engaging people in higher levels of PA after their 60s is not straightforward. The Functional Fitness MOT (FFMOT) is a new approach which aims to raise awareness about the importance of components of fitness (strength, balance, flexibility), highlight benefits of PA, engages older people in health behavior change discussions, and directs them to local activity resources. This battery of tests combined with a brief motivational interview has not been tested in terms of feasibility or effectiveness. To assess whether the FFMOT, provided in a health care setting, is appealing to older patients of a community physiotherapy service and to understand the views and perceptions of the older people undergoing the FFMOT regarding the intervention, as well as the views of the physiotherapy staff delivering the intervention. Secondary aims are to assess the feasibility of carrying out a phase 2 pilot randomized controlled trial of the FFMOT, in the context of a community physiotherapy service, by establishing whether enough patients can be recruited and retained in the study, and enough outcome data can be generated. A mixed-methods feasibility study will be conducted in two physiotherapy outpatient clinics in the United Kingdom. A total of 30 physically inactive, medically stable older adults over the age of 60 will be provided with an individual FFMOT, comprising a set of six standardized, validated, age-appropriate tests aimed at raising awareness of the different components of fitness. The results of these tests will be used to provide the participants with feedback on performance in comparison to sex and age-referenced norms. This will be followed by tailored advice on how to become more active and improve fitness, including advice on local opportunities to be more active. Subsequently, participants will be invited to attend a focus group to discuss barriers and motivators to being more active, health behavior change, and the scope for individuals to improve their PA levels. To inform the design of a future trial, descriptive (eg, recruitment and retention rates), quantitative (Community Healthy Activities Model Program for Seniors; CHAMPS physical activity questionnaire), and qualitative data (focus group discussions, semi-structured staff interviews) will be collected. Recruitment and enrolment for the trial started in September 2015. Follow-up will be completed in June 2016. Results are expected to be available at the end of 2016. Allied health professionals play a key role in encouraging older adults to increase their PA, but with little evidence on how best to do this within their clinical practice. The purpose of this feasibility study is to examine the introduction of a new service: The FFMOT. The views and perceptions of the older people undergoing the FFMOT and relating to its delivery in clinical practice will be explored. Data, which will inform the feasibility of a randomized controlled trial of effectiveness of the FFMOT in promoting improved PA, will be reported. International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN38950042; http://www.isrctn.com/ISRCTN38950042.

A pilot randomized controlled trial of the feasibility of a self-directed coping skills intervention for couples facing prostate cancer: Rationale and design

PubMed Central

2012-01-01

Background Although it is known both patients’ and partners’ reactions to a prostate cancer diagnosis include fear, uncertainty, anxiety and depression with patients’ partners’ reactions mutually determining how they cope with and adjust to the illness, few psychosocial interventions target couples. Those that are available tend to be led by highly trained professionals, limiting their accessibility and long-term sustainability. In addition, it is recognised that patients who might benefit from conventional face-to-face psychosocial interventions do not access these, either by preference or because of geographical or mobility barriers. Self-directed interventions can overcome some of these limitations and have been shown to contribute to patient well-being. This study will examine the feasibility of a self-directed, coping skills intervention for couples affected by cancer, called Coping-Together, and begin to explore its potential impact on couples’ illness adjustment. The pilot version of Coping-Together includes a series of four booklets, a DVD, and a relaxation audio CD. Methods/design In this double-blind, two-group, parallel, randomized controlled trial, 70 couples will be recruited within 4 months of a prostate cancer diagnosis through urology private practices and randomized to: 1) Coping-Together or 2) a minimal ethical care condition. Minimal ethical care condition couples will be mailed information booklets available at the Cancer Council New South Wales and a brochure for the Cancer Council Helpline. The primary outcome (anxiety) and additional secondary outcomes (distress, depression, dyadic adjustment, quality of life, illness or caregiving appraisal, self-efficacy, and dyadic and individual coping) will be assessed at baseline (before receiving study material) and 2 months post-baseline. Intention-to-treat and per protocol analysis will be conducted. Discussion As partners’ distress rates exceed not only population norms, but also those reported by patients themselves, it is imperative that coping skills interventions target the couple as a unit and enhance both partners’ ability to overcome cancer challenges. This pilot study will examine the feasibility and potential efficacy of Coping-Together in optimising couples’ illness adjustment. This is one of the first feasibility studies to test this innovative coping intervention, which in turn will contribute to the larger literature advocating for psychosocial care of couples affected by prostate cancer. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12611000438954 PMID:23013404

Task-oriented training with computer gaming in people with rheumatoid arthritisor osteoarthritis of the hand: study protocol of a randomized controlled pilot trial.

PubMed

Srikesavan, Cynthia Swarnalatha; Shay, Barbara; Robinson, David B; Szturm, Tony

2013-03-09

Significant restriction in the ability to participate in home, work and community life results from pain, fatigue, joint damage, stiffness and reduced joint range of motion and muscle strength in people with rheumatoid arthritis or osteoarthritis of the hand. With modest evidence on the therapeutic effectiveness of conventional hand exercises, a task-oriented training program via real life object manipulations has been developed for people with arthritis. An innovative, computer-based gaming platform that allows a broad range of common objects to be seamlessly transformed into therapeutic input devices through instrumentation with a motion-sense mouse has also been designed. Personalized objects are selected to target specific training goals such as graded finger mobility, strength, endurance or fine/gross dexterous functions. The movements and object manipulation tasks that replicate common situations in everyday living will then be used to control and play any computer game, making practice challenging and engaging. The ongoing study is a 6-week, single-center, parallel-group, equally allocated and assessor-blinded pilot randomized controlled trial. Thirty people with rheumatoid arthritis or osteoarthritis affecting the hand will be randomized to receive either conventional hand exercises or the task-oriented training. The purpose is to determine a preliminary estimation of therapeutic effectiveness and feasibility of the task-oriented training program. Performance based and self-reported hand function, and exercise compliance are the study outcomes. Changes in outcomes (pre to post intervention) within each group will be assessed by paired Student t test or Wilcoxon signed-rank test and between groups (control versus experimental) post intervention using unpaired Student t test or Mann-Whitney U test. The study findings will inform decisions on the feasibility, safety and completion rate and will also provide preliminary data on the treatment effects of the task-oriented training compared with conventional hand exercises in people with rheumatoid arthritis or osteoarthritis of the hand. ClinicalTrials.gov: NCT01635582.

Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management.

PubMed

Gold, Jeffrey I; Mahrer, Nicole E

2018-04-01

To conduct a randomized control trial to evaluate the feasibility and efficacy of virtual reality (VR) compared with standard of care (SOC) for reducing pain, anxiety, and improving satisfaction associated with blood draw in children ages 10-21 years. In total, 143 triads (patients, their caregiver, and the phlebotomist) were recruited in outpatient phlebotomy at a pediatric hospital and randomized to receive either VR or SOC when undergoing routine blood draw. Patients and caregivers completed preprocedural and postprocedural standardized measures of pain, anxiety, and satisfaction, and phlebotomists reported about the patient's experience during the procedure. Findings showed that VR significantly reduced acute procedural pain and anxiety compared with SOC. A significant interaction between patient-reported anxiety sensitivity and treatment condition indicated that patients undergoing routine blood draw benefit more from VR intervention when they are more fearful of physiological sensations related to anxiety. Patients and caregivers in the VR condition reported high levels of satisfaction with the procedure. VR is feasible, tolerated, and well-liked by patients, caregivers, and phlebotomists alike for routine blood draw. Given the immersive and engaging nature of the VR experience, VR has the capacity to act as a preventive intervention transforming the blood draw experience into a less distressing, potentially pain-free routine medical procedure, particularly for pediatric patients with high anxiety sensitivity. VR holds promise to reduce negative health outcomes for children and reduce distress in caregivers, while facilitating increased satisfaction and throughput in hectic outpatient phlebotomy clinics.

Training cognitive flexibility in patients with anorexia nervosa: a pilot randomized controlled trial of cognitive remediation therapy.

PubMed

Brockmeyer, Timo; Ingenerf, Katrin; Walther, Stephan; Wild, Beate; Hartmann, Mechthild; Herzog, Wolfgang; Bents, Hinrich; Friederich, Hans-Christoph

2014-01-01

Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa (AN). Cognitive Remediation Therapy (CRT) is a specific treatment targeting this cognitive style. The aim of this study was to investigate the feasibility and efficacy (by estimating the effect size) of specifically tailored CRT for AN, compared to non-specific cognitive training. A prospective, randomized controlled, superiority pilot trial was conducted. Forty women with AN receiving treatment as usual (TAU) were randomized to receive either CRT or non-specific neurocognitive therapy (NNT) as an add-on. Both conditions comprised 30 sessions of computer-assisted (21 sessions) and face-to-face (9 sessions) training over a 3-week period. CRT focused specifically on cognitive flexibility. NNT was comprised of tasks designed to improve attention and memory. The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting. Data available from 25 treatment completers were analyzed. Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment (p = 0.027; between-groups effect size d = 0.62). Participants in both conditions showed high treatment acceptance. This study confirms the feasibility of CRT for AN, and provides a first estimate of the effect size that can be achieved using CRT for AN. Furthermore, the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group. Copyright © 2013 Wiley Periodicals, Inc.

A Feasibility Study of Moxibustion for Treating Anorexia and Improving Quality of Life in Patients With Metastatic Cancer: A Randomized Sham-Controlled Trial.

PubMed

Jeon, Ju-Hyun; Cho, Chong-Kwan; Park, So-Jung; Kang, Hwi-Joong; Kim, Kyungmin; Jung, In-Chul; Kim, Young-Il; Lee, Suk-Hoon; Yoo, Hwa-Seung

2017-03-01

The aim of this study was to determine the feasibility, acceptability, and safety of using moxibustion for treating anorexia and improving quality of life in patients with metastatic cancer. We conducted a randomized sham-controlled trial of moxibustion. Sixteen patients with metastatic cancer were recruited from Daejeon, South Korea. The patients were randomly placed into a true or a sham moxibustion group and received 10 true or sham moxibustion treatments administered to the abdomen (CV12, CV8, CV4) and legs (ST36) over a 2-week period. Outcome measures included interest in participating in the trial, identification of successful recruitment strategies, the appropriateness of eligibility criteria, and compliance with the treatment plan (ie, attendance at treatment sessions). Clinical outcomes included results of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), answers on the European Organization for Research and Treatment of Cancer 30-item core quality of life (EORTC QLQ-C30) questionnaires, scores on the visual analogue scale (VAS), and the results from blood tests and a safety evaluation. Moxibustion was an acceptable intervention in patients with metastatic cancer. Compliance with the treatment protocol was high, with 11 patients completing all 10 treatments. No serious adverse events related to moxibustion occurred, but 4 patients in the true moxibustion group reported mild rubefaction, which disappeared in a few hours. This study suggests that moxibustion may be safely used to treat anorexia and improve quality of life in patients with metastatic cancer. However, further research is needed to confirm this result.

Brief psychosocial therapy for the treatment of agitation in Alzheimer disease (the CALM-AD trial).

PubMed

Ballard, Clive; Brown, Richard; Fossey, Jane; Douglas, Simon; Bradley, Paul; Hancock, Judith; James, Ian A; Juszczak, Edmund; Bentham, Peter; Burns, Alistair; Lindesay, James; Jacoby, Robin; O'Brien, John; Bullock, Roger; Johnson, Tony; Holmes, Clive; Howard, Robert

2009-09-01

Good practice guidelines state that a psychological intervention should usually precede pharmacotherapy, but there are no data evaluating the feasibility of psychological interventions used in this way. At the first stage of a randomized blinded placebo-controlled trial, 318 patients with Alzheimer disease (AD) with clinically significant agitated behavior were treated in an open design with a psychological intervention (brief psychosocial therapy [BPST]) for 4 weeks, preceding randomization to pharmacotherapy. The therapy involved social interaction, personalized music, or removal of environmental triggers. Overall, 318 patients with AD completed BPST with an improvement of 5.6 points on the total Cohen-Mansfield Agitation Inventory (CMAI; mean [SD], 63.3 [16.0] to 57.7 [18.4], t = 4.8, df = 317, p < 0.0001). Therapy worksheets were completed in six of the eight centers, with the key elements of the intervention delivered according to the manual for >95% of patients. More detailed evaluation of outcome was completed for the 198 patients with AD from these centers, who experienced a mean improvement of 6.6 points on the total CMAI (mean [SD], 62.2 [14.3] to 55.6 [15.8], t = 6.5, df = 197, p < 0.0001). Overall, 43% of participants achieved a 30% improvement in their level of agitation. The specific attributable benefits of BPST cannot be determined from an open trial. However, the BPST therapy was feasible and was successfully delivered according to an operationalized manual. The encouraging outcome indicates the need for a randomized controlled trial of BPST.

A Self-Directed Mobile Intervention (WaznApp) to Promote Weight Control Among Employees at a Lebanese University: Protocol for a Feasibility Pilot Randomized Controlled Trial

PubMed Central

2018-01-01

Background Overweight and obesity have become major health problems globally with more than 1.9 billion overweight adults. In Lebanon, the prevalence of obesity and overweight is 65.4% combined. Risk factors of obesity and overweight are preventable and can be addressed by modifications in the environment and in an individual’s lifestyle. Mobile technologies are increasingly used in behavioral, self-directed weight management interventions, providing users with additional opportunities to attain weight control (weight loss, weight gain prevention, etc). Mobile apps may allow for the delivery of Just-in-Time Adaptive Interventions (JITAIs), which provide support through skill building, emotional support, and instrumental support, following the participants’ progress. A few commercially available apps offer JITAI features, but no studies have tested their efficacy. Objective The primary objective of this study is to examine the feasibility of a self-directed weight loss intervention, targeting employees of an academic institution, using a virtual coaching app with JITAI features (Lark) and a self-help calorie-counting app (MyFitnessPal). The secondary objective is to estimate the effects of the intervention on main study outcomes. Methods This study is a single-center, parallel, randomized controlled trial with 2 study arms (intervention and control). Participants will be randomly allocated in equal proportions to the intervention (Lark) and control groups (MyFitnessPal). To be eligible for this study, participants must be employed full- or part-time at the university or its medical center, able to read English, have a smartphone, and be interested in controlling their weight. Recruitment strategies entail email invitations, printed posters, and social media postings. We will assess quantitative rates of recruitment, adherence, and retention, self-reported app quality using the user version of the Mobile App Rating Scale. We will also assess changes in weight-related outcomes (absolute weight and waist circumference), behavioral outcomes (physical activity and diet), and cognitive factors (motivation to participate in the trial and to manage weight). Results WaznApp was funded in June 2017, and recruitment started in March 2018. Conclusions This study will provide information as to whether the selected mobile apps offer a feasible solution for promoting weight management in an academic workplace. The results will inform a larger trial whose results might be replicated in similar workplaces in Lebanon and the Middle East and North Africa region, and will be used as a benchmark for further investigations in other settings and similar target groups. Trial Registration ClinicalTrials.gov NCT03321331; https://clinicaltrials.gov/ct2/show/NCT03321331 (Archived by WebCite at http://www.webcitation.org/6ys9NOLo5) Registered Report Identifier RR1-10.2196/9793 PMID:29769174

Cognitive-behavioral therapy for sleep disturbances in treating posttraumatic stress disorder symptoms: A meta-analysis of randomized controlled trials.

PubMed

Ho, Fiona Yan-Yee; Chan, Christian S; Tang, Kristen Nga-Sze

2016-02-01

Sleep disturbances are frequently reported in patients with posttraumatic stress disorder (PTSD). There is evidence that sleep disturbance is not only a secondary symptom but also a risk factor for PTSD. Sleep-specific psychological treatments provide an alternative to conventional trauma-focused psychological treatments. The current meta-analysis evaluated the efficacy of sleep-specific cognitive-behavioral therapy (CBT) in mitigating PTSD, sleep, and depressive symptoms. A total of 11 randomized controlled trials were included in the meta-analytic comparisons between sleep-specific CBT and waiting-list control groups at posttreatment. Random effects models showed significant reduction in self-report PTSD and depressive symptoms and insomnia severity in the sleep-specific CBT group. The corresponding effect sizes, measured in Hedges' g, were 0.58, 0.44, and 1.15, respectively. The effect sizes for sleep diary-derived sleep onset latency, wake after sleep onset, and sleep efficiency were 0.83, 1.02 and 1.15, respectively. The average study attrition rate of sleep-specific CBT was relatively low (12.8%), with no significant difference from the control group (9.4%). In conclusion, sleep-specific CBT appears to be efficacious and feasible in treating PTSD symptoms. Due to the relatively small number of randomized controlled trials available, further research is warranted to confirm its efficacy and acceptability, especially in comparison to trauma-specific psychological treatments. Copyright © 2015 Elsevier Ltd. All rights reserved.

The Impact of a School-Based Weight Management Program Involving Parents via mHealth for Overweight and Obese Children and Adolescents with Intellectual Disability: A Randomized Controlled Trial

PubMed Central

Leung, Cynthia; Chen, Hong; Brown, Michael; Chen, Jyu-Lin; Cheung, Gordon; Lee, Paul H.

2017-01-01

There is a scarcity of resources and studies that utilize targeted weight management interventions to engage parents via mHealth tools targeting obese children and adolescents with mild intellectual disabilities (MIDs) extended from school to a home setting. To test the feasibility and acceptability of a school-based weight program (SBWMP) involving parents via mHealth tools designed to reduce weight, enhance knowledge and adopt healthy lifestyles, and thereby achieve better psychosocial well-being among children and adolescents with MIDs. Four special schools were randomly assigned as intervention or control schools. Students from the intervention group (n = 63) were compared to those in the control group (n = 52), which comprised those with usual school planned activities and no parental involvement. Demographics were considered as covariates in a general linear model, an ordinal regression model and a binary logistic regression model analyzing the relationships between the SBWMP and the outcome variables at baseline (T0) and six months later (T1). Body weight, body mass index, and triceps and subscapular skinfold thickness were lower in the intervention group compared to the control group, although the differences were not statistically significant. There was a positive and direct impact of the SBWMP on students’ health knowledge and psychological impacts in the intervention group. The SBWMP extended to the home involving parents via mHealth tools is a feasible and acceptable program for this group with MIDs and their parents. PMID:28981460

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

PubMed

Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Tailored Education for Older Patients to Facilitate Engagement in Falls Prevention Strategies after Hospital Discharge—A Pilot Randomized Controlled Trial

PubMed Central

Hill, Anne-Marie; Etherton-Beer, Christopher; Haines, Terry P.

2013-01-01

Background The aims of the study were to evaluate the effect of providing tailored falls prevention education in hospital on: i) engagement in targeted falls prevention behaviors in the month after discharge: ii) patients’ self-perceived risk and knowledge about falls and falls prevention strategies after receiving the education. Methods A pilot randomized controlled trial (n = 50): baseline and outcome assessments conducted by blinded researchers. Participants: hospital inpatients 60 years or older, discharged to the community. Participants were randomized into two groups. The intervention was a tailored education package consisting of multimedia falls prevention information with trained health professional follow-up, delivered in addition to usual care. Outcome measures were engagement in falls prevention behaviors in the month after discharge measured at one month after discharge with a structured survey, and participants’ knowledge, confidence and motivation levels before and after receiving the education. The feasibility of providing the intervention was examined and falls outcomes (falls, fall-related injuries) were also collected. Results Forty-eight patients (98%) provided follow-up data. The complete package was provided to 21 (84%) intervention group participants. Participants in the intervention group were significantly more likely to plan how to safely restart functional activities [Adjusted odds ratio 3.80, 95% CI (1.07, 13.52), p = 0.04] and more likely to complete other targeted behaviors such as completing their own home exercise program [Adjusted odds ratio 2.76, 95% CI (0.72, 10.50), p = 0.14] than the control group. The intervention group was significantly more knowledgeable, confident and motivated to engage in falls prevention strategies after receiving the education than the control group. There were 23 falls (n = 5 intervention; n = 18 control) and falls rates were 5.4/1000 patient days (intervention); 18.7/1000 patient days (control). Conclusion This tailored education was received positively by older people, resulted in increased engagement in falls prevention strategies after discharge and is feasible to deliver to older hospital patients. Trial registration The study was registered with the Australian New Zealand Clinical Trials Registry; ACTRN12611000963921 on 8th November 2011. PMID:23717424

Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

PubMed

Ashford, Miriam T; Olander, Ellinor K; Rowe, Heather; Fisher, Jane Rw; Ayers, Susan

2018-04-20

Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. Postpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility. A total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed iWaWa's accessibility, anonymity, and weekly reminders, as well as the introduction to the principles of cognitive-behavioral therapy (CBT) and mindfulness. However, iWaWa was also experienced as not user-friendly enough, too long, and not smartphone-friendly. Parts of the content were experienced as not always relevant and appropriate. Participants felt that iWaWa could be improved by having it in a smartphone app format and by making the content more concise and inclusive of different parenting styles. Despite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa's future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence. ClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd). ©Miriam T Ashford, Ellinor K Olander, Heather Rowe, Jane RW Fisher, Susan Ayers. Originally published in JMIR Mental Health (http://mental.jmir.org), 20.04.2018.

Can community midwives prevent antenatal depression? An external pilot study to test the feasibility of a cluster randomized controlled universal prevention trial.

PubMed

Brugha, T S; Smith, J; Austin, J; Bankart, J; Patterson, M; Lovett, C; Morgan, Z; Morrell, C J; Slade, P

2016-01-01

Repeated epidemiological surveys show no decline in depression although uptake of treatments has grown. Universal depression prevention interventions are effective in schools but untested rigorously in adulthood. Selective prevention programmes have poor uptake. Universal interventions may be more acceptable during routine healthcare contacts for example antenatally. One study within routine postnatal healthcare suggested risk of postnatal depression could be reduced in non-depressed women from 11% to 8% by giving health visitors psychological intervention training. Feasibility and effectiveness in other settings, most notably antenatally, is unknown. We conducted an external pilot study using a cluster trial design consisting of recruitment and enhanced psychological training of randomly selected clusters of community midwives (CMWs), recruitment of pregnant women of all levels of risk of depression, collection of baseline and outcome data prior to childbirth, allowing time for women 'at increased risk' to complete CMW-provided psychological support sessions. Seventy-nine percent of eligible women approached agreed to take part. Two hundred and ninety-eight women in eight clusters participated and 186 termed 'at low risk' for depression, based on an Edinburgh Perinatal Depression Scale (EPDS) score of <12 at 12 weeks gestation, provided baseline and outcome data at 34 weeks gestation. All trial protocol procedures were shown to be feasible. Antenatal effect sizes in women 'at low risk' were similar to those previously demonstrated postnatally. Qualitative work confirmed the acceptability of the approach to CMWs and intervention group women. A fully powered trial testing universal prevention of depression in pregnancy is feasible, acceptable and worth undertaking.

The effect of targeted treatment on people with patellofemoral pain: a pragmatic, randomised controlled feasibility study.

PubMed

Drew, Benjamin T; Conaghan, Philip G; Smith, Toby O; Selfe, James; Redmond, Anthony C

2017-08-04

Targeted treatment, matched according to specific clinical criteria e.g. hip muscle weakness, may result in better outcomes for people with patellofemoral pain (PFP). However, to ensure the success of future trials, a number of questions on the feasibility of a targeted treatment need clarification. The aim of the study was to explore the feasibility of matched treatment (MT) compared to usual care (UC) management for a subgroup of people with PFP determined to have hip weakness and to explore the mechanism of effect for hip strengthening. In a pragmatic, randomised controlled feasibility study, 24 participants with PFP (58% female; mean age 29 years) were randomly allocated to receive either MT aimed specifically at hip strengthening, or UC over an eight-week period. The primary outcomes were feasibility outcomes, which included rates of adherence, attrition, eligibility, missing data and treatment efficacy. Secondary outcomes focused on the mechanistic outcomes of the intervention, which included hip kinematics. Conversion to consent (100%), missing data (0%), attrition rate (8%) and adherence to both treatment and appointments (>90%) were deemed successful endpoints. The analysis of treatment efficacy showed that the MT group reported a greater improvement for the Global Rating of Change Scale (62% vs. 9%) and the Anterior Knee Pain Scale (-5.23 vs. 1.18) but no between-group differences for either average or worst pain. Mechanistic outcomes showed a greatest reduction in peak hip internal rotation angle for the MT group (13.1% vs. -2.7%). This feasibility study indicates that a definitive randomised controlled trial investigating a targeted treatment approach is achievable. Findings suggest the mechanism of effect of hip strengthening may be to influence kinematic changes in hip function in the transverse plane. This study was registered retrospectively. ISRCTN74560952 . Registration date: 2017-02-06.

Reduce chest pain using modified silicone fluted drain tube for chest drainage after video-assisted thoracic surgery (VATS) lung resection

PubMed Central

Li, Xin; Hu, Bin; Miao, Jinbai

2016-01-01

Background The aim of this study was to assess the feasibility, efficacy and safety of a modified silicone fluted drain tube after video-assisted thoracic surgery (VATS) lung resection. Methods The prospective randomized study included 50 patients who underwent VATS lung resection between March 2015 and June 2015. Eligible patients were randomized into two groups: experimental group (using the silicone fluted drain tubes for chest drainage) and control group (using standard drain tubes for chest drainage). The volume and characteristics of drainage, postoperative (PO) pain scores and hospital stay were recorded. All patients received standard care during hospital admission. Results In accordance with the exit criteria, three patients were excluded from study. The remaining 47 patients included in the final analysis were divided into two groups: experiment group (N=24) and control group (N=23). There was no significant difference between the two groups in terms of age, sex, height, weight, clinical diagnosis and type of surgical procedure. There was a trend toward less PO pain in experimental group on postoperative day (POD) 1, with a statistically significant difference. Patients in experimental group had a reduced occurrence of fever [temperature (T) >37.4 °C] compared to the control group. Conclusions The silicone fluted drain tube is feasible and safe and may relieve patient PO pain and reduce occurrence of fever without the added risk of PO complications. PMID:26941976

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

PubMed

Koutoukidis, Dimitrios A; Beeken, Rebecca J; Manchanda, Ranjit; Burnell, Matthew; Knobf, M Tish; Lanceley, Anne

2016-03-10

Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity. This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention. The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population. ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy

PubMed Central

Bricker, Jonathan B.; Mull, Kristin; Kientz, Julie A.; Vilardaga, Roger M.; Mercer, Laina D.; Akioka, Katrina; Heffner, Jaimee L.

2014-01-01

Background There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered Acceptance and Commitment Therapy (ACT) application for smoking cessation versus an application following US Clinical Practice Guidelines. Method Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (N = 196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p <.0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n = 88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:25085225

Feasibility and safety of exercise stress testing using an anti-gravity treadmill with Tc-99m tetrofosmin single-photon emission computed tomography (SPECT) myocardial perfusion imaging: A pilot non-randomized controlled study.

PubMed

Daly, Patrick; Kayse, Regina; Rudick, Steven; Robbins, Nathan; Scheler, Jennifer; Harris, David; O'Donnell, Robert; Dwivedi, Alok K; Gerson, Myron C

2017-08-31

Exercise is the AHA/ACC guideline-recommended stress modality for myocardial perfusion imaging, but many patients are unable to exercise to target heart rate on a conventional treadmill. We examined the feasibility and safety of stress imaging using an anti-gravity treadmill in patients with perceived poor exercise capacity. 49 patients were recruited for stress testing by anti-gravity treadmill (n = 29) or to a regadenoson control group (n = 20). Seventeen anti-gravity test patients (59%) reached target heart rate obviating the need for a pharmacologic stress agent. Adverse effects of the anti-gravity treadmill were limited to minor muscle aches in 5 subjects. Stress myocardial perfusion image quality judged by 3 blinded readers on a 5-point scale was comparable for the anti-gravity treadmill (4.30 ± SD 0.87) vs pharmacologic stress (4.28 ± SD 0.66). Stress testing using an anti-gravity treadmill is feasible and may help some patients safely achieve target heart rate.

Virtual Reality Job Interview Training for Individuals with Psychiatric Disabilities

PubMed Central

Smith, Matthew J.; Ginger, Emily J.; Wright, Michael; Wright, Katherine; Humm, Laura Boteler; Olsen, Dale; Bell, Morris D.; Fleming, Michael F.

2014-01-01

Services are available to help support existing employment for individual with psychiatric disabilities; however, there is a gap in services targeting job interview skills that can help obtain employment. We assessed the feasibility and efficacy of Virtual Reality Job Interview Training (VR-JIT) in a randomized controlled trial. Participants were randomized to VR-JIT (n=25) or treatment as usual (TAU) (n=12) groups. VR-JIT consisted of 10 hours of simulated job interviews with a virtual character and didactic online training. Participants attended 95% of lab-based training sessions and found VR-JIT easy-to-use and felt prepared for future interviews. The VR-JIT group improved their job interview role-play performance (p<0.05) and self-confidence (p<0.05) between baseline and follow-up as compared to the TAU group. VR-JIT performance scores increased over time (R-Squared=0.65). VR-JIT demonstrated initial feasibility and efficacy at improving job interview skills and self-confidence. Future research may help clarify whether this intervention is efficacious in community-based settings. PMID:25099298

Virtual reality job interview training for individuals with psychiatric disabilities.

PubMed

Smith, Matthew J; Ginger, Emily J; Wright, Michael; Wright, Katherine; Boteler Humm, Laura; Olsen, Dale; Bell, Morris D; Fleming, Michael F

2014-09-01

Services are available to help support existing employment for individuals with psychiatric disabilities; however, there is a gap in services targeting job interview skills that can help obtain employment. We assessed the feasibility and efficacy of Virtual Reality Job Interview Training (VR-JIT) in a randomized controlled trial. Participants were randomized to VR-JIT (n = 25) or treatment-as-usual (TAU) (n = 12) groups. VR-JIT consisted of 10 hours of simulated job interviews with a virtual character and didactic online training. The participants attended 95% of laboratory-based training sessions and found VR-JIT easy to use and felt prepared for future interviews. The VR-JIT group improved their job interview role-play performance (p ≤ 0.05) and self-confidence (p ≤ 0.05) between baseline and follow-up as compared with the TAU group. VR-JIT performance scores increased over time (R = 0.65). VR-JIT demonstrated initial feasibility and efficacy at improving job interview skills and self-confidence. Future research may help clarify whether this intervention is efficacious in community-based settings.

Interactive weekly mobile phone text messaging plus motivational interviewing in promotion of breastfeeding among women living with HIV in South Africa: study protocol for a randomized controlled trial.

PubMed

Zunza, Moleen; Cotton, Mark F; Mbuagbaw, Lawrence; Lester, Richard; Thabane, Lehana

2017-07-17

South Africa recently phased out access to free formula milk in the public sector in support of breastfeeding for women living with HIV. Few women living with HIV in South Africa choose breastfeeding and among those who do, many stop breastfeeding early. We sought to explore the feasibility of using mobile phone text messaging coupled with motivational interviewing to enhance adherence to breastfeeding practices. A randomized, parallel group, single-center pilot trial. Electronic sequence generation and random allocation will be done centrally. Women of low socioeconomic status, from Cape Town, South Africa will be randomly assigned within 24 h of giving birth at a primary healthcare clinic to a structured weekly text message plus motivational interviewing and usual standard of care, using a permutation of different block sizes. Criteria for feasibility success will include: five participants recruited per week (over 12 weeks), about 75% of all eligible participants consent for study participation, complete evaluation of outcomes in at least 70% of all recruited participants, breastfeeding adherence rates of at least 70% in the intervention group, six months after delivery. Participants will be evaluated soon after giving birth and post-delivery at weeks 2, 6, 10, and 24. Primary analysis will follow the "intention-to-treat" principle. Sub-group analysis will be used to assess sub-group effects. This pilot trial will evaluate the feasibility of conducting a larger trial on communication and support approaches to improve adherence to breastfeeding by HIV-infected women. Text messaging and motivational interviewing are simple interventions which may allow participants to access personalized adherence advice and support. ClinicalTrials.gov: NCT02949713 . Registered on 26 October 2016; Pan African Clinical Trial Registry PACTR201611001855404 . Registered on 8 November 2016.

Promoting physical activity in children with juvenile idiopathic arthritis through an internet-based program: results of a pilot randomized controlled trial.

PubMed

Lelieveld, Otto T H M; Armbrust, Wineke; Geertzen, Jan H B; de Graaf, Inez; van Leeuwen, Miek A; Sauer, Pieter J J; van Weert, Ellen; Bouma, Jelte

2010-05-01

Patients with juvenile idiopathic arthritis (JIA) are less physically active than healthy peers. Therefore, we developed an Internet-based intervention to improve physical activity (PA). The aim of this study was to examine the effectiveness of the program in improving PA. PA was determined by activity-related energy expenditure, PA level, time spent on moderate to vigorous PA, and the number of days with > or =1 hour of moderate to vigorous activity, and was assessed with a 7-day activity diary. Aerobic exercise capacity was assessed by means of a Bruce treadmill test and was recorded as maximum endurance time. Disease activity was assessed by using the JIA core set. Adherence was electronically monitored. Of 59 patients, 33 eligible patients were included and randomized in an intervention (n = 17, mean +/- SD age 10.6 +/- 1.5 years) or control waiting-list group (n = 16, mean +/- SD age 10.8 +/- 1.4 years). All patients completed baseline and T1 testing. PA significantly improved in both groups. Maximum endurance time significantly improved in the intervention group but not in the control group. In a subgroup analysis for patients with low PA (intervention: n = 7, control: n = 5), PA improved in the intervention group but not in the control group. The intervention was safe, feasible, and showed a good adherence. An Internet-based program for children with JIA ages 8-12 years directed at promoting PA in daily life effectively improves PA in those patients with low PA levels. It is also able to improve endurance and it is safe, feasible, and has good adherence.

A pilot randomized controlled trial of cognitive behavioral therapy for perinatal depression adapted for women with low incomes.

PubMed

O'Mahen, Heather; Himle, Joseph A; Fedock, Gina; Henshaw, Erin; Flynn, Heather

2013-07-01

Perinatal women with identified depression in prenatal care settings have low rates of engagement and adherence with depression-specific psychotherapy. We report the feasibility and symptom outcomes of Cognitive Behavioral Therapy (CBT) modified (mCBT) to address the needs of perinatal, low-income women with Major Depressive Disorder (MDD). Pregnant women (n = 1421) were screened for depressive symptoms in obstetrics clinics in conjunction with prenatal care visits. A total of 59 women met diagnostic criteria for MDD; 55 women were randomly assigned to mCBT or Treatment as Usual (TAU). The mCBT intervention included an initial engagement session, outreach, specific perinatal content and interpersonal components. Measures were gathered at pre-treatment, 16 week post-randomization, and 3-month follow-up. Most participants attended at least one CBT session and met study criteria for treatment adherence. Active research staff outreach promoted engagement and retention in the trial. Treatment satisfaction was rated as very good. In both observed and multiple imputation results, women who received mCBT demonstrated greater improvement in depressed mood than those in TAU at 16-week post-randomization and 3-month follow-up, Cohen's d = -0.71 (95% CI -4.93, -5.70). Modified CBT offers promise as a feasible and acceptable treatment for perinatal women with low-incomes in prenatal care settings. Targeted delivery and content modifications are needed to engage populations tailored to setting and psychosocial challenges specific to the perinatal period. © 2013 Wiley Periodicals, Inc.

Single-dose intravenous iron infusion versus red blood cell transfusion for the treatment of severe postpartum anaemia: a randomized controlled pilot study.

PubMed

Holm, C; Thomsen, L L; Norgaard, A; Langhoff-Roos, J

2017-02-01

There are no randomized trials comparing intravenous iron to RBC transfusion for the treatment of severe postpartum anaemia. The objectives of this study were to evaluate the feasibility of randomizing women with severe postpartum anaemia secondary to postpartum haemorrhage to RBC transfusion or intravenous iron, and to describe patient-reported outcomes, and haematological and iron parameters. Women with a postpartum haemorrhage exceeding 1000 ml and an Hb between 5·6 and 8·1 g/dl were randomized to 1500 mg of intravenous iron (n = 7) isomaltoside or RBC transfusion (n = 6). Participants completed the Multidimensional Fatigue Inventory and Edinburgh Postnatal Depression Scale, and blood samples were drawn at inclusion, daily during the first week and at weeks 3, 8 and 12. We screened 162 women and included 13 (8%). There was no significant difference between groups in fatigue or depression scores. RBC transfusion was associated with a higher Hb on day 1, inhibition of reticulocytosis during the first week and low iron levels. Intravenous iron was associated with increased reticulocytosis during the first week, repleted iron stores and a higher Hb in weeks 3-12. This pilot study shows that intravenous iron could be an attractive alternative to RBC transfusion in severe postpartum anaemia, and that a larger trial is needed and feasible. © 2016 The Authors. Vox Sanguinis published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.

Teen Online Problem Solving for Teens With Traumatic Brain Injury: Rationale, Methods, and Preliminary Feasibility of a Teen Only Intervention

PubMed Central

Wade, Shari L.; Narad, Megan E.; Kingery, Kathleen M.; Taylor, H. Gerry; Stancin, Terry; Kirkwood, Michael W.; Yeates, Keith O.

2017-01-01

Purpose/Objective To describe the Teen Online Problem Solving—Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving—Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11–18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Results Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). Conclusions/Implications TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. PMID:28836809

EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial.

PubMed

Simon, Steffen T; Kloke, Marianne; Alt-Epping, Bernd; Gärtner, Jan; Hellmich, Martin; Hein, Rebecca; Piel, Maren; Cornely, Oliver A; Nauck, Friedemann; Voltz, Raymond

2016-11-01

Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited. To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness. Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees. Twenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group. The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial. Copyright © 2016. Published by Elsevier Inc.

Design and methods for "Commit to Get Fit" - a pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents.

PubMed

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-03-01

Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. Copyright © 2015 Elsevier Inc. All rights reserved.

Design and methods for “Commit to Get Fit” – A pilot study of a school-based mindfulness intervention to promote healthy diet and physical activity among adolescents

PubMed Central

Salmoirago-Blotcher, Elena; Druker, Sue; Meyer, Florence; Bock, Beth; Crawford, Sybil; Pbert, Lori

2015-01-01

Introduction Cardiovascular prevention is more effective if started early in life, but available interventions to promote healthy lifestyle habits among youth have been ineffective. Impulsivity in particular has proven to be an important barrier to the adoption of healthy behaviors in youth. Observational evidence suggests that mindfulness interventions may reduce impulsivity and improve diet and physical activity. We hypothesize that mindfulness training in adjunct to traditional health education will improve dietary habits and physical activity among teenagers by reducing impulsive behavior and improving planning skills. Methods/Design The Commit to Get Fit study is a pilot cluster randomized controlled trial examining the feasibility, acceptability and preliminary efficacy of school-based mindfulness training in adjunct to traditional health education for promotion of a healthy diet and physical activity among adolescents. Two schools in central Massachusetts (30 students per school) will be randomized to receive mindfulness training plus standard health education (HE-M) or an attention-control intervention plus standard health education (HE-AC). Assessments will be conducted at baseline, intervention completion (2 months), and 8 months. Primary outcomes are feasibility and acceptability. Secondary outcomes include physical activity, diet, impulsivity, mood, body mass index, and quality of life. Conclusions This study will provide important information about feasibility and preliminary estimates of efficacy of a school-delivered mindfulness and health education intervention to promote healthy dietary and physical activity behaviors among adolescents. Our findings will provide important insights about the possible mechanisms by which mindfulness training may contribute to behavioral change and inform future research in this important area. PMID:25687667

An open-label randomized-controlled trial of low dose aspirin with an early screening test for pre-eclampsia and growth restriction (TEST): Trial protocol.

PubMed

Mone, Fionnuala; Mulcahy, Cecilia; McParland, Peter; Stanton, Alice; Culliton, Marie; Downey, Paul; McCormack, Dorothy; Tully, Elizabeth; Dicker, Patrick; Breathnach, Fionnuala; Malone, Fergal D; McAuliffe, Fionnuala M

2016-07-01

Pre-eclampsia remains a worldwide cause of maternal and perinatal morbidity and mortality. Low dose aspirin (LDA) can reduce the occurrence of pre-eclampsia in women with identifiable risk factors. Emerging screening tests can determine the maternal risk of developing placental disease, such as pre-eclampsia from the first trimester of pregnancy. The aim of this study is to determine if it is more beneficial in terms of efficacy and acceptability to routinely prescribe LDA to nulliparous low-risk women compared to test indicated LDA on the basis of a positive screening test for placental disease. We propose a three armed multi-center open-labeled randomized control trial of; (i) routine LDA, (ii) no aspirin, and (iii) LDA on the basis of a positive first trimester pre-eclampsia screening test. LDA (75mg once daily) shall be given from the first trimester until 36-week gestation. The primary outcome measures include; (i) the proportion of eligible women that agree to participate (acceptability), (ii) compliance with study protocol (acceptability and feasibility), (iii) the proportion of women in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (feasibility) and (iv) the proportion of women with a completed screening test that are issued the screening result within one week of having the test performed (feasibility). This will be the first clinical trial to determine the efficacy and acceptability in low-risk women of taking routine LDA versus no aspirin versus LDA based on a positive first trimester screening test for the prevention of placental disease. Copyright © 2016 Elsevier Inc. All rights reserved.

The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer: a randomized pilot study.

PubMed

Mertz, Birgitte Goldschmidt; Dunn-Henriksen, Anne Katrine; Kroman, Niels; Johansen, Christoffer; Andersen, Kenneth Geving; Andersson, Michael; Mathiesen, Ulla Breitenstein; Vibe-Petersen, Jette; Dalton, Susanne Oksbjerg; Envold Bidstrup, Pernille

2017-12-01

Our aim was to determine the feasibility and effectiveness of an individual, nurse-navigator intervention for relieving distress, anxiety, depression and health-related quality of life in women who have been treated for breast cancer (BC) and are experiencing moderate-to-severe psychological and physical symptoms. Fifty women with newly diagnosed BC who reported distress (score ≥7 on distress thermometer) before surgery were included consecutively in a pilot study and randomized 1:1 to the intervention or the control group. The intervention comprised repeated screening with patient reported outcome measures and nurse navigation. A total of 66 women who were not distressed (score <7) were followed longitudinally as an observational group. Participants filled in four questionnaires, at baseline, after 6 months and 12 months. The primary outcome was psychological distress and the secondary outcomes were anxiety, depression, health-related quality of life and feasibility of the intervention. Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation and lower levels of distress (mean 2.7 vs. 5.1, p<.01), anxiety (mean 5.1 vs. 7.8, p = .02) and depression (mean 2.2 vs. 4.4, p = .04) after 12 months compared to the control group. No significant effects were seen on health-related quality of life. The study shows promising feasibility of the individually tailored nurse-navigation intervention and while no significant effects were observed after 6 months, we did find statistically significant effects on distress, anxiety and depression 12 months after diagnosis. Our results will assist in developing rehabilitation to the most vulnerable patients.

Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors

PubMed Central

Cases, Mallory G.; Frugé, Andrew D.; De Los Santos, Jennifer F.; Locher, Julie L.; Cantor, Alan B.; Smith, Kerry P.; Glover, Tony A.; Cohen, Harvey J.; Daniel, Michael; Morrow, Casey D.; Moellering, Douglas R.; Demark-Wahnefried, Wendy

2016-01-01

Background Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. Methods This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12 months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged ≥60 (ASCS). Results Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. Conclusion To date, recruitment and implementation of Harvest for Health appears feasible. Discussion Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL. PMID:27565830

Detailed methods of two home-based vegetable gardening intervention trials to improve diet, physical activity, and quality of life in two different populations of cancer survivors.

PubMed

Cases, Mallory G; Frugé, Andrew D; De Los Santos, Jennifer F; Locher, Julie L; Cantor, Alan B; Smith, Kerry P; Glover, Tony A; Cohen, Harvey J; Daniel, Michael; Morrow, Casey D; Moellering, Douglas R; Demark-Wahnefried, Wendy

2016-09-01

Cancer survivors suffer from long-term adverse effects that reduce health-related quality of life (QOL) and physical functioning, creating an urgent need to develop effective, durable, and disseminable interventions. Harvest for Health, a home-based vegetable gardening intervention, holds promise for these domains. This report describes the methods and recruitment experiences from two randomized controlled feasibility trials that employ a waitlist-controlled design. Delivered in partnership with Cooperative Extension Master Gardeners, this intervention provides one-on-one mentorship of cancer survivors in planning and maintaining three seasonal vegetable gardens over 12months. The primary aim is to determine intervention feasibility and acceptability; secondary aims are to explore effects on objective and subjective measures of diet, physical activity and function, and QOL and examine participant factors associated with potential effects. One trial is conducted exclusively among 82 female breast cancer survivors residing in the Birmingham, AL metropolitan area (BBCS); another broadly throughout Alabama among 46 older cancer survivors aged >60 (ASCS). Response rates were 32.6% (BBCS) and 52.3% (ASCS). Both trials exceeded 80% of their accrual target. Leading reasons for ineligibility were removal of >10 lymph nodes (lymphedema risk factor), lack of physician approval, and unwillingness to be randomized to the waitlist. To date, recruitment and implementation of Harvest for Health appears feasible. Although both studies encountered recruitment challenges, lessons learned can inform future larger-scale studies. Vegetable gardening interventions are of interest to cancer survivors and may provide opportunities to gain life skills leading to improvements in overall health and QOL. Copyright © 2016 Elsevier Inc. All rights reserved.

Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention.

PubMed

Wade, Shari L; Narad, Megan E; Kingery, Kathleen M; Taylor, H Gerry; Stancin, Terry; Kirkwood, Michael W; Yeates, Keith O

2017-08-01

To describe the Teen Online Problem Solving-Teen Only (TOPS-TO) intervention relative to the original Teen Online Problem Solving-Family (TOPS-F) intervention, to describe a randomized controlled trial to assess intervention efficacy, and to report feasibility and acceptability of the TOPS-TO intervention. Research method and design: This is a multisite randomized controlled trial, including 152 teens (49 TOPS-F, 51 TOPS-TO, 52 IRC) between the ages of 11-18 who were hospitalized for a moderate to severe traumatic brain injury in the previous 18 months. Assessments were completed at baseline, 6-months post baseline, and 12-months post baseline. Data discussed include adherence and satisfaction data collected at the 6-month assessment (treatment completion) for TOPS-F and TOPS-TO. Adherence measures (sessions completed, dropout rates, duration of treatment engagement, and rates of program completion) were similar across treatment groups. Overall, teen and parent reported satisfaction was high and similar across groups. Teens spent a similar amount of time on the TOPS website across groups, and parents in the TOPS-F spent more time on the TOPS website than those in the TOPS-TO group (p = .002). Parents in the TOPS-F group rated the TOPS website as more helpful than those in the TOPS-TO group (p = .05). TOPS-TO intervention is a feasible and acceptable intervention approach. Parents may perceive greater benefit from the family based intervention. Further examination is required to understand the comparative efficacy in improving child and family outcomes, and who is likely to benefit from each approach. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients.

PubMed

Kleidon, Tricia M; Ullman, Amanda J; Gibson, Victoria; Chaseling, Brett; Schoutrop, Jason; Mihala, Gabor; Rickard, Claire M

2017-11-01

To evaluate feasibility of an efficacy trial comparing peripherally inserted central catheter (PICC) dressing and securement techniques to prevent complications and failure. This pilot, 3-armed, randomized controlled trial was undertaken at Royal Children's Hospital and Lady Cilento Children's Hospital, Brisbane, Australia, between April 2014 and September 2015. Pediatric participants (N = 101; age range, 0-18 y) were assigned to standard care (bordered polyurethane [BPU] dressing, sutureless securement device), tissue adhesive (TA) (plus BPU dressing), or integrated securement dressings (ISDs). Average PICC dwell time was 8.1 days (range, 0.2-27.7 d). Primary outcome was trial feasibility including PICC failure. Secondary outcomes were PICC complications, dressing performance, and parent and staff satisfaction. Protocol feasibility was established. PICC failure was 6% (2/32) with standard care, 6% (2/31) with ISD, and 3% (1/32) with TA. PICC complications were 16% across all groups. TA provided immediate postoperative hemostasis, prolonging the first dressing change until 5.5 days compared with 3.5 days and 2.5 days with standard care and ISD respectively. Bleeding was the most common reason for first dressing change: standard care (n = 18; 75%), ISD (n = 11; 69%), TA (n = 4; 27%). Parental satisfaction (median 9.7/10; P = .006) and staff feedback (9.2/10; P = .002) were most positive for ISD. This research suggests safety and acceptability of different securement dressings compared with standard care; securement dressings may also reduce dressing changes after insertion. Further research is required to confirm clinically cost-effective methods to prevent PICC failure. Copyright © 2017 SIR. Published by Elsevier Inc. All rights reserved.

Nordic Walking as an Exercise Intervention to Reduce Pain in Women With Aromatase Inhibitor-Associated Arthralgia: A Feasibility Study.

PubMed

Fields, Jo; Richardson, Alison; Hopkinson, Jane; Fenlon, Deborah

2016-10-01

Women taking aromatase inhibitors as treatment for breast cancer commonly experience joint pain and stiffness (aromatase inhibitor-associated arthralgia [AIAA]), which can cause problems with adherence. There is evidence that exercise might be helpful, and Nordic walking could reduce joint pain compared to normal walking. To determine the feasibility of a trial of Nordic walking as an exercise intervention for women with AIAA. A feasibility study was carried out in a sample of women with AIAA using a randomized control design. Women were randomized to exercise (six-week supervised group Nordic walking training once per week with an increasing independent element, followed by six weeks 4 × 30 minutes/week independent Nordic walking); or enhanced usual care. Data were collected on recruitment, retention, exercise adherence, safety, and acceptability. The Brief Pain Inventory, GP Physical Activity Questionnaire, and biopsychosocial measures were completed at baseline, six and 12 weeks. Forty of 159 eligible women were recruited and attrition was 10%. There was no increased lymphedema and no long-term or serious injury. Adherence was >90% for weekly supervised group Nordic walking, and during independent Nordic walking, >80% women managed one to two Nordic walking sessions per week. From baseline to study end point, overall activity levels increased and pain reduced in both the intervention and control groups. Our findings indicate that women with AIAA are prepared to take up Nordic walking, complete a six-week supervised course and maintain increased activity levels over a 12-week period with no adverse effects. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Static Magnetic Field Therapy for Carpal Tunnel Syndrome: A Feasibility Study

PubMed Central

Colbert, Agatha P.; Markov, Marko S.; Carlson, Nels; Gregory, William L.; Carlson, Hans; Elmer, Patricia J.

2010-01-01

Objectives To assess the feasibility of conducting trials of static magnetic field (SMF) therapy for carpal tunnel syndrome (CTS), to collect preliminary data on the effectiveness of two SMF dosages and to explore the influence of a SMF on median nerve conduction. Design Randomized, double blind, sham controlled trial with 6-week intervention and 12-week follow-up. Setting University hospital outpatient clinics Participants Women and men (N=60), ages 21–65, with electrophysiologically-confirmed CTS diagnosis, recruited from the general population. Interventions Participants wore nightly either neodymium magnets that delivered either 15 or 45mTesla (mT) to the contents of the carpal canal, or a non-magnetic disk. Main Outcome Measures Symptom Severity Scale (SSS) and Function Severity Scale (FSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) and 4 median nerve parameters: sensory distal latency, sensory nerve action potential amplitude, motor distal latency and compound motor action potential amplitude). Results 58 of 60 randomized participants completed the study. There were no significant between-group differences for change in the primary endpoint SSS or for FSS or median nerve conduction parameters. For the SSS and the FSS each group showed a reduction at 6-weeks indicating improvement in symptoms. Conclusions This study demonstrated the feasibility and safety of testing SMF therapy for CTS. There were no between-group differences observed for the BCTQ or median nerve parameters following 6 weeks of SMF therapy. Significant within-group, symptomatic improvements of the same magnitude were experienced by participants in both active and sham magnet groups. Future studies are needed to optimize SMF dosimetry and resolve issues related to the use of sham controls in SMF trials. PMID:20599049

Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial.

PubMed

Kingston, Dawn; McDonald, Sheila; Biringer, Anne; Austin, Marie-Paule; Hegadoren, Kathy; McDonald, Sarah; Giallo, Rebecca; Ohinmaa, Arto; Lasiuk, Gerri; MacQueen, Glenda; Sword, Wendy; Lane-Smith, Marie; van Zanten, Sander Veldhuyzen

2014-01-02

Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed. The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening. ClinicalTrials.gov Identifier: NCT01899534.

A cluster randomized trial of strategies to increase uptake amongst young women invited for their first cervical screen: The STRATEGIC trial.

PubMed

Kitchener, H; Gittins, M; Cruickshank, M; Moseley, C; Fletcher, S; Albrow, R; Gray, A; Brabin, L; Torgerson, D; Crosbie, E J; Sargent, A; Roberts, C

2018-06-01

Objectives To measure the feasibility and effectiveness of interventions to increase cervical screening uptake amongst young women. Methods A two-phase cluster randomized trial conducted in general practices in the NHS Cervical Screening Programme. In Phase 1, women in practices randomized to intervention due for their first invitation to cervical screening received a pre-invitation leaflet and, separately, access to online booking. In Phase 2, non-attenders at six months were randomized to one of: vaginal self-sample kits sent unrequested or offered; timed appointments; nurse navigator; or the choice between nurse navigator or self-sample kits. Primary outcome was uplift in intervention vs. control practices, at 3 and 12 months post invitation. Results Phase 1 randomized 20,879 women. Neither pre-invitation leaflet nor online booking increased screening uptake by three months (18.8% pre-invitation leaflet vs. 19.2% control and 17.8% online booking vs. 17.2% control). Uptake was higher amongst human papillomavirus vaccinees at three months (OR 2.07, 95% CI 1.69-2.53, p < 0.001). Phase 2 randomized 10,126 non-attenders, with 32-34 clusters for each intervention and 100 clusters as controls. Sending self-sample kits increased uptake at 12 months (OR 1.51, 95% CI 1.20-1.91, p = 0.001), as did timed appointments (OR 1.41, 95% CI 1.14-1.74, p = 0.001). The offer of a nurse navigator, a self-sample kits on request, and choice between timed appointments and nurse navigator were ineffective. Conclusions Amongst non-attenders, self-sample kits sent and timed appointments achieved an uplift in screening over the short term; longer term impact is less certain. Prior human papillomavirus vaccination was associated with increased screening uptake.

Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

PubMed

Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

2016-02-01

Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster effect was taken into account, the difference in Insomnia Severity Index reduction between the intervention versus control groups was non-significant, the results highlight that reductions in insomnia severity can be gained using trained pharmacists providing brief behavioural interventions. Future research in this area is warranted, with appropriately sized studies using the conventional, robust randomized trial design. © 2015 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.

The effects of video-game training on broad cognitive transfer in multiple sclerosis: A pilot randomized controlled trial.

PubMed

Janssen, Alisha; Boster, Aaron; Lee, HyunKyu; Patterson, Beth; Prakash, Ruchika Shaurya

2015-01-01

Multiple sclerosis (MS) is a neurodegenerative disease of the central nervous system that results in diffuse nerve damage and associated physical and cognitive impairments. Of the few comprehensive rehabilitation options that exist for populations with lower baseline cognitive functioning, those that have been successful at eliciting broad cognitive improvements have focused on a multimodal training approach, emphasizing complex cognitive processing that utilizes multiple domains simultaneously. The current study sought to determine the feasibility of an 8-week, hybrid-variable priority training (HVT) program, with a secondary aim to assess the success of this training paradigm at eliciting broad cognitive transfer effects. Capitalizing on the multimodal training modalities offered by the Space Fortress platform, we compared the HVT strategy-based intervention with a waitlist control group, to primarily assess skill acquisition and secondarily determine presence of cognitive transfer. Twenty-eight participants met inclusionary criteria for the study and were randomized to either training or waitlist control groups. To assess broad transfer effects, a battery of neuropsychological tests was administered pre- and post-intervention. The results indicated an overall improvement in skill acquisition and evidence for the feasibility of the intervention, but a lack of broad transfer to tasks of cognitive functioning. Participants in the training group, however, did show improvements on a measure of spatial short-term memory. The current investigation provided support for the feasibility of a multimodal training approach, using the HVT strategy, within the MS population, but lacked broad transfer to multiple domains of cognitive functioning. Future improvements to obtain greater cognitive transfer efficacy would include a larger sample size, a longer course of training to evoke greater game score improvement, the inclusion of only cognitively impaired individuals, and integration of subjective measures of improvement in addition to objective tests of cognitive performance.

Tai Chi for Reducing Dual-task Gait Variability, a Potential Mediator of Fall Risk in Parkinson's Disease: A Pilot Randomized Controlled Trial.

PubMed

Vergara-Diaz, Gloria; Osypiuk, Kamila; Hausdorff, Jeffrey M; Bonato, Paolo; Gow, Brian J; Miranda, Jose Gv; Sudarsky, Lewis R; Tarsy, Daniel; Fox, Michael D; Gardiner, Paula; Thomas, Cathi A; Macklin, Eric A; Wayne, Peter M

2018-01-01

To assess the feasibility and inform design features of a fully powered randomized controlled trial (RCT) evaluating the effects of Tai Chi (TC) in Parkinson's disease (PD) and to select outcomes most responsive to TC assessed during off-medication states. Two-arm, wait-list controlled RCT. Tertiary care hospital. Thirty-two subjects aged 40-75 diagnosed with idiopathic PD within 10 years. Six-month TC intervention added to usual care (UC) versus UC alone. Primary outcomes were feasibility-related (recruitment rate, adherence, and compliance). Change in dual-task (DT) gait stride-time variability (STV) from baseline to 6 months was defined, a priori, as the clinical outcome measure of primary interest. Other outcomes included: PD motor symptom progression (Unified Parkinson's Disease Rating Scale [UPDRS]), PD-related quality of life (PDQ-39), executive function (Trail Making Test), balance confidence (Activity-Specific Balance Confidence Scale, ABC), and Timed Up and Go test (TUG). All clinical assessments were made in the off-state for PD medications. Thirty-two subjects were enrolled into 3 sequential cohorts over 417 days at an average rate of 0.08 subjects per day. Seventy-five percent (12/16) in the TC group vs 94% (15/16) in the UC group completed the primary 6-month follow-up assessment. Mean TC exposure hours overall: 52. No AEs occurred during or as a direct result of TC exercise. Statistically nonsignificant improvements were observed in the TC group at 6 months in DT gait STV (TC [20.1%] vs UC [-0.1%] group [effect size 0.49; P = .47]), ABC, TUG, and PDQ-39. UPDRS progression was modest and very similar in TC and UC groups. Conducting an RCT of TC for PD is feasible, though measures to improve recruitment and adherence rates are needed. DT gait STV is a sensitive and logical outcome for evaluating the combined cognitive-motor effects of TC in PD.

Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention

PubMed Central

Stinson, Jennifer; Stergiou-Kita, Mary; Leck, Joanne

2017-01-01

Background Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. Objective The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. Methods A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the “Empowering Youth Towards Employment” intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Results Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Conclusions Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Trial Registration Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc) PMID:29146566

Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention.

PubMed

Lindsay, Sally; Stinson, Jennifer; Stergiou-Kita, Mary; Leck, Joanne

2017-11-16

Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the "Empowering Youth Towards Employment" intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc). ©Sally Lindsay, Jennifer Stinson, Mary Stergiou-Kita, Joanne Leck. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.11.2017.

Novel Use of Google Glass for Procedural Wireless Vital Sign Monitoring.

PubMed

Liebert, Cara A; Zayed, Mohamed A; Aalami, Oliver; Tran, Jennifer; Lau, James N

2016-08-01

Purpose This study investigates the feasibility and potential utility of head-mounted displays for real-time wireless vital sign monitoring during surgical procedures. Methods In this randomized controlled pilot study, surgery residents (n = 14) performed simulated bedside procedures with traditional vital sign monitors and were randomized to addition of vital sign streaming to Google Glass. Time to recognition of preprogrammed vital sign deterioration and frequency of traditional monitor use was recorded. User feedback was collected by electronic survey. Results The experimental group spent 90% less time looking away from the procedural field to view traditional monitors during bronchoscopy (P = .003), and recognized critical desaturation 8.8 seconds earlier; the experimental group spent 71% (P = .01) less time looking away from the procedural field during thoracostomy, and recognized hypotension 10.5 seconds earlier. Trends toward earlier recognition of deterioration did not reach statistical significance. The majority of participants agreed that Google Glass increases situational awareness (64%), is helpful in monitoring vitals (86%), is easy to use (93%), and has potential to improve patient safety (85%). Conclusion In this early feasibility study, use of streaming to Google Glass significantly decreased time looking away from procedural fields and resulted in a nonsignificant trend toward earlier recognition of vital sign deterioration. Vital sign streaming with Google Glass or similar platforms is feasible and may enhance procedural situational awareness. © The Author(s) 2016.

Acceptability of randomization to levonorgestrel versus copper intrauterine device among women requesting IUD insertion for contraception

PubMed Central

Achilles, Sharon L.; Chen, Beatrice A.; Lee, Jessica K.; Gariepy, Aileen M.; Creinin, Mitchell D.

2015-01-01

Objective Assess feasibility of randomizing women to intrauterine device (IUD) type. Study Design Women enrolling in a 2-month study who desired an IUD for contraception were randomized 1:1 to receive a levonorgestrel 52mg IUD (LNG-IUD) or copper T380A (Cu-IUD), understanding they could switch IUD type at the end of the study. Results Randomization to IUD type was acceptable to 54/55 (98%) women who screened. All 32 enrolled participants completed follow-up. Two women exchanged their IUD (Cu-IUD to LNG-IUD) and 2 requested removal (1 LNG-IUD, 1 Cu-IUD). Overall, 88% continued their assigned IUD. Conclusions Randomization to IUD type is feasible and few women change their IUD. PMID:26297203

A cluster-randomized controlled knowledge translation feasibility study in Alberta community pharmacies using the PARiHS framework: study protocol.

PubMed

Rosenthal, Meagen M; Tsuyuki, Ross T; Houle, Sherilyn Kd

2015-01-01

Despite evidence of benefit for pharmacist involvement in chronic disease management, the provision of these services in community pharmacy has been suboptimal. The Promoting Action on Research Implementation in Health Services (PARiHS) framework suggests that for knowledge translation to be effective, there must be evidence of benefit, a context conducive to implementation, and facilitation to support uptake. We hypothesize that while the evidence and context components of this framework are satisfied, that uptake into practice has been insufficient because of a lack of facilitation. This protocol describes the rationale and methods of a feasibility study to test a facilitated pharmacy practice intervention based on the PARiHS framework, to assist community pharmacists in increasing the number of formal and documented medication management services completed for patients with diabetes, dyslipidemia, and hypertension. A cluster-randomized before-after design will compare ten pharmacies from within a single organization, with the unit of randomization being the pharmacy. Pharmacies will be randomized to facilitated intervention based on the PARiHS framework or usual practice. The Alberta Context Tool will be used to establish the context of practice in each pharmacy. Pharmacies randomized to the intervention will receive task-focused facilitation from an external facilitator, with the goal of developing alternative team processes to allow the greater provision of medication management services for patients with diabetes, hypertension, and dyslipidemia. The primary outcome will be a process evaluation of the needs of community pharmacies to provide more clinical services, the acceptability and uptake of modifications made, and the willingness of pharmacies to participate. Secondary outcomes will include the change in the number of formal and documented medication management services in the aforementioned chronic conditions provided 6 months before, versus after, the intervention between the two groups, and identification of feasible quantitative outcomes for evaluating the effect of the intervention on patient care outcomes. To date, the study has identified and enrolled the ten pharmacies required and initiated the intervention process. This study will be the first to examine the role of facilitation in pharmacy practice, with the goal of scalable and sustainable practice change. Clinicaltrials.gov identifier NCT02191111.

Feasibility, Acceptability and Findings from a Pilot Randomized Controlled Intervention Study on the Impact of a Book Designed to Inform Patients about Cancer Clinical Trials

PubMed Central

Carney, Patricia A.; Tucker, Erin K.; Newby, Timothy A.; Beer, Tomasz M.

2014-01-01

Objective To assess the feasibility, acceptability and changes in knowledge among cancer patients assigned to receive a 160 page book on experimental cancer therapies and clinical trials. Methods We enrolled 20 patients with cancer who had never participated in a clinical trial, and randomly assigned them to receive the book either during Week 1or Week 4 of the study. We collected baseline patient demographic and cancer related information as well as knowledge about cancer clinical trials at Week 0. Follow-up surveys were administered at Weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book Early (at Week 1) to those who received it Later (at Week 4). Results One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by Week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at Week 3 and 95.5% in the Late Group at Week 6). Within group pair-wise comparisons found significant difference between baseline and Week 6 in content-specific knowledge scores among participants in the Late Group (79% vs. 92.1%, p=0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Conclusions Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials. PMID:24127249

Feasibility, acceptability and findings from a pilot randomized controlled intervention study on the impact of a book designed to inform patients about cancer clinical trials.

PubMed

Carney, Patricia A; Tucker, Erin K; Newby, Timothy A; Beer, Tomasz M

2014-03-01

This study was conducted to assess the feasibility, acceptability, and changes in knowledge among cancer patients assigned to receive a 160-page book on experimental cancer therapies and clinical trials. We enrolled 20 patients with cancer who had never participated in a clinical trial and randomly assigned them to receive the book either during week 1 or week 4 of the study. We collected baseline patient demographic and cancer-related information as well as knowledge about cancer clinical trials at week 0. Follow-up surveys were administered at weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book early (at week 1) to those who received it later (at week 4). One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at week 3 and 95.5% in the Late Group at week 6). Within group pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials.

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial.

PubMed

Lamontagne, Marie-Eve; Perreault, Kadija; Gagnon, Marie-Pierre

2014-04-10

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development. A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness. Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings. Clinical trial KT Canada 87776.

Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke.

PubMed

Dawson, Jesse; Pierce, David; Dixit, Anand; Kimberley, Teresa J; Robertson, Michele; Tarver, Brent; Hilmi, Omar; McLean, John; Forbes, Kirsten; Kilgard, Michael P; Rennaker, Robert L; Cramer, Steven C; Walters, Matthew; Engineer, Navzer

2016-01-01

Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl-Meyer Assessment-Upper Extremity). Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl-Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, -0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl-Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161. © 2015 The Authors.

Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke

PubMed Central

Pierce, David; Dixit, Anand; Kimberley, Teresa J.; Robertson, Michele; Tarver, Brent; Hilmi, Omar; McLean, John; Forbes, Kirsten; Kilgard, Michael P.; Rennaker, Robert L.; Cramer, Steven C.; Walters, Matthew; Engineer, Navzer

2016-01-01

Background and Purpose— Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Methods— Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl–Meyer Assessment-Upper Extremity). Results— Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl–Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, −0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl–Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). Conclusions— This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed. Clinical Trial Registration— URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161. PMID:26645257

Supervising for Home Safety Program: A Randomized Controlled Trial (RCT) Testing Community-Based Group Delivery.

PubMed

Morrongiello, Barbara A; Hou, Sharon; Bell, Melissa; Walton, Kathryn; Filion, A Jordan; Haines, Jess

2017-08-01

The individually delivered Supervising for Home Safety (SHS) program improves caregivers' injury-related beliefs and supervision practices. The current randomized controlled trial used a group delivery in a community setting and assessed program impact, feasibility, and acceptance. Caregivers of 2-5-year-olds were randomized to receive either the SHS or an attention-matched control program. In the SHS group only, there were increases from baseline to postintervention in the following: beliefs about children's vulnerability to injury, caregiver preventability of injuries, and self-efficacy to do so; readiness for change in supervision; and watchful supervision. Face-to-face recruitment by staff at community organizations proved most successful. Caregivers' satisfaction ratings were high, as was caregiver engagement (95% completed at least seven of the nine sessions). The SHS program can be delivered to groups of caregivers in community settings, is positively received by caregivers, and produces desirable changes that can be expected to improve caregivers' home safety practices. © The Author 2016. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Feasibility of a Patient-Controlled Cognitive Behavioral Intervention for Pain, Fatigue, and Sleep Disturbance in Cancer

PubMed Central

Kwekkeboom, Kristine L.; Abbott-Anderson, Kristen; Wanta, Britt

2009-01-01

Purpose To evaluate the feasibility of a patient-controlled cognitive-behavioral intervention for pain, fatigue, and sleep disturbance during treatment for advanced cancer, and to assess initial efficacy of the intervention in controlling symptoms. Design One-group pretest-posttest design. Setting Outpatient oncology clinics at a Comprehensive Cancer Center in the Midwestern United States. Sample 30 adults with advanced (recurrent or metastatic) colorectal, lung, prostate, or GYN cancer receiving chemotherapy or radiotherapy. Methods Participants completed baseline measures (demographics, symptom inventory) and received education and training to use an MP3 player loaded with 12 cognitive-behavioral strategies (e.g., relaxation exercises, guided imagery, nature sound recordings). Participants used the strategies as needed for symptom management over the following 2-weeks, keeping a log of symptom ratings with each use. Following the two-week intervention, participants completed a second symptom inventory and an evaluation of the intervention. Main Research Variables Feasibility, patient-controlled cognitive-behavioral intervention, pain, fatigue, sleep disturbance. Findings 73% of the 43 eligible patients agreed to participate (N=30) and of these, 90% (n=27) completed the study. The majority of participants reported that they enjoyed the intervention, had learned useful skills, and perceived improvement in their symptoms. Symptom scores at 2-weeks did not differ significantly from baseline, however significant reductions in pain, fatigue, and sleep disturbance severity were found in ratings made immediately before and after use of a cognitive-behavioral strategy. Conclusions The patient-controlled cognitive-behavioral intervention appears feasible for further study and could reduce day-to-day severity of co-occurring pain, fatigue, and sleep disturbance. Implications for Nursing A randomized controlled trial is necessary to test efficacy of the intervention for co-occurring pain, fatigue, and sleep disturbance. In the mean time, based on previous efficacy studies, cognitive-behavioral strategies can be recommended for certain individual symptoms. PMID:20439200

Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia.

PubMed

Deem, Steven; Yanez, David; Sissons-Ross, Laura; Broeckel, Jo Ann Elrod; Daniel, Stephen; Treggiari, Miriam

2016-01-01

Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >10(6) cfu per milliliter and the incidence of invasively diagnosed VAP. A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31-3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42-3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21-6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30-7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483).

Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia

PubMed Central

Yanez, David; Sissons-Ross, Laura; Elrod Broeckel, Jo Ann; Daniel, Stephen; Treggiari, Miriam

2016-01-01

Rationale: Ventilator-associated pneumonia (VAP) is a prevalent and costly nosocomial infection related to instrumentation of the airway with an endotracheal tube (ETT), enabling microaspiration of contaminated secretions. Modification of the ETT design to reduce microaspiration and/or biofilm formation may play an important role in VAP prevention. However, there is insufficient evidence to provide strong recommendations regarding the use of modified ETT and unaddressed safety concerns. Objectives: We performed a pilot randomized controlled trial comparing two modified ETTs designed specifically to prevent VAP, with the standard ETT, to test the feasibility of and inform planning for a large, pivotal, randomized trial. Methods: This study was conducted with institutional review board approval under exception from informed consent. We randomized in a blinded fashion patients undergoing emergency endotracheal intubation both out of and in hospital to receive one of three different ETT types: (1) a polyurethane-cuffed tube (PUC-ETT), (2) a polyurethane-cuffed tube equipped with a port for continuous aspiration of subglottic secretions (PUC-CASS-ETT), or a (3) standard polyvinylchloride-cuffed tube (PVC-ETT). In addition to investigating feasibility and safety, the study coprimary end points were tracheal bacterial colonization reaching a cfu count >106 cfu per milliliter and the incidence of invasively diagnosed VAP. Measurements and Main Results: A total of 102 subjects were randomized and met the eligibility criteria. Randomization procedures performed well and integrity of blinding at randomization was maintained. The majority of intubations occurred in the hospital setting (n = 77), and the remainder occurred out of hospital (n = 25). Compared with the PVC-ETT, there were no significant differences in tracheal colonization for PUC-ETT (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.31–3.09) or for PUC-CASS-ETT (OR, 1.26; 95% CI, 0.42–3.76). There were no differences in the risk of invasively diagnosed VAP (OR, 1.14; 95% CI, 0.21–6.08 for PUC-ETT; OR, 1.47; 95% CI, 0.30–7.10 for PUC-CASS-ETT), or of clinically diagnosed VAP by either clinical signs or chest radiograph criteria. We did not observe unexpected or serious adverse events related to the devices. Conclusions: A randomized trial of ETTs inserted during emergency intubation for the prevention of VAP is feasible and did not appear to carry heightened safety concerns. These preliminary data did not suggest different patterns of tracheal colonization or occurrence of VAP among the study groups. Clinical trial registered with www.clinicaltrials.gov (NCT01744483). PMID:26523433

Random Forest Application for NEXRAD Radar Data Quality Control

NASA Astrophysics Data System (ADS)

Keem, M.; Seo, B. C.; Krajewski, W. F.

2017-12-01

Identification and elimination of non-meteorological radar echoes (e.g., returns from ground, wind turbines, and biological targets) are the basic data quality control steps before radar data use in quantitative applications (e.g., precipitation estimation). Although WSR-88Ds' recent upgrade to dual-polarization has enhanced this quality control and echo classification, there are still challenges to detect some non-meteorological echoes that show precipitation-like characteristics (e.g., wind turbine or anomalous propagation clutter embedded in rain). With this in mind, a new quality control method using Random Forest is proposed in this study. This classification algorithm is known to produce reliable results with less uncertainty. The method introduces randomness into sampling and feature selections and integrates consequent multiple decision trees. The multidimensional structure of the trees can characterize the statistical interactions of involved multiple features in complex situations. The authors explore the performance of Random Forest method for NEXRAD radar data quality control. Training datasets are selected using several clear cases of precipitation and non-precipitation (but with some non-meteorological echoes). The model is structured using available candidate features (from the NEXRAD data) such as horizontal reflectivity, differential reflectivity, differential phase shift, copolar correlation coefficient, and their horizontal textures (e.g., local standard deviation). The influence of each feature on classification results are quantified by variable importance measures that are automatically estimated by the Random Forest algorithm. Therefore, the number and types of features in the final forest can be examined based on the classification accuracy. The authors demonstrate the capability of the proposed approach using several cases ranging from distinct to complex rain/no-rain events and compare the performance with the existing algorithms (e.g., MRMS). They also discuss operational feasibility based on the observed strength and weakness of the method.

Randomized Multicenter Feasibility Trial of Myofascial Physical Therapy for Treatment of Urologic Chronic Pelvic Pain Syndrome

PubMed Central

FitzGerald, Mary P; Anderson, Rodney U; Potts, Jeannette; Payne, Christopher K; Peters, Kenneth M; Clemens, J Quentin; Kotarinos, Rhonda; Fraser, Laura; Cosby, Annamarie; Fortman, Carole; Neville, Cynthia; Badillo, Suzanne; Odabachian, Lisa; Sanfield, Anna; O’Dougherty, Betsy; Halle-Podell, Rick; Cen, Liyi; Chuai, Shannon; Landis, J Richard; Kusek, John W; Nyberg, Leroy M

2010-01-01

Objectives To determine the feasibility of conducting a randomized clinical trial designed to compare two methods of manual therapy (myofascial physical therapy (MPT) and global therapeutic massage (GTM)) among patients with urologic chronic pelvic pain syndromes. Materials and Methods Our goal was to recruit 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at six clinical centers. Eligible patients were randomized to either MPT or GTM and were scheduled to receive up to 10 weekly treatments, each 1 hour in duration. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events which occurred during study treatment, and rate of response to therapy as assessed by the Patient Global Response Assessment (GRA). Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. Results Twenty-three (49%) men and 24 (51%) women were randomized over a six month period. Twenty-four (51%) patients were randomized to GTM, 23 (49%) to MPT; 44 (94%) patients completed the study. Therapist adherence to the treatment protocols was excellent. The GRA response rate of 57% in the MPT group was significantly higher than the rate of 21% in the GTM treatment group (p=0.03). Conclusions The goals to judge feasibility of conducting a full-scale trial of physical therapy methods were met. The preliminary findings of a beneficial effect of MPT warrants further study. PMID:19535099

Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial.

PubMed

Ullman, Amanda J; Kleidon, Tricia; Gibson, Victoria; McBride, Craig A; Mihala, Gabor; Cooke, Marie; Rickard, Claire M

2017-08-30

Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure. An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined. Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5). Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children. ACTRN12614000280606 ; prospectively registered on 17/03/2014.

Effectiveness of a smart phone app on improving immunization of children in rural Sichuan Province, China: study protocol for a paired cluster randomized controlled trial

PubMed Central

2014-01-01

Background Although good progress has been achieved in expanding immunization of children in China, disparities exist across different provinces. Information gaps both from the service supply and demand sides hinder timely vaccination of children in rural areas. The rapid development of mobile health technology (mHealth) provides unprecedented opportunities for improving health services and reaching underserved populations. However, there is a lack of literature that rigorously evaluates the impact of mHealth interventions on immunization coverage as well as the usability and feasibility of smart phone applications (apps). This study aims to assess the effectiveness of a smart phone-based app (Expanded Program on Immunization app, or EPI app) on improving the coverage of children’s immunization. Methods/Design This cluster randomized trial will take place in Xuanhan County, Sichuan Province, China. Functionalities of the app include the following: to make appointments automatically, record and update children’s immunization information, generate a list of children who missed their vaccination appointments, and send health education information to village doctors. After pairing, 36 villages will be randomly allocated to the intervention arm (n = 18) and control arm (n = 18). The village doctors in the intervention arm will use the app while the village doctors in the control arm will record and manage immunization in the usual way in their catchment areas. A household survey will be used at baseline and at endline (8 months of implementation). The primary outcome is full-dose coverage and the secondary outcome is immunization coverage of the five vaccines that are included in the national Expanded Program on Immunization program as well as Hib vaccine, Rotavirus vaccine and Pneumococcal conjugate vaccine. Multidimensional evaluation of the app will also be conducted to assess usability and feasibility. Discussion This study is the first to evaluate the effectiveness of a smart phone app for child immunization in rural China. This study will contribute to the knowledge about the usability and feasibility of a smart phone app for managing immunization in rural China and to similar populations in different settings. Trial registration Chinese Clinical Trials Registry (ChiCTR): ChiCTR-TRC-13003960 PMID:24645829

Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis.

PubMed

Nimri, Revital; Muller, Ido; Atlas, Eran; Miller, Shahar; Kordonouri, Olga; Bratina, Natasa; Tsioli, Christiana; Stefanija, Magdalena A; Danne, Thomas; Battelino, Tadej; Phillip, Moshe

2014-03-01

Artificial pancreas (AP) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions. To assess the feasibility, safety, and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient's home. Two-arm study, each covering four consecutive nights comparing the MD-Logic AP ('closed-loop' arm) with sensor-augmented pump therapy ('control' arm). Fifteen patients (mean age 19 ± 10.4 yr, A1c 7.5 ± 0.5% or 58 ± 5.9 mmol/mol, diabetes duration 9.9 ± 8.2 yr) were randomly assigned either to 'Group A' (first 'closed-loop', then 'control' arm) or to 'Group B' (vice versa). Investigators were masked to treatment intervention. Primary endpoints were the time spent with glucose levels below 70 mg/dL and the percentage of nights in which the mean overnight glucose levels were within 90-140 mg/dL. Endpoint analyses were based on unmodified sensor glucose readings of the four study nights. Time of glucose levels spent below 70 mg/dL was significantly shorter on the closed-loop nights than on control nights, median and interquartile range 3.8 (0, 11.6) and 48.7 (0.6, 67.9) min, respectively; p = 0.0034. The percentage of individual nights in which mean overnight glucose level was within 90-140 mg/dL was 67 (33, 88), and 50 (25, 75), under closed-loop and control nights, respectively, with no statistical difference. Secondary endpoint analyses demonstrated significant improvements in hypoglycemia parameters. No serious adverse events were reported. This interim analysis demonstrates the feasibility, safety, and efficiency of the MD-Logic AP system in home use, and demonstrates an improvement over sensor-augmented pump therapy. (ClinicalTrials.gov identifier NCT01726829). © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment.

PubMed

Naylor, Jennifer C; Kilts, Jason D; Bradford, Daniel W; Strauss, Jennifer L; Capehart, Bruce P; Szabo, Steven T; Smith, Karen D; Dunn, Charlotte E; Conner, Kathryn M; Davidson, Jonathan R T; Wagner, Henry Ryan; Hamer, Robert M; Marx, Christine E

2015-05-01

Many individuals with post-traumatic stress disorder (PTSD) experience persistent symptoms despite pharmacological treatment with antidepressants. Several open-label monotherapy and adjunctive studies have suggested that aripiprazole (a second-generation antipsychotic) may have clinical utility in PTSD. However, there have been no randomized placebo-controlled trials of aripiprazole use for PTSD. We thus conducted a pilot randomized controlled trial of adjunctive aripiprazole versus placebo among Veterans with chronic PTSD serving in the US military since 11 September 2001 to assess the feasibility, safety, tolerability, and therapeutic potential of aripiprazole. Sixteen Veterans were randomized, and 14 completed at least 4 weeks of the study; 12 completed the entire 8-week trial. Outcome measures included the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores. Aripiprazole was well-tolerated in this cohort, and improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores were as hypothesized. Although CAPS change scores did not reach statistical significance, aripiprazole outperformed placebo by 9 points on the CAPS in the last observation carried forward analysis compared with the placebo group (n = 7 per group), and by 20 points in the group randomized to aripiprazole that completed the entire study (n = 5) compared with the placebo group (n = 7). Results suggest promise for aripiprazole as an adjunctive strategy for the treatment of PTSD.

Implications of clinical trial design on sample size requirements.

PubMed

Leon, Andrew C

2008-07-01

The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two particularly relevant aspects of such a design often receive insufficient attention in an RCT. Multiple outcomes inflate type I error, and an unreliable assessment process introduces bias and reduces statistical power. Here we describe how both unreliability and multiple outcomes can increase the study costs and duration and reduce the feasibility of the study. The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity.

Promoting healthy transition to college through mindfulness training with first-year college students: Pilot randomized controlled trial.

PubMed

Dvořáková, Kamila; Kishida, Moé; Li, Jacinda; Elavsky, Steriani; Broderick, Patricia C; Agrusti, Mark R; Greenberg, Mark T

2017-01-01

Given the importance of developmental transitions on young adults' lives and the high rates of mental health issues among U.S. college students, first-year college students can be particularly vulnerable to stress and adversity. This pilot study evaluated the effectiveness and feasibility of mindfulness training aiming to promote first-year college students' health and wellbeing. 109 freshmen were recruited from residential halls (50% Caucasian, 66% female). Data collection was completed in November 2014. A randomized control trial was conducted utilizing the Learning to BREATHE (L2B) program, a universal mindfulness program adapted to match the developmental tasks of college transition. Participation in the pilot intervention was associated with significant increase in students' life satisfaction, and significant decrease in depression and anxiety. Marginally significant decrease was found for sleep issues and alcohol consequences. Mindfulness-based programs may be an effective strategy to enhance a healthy transition into college.

Emotional Freedom Techniques in the Treatment of Unhealthy Eating Behaviors and Related Psychological Constructs in Adolescents: A Randomized Controlled Pilot Trial.

PubMed

Stapleton, Peta; Chatwin, Hannah; William, Mary; Hutton, Amanda; Pain, Amanda; Porter, Brett; Sheldon, Terri

2016-01-01

In Australia and throughout much of the world, rates of obesity continue to climb as do the prevalence of eating disorders, particularly in adolescents. Psychological consequences of childhood obesity include low self-esteem, depression, body dissatisfaction, and social maladjustment (Young-Hyman et al., 2012). This feasibility study sought to examine the impact of a six-week Emotional Freedom Techniques (EFT) group treatment program upon eating behaviours, self-esteem, compassion, and psychological symptoms. Forty-four students were randomly allocated to either the EFT group or the waitlist control group. Results revealed a delayed effect for both groups at post-intervention, with improved eating habits, self-esteem, and compassion at follow-up. Findings provide preliminary support for EFT as an effective treatment strategy for increasing healthy eating behaviours and improving associated weight-related psychopathology. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs.

PubMed

Schelvis, Roosmarijn M C; Oude Hengel, Karen M; Burdorf, Alex; Blatter, Birgitte M; Strijk, Jorien E; van der Beek, Allard J

2015-09-01

Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of alternative designs for the evaluation of occupational health interventions, which permit causal inferences, formulated along two study design approaches: experimental (stepped-wedge) and observational (propensity scores, instrumental variables, multiple baseline design, interrupted time series, difference-in-difference, and regression discontinuity). For each design, the unique characteristics are presented including the advantages and disadvantages compared to the RCT, illustrated by empirical examples in occupational health. This overview shows that several appropriate alternatives for the RCT design are feasible and available, which may provide sufficiently strong evidence to guide decisions on implementation of interventions in workplaces. Researchers are encouraged to continue exploring these designs and thus contribute to evidence-based occupational health.

Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study.

PubMed

Bauer, Brent A; Cutshall, Susanne M; Wentworth, Laura J; Engen, Deborah; Messner, Penny K; Wood, Christina M; Brekke, Karen M; Kelly, Ryan F; Sundt, Thoralf M

2010-05-01

Integrative therapies such as massage have gained support as interventions that improve the overall patient experience during hospitalization. Cardiac surgery patients undergo long procedures and commonly have postoperative back and shoulder pain, anxiety, and tension. Given the promising effects of massage therapy for alleviation of pain, tension, and anxiety, we studied the efficacy and feasibility of massage therapy delivered in the postoperative cardiovascular surgery setting. Patients were randomized to receive a massage or to have quiet relaxation time (control). In total, 113 patients completed the study (massage, n=62; control, n=51). Patients receiving massage therapy had significantly decreased pain, anxiety, and tension. Patients were highly satisfied with the intervention, and no major barriers to implementing massage therapy were identified. Massage therapy may be an important component of the healing experience for patients after cardiovascular surgery. Copyright 2009 Elsevier Ltd. All rights reserved.

Advance care treatment plan (ACT-Plan) for African American family caregivers: a pilot study.

PubMed

Bonner, Gloria J; Wang, Edward; Wilkie, Diana J; Ferrans, Carol E; Dancy, Barbara; Watkins, Yashika

2014-01-01

Research is limited on end-of-life treatment decisions made by African American family caregivers. In a pilot study, we examined the feasibility of implementing an advance care treatment plan (ACT-Plan), a group-based education intervention, with African American dementia caregivers. Theoretically based, the ACT-Plan included strategies to enhance knowledge, self-efficacy, and behavioral skills to make end-of-life treatment plans in advance. Cardiopulmonary resuscitation, mechanical ventilation, and tube feeding were end-of-life treatments discussed in the ACT-Plan. In a four-week pre/posttest two-group design at urban adult day care centers, 68 caregivers were assigned to the ACT-Plan or attention-control health promotion conditions. Findings strongly suggest that the ACT-Plan intervention is feasible and appropriate for African American caregivers. Self-efficacy and knowledge about dementia, cardiopulmonary resuscitation, mechanical ventilation, and tube feeding increased for ACT-Plan participants but not for the attention-control. More ACT-Plan than attention-control participants developed advance care plans for demented relatives. Findings warrant a randomized efficacy trial.

Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

PubMed

Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

2018-03-26

Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

Distribution-dependent robust linear optimization with applications to inventory control

PubMed Central

Kang, Seong-Cheol; Brisimi, Theodora S.

2014-01-01

This paper tackles linear programming problems with data uncertainty and applies it to an important inventory control problem. Each element of the constraint matrix is subject to uncertainty and is modeled as a random variable with a bounded support. The classical robust optimization approach to this problem yields a solution with guaranteed feasibility. As this approach tends to be too conservative when applications can tolerate a small chance of infeasibility, one would be interested in obtaining a less conservative solution with a certain probabilistic guarantee of feasibility. A robust formulation in the literature produces such a solution, but it does not use any distributional information on the uncertain data. In this work, we show that the use of distributional information leads to an equally robust solution (i.e., under the same probabilistic guarantee of feasibility) but with a better objective value. In particular, by exploiting distributional information, we establish stronger upper bounds on the constraint violation probability of a solution. These bounds enable us to “inject” less conservatism into the formulation, which in turn yields a more cost-effective solution (by 50% or more in some numerical instances). To illustrate the effectiveness of our methodology, we consider a discrete-time stochastic inventory control problem with certain quality of service constraints. Numerical tests demonstrate that the use of distributional information in the robust optimization of the inventory control problem results in 36%–54% cost savings, compared to the case where such information is not used. PMID:26347579

Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Suboptimally Controlled Adolescents With Type 1 Diabetes: A 3-Week, Free-Living, Randomized Crossover Trial.

PubMed

Tauschmann, Martin; Allen, Janet M; Wilinska, Malgorzata E; Thabit, Hood; Acerini, Carlo L; Dunger, David B; Hovorka, Roman

2016-11-01

This study evaluated the feasibility, safety, and efficacy of day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes under free-living conditions. In an open-label randomized crossover study, 12 suboptimally controlled adolescents on insulin pump therapy (mean ± SD age 14.6 ± 3.1 years; HbA 1c 69 ± 8 mmol/mol [8.5 ± 0.7%]; duration of diabetes 7.8 ± 3.5 years) underwent two 21-day periods in which hybrid closed-loop insulin delivery was compared with sensor-augmented insulin pump therapy in random order. During the closed-loop intervention, a model predictive algorithm automatically directed insulin delivery between meals and overnight. Participants used a bolus calculator to administer prandial boluses. The proportion of time that sensor glucose was in the target range (3.9-10 mmol/L; primary end point) was increased during the closed-loop intervention compared with sensor-augmented insulin pump therapy by 18.8 ± 9.8 percentage points (mean ± SD; P < 0.001), the mean sensor glucose level was reduced by 1.8 ± 1.3 mmol/L (P = 0.001), and the time spent above target was reduced by 19.3 ± 11.3 percentage points (P < 0.001). The time spent with sensor glucose levels below 3.9 mmol/L was low and comparable between interventions (median difference 0.4 [interquartile range -2.2 to 1.3] percentage points; P = 0.33). Improved glucose control during closed-loop was associated with increased variability of basal insulin delivery (P < 0.001) and an increase in the total daily insulin dose (53.5 [39.5-72.1] vs. 51.5 [37.6-64.3] units/day; P = 0.006). Participants expressed positive attitudes and experience with the closed-loop system. Free-living home use of day-and-night closed-loop in suboptimally controlled adolescents with type 1 diabetes is safe, feasible, and improves glucose control without increasing the risk of hypoglycemia. Larger and longer studies are warranted. © 2016 by the American Diabetes Association.

Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial.

PubMed

Kirkevold, Marit; Kildal Bragstad, Line; Bronken, Berit A; Kvigne, Kari; Martinsen, Randi; Gabrielsen Hjelle, Ellen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir B; Sveen, Unni

2018-04-03

Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia. The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity. The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home. NCT02338869 ; registered 10/04/2014 (On-going trial).

Development of a home-based training program for post-ward geriatric rehabilitation patients with cognitive impairment: study protocol of a randomized-controlled trail.

PubMed

Bongartz, Martin; Kiss, Rainer; Ullrich, Phoebe; Eckert, Tobias; Bauer, Jürgen; Hauer, Klaus

2017-09-12

Geriatric patients with cognitive impairment (CI) show an increased risk for a negative rehabilitation outcome and reduced functional recovery following inpatient rehabilitation. Despite this obvious demand, evidence-based training programs at the transition from rehabilitation to the home environments are lacking. The aim of this study is to evaluate the efficacy of a feasible and cost-effective home-based training program to improve motor performance and to promote physical activity, specifically-tailored for post-ward geriatric patients with CI. A sample of 101 geriatric patients with mild to moderate stage CI following ward-based rehabilitation will be recruited for a blinded, randomized controlled trial with two arms. The intervention group will conduct a 12 week home-based training, consisting of (1) Exercises to improve strength/power, and postural control; (2) Individual walking trails to enhance physical activity; (3) Implementation of patient-specific motivational strategies to promote behavioral changes. The control group will conduct 12 weeks of unspecific flexibility exercise. Both groups will complete a baseline measurement before starting the program, at the end of the intervention, and after 24 weeks for follow-up. Sensor-based as well as questionnaire-based measures will be applied to comprehensively assess intervention effects. Primary outcomes document motor performance, assessed by the Short Physical Performance Battery, and level of physical activity (PA), as assessed by duration of active episodes (i.e., sum of standing and walking). Secondary outcomes include various medical, psycho-social, various PA and motor outcomes, including sensor-based assessment as well as cost effectiveness. Our study is among the first to provide home-based training in geriatric patients with CI at the transition from a rehabilitation unit to the home environment. The program offers several unique approaches, e.g., a comprehensive and innovative assessment strategy and the integration of individually-tailored motivational strategies. We expect the program to be safe and feasible in geriatric patients with CI with the potential to enhance the sustainability of geriatric rehabilitation programs in patients with CI. International Standard Randomized Controlled Trial (# ISRCTN82378327 ). Registered: August 10, 2015.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Andresen, Andrew A; Jones, Mark E; Lyons, Kevin J; Hondras, Maria A; Killinger, Lisa Z; Wolinsky, Fredric D; Wallace, Robert B

2013-01-16

Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes. This pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

Use of prism adaptation in children with unilateral brain lesion: Is it feasible?

PubMed

Riquelme, Inmaculada; Henne, Camille; Flament, Benoit; Legrain, Valéry; Bleyenheuft, Yannick; Hatem, Samar M

2015-01-01

Unilateral visuospatial deficits have been observed in children with brain damage. While the effectiveness of prism adaptation for treating unilateral neglect in adult stroke patients has been demonstrated previously, the usefulness of prism adaptation in a pediatric population is still unknown. The present study aims at evaluating the feasibility of prism adaptation in children with unilateral brain lesion and comparing the validity of a game procedure designed for child-friendly paediatric intervention, with the ecological task used for prism adaptation in adult patients. Twenty-one children with unilateral brain lesion randomly were assigned to a prism group wearing prismatic glasses, or a control group wearing neutral glasses during a bimanual task intervention. All children performed two different bimanual tasks on randomly assigned consecutive days: ecological tasks or game tasks. The efficacy of prism adaptation was measured by assessing its after-effects with visual open loop pointing (visuoproprioceptive test) and subjective straight-ahead pointing (proprioceptive test). Game tasks and ecological tasks produced similar after-effects. Prismatic glasses elicited a significant shift of visuospatial coordinates which was not observed in the control group. Prism adaptation performed with game tasks seems an effective procedure to obtain after-effects in children with unilateral brain lesion. The usefulness of repetitive prism adaptation sessions as a therapeutic intervention in children with visuospatial deficits and/or neglect, should be investigated in future studies. Copyright © 2015 Elsevier Ltd. All rights reserved.

Internet-Based Exposure and Behavioral Activation for Complicated Grief and Rumination: A Randomized Controlled Trial.

PubMed

Eisma, Maarten C; Boelen, Paul A; van den Bout, Jan; Stroebe, Wolfgang; Schut, Henk A W; Lancee, Jaap; Stroebe, Margaret S

2015-11-01

This study examined the effectiveness and feasibility of therapist-guided Internet-delivered exposure (EX) and behavioral activation (BA) for complicated grief and rumination. Forty-seven bereaved individuals with elevated levels of complicated grief and grief rumination were randomly assigned to three conditions: EX (N=18), BA (N=17), or a waiting-list (N=12). Treatment groups received 6 homework assignments over 6 to 8weeks. Intention-to-treat analyses showed that EX reduced complicated grief, posttraumatic stress, depression, grief rumination, and brooding levels relative to the control group at posttreatment (d=0.7-1.2). BA lowered complicated grief, posttraumatic stress, and grief rumination levels at posttreatment (d=0.8-0.9). At 3-month follow-up, effects of EX were maintained on complicated grief and grief rumination (d=0.6-1.2), and for BA on complicated grief, posttraumatic stress, and grief rumination (d=0.8-0.9). EX reduced depression more strongly than BA (d=0.6). Completers analyses corroborated results for EX, and partially those for BA, but no group differences were detected. BA suffered from high dropout (59%), relative to EX (33%) and the waiting-list (17%). Feasibility appeared higher for EX than BA. Results supported potential applicability of online exposure but not behavioral activation to decrease complicated grief and rumination. Copyright © 2015. Published by Elsevier Ltd.

Design and feasibility of a memory intervention with focus on self-management for cognitive impairment in epilepsy.

PubMed

Caller, Tracie A; Secore, Karen L; Ferguson, Robert J; Roth, Robert M; Alexandre, Faith P; Henegan, Patricia L; Harrington, Jessica J; Jobst, Barbara C

2015-03-01

The aim of this study was to assess the feasibility of a self-management intervention targeting cognitive dysfunction to improve quality of life and reduce memory-related disability in adults with epilepsy. The intervention incorporates (1) education on cognitive function in epilepsy, (2) self-awareness training, (3) compensatory strategies, and (4) application of these strategies in day-to-day life using problem-solving therapy. In addition to the behavioral modification, formal working memory training was conducted by utilizing a commercially available program in a subgroup of patients. Our findings suggest that a self-management intervention targeting cognitive dysfunction was feasible for delivery to a rural population with epilepsy, with 13 of 16 enrolled participants completing the 8-session program. Qualitative data indicate high satisfaction and subjective improvement in cognitive functioning in day-to-day life. These findings provide support for further evaluation of the efficacy of this intervention through a randomized controlled trial. Copyright © 2015 Elsevier Inc. All rights reserved.

Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS).

PubMed

Kennedy, Courtney C; Thabane, Lehana; Ioannidis, George; Adachi, Jonathan D; Papaioannou, Alexandra

2014-12-01

To evaluate the feasibility of implementing an interdisciplinary, multifaceted knowledge translation intervention within long-term care (LTC) and to identify any challenges that should be considered in designing future studies. Cluster randomized controlled trial. Forty LTC homes across the province of Ontario, Canada. LTC teams composed of physicians, nurses, pharmacists, and other staff. Cluster-level feasibility measures, including recruitment, retention, data completion, and participation in the intervention. A process evaluation was completed by directors of care indicating which process/policy changes had been implemented. Recruitment and retention rates were 22% and 63%, respectively. Good fidelity with the intervention was achieved, including attendance at educational meetings. After ViDOS, 7 process indicators were being newly implemented by more than 50% of active intervention homes. Despite recruitment and retention challenges, the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity. This study is registered at ClinicalTrials.gov NCT01398527. Copyright © 2014. Published by Elsevier Inc.

A Randomized controlled trial of the effect of yoga and peer support on glycaemic outcomes in women with type 2 diabetes mellitus: a feasibility study.

PubMed

Sreedevi, Aswathy; Gopalakrishnan, Unnikrishnan Ambika; Karimassery Ramaiyer, Sundaram; Kamalamma, Leelamoni

2017-02-07

Type two diabetes is a complex and demanding chronic disease and its impact in a state (Kerala) which leads India in terms of the number of people with Diabetes is profound. Though the male to female ratio among the people with diabetes is roughly equal, women are uniquely and more severely affected. Management of type two Diabetes requires considerable dexterity on the part of the patient to manage drugs, diet and exercise. Therefore, in a low middle-income country like India it is necessary to look at low cost interventions that can empower the patient and build on available resources to help manage diabetes. Hence, we studied the feasibility and effect of two low cost interventions; yoga and peer support on glycaemic and other outcomes among women with type two diabetes. An open label parallel three armed randomized control trial was conducted among 124 recruited women with Diabetes for three months. Block randomization with a block length of six was carried out with each group having at least 41 women. In the Yoga arm, sessions by an instructor, consisting of a group of postures coordinated with breathing were conducted for an hour, two days a week. In the peer support arm each peer mentor after training visited 13-14 women with diabetes every week followed by a phone call. The meeting was about applying disease management or prevention plans in daily life. There was a trend in decline of fasting plasma glucose in the peer and yoga group and of glycosylated haemoglobin (HbA1c) in the yoga group only, though not significant. A significant decrease was observed in diastolic blood pressure and hip circumference in the yoga group. The process indicated that most (80%) of the women in the yoga group attended classes regularly and 90% of the women in the peer group reported that peer mentoring was useful. The effect of yoga and peer support on glycaemic outcomes was incremental. Longer term studies are necessary to ascertain the benefits shown by this feasibility study. CTRI/2011/12/002227 dated 14/12/2011.

Training Endogenous Task Shifting Using Music Therapy: A Feasibility Study.

PubMed

Lynch, Colleen; LaGasse, A Blythe

2016-01-01

People with acquired brain injury (ABI) are highly susceptible to disturbances in executive functioning (EF), and these effects are pervasive. Research studies using music therapy for cognitive improvement in this population are limited. The purpose of this study was to determine the feasibility of a Musical Executive Function Training (MEFT) intervention to address task-shifting skills in adults with ABI and to obtain preliminary evidence of intervention effect on task shifting. Fourteen participants were randomly assigned to one of three groups: a music therapy intervention group (MTG), a singing group (SG), or the no-intervention control group (CG). The SG and MTG met for one hour a day for five days. Feasibility measures included participant completion rates and intervention fidelity. Potential benefits were measured using the Trail Making Test and the Paced Auditory Serial Addition Task as a pre- and posttest measure. Participant completion rates and interventionist fidelity to the protocol supported feasibility. One-way ANOVA of the pre- and posttest group differences revealed a trend toward improvement in the MTG over the SG. Feasibility and effect size data support a larger trial of the MEFT protocol. © the American Music Therapy Association 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Novel virtual reality system integrating online self-face viewing and mirror visual feedback for stroke rehabilitation: rationale and feasibility.

PubMed

Shiri, Shimon; Feintuch, Uri; Lorber-Haddad, Adi; Moreh, Elior; Twito, Dvora; Tuchner-Arieli, Maya; Meiner, Zeev

2012-01-01

To introduce the rationale of a novel virtual reality system based on self-face viewing and mirror visual feedback, and to examine its feasibility as a rehabilitation tool for poststroke patients. A novel motion capture virtual reality system integrating online self-face viewing and mirror visual feedback has been developed for stroke rehabilitation.The system allows the replacement of the impaired arm by a virtual arm. Upon making small movements of the paretic arm, patients view themselves virtually performing healthy full-range movements. A sample of 6 patients in the acute poststroke phase received the virtual reality treatment concomitantly with conservative rehabilitation treatment. Feasibility was assessed during 10 sessions for each participant. All participants succeeded in operating the system, demonstrating its feasibility in terms of adherence and improvement in task performance. Patients' performance within the virtual environment and a set of clinical-functional measures recorded before the virtual reality treatment, at 1 week, and after 3 months indicated neurological status and general functioning improvement. These preliminary results indicate that this newly developed virtual reality system is safe and feasible. Future randomized controlled studies are required to assess whether this system has beneficial effects in terms of enhancing upper limb function and quality of life in poststroke patients.