Sample records for feasibility pilot study

  1. 76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

  2. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    PubMed

    Eldridge, Sandra M; Lancaster, Gillian A; Campbell, Michael J; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L; Bond, Christine M

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  3. 77 FR 13343 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of... acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications... technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also...

  4. Feasibility and Pilot Studies in Palliative Care Research: A Systematic Review.

    PubMed

    Jones, Terry A; Olds, Timothy S; Currow, David C; Williams, Marie T

    2017-07-01

    Feasibility and pilot study designs are common in palliative care research. Finding standard guidelines on the structure and reporting of these study types is difficult. In feasibility and pilot studies in palliative care research, to determine 1) how commonly a priori feasibility are criteria reported and whether results are subsequently reported against these criteria? and 2) how commonly are participants' views on acceptability of burden of the study protocol assessed? Four databases (OVID Medline, EMBASE, CINAHL, and PubMed via caresearch.com.au.) were searched. Search terms included palliative care, terminal care, advance care planning, hospice, pilot, feasibility, with a publication date between January 1, 2012 and December 31, 2013. Articles were selected and appraised by two independent reviewers. Fifty-six feasibility and/or pilot studies were included in this review. Only three studies had clear a priori criteria to measure success. Sixteen studies reported participant acceptability or burden with measures. Forty-eight studies concluded feasibility. The terms "feasibility" and "pilot" are used synonymously in palliative care research when describing studies that test for feasibility. Few studies in palliative care research outline clear criteria for success. The assessment of participant acceptability and burden is uncommon. A gold standard for feasibility study design in palliative care research that includes both clear criteria for success and testing of the study protocol for participant acceptability and burden is needed. Such a standard would assist with consistency in the design, conduct and reporting of feasibility and pilot studies. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  5. 75 FR 80827 - Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-23

    ... Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2012. FOR FURTHER... Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs... FR 65750, November 23, 2007; 73 FR 78371, December 22, 2008). FDA has identified RFID as a promising...

  6. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

    PubMed Central

    Eldridge, Sandra M.; Lancaster, Gillian A.; Campbell, Michael J.; Thabane, Lehana; Hopewell, Sally; Coleman, Claire L.; Bond, Christine M.

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention. PMID:26978655

  7. 78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the... 13343), FDA terminated the acceptance of applications into the program and extended the pilot program for the nine accepted sponsors until May 8, 2013. The pilot program will be further extended for the...

  8. How to Train an Injured Brain? A Pilot Feasibility Study of Home-Based Computerized Cognitive Training.

    PubMed

    Verhelst, Helena; Vander Linden, Catharine; Vingerhoets, Guy; Caeyenberghs, Karen

    2017-02-01

    Computerized cognitive training programs have previously shown to be effective in improving cognitive abilities in patients suffering from traumatic brain injury (TBI). These studies often focused on a single cognitive function or required expensive hardware, making it difficult to be used in a home-based environment. This pilot feasibility study aimed to evaluate the feasibility of a newly developed, home-based, computerized cognitive training program for adolescents who suffered from TBI. Additionally, feasibility of study design, procedures, and measurements were examined. Case series, longitudinal, pilot, feasibility intervention study with one baseline and two follow-up assessments. Nine feasibility outcome measures and criteria for success were defined, including accessibility, training motivation/user experience, technical smoothness, training compliance, participation willingness, participation rates, loss to follow-up, assessment timescale, and assessment procedures. Five adolescent patients (four boys, mean age = 16 years 7 months, standard deviation = 9 months) with moderate to severe TBI in the chronic stage were recruited and received 8 weeks of cognitive training with BrainGames. Effect sizes (Cohen's d) were calculated to determine possible training-related effects. The new cognitive training intervention, BrainGames, and study design and procedures proved to be feasible; all nine feasibility outcome criteria were met during this pilot feasibility study. Estimates of effect sizes showed small to very large effects on cognitive measures and questionnaires, which were retained after 6 months. Our pilot study shows that a longitudinal intervention study comprising our novel, computerized cognitive training program and two follow-up assessments is feasible in adolescents suffering from TBI in the chronic stage. Future studies with larger sample sizes will evaluate training-related effects on cognitive functions and underlying brain structures.

  9. A tutorial on pilot studies: the what, why and how

    PubMed Central

    2010-01-01

    Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

  10. A pilot feasibility study of neurofeedback for children with autism.

    PubMed

    Steiner, Naomi J; Frenette, Elizabeth; Hynes, Caitlin; Pisarik, Elizabeth; Tomasetti, Kathryn; Perrin, Ellen C; Rene, Kirsten

    2014-06-01

    Neurofeedback (NFB) is an emerging treatment for children with autism spectrum disorder (ASD). This pilot study examined the feasibility of NFB for children with ASD. Ten children ages 7-12 with high functioning ASD and attention difficulties received a NFB attention training intervention. A standardized checklist captured feasibility, including focus during exercises and academic tasks, as well as off-task behaviors. Active behaviors and vocalizations were the most frequent off-task behaviors. Positive reinforcement and breaks including calm breathing exercises were the most common supports. Low motivation was associated with higher feasibility challenges, yet parental involvement and accommodations were helpful. This pilot study shows that it is feasible to conduct NFB sessions with children with high functioning autism and attention difficulties.

  11. Validity and Feasibility of a Digital Diet Estimation Method for Use with Preschool Children: A Pilot Study

    ERIC Educational Resources Information Center

    Nicklas, Theresa A.; O'Neil, Carol E.; Stuff, Janice; Goodell, Lora Suzanne; Liu, Yan; Martin, Corby K.

    2012-01-01

    Objective: The goal of the study was to assess the validity and feasibility of a digital diet estimation method for use with preschool children in "Head Start." Methods: Preschool children and their caregivers participated in validation (n = 22) and feasibility (n = 24) pilot studies. Validity was determined in the metabolic research unit using…

  12. 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. 
.

  13. Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation

    PubMed Central

    Kaur, Navaldeep; Figueiredo, Sabrina; Bouchard, Vanessa; Moriello, Carolina; Mayo, Nancy

    2017-01-01

    Introduction: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Methods: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word ‘pilot’ or ‘feasibility’ was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. Results: The specific purposes of piloting were stated in only 58% (n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Discussion: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources. PMID:28786333

  14. Development and Pilot-Testing of a Cognitive Behavioral Coping Skills Group Intervention for Patients with Chronic Hepatitis C.

    PubMed

    Evon, Donna M; Golin, Carol E; Ruffin, Rachel; Fried, Michael W

    2017-06-01

    Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design. Formative work included a literature review, qualitative interviews, and adaption, development, and review of study materials. A preliminary study protocol is described. We evaluate the feasibility of conducting a randomized controlled trial (RCT) of the CBCS-HCV with 12 study participants in Wave 1 testing to examine: (a) feasibility of intervention delivery; (b) patient acceptability; (c) recruitment, enrollment, retention; (d) feasibility of conducting a RCT; (d) therapist protocol fidelity; and (e) feasibility of data collection. Numerous lessons were learned. We found very high rates of data collection, participant attendance, engagement, retention and acceptability, and therapist protocol fidelity. We conclude that many aspects of the CBCS-HCV intervention and study protocol were highly feasible. The greatest challenge during this Wave 1 pilot study was efficiency of participant enrollment due to changes in standard of care treatment. These findings informed two additional waves of pilot testing to examine effect sizes and potential improvements in clinical outcomes, with results forthcoming.

  15. 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

  16. Quality of reporting of pilot and feasibility cluster randomised trials: a systematic review

    PubMed Central

    Chan, Claire L; Leyrat, Clémence; Eldridge, Sandra M

    2017-01-01

    Objectives To systematically review the quality of reporting of pilot and feasibility of cluster randomised trials (CRTs). In particular, to assess (1) the number of pilot CRTs conducted between 1 January 2011 and 31 December 2014, (2) whether objectives and methods are appropriate and (3) reporting quality. Methods We searched PubMed (2011–2014) for CRTs with ‘pilot’ or ‘feasibility’ in the title or abstract; that were assessing some element of feasibility and showing evidence the study was in preparation for a main effectiveness/efficacy trial. Quality assessment criteria were based on the Consolidated Standards of Reporting Trials (CONSORT) extensions for pilot trials and CRTs. Results Eighteen pilot CRTs were identified. Forty-four per cent did not have feasibility as their primary objective, and many (50%) performed formal hypothesis testing for effectiveness/efficacy despite being underpowered. Most (83%) included ‘pilot’ or ‘feasibility’ in the title, and discussed implications for progression from the pilot to the future definitive trial (89%), but fewer reported reasons for the randomised pilot trial (39%), sample size rationale (44%) or progression criteria (17%). Most defined the cluster (100%), and number of clusters randomised (94%), but few reported how the cluster design affected sample size (17%), whether consent was sought from clusters (11%), or who enrolled clusters (17%). Conclusions That only 18 pilot CRTs were identified necessitates increased awareness of the importance of conducting and publishing pilot CRTs and improved reporting. Pilot CRTs should primarily be assessing feasibility, avoiding formal hypothesis testing for effectiveness/efficacy and reporting reasons for the pilot, sample size rationale and progression criteria, as well as enrolment of clusters, and how the cluster design affects design aspects. We recommend adherence to the CONSORT extensions for pilot trials and CRTs. PMID:29122791

  17. Restoring effective sleep tranquility (REST): A feasibility and pilot study.

    PubMed

    Eakman, Aaron M; Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

    2017-06-01

    The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre-post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [ t  = 3.29, p  = .02]), reduced nightmares: t  = 2.79, p  = .03; fewer dysfunctional sleep beliefs: t  = 3.63, p  = .01, and greater ability to participate in social roles: t  = -2.86, p  = .03, along with trends towards improved satisfaction with participation and reduced pain interference. The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

  18. Restoring effective sleep tranquility (REST): A feasibility and pilot study

    PubMed Central

    Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

    2017-01-01

    Introduction The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. Method This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre–post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Findings Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [t = 3.29, p = .02]), reduced nightmares: t = 2.79, p = .03; fewer dysfunctional sleep beliefs: t = 3.63, p = .01, and greater ability to participate in social roles: t = –2.86, p = .03, along with trends towards improved satisfaction with participation and reduced pain interference. Conclusion The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver. PMID:28626295

  19. 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.

  20. Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

    ERIC Educational Resources Information Center

    Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

    2004-01-01

    Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

  1. Developing Metacognitive and Discursive Activities in the Indonesian Mathematics Education. Results of a Feasibility Study

    ERIC Educational Resources Information Center

    Kaune, Christa; Cohors-Fresenborg, Elmar; Nowinska, Edyta; Marpaung, Yansen; Handayani, Novi

    2012-01-01

    This article reports on the findings of a German-Indonesian feasibility study, which has been conducted to examine whether a more extensive pilot study could be successful. The objective of the pilot study is to enhance the mathematical skills of Indonesian students in the 7th class by increasing the number of students who can really understand…

  2. Opto-acoustic image fusion technology for diagnostic breast imaging in a feasibility study

    NASA Astrophysics Data System (ADS)

    Zalev, Jason; Clingman, Bryan; Herzog, Don; Miller, Tom; Ulissey, Michael; Stavros, A. T.; Oraevsky, Alexander; Lavin, Philip; Kist, Kenneth; Dornbluth, N. C.; Otto, Pamela

    2015-03-01

    Functional opto-acoustic (OA) imaging was fused with gray-scale ultrasound acquired using a specialized duplex handheld probe. Feasibility Study findings indicated the potential to more accurately characterize breast masses for cancer than conventional diagnostic ultrasound (CDU). The Feasibility Study included OA imagery of 74 breast masses that were collected using the investigational Imagio® breast imaging system. Superior specificity and equal sensitivity to CDU was demonstrated, suggesting that OA fusion imaging may potentially obviate the need for negative biopsies without missing cancers in a certain percentage of breast masses. Preliminary results from a 100 subject Pilot Study are also discussed. A larger Pivotal Study (n=2,097 subjects) is underway to confirm the Feasibility Study and Pilot Study findings.

  3. Evaluating the Feasibility, Effectiveness and Acceptability of an Active Play Intervention for Disadvantaged Preschool Children: A Pilot Study

    ERIC Educational Resources Information Center

    Stagnitti, Karen; Malakellis, Mary; Kershaw, Beth; Hoare, Majella; Kenna, Rachel; de Silva-Sanigorski, Andrea

    2011-01-01

    Australian children from disadvantaged families are at increased risk of delays in acquiring fundamental movement skills, with physical inactivity and increased risk of the potential consequences of obesity. The aims of this pilot study were to: 1) assess the fundamental movement skills of disadvantaged children; 2) evaluate the feasibility and…

  4. A Pilot Study Evaluating the Feasibility of Psychological First Aid for Nursing Home Residents.

    PubMed

    Brown, Lisa M; Bruce, Martha L; Hyer, Kathryn; Mills, Whitney L; Vongxaiburana, Elizabeth; Polivka-West, Lumarie

    2009-07-01

    OBJECTIVES: The objectives of the pilot study were to modify existing psychological first aid (PFA) materials so they would be appropriate for use with institutionalized elders, evaluate the feasibility of using nursing home staff to deliver the intervention to residents, and solicit feedback from residents about the intervention. The STORM Study, an acronym for "services for treating older residents' mental health", is the first step in the development of an evidence-based disaster mental health intervention for this vulnerable and underserved population. METHOD: Demographic characteristics were collected on participating residents and staff. Program evaluation forms were completed by staff participants during the pilot test and nurse training session. Staff and resident discussion groups were conducted during the pilot test to collect qualitative data on the use of PFA in nursing homes. RESULTS: Results demonstrate the feasibility of the PFA program to train staff to provide residents with PFA during disasters. CONCLUSIONS: Future research should focus on whether PFA improves coping and reduces stress in disaster exposed nursing home residents.

  5. Technical Analysis Feasibility Study on Smart Microgrid System in Sekolah Tinggi Teknik PLN

    NASA Astrophysics Data System (ADS)

    Suyanto, Heri

    2018-02-01

    Nowadays application of new and renewable energy as main resource of power plant has greatly increased. High penetration of renewable energy into the grid will influence the quality and reliability of the electricity system, due to the intermittent characteristic of new and renewable energy resources. Smart grid or microgrid technology has the ability to deal with this intermittent characteristic especially if these renewable energy resources integrated to grid in large scale, so it can improve the reliability and efficiency of the grid. We plan to implement smart microgrid system at Sekolah Tinggi Teknik PLN as a pilot project. Before the pilot project start, the feasibility study must be conducted. In this feasibility study, the renewable energy resources and load characteristic at the site will be measured. Then the technical aspect of this feasibility study will be analyzed. This paper explains that analysis of ths feasibility study.

  6. Lunar Analog

    NASA Technical Reports Server (NTRS)

    Cromwell, Ronita L.

    2009-01-01

    In this viewgraph presentation, a ground-based lunar analog is developed for the return of manned space flight to the Moon. The contents include: 1) Digital Astronaut; 2) Bed Design; 3) Lunar Analog Feasibility Study; 4) Preliminary Data; 5) Pre-pilot Study; 6) Selection of Stockings; 7) Lunar Analog Pilot Study; 8) Bed Design for Lunar Analog Pilot.

  7. OTEC riser cable system, Phase II: conceptual design

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1980-10-01

    Studies are summarized of conceptual designs of riser cable systems for OTEC pilot plants of both the spar and plantship configurations located at sites off the southeast coast of Puerto Rico. The studies utilize a baseline pilot plant riser cable, the design of which has been developed and reported on in other reports. Baseline riser cable systems for OTEC pilot plants are identified, system hardware consistent with these designs are conceptualized, and comparisons of the various system concepts are provided. It is concluded that there are three riser cable systems feasible for a spar pilot plant platform at the Puntamore » Yeguas site, and two riser cable systems feasible at the plantship pilot plant at the Punta Tuna site. Recommendations for further investigations in the areas of materials, hardware design and pre-installation site surveys are also addressed.« less

  8. Feasibility and acceptance of biofeedback-assisted mental training in an Austrian elementary school: a pilot study.

    PubMed

    Crevenna, Richard; Krammer, Christine; Keilani, Mohammad

    2016-04-01

    This pilot study aimed to investigate feasibility, acceptance, and effects of biofeedback-assisted mental training in a population of fifteen 10-year-old pupils in an Austrian elementary school. Participants were instructed in relaxation techniques by using biofeedback. Before intervention, after 6 weeks with active mental training and with regular instructions by the teacher, and after a further time period of 6 weeks without instructions, attention and concentration improved. The results indicate feasibility, good acceptance, and beneficial effects of biofeedback-assisted mental techniques in Austrian elementary school pupils.

  9. A Pilot and Feasibility Study of Virtual Reality as a Distraction for Children with Cancer

    ERIC Educational Resources Information Center

    Gershon, Jonathan; Zimand, Elana; Pickering, Melissa; Rothbaum, Barbara Olasov; Hodges, Larry

    2004-01-01

    Objective: To pilot and test the feasibility of a novel technology to reduce anxiety and pain associated with an invasive medical procedure in children with cancer. Method: Children with cancer (ages 7-19) whose treatment protocols required access of their subcutaneous venous port device (port access) were randomly assigned to a virtual reality…

  10. Pilot Evaluation of the Feasibility and Acceptability of StressOFF Strategies: A Single-Session School-Based Stress Management Program for Adolescents

    ERIC Educational Resources Information Center

    Shapiro, Amy J.; Heath, Nancy L.; Carsley, Dana

    2016-01-01

    The present study reports the pilot evaluation of the feasibility and acceptability of StressOFF Strategies, a "single-session" (45 min) adolescent-targeted, school-based psychoeducational program, which introduces cognitive behavioral techniques and mindfulness-based techniques. Five hundred and sixty-five Grade 9 students (57% female;…

  11. Faith-based intervention to increase fruit and vegetable intake among Koreans in the USA: a feasibility pilot.

    PubMed

    Hughes, Suzanne C; Obayashi, Saori

    2017-02-01

    In the USA, adults of Korean descent tend to eat fewer vegetables than adults in South Korea. The present pilot study examined the feasibility of developing and implementing a faith-based intervention to improve knowledge, attitudes and intake of fruit and vegetables (F&V) for Koreans in the USA. Feasibility pilot using a cluster-randomized intervention trial design. The multicomponent intervention included motivational interviewing sessions by telephone and church-based group activities. Eleven of the largest Korean churches in Southern California. Adults (n 71) from the eleven Korean churches. Feasibility was demonstrated for the study procedures, including recruitment of churches and individual participants. Allocating time throughout the study for church collaboration and having a study church coordinator to coordinate multiple churches were crucial. Participants' attendance at church activities (89 %) and participation by pastors and fellow churchgoers exceeded expectations. Participants' use of intervention materials was high (94 % or above) and satisfaction with coaching sessions was also high (75 % or above). Having a centralized coach trained in motivational interviewing, instead of one at each church, proved practical. Pilot results are promising for F&V knowledge, attitudes and behaviours. The intervention group improved knowledge and intake of the recommended amounts of F&V, above that of the control group. This pilot suggests that Koreans in the USA can be reached through their church and that a faith-based intervention study can be implemented to increase F&V intake. Preliminary results for the intervention appear promising but further research is needed to properly evaluate its efficacy.

  12. Intermittent Renewable Management Pilot Phase 2

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kiliccote, Sila; Homan, Gregory; Anderson, Robert

    The Intermittent Renewable Management Pilot - Phase 2 (IRM2) was designed to study the feasibility of demand-side resources to participate into the California Independent System Operator (CAISO) wholesale market as proxy demand resources (PDR). The pilot study focused on understanding the issues related with direct participation of third-parties and customers including customer acceptance; market transformation challenges (wholesale market, technology); technical and operational feasibility; and value to the rate payers, DR resource owners and the utility on providing an enabling mechanism for DR resources into the wholesale markets. The customer had the option of committing to either three contiguous hour blocksmore » for 24 days or six contiguous hours for 12 days a month with day-ahead notification that aligned with the CAISO integrated forward market. As a result of their being available, the customer was paid $10/ kilowatt (kW)-month for capacity in addition to CAISO energy settlements. The participants were limited to no more than a 2 megawatt (MW) capacity with a six-month commitment. Four participants successfully engaged in the pilot. In this report, we provide the description of the pilot, participant performance results, costs and value to participants as well as outline some of the issues encountered through the pilot. Results show that participants chose to participate with storage and the value of CAISO settlements were significantly lower than the capacity payments provided by the utility as incentive payments. In addition, this pilot revealed issues both on the participant side and system operations side. These issues are summarized in the report.The Intermittent Renewable Management Pilot - Phase 2 (IRM2) was designed to study the feasibility of demand-side resources to participate into the California Independent System Operator (CAISO) wholesale market as proxy demand resources (PDR). The pilot study focused on understanding the issues related with direct participation of third-parties and customers including customer acceptance; market transformation challenges (wholesale market, technology); technical and operational feasibility; and value to the rate payers, DR resource owners and the utility on providing an enabling mechanism for DR resources into the wholesale markets.« less

  13. Pilot Study: Foam Wedge Chin Support Static Tolerance Testing

    DTIC Science & Technology

    2017-10-24

    AFRL-SA-WP-SR-2017-0026 Pilot Study : Foam Wedge Chin Support Static Tolerance Testing Austin M. Fischer, BS1; William W...COVERED (From – To) April – October 2017 4. TITLE AND SUBTITLE Pilot Study : Foam Wedge Chin Support Static Tolerance Testing 5a. CONTRACT NUMBER...prototype to mitigate the increase in helmet weight and forward center of gravity. The purpose of this pilot study was to determine the feasibility and

  14. Matching Interventions to Children's Mental Health Needs: Feasibility and Acceptability of a Pilot School-Based Trauma Intervention Program

    ERIC Educational Resources Information Center

    Brown, Elissa J.; McQuaid, Jennifer; Farina, Lana; Ali, Rehana; Winnick-Gelles, Amy

    2006-01-01

    The primary goal was to develop and implement a school-based, trauma-specific intervention program for inner-city children exposed to the World Trade Center attacks on September 11th, 2001. The feasibility and acceptability of the program, and its research component, were examined. The efficacy of the program was evaluated in a pilot study.…

  15. 77 FR 74668 - Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-17

    ...; Formerly Docket No. 2004D-0499] Compliance Policy Guide; Radiofrequency Identification Feasibility Studies... extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency... 74669

  16. Functional aging in pilots : an examination of a mathematical model based on medical data on general aviation pilots.

    DOT National Transportation Integrated Search

    1982-06-01

    The purpose of this study was to apply mathematical procedures to the Federal Aviation Administration (FAA) pilot medical data to examine the feasibility of devising a linear numbering system such that (1) the cumulative probability distribution func...

  17. Early Childhood Development and Obesity Risk-Factors in a Multi-Ethnic, Low-Income Community: Feasibility of The "Five Hundred under Five" Social Determinants of Health Pilot Study

    ERIC Educational Resources Information Center

    Hearst, Mary O.; Martin, Lauren; Rafdal, Brooke H.; Robinson, Ronel; McConnell, Scott R.

    2013-01-01

    Objective: First, to describe a community-academic partnership that piloted a parent and home-based programme focused on the intersection of health and education from a social determinants foundation and determine the feasibility and acceptability of such work. Second, to examine trends and co-occurrence of social and environmental context,…

  18. Testing the Feasibility and Acceptability of a Chaplaincy Intervention to Improving Treatment Attitudes and Self-Efficacy of Adolescents With Cystic Fibrosis: A Pilot Study

    PubMed Central

    Cheng, Joy; Purcell, Hillary N.; Dimitriou, Sophia M.; Grossoehme, Daniel H.

    2015-01-01

    Religious factors are known to contribute to treatment adherence in different patient populations, and religious coping has been found to be particularly important to adolescents dealing with chronic diseases. Adherence to prescribed treatments slows disease progression and contributes to desirable outcomes in most patients, and, therefore, adherence-promoting interventions provided by chaplains could be beneficial to various patient populations. The current article describes a pilot study to test the feasibility of a theoretically and empirically based chaplain intervention to promote treatment adherence for adolescents with CF. Cognitive interviews were conducted 24 with adolescents with CF, and content analysis was used to identify themes, which informed revision of the intervention protocol. The authors thought that presenting the methods and results of this pilot study would be helpful for chaplains who want to conduct intervention research. The results indicated that the proposed intervention was acceptable and feasible to deliver in hard copy or an electronic platform. PMID:25793423

  19. RESULTS FROM EXPOSURE MONITORING PERFORMED DURING THE 1997 BALTIMORE PM PILOT STUDY

    EPA Science Inventory

    An eighteen day winter-time ambient and personal exposure monitoring study of particulate matter (PM) was conducted as part of an.integrated epidemiological-exposure pilot study of an aged population. Goals of the study were to determine the feasibility of performing active per...

  20. A palliative care hotline for multiple sclerosis: A pilot feasibility study.

    PubMed

    Knies, Andrea K; Golla, Heidrun; Strupp, Julia; Galushko, Maren; Schipper, Sabine; Voltz, Raymond

    2015-08-01

    Research findings suggest that patients severely affected by multiple sclerosis benefit from palliative care. Our objectives were to (1) implement a pilot palliative care counseling hotline for severely affected multiple sclerosis patients and their caregivers in order to connect them to palliative care, and (2) evaluate its preliminary feasibility through a pilot study. The hotline was designed in cooperation with the local state association of the German Multiple Sclerosis Society and based on a review of the literature. The initial study setting for the hotline was the broader region of the cities Cologne and Bonn in Germany. The hotline was introduced through a magazine published by the German Multiple Sclerosis Society and leaflets sent to local healthcare providers. Calls were conducted using a semistructured interview guide and documented by a standardized case report form. Measures to assess feasibility were both quantitative (e.g., number of calls) and qualitative (e.g., criteria for eligibility for palliative care). During its pilot year, the hotline received 18 calls. Some 15 callers were included in the analysis, and 10 of these 15 were deemed eligible for palliative care due to such criteria as medical characteristics, care or nursing conditions, caregiver strain, and concerns regarding death and dying. Access to palliative care services could be provided for all 10 callers. Based on our pilot feasibility study, the hotline seems to be a valuable service for patients severely affected by multiple sclerosis (MS) and their caregivers in order to gain information about and access to palliative care. It will be extended on a nationwide scale through a grant of the German Multiple Sclerosis Society. Awareness of the hotline needs to be enhanced in order to attract and support a significant number of new callers.

  1. The feasibility and acceptability of trial procedures for a pragmatic randomised controlled trial of a structured physical activity intervention for people diagnosed with colorectal cancer: findings from a pilot trial of cardiac rehabilitation versus usual care (no rehabilitation) with an embedded qualitative study.

    PubMed

    Hubbard, Gill; O'Carroll, Ronan; Munro, Julie; Mutrie, Nanette; Haw, Sally; Mason, Helen; Treweek, Shaun

    2016-01-01

    Pilot and feasibility work is conducted to evaluate the operational feasibility and acceptability of the intervention itself and the feasibility and acceptability of a trials' protocol design. The Cardiac Rehabilitation In Bowel cancer (CRIB) study was a pilot randomised controlled trial (RCT) of cardiac rehabilitation versus usual care (no rehabilitation) for post-surgical colorectal cancer patients. A key aim of the pilot trial was to test the feasibility and acceptability of the protocol design. A pilot RCT with embedded qualitative work was conducted in three sites. Participants were randomly allocated to cardiac rehabilitation or usual care groups. Outcomes used to assess the feasibility and acceptability of key trial parameters were screening, eligibility, consent, randomisation, adverse events, retention, completion, missing data, and intervention adherence rates. Colorectal patients' and clinicians' perceptions and experiences of the main trial procedures were explored by interview. Quantitative study. Three sites were involved. Screening, eligibility, consent, and retention rates were 79 % (156/198), 67 % (133/198), 31 % (41/133), and 93 % (38/41), respectively. Questionnaire completion rates were 97.5 % (40/41), 75 % (31/41), and 61 % (25/41) at baseline, follow-up 1, and follow-up 2, respectively. Sixty-nine percent (40) of accelerometer datasets were collected from participants; 31 % (20) were removed for not meeting wear-time validation. Qualitative study: Thirty-eight patients and eight clinicians participated. Key themes were benefits for people with colorectal cancer attending cardiac rehabilitation, barriers for people with colorectal cancer attending cardiac rehabilitation, generic versus disease-specific rehabilitation, key concerns about including people with cancer in cardiac rehabilitation, and barriers to involvement in a study about cardiac rehabilitation. The study highlights where threats to internal and external validity are likely to arise in any future studies of similar structured physical activity interventions for colorectal cancer patients using similar methods being conducted in similar contexts. This study shows that there is likely to be potential recruitment bias and potential imprecision due to sub-optimal completion of outcome measures, missing data, and sub-optimal intervention adherence. Hence, strategies to manage these risks should be developed to stack the odds in favour of conducting successful future trials. ISRCTN63510637.

  2. Feasibility and Preliminary Outcomes From a Pilot Study of an Integrated Health-Mental Health Promotion Program in School Mental Health Services

    PubMed Central

    George, Melissa W.; Trumpeter, Nevelyn N.; Wilson, Dawn K.; McDaniel, Heather L.; Schiele, Bryn; Prinz, Ron; Weist, Mark D.

    2014-01-01

    The prevalence of unmet health and mental health needs among youth has spurred the growing consensus to develop strategies that integrate services to promote overall well-being. This pilot study reports on the feasibility and outcomes of a theory-driven, family-focused, integrated health-mental health promotion program for underserved adolescents receiving school mental health services. Parent and adolescent assessments conducted prior to and following the brief, 6-session promotion program showed significant improvements in family support, youth self-efficacy, health behaviors, and mental health outcomes. Clinician reports contributed to a characterization of the feasibility, acceptability, and future recommendations for the integrated program. PMID:24297005

  3. Enhanced Flight Vision Systems Operational Feasibility Study Using Radar and Infrared Sensors

    NASA Technical Reports Server (NTRS)

    Etherington, Timothy J.; Kramer, Lynda J.; Severance, Kurt; Bailey, Randall E.; Williams, Steven P.; Harrison, Stephanie J.

    2015-01-01

    Approach and landing operations during periods of reduced visibility have plagued aircraft pilots since the beginning of aviation. Although techniques are currently available to mitigate some of the visibility conditions, these operations are still ultimately limited by the pilot's ability to "see" required visual landing references (e.g., markings and/or lights of threshold and touchdown zone) and require significant and costly ground infrastructure. Certified Enhanced Flight Vision Systems (EFVS) have shown promise to lift the obscuration veil. They allow the pilot to operate with enhanced vision, in lieu of natural vision, in the visual segment to enable equivalent visual operations (EVO). An aviation standards document was developed with industry and government consensus for using an EFVS for approach, landing, and rollout to a safe taxi speed in visibilities as low as 300 feet runway visual range (RVR). These new standards establish performance, integrity, availability, and safety requirements to operate in this regime without reliance on a pilot's or flight crew's natural vision by use of a fail-operational EFVS. A pilot-in-the-loop high-fidelity motion simulation study was conducted at NASA Langley Research Center to evaluate the operational feasibility, pilot workload, and pilot acceptability of conducting straight-in instrument approaches with published vertical guidance to landing, touchdown, and rollout to a safe taxi speed in visibility as low as 300 feet RVR by use of vision system technologies on a head-up display (HUD) without need or reliance on natural vision. Twelve crews flew various landing and departure scenarios in 1800, 1000, 700, and 300 RVR. This paper details the non-normal results of the study including objective and subjective measures of performance and acceptability. The study validated the operational feasibility of approach and departure operations and success was independent of visibility conditions. Failures were handled within the lateral confines of the runway for all conditions tested. The fail-operational concept with pilot in the loop needs further study.

  4. [Implementation of quality of care indicators for third-level public hospitals in Mexico].

    PubMed

    Saturno-Hernández, Pedro Jesús; Martínez-Nicolás, Ismael; Poblano-Verástegui, Ofelia; Vértiz-Ramírez, José de Jesús; Suárez-Ortiz, Erasto Cosme; Magaña-Izquierdo, Manuel; Kawa-Karasik, Simón

    2017-01-01

    To select, pilot test and implement a set of indicators for tertiary public hospitals. Quali-quantitative study in four stages: identification of indicators used internationally; selection and prioritization by utility, feasibility and reliability; exploration of the quality of sources of information in six hospitals; pilot feasibility and reliability, and follow-up measurement. From 143 indicators, 64 were selected and eight were prioritized. The scan revealed sources of information deficient. In the pilot, three indicators were feasible with reliability limited. Has conducted workshops to improve records and sources of information; nine hospitals reported measurements of a quarter. Eight priority indicators could not be measured immediately due to limitations in the data sources for its construction. It is necessary to improve mechanisms of registration and processing of data in this group of hospital.

  5. Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England.

    PubMed

    Ponsford, Ruth; Allen, Elizabeth; Campbell, Rona; Elbourne, Diana; Hadley, Alison; Lohan, Maria; Melendez-Torres, G J; Mercer, Catherine H; Morris, Steve; Young, Honor; Bonell, Chris

    2018-01-01

    Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative data on births and termination to self-report survey data to measure our primary outcome (unintended teenage pregnancy) will also be tested. This will be the first UK-based pilot trial of a school-wide social marketing intervention to reduce unintended teenage pregnancy and improve sexual health. If this study indicates feasibility and acceptability of the optimised Positive Choices intervention in English secondary schools, plans will be initiated for a phase III trial and economic evaluation of the intervention. ISRCTN registry (ISCTN12524938. Registered 03/07/2017).

  6. Feasibility of using a personal digital assistant to self-monitor diet and fluid intake: a pilot study.

    PubMed

    Welch, Janet; Dowell, Shannon; Johnson, Cynthia S

    2007-01-01

    The feasibility of using an electronic device to self-monitor diet and fluid intake was assessed using the treatment implementation model. The three patients on hemodialysis who participated in this pilot study were asked to self-monitor diet and fluid intake for 12 weeks with a personal digital assistant. The intervention was delivered as intended; however, participants reported problems with usability, and compliance to self-monitoring was lower than desirable. Further adjustments to the intervention will be made before testing efficacy.

  7. SUPERFUND TREATABILITY CLEARINGHOUSE: FINAL REPORT: SOIL TREATMENT PILOT STUDY BRIO/DOP SITE

    EPA Science Inventory

    Bench and pilot-scale studies were conducted to demonstrate the feasibility of using solid-phase biodegradation for destroying portions of organic constituents present in the soil. The predominant constituents at the BRIO DOP site located in Texas were volatile compounds such...

  8. Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

    PubMed

    Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

    2018-03-01

    Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Feasibility of a patient-centred nutrition intervention to improve oral intakes of patients at risk of pressure ulcer: a pilot randomised control trial.

    PubMed

    Roberts, Shelley; Desbrow, Ben; Chaboyer, Wendy

    2016-06-01

    Nutrition is important for pressure ulcer prevention. This randomised control pilot study assessed the feasibility of conducting a larger trial to test the effectiveness of a patient-centred intervention for improving the dietary intakes of patients at risk of pressure ulcer in hospital. A 3-day intervention targeting patients at risk of pressure ulcer was developed, based on three main foundations: patient education, patient participation and guided goal setting. The intervention was piloted in three wards in a metropolitan hospital in Queensland, Australia. Participants were randomised into control or intervention groups and had their oral intakes monitored. A subset of intervention patients was interviewed on their perceptions of the intervention. Feasibility was tested against three criteria: ≥75% recruitment; ≥80% retention; and ≥80% intervention fidelity. Secondary outcomes related to effects on energy and protein intakes. Eighty patients participated in the study and 66 were included in final analysis. The recruitment rate was 82%, retention rate was 88%, and 100% of intervention patients received the intervention. Patients viewed the intervention as motivating and met significantly more of their estimated energy and protein requirements over time. This pilot study indicates that the intervention is feasible and acceptable by patients at risk of pressure ulcer. A larger trial is needed to confirm the effectiveness of the intervention in the clinical setting. © 2015 Nordic College of Caring Science.

  10. Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study.

    PubMed

    Halkett, Georgia K B; Lobb, Elizabeth A; Miller, Lisa; Shaw, Thérèse; Moorin, Rachael; Long, Anne; King, Anne; Clarke, Jenny; Fewster, Stephanie; Nowak, Anna K

    2017-02-11

    The aim of this pilot study was to test the feasibility and acceptability of a family carer intervention for carers of patients with high-grade glioma (HGG). The intervention consisted of: (1) an initial telephone assessment of carer needs; (2) a personalised tabbed resource file; (3) nurse-led home visit; and (4) ongoing telephone support. Two consumer representatives reviewed the intervention resources. The intervention was then piloted with participants who were the primary carer for patients undergoing treatment for HGG in Western Australia. Two consumers provided feedback on the resource, and 10 carers participated in the pilot. Positive feedback was received about the resource manual and intervention. Suggestions were also made for changes which were implemented into the trial. The surveys were shortened based on feedback. Participants identified a large range of issues during nursing assessments which would not otherwise be identified or addressed for carers receiving routine care. As a result of providing the intervention, the nurse was able to make referrals to address needs that were identified. This pilot study enabled us to refine and test the Care-IS intervention and test the feasibility and acceptability of proposed survey instruments. We were also able to estimate recruitment and retention and the overall study timeline required for the randomised controlled trial we are now conducting. It has also demonstrated the role of the nurse who delivered the intervention and allowed us to refine communication and referral pathways.

  11. Automated Pilot Performance Assessment in the T-37: A Feasibility Study. Final Report (May 1968-April 1971).

    ERIC Educational Resources Information Center

    Knoop, Patricia A.; Welde, William L.

    Air Force investigators conducted a three year program to develop a capability for automated quantification and assessment of in-flight pilot performance. Such a capability enhances pilot training by making ratings more objective, valid, reliable and sensitive, and by freeing instructors from rating responsibilities, allowing them to concentrate…

  12. Simulation of prenatal maternal sounds in NICU incubators: a pilot safety and feasibility study.

    PubMed

    Panagiotidis, John; Lahav, Amir

    2010-10-01

    This pilot study evaluated the safety and feasibility of an innovative audio system for transmitting maternal sounds to NICU incubators. A sample of biological sounds, consisting of voice and heartbeat, were recorded from a mother of a premature infant admitted to our unit. The maternal sounds were then played back inside an unoccupied incubator via a specialized audio system originated and compiled in our lab. We performed a series of evaluations to determine the safety and feasibility of using this system in NICU incubators. The proposed audio system was found to be safe and feasible, meeting criteria for humidity and temperature resistance, as well as for safe noise levels. Simulation of maternal sounds using this system seems achievable and applicable and received local support from medical staff. Further research and technology developments are needed to optimize the design of the NICU incubators to preserve the acoustic environment of the womb.

  13. An Internet-Based Telerehabilitation System for the Assessment of Motor Speech Disorders: A Pilot Study

    ERIC Educational Resources Information Center

    Hill, Anne J.; Theodoros, Deborah G.; Russell, Trevor G.; Cahill, Louise M.; Ward, Elizabeth C.; Clark, Kathy M.

    2006-01-01

    Purpose: This pilot study explored the feasibility and effectiveness of an Internet-based telerehabilitation application for the assessment of motor speech disorders in adults with acquired neurological impairment. Method: Using a counterbalanced, repeated measures research design, 2 speech-language pathologists assessed 19 speakers with…

  14. Measuring the Immeasurable: A Pilot Study of Museum Effectiveness.

    ERIC Educational Resources Information Center

    Borun, Minda

    The report describes a one-year pilot study of museum effectiveness conducted at the Franklin Institute Science Museum and Planetarium in Philadelphia. The study was intended to develop models for testing visitor response, provide useable information to museum staff, and test the feasibility of a large-scale investigation of science museums.…

  15. Using the Habit App for Weight Loss Problem Solving: Development and Feasibility Study.

    PubMed

    Pagoto, Sherry; Tulu, Bengisu; Agu, Emmanuel; Waring, Molly E; Oleski, Jessica L; Jake-Schoffman, Danielle E

    2018-06-20

    Reviews of weight loss mobile apps have revealed they include very few evidence-based features, relying mostly on self-monitoring. Unfortunately, adherence to self-monitoring is often low, especially among patients with motivational challenges. One behavioral strategy that is leveraged in virtually every visit of behavioral weight loss interventions and is specifically used to deal with adherence and motivational issues is problem solving. Problem solving has been successfully implemented in depression mobile apps, but not yet in weight loss apps. This study describes the development and feasibility testing of the Habit app, which was designed to automate problem-solving therapy for weight loss. Two iterative single-arm pilot studies were conducted to evaluate the feasibility and acceptability of the Habit app. In each pilot study, adults who were overweight or obese were enrolled in an 8-week intervention that included the Habit app plus support via a private Facebook group. Feasibility outcomes included retention, app usage, usability, and acceptability. Changes in problem-solving skills and weight over 8 weeks are described, as well as app usage and weight change at 16 weeks. Results from both pilots show acceptable use of the Habit app over 8 weeks with on average two to three uses per week, the recommended rate of use. Acceptability ratings were mixed such that 54% (13/24) and 73% (11/15) of participants found the diet solutions helpful and 71% (17/24) and 80% (12/15) found setting reminders for habits helpful in pilots 1 and 2, respectively. In both pilots, participants lost significant weight (P=.005 and P=.03, respectively). In neither pilot was an effect on problem-solving skills observed (P=.62 and P=.27, respectively). Problem-solving therapy for weight loss is feasible to implement in a mobile app environment; however, automated delivery may not impact problem-solving skills as has been observed previously via human delivery. ClinicalTrials.gov NCT02192905; https://clinicaltrials.gov/ct2/show/NCT02192905 (Archived by WebCite at http://www.webcitation.org/6zPQmvOF2). ©Sherry Pagoto, Bengisu Tulu, Emmanuel Agu, Molly E Waring, Jessica L Oleski, Danielle E Jake-Schoffman. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.06.2018.

  16. Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

    PubMed

    Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc

    2017-02-01

    Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

  17. Assessing the impact of care farms on quality of life and offending: a pilot study among probation service users in England

    PubMed Central

    Elsey, Helen; Farragher, Tracey; Tubeuf, Sandy; Bragg, Rachel; Elings, Marjolein; Brennan, Cathy; Gold, Rochelle; Shickle, Darren; Wickramasekera, Nyantara; Richardson, Zoe; Cade, Janet; Murray, Jenni

    2018-01-01

    Objectives To assess the feasibility of conducting a cost-effectiveness study of using care farms (CFs) to improve quality of life and reduce reoffending among offenders undertaking community orders (COs). To pilot questionnaires to assess quality of life, connection to nature, lifestyle behaviours, health and social-care use. To assess recruitment and retention at 6 months and feasibility of data linkage to Police National Computer (PNC) reconvictions data and data held by probation services. Design Pilot study using questionnaires to assess quality of life, individually linked to police and probation data. Setting The pilot study was conducted in three probation service regions in England. Each site included a CF and at least one comparator CO project. CFs are working farms used with a range of clients, including offenders, for therapeutic purposes. The three CFs included one aquaponics and horticulture social enterprise, a religious charity focusing on horticulture and a family-run cattle farm. Comparator projects included sorting secondhand clothes and activities to address alcohol misuse and anger management. Participants We recruited 134 adults (over 18) serving COs in England, 29% female. Results 52% of participants completed follow-up questionnaires. Privatisation of UK probation trusts in 2014 negatively impacted on recruitment and retention. Linkage to PNC data was a more successful means of follow-up, with 90% consenting to access their probation and PNC data. Collection of health and social-care costs and quality-adjusted life year derivation were feasible. Propensity score adjustment provided a viable comparison method despite differences between comparators. We found worse health and higher reoffending risk among CF participants due to allocation of challenging offenders to CFs, making risk of reoffending a confounder. Conclusions Recruitment would be feasible in a more stable probation environment. Follow-up was challenging; however, assessing reconvictions from PNC data is feasible and a potential primary outcome for future studies. PMID:29550778

  18. Maintenance Model of Integrated Psychosocial Treatment in Pediatric Bipolar Disorder: A Pilot Feasibility Study

    ERIC Educational Resources Information Center

    West, Amy E.; Henry, David B.; Pavuluri, Mani N.

    2007-01-01

    Objective: The chronic and refractory course of pediatric bipolar disorder merits the study of adjunctive psychosocial interventions designed to facilitate long-term improvements. The objective of this study is to conduct a pilot study of a maintenance model of the child- and family-focused cognitive-behavioral therapy program (CFF-CBT), which…

  19. Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of Two Pilot Studies

    ERIC Educational Resources Information Center

    Jennings, Patricia A.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

    2011-01-01

    Cultivating Awareness and Resilience in Education (CARE) is a professional development program designed to reduce stress and improve teachers' performance. Two pilot studies examined program feasibility and attractiveness and preliminary evidence of efficacy. Study 1 involved educators from a high-poverty urban setting (n = 31). Study 2 involved…

  20. Substance Use Recovery Outcomes among a Cohort of Youth Participating in a Mobile-Based Texting Aftercare Pilot Program

    PubMed Central

    Gonzales, Rachel; Ang, Alfonso; Murphy, Debra A.; Glik, Deborah C.; Anglin, M. Douglas

    2014-01-01

    Project ESQYIR (Educating & Supporting inquisitive Youth in Recovery) is a pilot study examining the feasibility of a 12-week mobile-based aftercare intervention for youth (ages 12 to 24) transitioning out of community-based substance abuse treatment programs. From January 2012 through July 2013, a total of 80 youth were recruited from outpatient and residential treatment programs, geographically dispersed throughout Los Angeles County, California. Results revealed that youth who participated in the texting mobile pilot intervention were significantly less likely to relapse to their primary compared to the aftercare as usual control condition (OR = 0.52, p = 0.002) over time (from baseline throughout the 12-week aftercare pilot program to a 90-day follow-up). Participants in the texting aftercare pilot program also reported significantly less substance use problem severity (β = −0.46, p = .03) and were more likely to participate in extracurricular recovery behaviors (β = 1.63, p = .03) compared to participants in the standard aftercare group. Collectively, findings from this pilot aftercare study suggest that mobile texting could provide a feasible way to engage youth in recovery after substance abuse treatment to aid with reducing relapse and promoting lifestyle behavior change. PMID:24629885

  1. Effects of a short duration, high dose contact improvisation dance workshop on Parkinson disease: a pilot study.

    PubMed

    Marchant, David; Sylvester, Jennifer L; Earhart, Gammon M

    2010-10-01

    This study explored the feasibility and possible benefits of contact improvisation (CI) as an exercise intervention for individuals with PD. This was an uncontrolled pilot study. Eleven people with PD (H&Y=2.4 ± 0.4) participated in a workshop of 10 1.5-h CI classes over 2 weeks, dancing with previously trained student CI dancers. Measures of disease severity, balance, functional mobility, and gait were compared 1 week before and after the workshop. Participants demonstrated improvements on the Unified Parkinson Disease Rating Scale-Motor Subsection and Berg balance scores, along with increased swing and decreased stance percentages during walking. Backward step length also increased. Participants expressed a high level of enjoyment and interest in taking future CI classes. This pilot study supports the feasibility of CI as an intervention to address mobility limitations associated with PD. Copyright © 2010 Elsevier Ltd. All rights reserved.

  2. Development and evaluation of a dietary self-management programme for older adults with low literacy and heart disease: pilot study of feasibility and acceptability.

    PubMed

    Shao, Jung-Hua; Chen, Su-Hui

    2016-12-01

    To develop a dietary self-management programme for salt-, fluid-, fat- and cholesterol-intake behaviours for older adults with low literacy and heart disease and evaluate the feasibility and acceptability of the programme. Eating behaviours such as fluid, salt, fat and cholesterol intake are an important factor related to heart disease outcomes. People with low literacy have difficulty following recommended health behaviours, but limited research has investigated intervention programmes for this population. Programme development and pilot testing its feasibility and acceptability. Recommendations were also collected from participants and the research assistant for future large-scale interventions. The study had two phases. Phase I consisted of programme development based on previous qualitative findings, a systematic review of the literature, clinical practice experience and expert opinion. In Phase II, we pilot tested the programme from January - June 2014 in a convenience sample of 10 older adults with low literacy, heart disease and recruited from a medical centre in northern Taiwan. Pilot testing showed that our programme was feasible and acceptable to older adults with low literacy and heart disease. Moreover, the final version of the programme was revised based on participants' and the research assistant's recommendations. Our study results suggest that with guidance and assistance, older adults with low literacy and heart disease can be motivated to take action for their health and are empowered by learning how to self-manage their heart-healthy eating behaviours. © 2016 John Wiley & Sons Ltd.

  3. A Pilot SMART for Developing an Adaptive Treatment Strategy for Adolescent Depression

    PubMed Central

    Gunlicks-Stoessel, Meredith; Mufson, Laura; Westervelt, Ana; Almirall, Daniel; Murphy, Susan

    2015-01-01

    Objective(s) This pilot study was conducted to assess the feasibility and acceptability of four adaptive treatment strategies (ATSs) for adolescent depression to plan for a subsequent full-scale clinical trial. The ATSs aim to address two questions that arise when personalizing treatment: (1) for adolescents treated with Interpersonal Psychotherapy for depressed adolescents (IPT-A) (Mufson et al, 2004), at what time point should therapists make the determination that the adolescent is not likely to respond if the initial treatment plan is continued (week 4 or week 8), and (2) for adolescents who are judged to need their treatment augmented, should the therapist increase the number of IPT-A sessions or add pharmacotherapy (fluoxetine). Method A 16 week pilot sequential multiple assignment randomized trial (SMART) was conducted with 32 adolescents (mean age = 14.9) who had a diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder NOS. Adolescents were primarily female (75%) and Caucasian (84.4%). Data regarding the feasibility and acceptability of the study and treatment procedures and treatment response rates was collected. Results Week 4 was the more feasible and acceptable decision point for assessing need for a change to treatment. Adolescents, parents, and therapists reported a range of attitudes about medication and more intensive therapy as treatment options. Conclusions The ATSs including the week 4 decision point showed promise in terms of their feasibility and acceptability. Results from the pilot study have yielded additional research questions for the full-scale SMART and will improve our ability to successfully conduct the trial. PMID:25785788

  4. Feasibility study for thermal treatment of solid tire wastes in Bangladesh by using pyrolysis technology

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Islam, M.R., E-mail: mrislam1985@yahoo.com; Joardder, M.U.H.; Hasan, S.M.

    2011-09-15

    In this study on the basis of lab data and available resources in Bangladesh, feasibility study has been carried out for pyrolysis process converting solid tire wastes into pyrolysis oils, solid char and gases. The process considered for detailed analysis was fixed-bed fire-tube heating pyrolysis reactor system. The comparative techno-economic assessment was carried out in US$ for three different sizes plants: medium commercial scale (144 tons/day), small commercial scale (36 tons/day), pilot scale (3.6 tons/day). The assessment showed that medium commercial scale plant was economically feasible, with the lowest unit production cost than small commercial and pilot scale plants formore » the production of crude pyrolysis oil that could be used as boiler fuel oil and for the production of upgraded liquid-products.« less

  5. 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.

  6. Development and feasibility of Inlife: A pilot study of an online social support intervention for informal caregivers of people with dementia.

    PubMed

    Dam, Alieske E H; van Boxtel, Martin P J; Rozendaal, Nico; Verhey, Frans R J; de Vugt, Marjolein E

    2017-01-01

    Informal caregivers of individuals with dementia have an increased risk to face social isolation due to progression of the disease. Online social media interventions might offer a new opportunity to increase access to social support and enhance positive interactions and openness in dementia care networks. This explorative pilot study describes (1) the development of an online social support intervention Inlife, and (2) the evaluation of the feasibility of this intervention and the measurements to assess its effectiveness. The Medical Research Council (MRC) framework guided the development of the online social support intervention. This is a stepwise approach that integrates potential users' views with the development and validation of the program content. The program was developed by combining (1) individual caregiver interviews (n = 10), (2) focus group sessions with experts and web designers (n = 6), and (3) individual think-aloud tests (n = 2). Subsequently, a pilot study with informal caregivers was conducted (n = 25) to examine the program's feasibility and preliminary effectiveness. Online self-report measures were completed at baseline and at four follow-up time points. In total, 23 participants completed the newly developed Inlife intervention. Despite the high number of low-active users (17/23, 73%), Inlife had a good feasibility score of 7.1 (range: 1-10). The Calendar and Timeline were used most frequently and contributed to better care coordination and positive interactions. Although the Inlife platform received a sufficient feasibility rating, the uptake was not optimal. Therefore, the Inlife platform was adapted to limit the number of low-active users and improve user friendliness. Recommendations for additional treatment adherence were provided. The development according to the MRC framework and the sufficient feasibility rating of Inlife formed the basis for a future effectiveness study.

  7. Development and Feasibility of a Structured Goals of Care Communication Guide.

    PubMed

    Bekelman, David B; Johnson-Koenke, Rachel; Ahluwalia, Sangeeta C; Walling, Anne M; Peterson, Jamie; Sudore, Rebecca L

    2017-09-01

    Discussing goals of care and advance care planning is beneficial, yet how to best integrate goals of care communication into clinical care remains unclear. To develop and determine the feasibility of a structured goals of care communication guide for nurses and social workers. Developmental study with providers in an academic and Veterans Affairs (VA) health system (n = 42) and subsequent pilot testing with patients with chronic obstructive pulmonary disease or heart failure (n = 15) and informal caregivers (n = 4) in a VA health system. During pilot testing, the communication guide was administered, followed by semistructured, open-ended questions about the content and process of communication. Changes to the guide were made iteratively, and subsequent piloting occurred until no additional changes emerged. Provider and patient feedback to the communication guide. Iterative input resulted in the goals of care communication guide. The guide included questions to elicit patient understanding of and attitudes toward the future of illness, clarify values and goals, identify end-of-life preferences, and agree on a follow-up plan. Revisions to guide content and phrasing continued during development and pilot testing. In pilot testing, patients validated the importance of the topic; none said the goals of care discussion should not be conducted. Patients and informal caregivers liked the final guide length (∼30 minutes), felt it flowed well, and was clear. In this developmental and pilot study, a structured goals of care communication guide was iteratively designed, implemented by nurses and social workers, and was feasible based on administration time and acceptability by patients and providers.

  8. Feasibility and Reliability of Physical Fitness Tests in Older Adults with Intellectual Disability: A Pilot Study

    ERIC Educational Resources Information Center

    Hilgenkamp, Thessa I. M.; van Wijck, Ruud; Evenhuis, Heleen M.

    2012-01-01

    Background: Physical fitness is relevant for wellbeing and health, but knowledge on the feasibility and reliability of instruments to measure physical fitness for older adults with intellectual disability is lacking. Methods: Feasibility and test-retest reliability of a physical fitness test battery (Box and Block Test, Response Time Test, walking…

  9. Bupropion SR in Adolescents with Comorbid ADHD and Nicotine Dependence: A Pilot Study

    ERIC Educational Resources Information Center

    Upadhyaya, Himanshu P.; Brady, Kathleen T.; Wang, Wei

    2004-01-01

    Objective: Bupropion SR has been shown to be effective for the treatment of nicotine dependence in adults. This open-label pilot study was designed to examine the feasibility and preliminary tolerability of bupropion SR in adolescents with nicotine dependence. Method: Sixteen adolescents aged 12 to 19 years were enrolled in the study. Eleven of…

  10. A Flexible Pilot-Scale Setup for Real-Time Studies in Process Systems Engineering

    ERIC Educational Resources Information Center

    Panjapornpon, Chanin; Fletcher, Nathan; Soroush, Masoud

    2006-01-01

    This manuscript describes a flexible, pilot-scale setup that can be used for training students and carrying out research in process systems engineering. The setup allows one to study a variety of process systems engineering concepts such as design feasibility, design flexibility, control configuration selection, parameter estimation, process and…

  11. Parent-Implemented Social-Pragmatic Communication Intervention: A Pilot Study

    ERIC Educational Resources Information Center

    Meadan, Hedda; Angell, Maureen E.; Stoner, Julia B.; Daczewitz, Marcus E.

    2014-01-01

    This pilot study investigated the feasibility and effectiveness of a home-based parent training and coaching program on the use of naturalistic and visual teaching strategies by parents of children (aged 2-5 years) with Down syndrome to promote and enhance these children's social-pragmatic communication skills. Five parent interventionist-child…

  12. The Feasibility of Virtual Home Visits to Provide Early Intervention: A Pilot Study

    ERIC Educational Resources Information Center

    Kelso, Ginger L.; Fiechtl, Barbara J.; Olsen, Susan T.; Rule, Sarah

    2009-01-01

    Although videoconferencing has been used to deliver distance education, tutoring for children, and telemedicine observations, there is limited information on the efficacy of its use in delivering part C early intervention services. Four families receiving early intervention services in a rural program participated in a pilot study to test the…

  13. Nutrition education program for food bank clients: A pilot study

    USDA-ARS?s Scientific Manuscript database

    Many low income families depend on foods from food banks. The objective of the study was to determine program content and examine feasibility of a pilot nutrition education program for food bank clients. Formative research was conducted with staff at a local food bank and its pantries and adult clie...

  14. Immediate effects after stochastic resonance whole-body vibration on physical performance on frail elderly for skilling-up training: a blind cross-over randomised pilot study.

    PubMed

    Rogan, Slavko; Schmidtbleicher, Dietmar; Radlinger, Lorenz

    2014-10-01

    This pilot study examined the feasibility outcome recruitment, safety and compliance of the investigation for stochastic resonance whole-body vibration (SR-WBV) training. Another aim was to evaluate the effect size of one SR-WBV intervention session on Short Physical Performance Battery (SPPB), Expanded Timed Get Up-and-Go (ETGUG), isometric maximal voluntary contraction (IMVC) and rate of force development (IRFD) and chair rising (CR). Randomised double-blinded controlled cross-over pilot study. Feasibility outcomes included recruitment, safety and compliance. For secondary outcomes, SPPB, ETGUG, IMVC, IRFD and CR were measured before and 2-min after intervention. Nonparametric Rank-Order Tests of Puri and Sen L Statistics to Ranked Data were proposed. Wilcoxon signed-ranked tests were used to analyse the differences after SR-WBV intervention and sham intervention. Treatment effects between the interventions were compared by a Mann-Whitney U test. Among 24 eligible frail elderly, 12 agreed to participate and 3 drop out. The adherence was 15 of 24 intervention sessions. For secondary outcome, effect sizes (ES) for SR-WBV intervention on SPPB, ETGUG and CR were determined. This pilot study indicate that the training protocol used in this form for frail elderly individuals is feasible but with modification due to the fact that not all defined feasibility outcomes target was met. SR-WBV with 6 Hz, noise level 4 shows benefit improvements on SPPB (ES 0.52), ETGUG (part sit-to-stand movement: ES 0.81; total time: ES 0.85) and CR (ES 0.66). Further research is desired to determine whether a new adapted training protocol is necessary for SR-WBV in the "skilling up" phase in frail elderly individuals.

  15. The use of telehealth (text messaging and video communications) in patients with cystic fibrosis: A pilot study.

    PubMed

    Gur, Michal; Nir, Vered; Teleshov, Anna; Bar-Yoseph, Ronen; Manor, Eynav; Diab, Gizelle; Bentur, Lea

    2017-05-01

    Background Poor communications between cystic fibrosis (CF) patients and health-care providers may result in gaps in knowledge and misconceptions about medication usage, and can lead to poor adherence. We aimed to assess the feasibility of using WhatsApp and Skype to improve communications. Methods This single-centre pilot study included CF patients who were older than eight years of age assigned to two groups: one without intervention (control group), and one with intervention. Each patient from the intervention group received Skype-based online video chats and WhatsApp messages from members of the multidisciplinary CF team. CF questionnaires, revised (CFQ-R) scores, knowledge and adherence based on CF My Way and patients satisfaction were evaluated before and after three months. Feasibility was assessed by session attendance, acceptability and satisfaction survey. Descriptive analysis and paired and non-paired t-tests were used as applicable. Results Eighteen patients were recruited to this feasibility study (nine in each group). Each intervention group participant had between four and six Skype video chats and received 22-45 WhatsApp messages. In this small study, CFQ-R scores, knowledge, adherence and patient satisfaction were similar in both groups before and after the three-month intervention. Conclusions A telehealth-based approach, using Skype video chats and WhatsApp messages, was feasible and acceptable in this pilot study. A larger and longer multi-centre study is warranted to examine the efficacy of these interventions to improve knowledge, adherence and communication.

  16. Using Electronic Health Records to Enhance a Peer Health Navigator Intervention: A Randomized Pilot Test for Individuals with Serious Mental Illness and Housing Instability.

    PubMed

    Kelly, Erin L; Braslow, Joel T; Brekke, John S

    2018-05-03

    Individuals with serious mental illnesses have high rates of comorbid physical health issues and have numerous barriers to addressing their health and health care needs. The present pilot study tested the feasibility of a modified form of the "Bridge" peer-health navigator intervention delivered in a usual care setting by agency personnel. The modifications concerned the use of an electronic personal health record with individuals experiencing with housing instability. Twenty participants were randomized to receive the intervention immediately or after 6 months. Health navigator contacts and use of personal health records were associated with improvements in health care and self-management. This pilot study demonstrated promising evidence for the feasibility of adding personal health record use to a peer-led intervention.

  17. Feasibility of online nutrition education in the workplace: Working Toward Healthy Lifestyles

    USDA-ARS?s Scientific Manuscript database

    Objective: Determination of feasibility of online nutrition education in the federal workplace. Design: Pre-test/post-test pilot study with data collection occurring from September to December 2016. Setting: Two United States Department of Agriculture workplaces. Participants: Convenience sample ...

  18. Information technology feasibility study for the Washington State commercial vehicle information systems and networks (CVISN) pilot project

    DOT National Transportation Integrated Search

    1998-01-08

    The CVISN Pilot Project will prototype the use of a comprehensive interface to state and federal motor carrier data systems and will deliver real-time, decision-making information to weigh stations and commercial vehicle enforcement officers. In addi...

  19. Reach Out Churches: A Community-Based Participatory Research Pilot Trial to Assess the Feasibility of a Mobile Health Technology Intervention to Reduce Blood Pressure Among African Americans.

    PubMed

    Skolarus, Lesli E; Cowdery, Joan; Dome, Mackenzie; Bailey, Sarah; Baek, Jonggyu; Byrd, James Brian; Hartley, Sarah E; Valley, Staci C; Saberi, Sima; Wheeler, Natalie C; McDermott, Mollie; Hughes, Rebecca; Shanmugasundaram, Krithika; Morgenstern, Lewis B; Brown, Devin L

    2017-06-01

    Innovative strategies are needed to reduce the hypertension epidemic among African Americans. Reach Out was a faith-collaborative, mobile health, randomized, pilot intervention trial of four mobile health components to reduce high blood pressure (BP) compared to usual care. It was designed and tested within a community-based participatory research framework among African Americans recruited and randomized from churches in Flint, Michigan. The purpose of this pilot study was to assess the feasibility of the Reach Out processes. Feasibility was assessed by willingness to consent (acceptance of randomization), proportion of weeks participants texted their BP readings (intervention use), number lost to follow-up (retention), and responses to postintervention surveys and focus groups (acceptance of intervention). Of the 425 church members who underwent BP screening, 94 enrolled in the study and 73 (78%) completed the 6-month outcome assessment. Median age was 58 years, and 79% were women. Participants responded with their BPs on an average of 13.7 (SD = 10.7) weeks out of 26 weeks that the BP prompts were sent. All participants reported satisfaction with the intervention. Reach Out, a faith-collaborative, mobile health intervention was feasible. Further study of the efficacy of the intervention and additional mobile health strategies should be considered.

  20. 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.

  1. Re-estimating sample size in cluster randomised trials with active recruitment within clusters.

    PubMed

    van Schie, S; Moerbeek, M

    2014-08-30

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster level and individual level variance should be known before the study starts, but this is often not the case. We suggest using an internal pilot study design to address this problem of unknown variances. A pilot can be useful to re-estimate the variances and re-calculate the sample size during the trial. Using simulated data, it is shown that an initially low or high power can be adjusted using an internal pilot with the type I error rate remaining within an acceptable range. The intracluster correlation coefficient can be re-estimated with more precision, which has a positive effect on the sample size. We conclude that an internal pilot study design may be used if active recruitment is feasible within a limited number of clusters. Copyright © 2014 John Wiley & Sons, Ltd.

  2. Airborne Conflict Management within Confined Airspace in a Piloted Simulation of DAG-TM Autonomous Aircraft Operations

    NASA Technical Reports Server (NTRS)

    Barmore, Bryan; Johnson, Edward; Wing, David J.; Barhydt, Richard

    2003-01-01

    A human-in-the-loop experiment was performed at the NASA Langley Research Center to study the feasibility of Distributed Air/Ground Traffic Management (DAG-TM) autonomous aircraft operations in highly constrained airspace. The airspace was constrained by a pair of special use airspace (SUA) regions on either side of the pilot s planned route. The available airspace was further varied by changing the separation standard for lateral separation between 3 nm and 5 nm. The pilot had to maneuver through the corridor between the SUA s, avoid other traffic and meet flow management constraints. Traffic flow management (TFM) constraints were imposed as a required time of arrival and crossing altitude at an en route fix. This is a follow-up study to work presented at the 4th USA/Europe Air Traffic Management R&D Seminar in December 2001. Nearly all of the pilots were able to meet their TFM constraints while maintaining adequate separation from other traffic. In only 3 out of 59 runs were the pilots unable to meet their required time of arrival. Two loss of separation cases are studied and it is found that the pilots need conflict prevention information presented in a clearer manner. No degradation of performance or safety was seen between the wide and narrow corridors. Although this was not a thorough study of the consequences of reducing the en route lateral separation, nothing was found that would refute the feasibility of reducing the separation requirement from 5 nm to 3 nm. The creation of additional, second-generation conflicts is also investigated. Two resolution methods were offered to the pilots: strategic and tactical. The strategic method is a closed-loop alteration to the Flight Management System (FMS) active route that considers other traffic as well as TFM constraints. The tactical resolutions are short-term resolutions that leave avoiding other traffic conflicts and meeting the TFM constraints to the pilot. Those that made use of the strategic tools avoided additional conflicts, whereas, those making tactical maneuvers often caused additional conflicts. Many of these second-generation conflicts could be avoided by improved conflict prevention tools that clearly present to the pilot which maneuver choices will result in a conflict-free path. These results, together with previously reported studies, continue to support the feasibility of autonomous aircraft operations.

  3. Feasibility Study of the Social Enterprise Intervention with Homeless Youth

    ERIC Educational Resources Information Center

    Ferguson, Kristin M.; Xie, Bin

    2008-01-01

    Objective: To reduce mental health symptoms and high-risk behaviors and increase social support and service utilization among street-living youth, the authors conducted a pilot study to assess the feasibility of the social enterprise intervention (SEI) at a homeless youth agency. Method: Convenience sampling was used to recruit 16 street-living…

  4. Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment.

    PubMed

    Middleton, Lee J; Daniels, Jane P; Weckesser, Annalise; Bhattacharya, Siladitya

    2017-03-11

    Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design based on chosen recruitment options, but trialists should consider carefully any practical arrangements should groups need to be dropped during a study. International Standard Randomised Controlled Trial Number, ISRCTN97865475 . Registered on 20 March 2014.

  5. "Let's Talk about Drugs": Pilot Study of a Community-Level Drug Prevention Intervention Based on Motivational Interviewing Principles

    ERIC Educational Resources Information Center

    Newbery, Natasha; McCambridge, Jim; Strang, John

    2007-01-01

    Purpose: The feasibility of a community-level drug prevention intervention based upon the principles of motivational interviewing within a further education college was investigated in a pilot study. Design/methodology/approach: The implementation over the course of a single term of "Let's Talk about Drugs" was studied with both action…

  6. Physically Active Lessons: Evaluation Report and Executive Summary

    ERIC Educational Resources Information Center

    Miller, Sarah; Gildea, Aideen Gildea; Sloan, Seaneen; Thurston, Allen

    2015-01-01

    This is a report of a pilot study of the Physically Active Lessons (PAL) programme, which was piloted in five primary schools in Hertfordshire between February and July 2014. PAL involves adapting lesson plans to combine short bursts of physical activity with academic content. The study had two aims: (1) to explore the feasibility of adapting a…

  7. A Pilot Study of an Online Workplace Nutrition Program: The Value of Participant Input in Program Development

    ERIC Educational Resources Information Center

    Cousineau, Tara; Houle, Brian; Bromberg, Jonas; Fernandez, Kathrine C.; Kling, Whitney C.

    2008-01-01

    Objective: Tailored nutrition Web programs constitute an emerging trend in obesity prevention. Initial investment in innovative technology necessitates that the target population be well understood. This pilot study's purpose was to determine the feasibility of a workplace nutrition Web program. Design: Formative research was conducted with gaming…

  8. Pilot Testing for Feasibility in a Study of Student Retention and Attrition in Online Undergraduate Programs

    ERIC Educational Resources Information Center

    Fraser, Joy; Fahlman, Dorothy; Arscott, Jane; Guillot, Isabelle

    2018-01-01

    Prior to undertaking a descriptive study on attrition and retention of students in two online undergraduate health administration and human service programs, a pilot test was conducted to assess the procedures for participant recruitment, usability of the survey questionnaire, and data collection processes. A retention model provided the…

  9. Children's food store, restaurant, and home food environments and their relationship with body mass index: a pilot study.

    PubMed

    Holsten, Joanna E; Compher, Charlene W

    2012-01-01

    This pilot research assessed the feasibility and utility of a study designed to examine the relationship between children's BMI and food store, restaurant, and home food environments. Home visits were conducted with sixth-grade children (N = 12). BMI z-scores were calculated with weight and height measurements. Nutrition Environment Measures Surveys evaluated children's food environments. The study protocol involved a feasible time duration, minimal missing data for primary variables, and participant satisfaction. Potential design problems included the homogeneous store environments and low restaurant exposure of the sample recruited from one school, and the adequacy of a single cross-sectional measure of the home environment.

  10. Medication coaching program for patients with minor stroke or TIA: a pilot study.

    PubMed

    Sides, Elizabeth G; Zimmer, Louise O; Wilson, Leslie; Pan, Wenqin; Olson, Daiwai M; Peterson, Eric D; Bushnell, Cheryl

    2012-07-25

    Patients who are hospitalized with a first or recurrent stroke often are discharged with new medications or adjustment to the doses of pre-admission medications, which can be confusing and pose safety issues if misunderstood. The purpose of this pilot study was to assess the feasibility of medication coaching via telephone after discharge in patients with stroke. Two-arm pilot study of a medication coaching program with 30 patients (20 intervention, 10 control). Consecutive patients admitted with stroke or TIA with at least 2 medications changed between admission and discharge were included. The medication coach contacted intervention arm patients post-discharge via phone call to discuss risk factors, review medications and triage patients' questions to a stroke nurse and/or pharmacist. Intervention and control participants were contacted at 3 months for outcomes. The main outcomes were feasibility (appropriateness of script, ability to reach participants, and provide requested information) and participant evaluation of medication coaching. The median lengths of the coaching and follow-up calls with requested answers to these questions were 27 minutes and 12 minutes, respectively, and participant evaluations of the coaching were positive. The intervention participants were more likely to have seen their primary care provider than were control participants by 3 months post discharge. This medication coaching study executed early after discharge demonstrated feasibility of coaching and educating stroke patients with a trained coach. Results from our small pilot showed a possible trend towards improved appointment-keeping with primary care providers in those who received coaching.

  11. Virtual Service, Real Data: Results of a Pilot Study.

    ERIC Educational Resources Information Center

    Kibbee, Jo; Ward, David; Ma, Wei

    2002-01-01

    Describes a pilot project at the University of Illinois at Urbana-Champaign reference and undergraduate libraries to test the feasibility of offering real-time online reference service via their Web site. Discusses software selection, policies and procedures, promotion and marketing, user interface, training and staffing, data collection, and…

  12. Substance use recovery outcomes among a cohort of youth participating in a mobile-based texting aftercare pilot program.

    PubMed

    Gonzales, Rachel; Ang, Alfonso; Murphy, Debra A; Glik, Deborah C; Anglin, M Douglas

    2014-07-01

    Project ESQYIR (Educating & Supporting Inquisitive Youth in Recovery) is a pilot study examining the feasibility of a 12-week mobile-based aftercare intervention for youth (ages 12 to 24) transitioning out of community-based substance abuse treatment programs. From January 2012 through July 2013, a total of 80 youth were recruited from outpatient and residential treatment programs, geographically dispersed throughout Los Angeles County, California. Results revealed that youth who participated in the texting mobile pilot intervention were significantly less likely to relapse to their primary compared to the aftercare as usual control condition (OR=0.52, p=0.002) over time (from baseline throughout the 12-week aftercare pilot program to a 90-day follow-up). Participants in the texting aftercare pilot program also reported significantly less substance use problem severity (β=-0.46, p=0.03) and were more likely to participate in extracurricular recovery behaviors (β=1.63, p=0.03) compared to participants in the standard aftercare group. Collectively, findings from this pilot aftercare study suggest that mobile texting could provide a feasible way to engage youth in recovery after substance abuse treatment to aid with reducing relapse and promoting lifestyle behavior change. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Understanding Treatment Burden and Quality of Life Impact of Participating in an Early-Phase Pediatric Oncology Clinical Trial: A Pilot Study.

    PubMed

    Crane, Stacey; Backus, Lori; Stockman, Beth; Carpenter, Janet S; Lin, Li; Haase, Joan

    Early-phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention and completion of measures. Measures completed included the following: demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition.

  14. Understanding Treatment Burden and Quality of Life Impact of Participating in an Early Phase Pediatric Oncology Clinical Trial: A Pilot Study

    PubMed Central

    BACKUS, LORI; STOCKMAN, BETH; CARPENTER, JANET S.; LIN, LI; HAASE, JOAN

    2017-01-01

    Purpose Early phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. Methods In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention, and completion of measures. Measures completed included: Demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Results Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. Conclusions While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition. PMID:28849701

  15. Pilot Interactions in an Over-Constrained Conflict Scenario as Studied in a Piloted Simulation of Autonomous Aircraft Operations

    NASA Technical Reports Server (NTRS)

    Wing, David J.; Barhydt, Richard; Barmore, Bryan; Krishnamurthy, Karthik

    2003-01-01

    Feasibility and safety of autonomous aircraft operations were studied in a multi-piloted simulation of overconstrained traffic conflicts to determine the need for, and utility of, priority flight rules to maintain safety in this extraordinary and potentially hazardous situation. An overconstrained traffic conflict is one in which the separation assurance objective is incompatible with other objectives. In addition, a proposed scheme for implementing priority flight rules by staggering the alerting time between the two aircraft in conflict was tested for effectiveness. The feasibility study was conducted through a simulation in the Air Traffic Operations Laboratory at the NASA Langley Research Center. This research activity is a continuation of the Distributed Air-Ground Traffic Management feasibility analysis reported in the 4th USA/Europe Air Traffic Management R&D Seminar in December 2001 (paper #48). The over-constrained conflict scenario studied here consisted of two piloted aircraft that were assigned an identical en-route waypoint arrival time and altitude crossing restriction. The simulation results indicated that the pilots safely resolved the conflict without the need for a priority flight rule system. Occurrences of unnecessary maneuvering near the common waypoint were traced to false conflict alerts, generated as the result of including waypoint constraint information in the broadcast data link message issued from each aircraft. This result suggests that, in the conservative interests of safety, broadcast intent information should be based on the commanded trajectory and not on the Flight Management System flight plan, to which the aircraft may not actually adhere. The use of priority flight rules had no effect on the percentage of the aircraft population meeting completely predictable which aircraft in a given pair would meet the constraints and which aircraft would make the first maneuver to yield right-of-way. Therefore, the proposed scheme for implementing priority flight rules through staggering the alerting time between the two aircraft was completely effective. The data and observations from this experiment, together with results from the previously reported study, support the feasibility of autonomous aircraft operations.

  16. A Pilot Study of Naltrexone and BASICS for Heavy Drinking Young Adults

    PubMed Central

    Leeman, Robert F.; Palmer, Rebekka S.; Corbin, William R.; Romano, Denise M.; Meandzija, Boris; O’Malley, Stephanie S.

    2008-01-01

    Heavy drinking young adults often have limited motivation to change their drinking behavior. Adding pharmacotherapy to brief counseling is a novel approach to treating this population. A small open-label pilot study was conducted to assess the feasibility of offering eight weeks of daily and targeted (i.e., taken as needed in anticipation of drinking) naltrexone with BASICS (brief motivational) counseling to heavy drinking young adults; to assess the tolerability of the medication in this population and to obtain preliminary efficacy data. The sample (N = 14) showed strong adherence to study appointments and medication taking, supporting the feasibility of this approach. Overall, the medication was well-tolerated. Significant reductions from baseline were observed in drinks per drinking day and in percent heavy drinking days and these gains were maintained one month after treatment ended. A significant decrease in alcohol-related consequences was also observed. Findings from this small pilot study suggest that naltrexone in combination with BASICS represents a promising strategy to reduce heavy drinking among young adults. PMID:18502591

  17. Executive Function Computerized Training in Very Preterm-Born Children: A Pilot Study.

    PubMed

    Aarnoudse-Moens, Cornelieke S H; Twilhaar, E Sabrina; Oosterlaan, Jaap; van Veen, Heske G; Prins, Pier J M; van Kaam, Anton H L C; van Wassenaer-Leemhuis, Aleid G

    2018-06-01

    Attention problems are one of the most pronounced and documented consequences of very preterm birth (gestational age ≤32 weeks). However, up to now, there is no research published on suitable interventions at school age aimed to overcome these problems. Research in this population did show that executive functions (EFs) are strongly associated with inattention. BrainGame Brian is a newly developed computerized training, in which, in 25 training sessions, the core EFs, including working memory, impulse control, and cognitive flexibility, are trained. This pilot study aimed to examine the feasibility of studying BrainGame Brian in very preterm-born children with attention problems. Pilot feasibility intervention study with one baseline and one follow-up assessment. Feasibility was measured by the participation rate, dropout rate, and user experiences with regard to effort, training characteristics, and recommendation to others. From a larger cohort study, 15 very preterm-born children at age 10 years with parent-reported attention problems on the Child Behavior Checklist/6-18 years were invited to participate in this pilot study. BrainGame Brian was performed for a period of 6 weeks. Training outcome measures included visual working memory, impulse control, cognitive flexibility, speed variability, and parent-rated attention, for which pre- and post-training differences were examined at the group level by the Wilcoxon signed-rank test as well as for each individual child separately by the reliable change index. Twelve of 15 children and their parents agreed to participate and 11 children successfully completed BrainGame Brian in the 6-week period. Parents were positive about training characteristics and lack of interference with schooling, but scored the effort as high. We found clinically significant changes in visual working memory and speed variability in post-training assessments. BrainGame Brian is a feasible intervention for very preterm-born children with attention problems.

  18. Assessing the impact of care farms on quality of life and offending: a pilot study among probation service users in England.

    PubMed

    Elsey, Helen; Farragher, Tracey; Tubeuf, Sandy; Bragg, Rachel; Elings, Marjolein; Brennan, Cathy; Gold, Rochelle; Shickle, Darren; Wickramasekera, Nyantara; Richardson, Zoe; Cade, Janet; Murray, Jenni

    2018-03-17

    To assess the feasibility of conducting a cost-effectiveness study of using care farms (CFs) to improve quality of life and reduce reoffending among offenders undertaking community orders (COs). To pilot questionnaires to assess quality of life, connection to nature, lifestyle behaviours, health and social-care use. To assess recruitment and retention at 6 months and feasibility of data linkage to Police National Computer (PNC) reconvictions data and data held by probation services. Pilot study using questionnaires to assess quality of life, individually linked to police and probation data. The pilot study was conducted in three probation service regions in England. Each site included a CF and at least one comparator CO project. CFs are working farms used with a range of clients, including offenders, for therapeutic purposes. The three CFs included one aquaponics and horticulture social enterprise, a religious charity focusing on horticulture and a family-run cattle farm. Comparator projects included sorting secondhand clothes and activities to address alcohol misuse and anger management. We recruited 134 adults (over 18) serving COs in England, 29% female. 52% of participants completed follow-up questionnaires. Privatisation of UK probation trusts in 2014 negatively impacted on recruitment and retention. Linkage to PNC data was a more successful means of follow-up, with 90% consenting to access their probation and PNC data. Collection of health and social-care costs and quality-adjusted life year derivation were feasible. Propensity score adjustment provided a viable comparison method despite differences between comparators. We found worse health and higher reoffending risk among CF participants due to allocation of challenging offenders to CFs, making risk of reoffending a confounder. Recruitment would be feasible in a more stable probation environment. Follow-up was challenging; however, assessing reconvictions from PNC data is feasible and a potential primary outcome for future studies. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. A Pilot Study Assessing the Feasibility of a Facial Emotion Training Paradigm for School-Age Children with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Russo-Ponsaran, Nicole M.; Evans-Smith, Bernadette; Johnson, Jason K.; McKown, Clark

    2014-01-01

    Many children with autism spectrum disorders (ASDs) demonstrate facial emotion recognition and expression impairments. These impairments may contribute to social disability and may put children with ASDs at risk for developing further mental health problems. In this pilot study, we examined the use of a coach- and computer-assisted facial emotion…

  20. Development of a Family Intervention for Native Hawaiian Women with Cancer: A Pilot Study

    ERIC Educational Resources Information Center

    Mokuau, Noreen; Braun, Kathryn L.; Wong, Linda K.; Higuchi, Paula; Gotay, Carolyn C.

    2008-01-01

    Native Hawaiian women have high cancer rates and low survival rates. As with other women, a major source of support for Native Hawaiian women is their families. This pilot study reports on the feasibility of providing and measuring a culturally appropriate intervention designed to help Native Hawaiian women and their families deal with cancer. The…

  1. Open-Trial Pilot Study of a Comprehensive School-Based Intervention for High-Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Lopata, Christopher; Thomeer, Marcus L.; Volker, Martin A.; Lee, Gloria K.; Smith, Tristram H.; Rodgers, Jonathan D.; Smith, Rachael A.; Gullo, Gaetano; McDonald, Christin A.; Mirwis, Joshua; Toomey, Jennifer A.

    2013-01-01

    There is a notable lack of manualized comprehensive school-based interventions (CSBIs) for children with high-functioning autism spectrum disorders (HFASDs). This pilot study examined the feasibility and initial efficacy of a CSBI for 12 children with HFASDs, aged 6 to 9 years. Treatment included a 3-week summer preparation program followed by a…

  2. Training Community Mental Health Therapists to Deliver a Package of Evidence-Based Practice Strategies for School-Age Children with Autism Spectrum Disorders: A Pilot Study

    ERIC Educational Resources Information Center

    Brookman-Frazee, Lauren I.; Drahota, Amy; Stadnick, Nicole

    2012-01-01

    Research on moving evidence-based practice (EBP) intervention strategies to community service settings for children with autism spectrum disorders (ASD) is urgently needed. The current pilot study addresses this need by examining the feasibility, acceptability and preliminary outcomes of training therapists practicing in community mental health…

  3. A Pilot SMART for Developing an Adaptive Treatment Strategy for Adolescent Depression.

    PubMed

    Gunlicks-Stoessel, Meredith; Mufson, Laura; Westervelt, Ana; Almirall, Daniel; Murphy, Susan

    2016-01-01

    This pilot study was conducted to assess the feasibility and acceptability of 4 adaptive treatment strategies (ATSs) for adolescent depression to plan for a subsequent full-scale clinical trial. The ATSs aim to address 2 questions that arise when personalizing treatment: (a) For adolescents treated with Interpersonal Psychotherapy for depressed adolescents (IPT-A; Mufson et al., 2004 ), at what time point should therapists make the determination that the adolescent is not likely to respond if the initial treatment plan is continued (week 4 or week 8)? (b) For adolescents who are judged to need their treatment augmented, should the therapist increase the number of IPT-A sessions or add pharmacotherapy (fluoxetine)? A 16-week pilot sequential multiple assignment randomized trial (SMART) was conducted with 32 adolescents (M age = 14.9) who had a diagnosis of major depressive disorder, dysthymic disorder, or depressive disorder not otherwise specified. Adolescents were primarily female (75%) and Caucasian (84.4%). Data regarding the feasibility and acceptability of the study and treatment procedures and treatment response rates were collected. Week 4 was the more feasible and acceptable decision point for assessing need for a change to treatment. Adolescents, parents, and therapists reported a range of attitudes about medication and more intensive therapy as treatment options. Results from the pilot study have yielded additional research questions for the full-scale SMART and will improve our ability to successfully conduct the trial.

  4. Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

    PubMed

    Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

    2017-08-01

    The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

  5. A community health worker intervention to improve management of hypertension among Filipino Americans in New York and New Jersey: a pilot study.

    PubMed

    Ursua, Rhodora A; Aguilar, David E; Wyatt, Laura C; Katigbak, Carina; Islam, Nadia S; Tandon, S Darius; Nur, Potri Ranka Manis Queano; Van Devanter, Nancy; Rey, Mariano J; Trinh-Shevrin, Chau

    2014-01-01

    The purpose of the pilot study was to assess the feasibility and efficacy of a 4-month community health worker (CHW) intervention to improve hypertension management among Filipino immigrants in New York and New Jersey. Single-arm CHW pilot intervention using a pre-post design delivered by 5 CHWs. New York City, NY and Jersey City, NJ. Of 88 Filipino individuals recruited for the study, 39 received the full pilot intervention, 18 received a partial intervention, and 31 dropped out; 13 Filipino participants, 10 CHW Trainers, and 3 Filipino CHWs were interviewed for qualitative analysis. Individuals participated in 4 workshops related to hypertension management and cardiovascular disease (CVD) risk factors and received monthly in-person visits, and twice monthly phone calls individually from a CHW. Primary outcomes included blood pressure (BP) reduction and control, appointment keeping, and medication adherence; secondary outcomes included weight, body mass index (BMI), self-efficacy related to diet, exercise, and medication taking, CVD knowledge, and nutrition (salt/ sodium and cholesterol/fat). A mixed method analysis was used to assess the intervention, utilizing quantitative and qualitative methods. By the end of the intervention, significant changes were exhibited for systolic and diastolic BP, weight, and BMI (P<.01). Significant changes were not seen for medication adherence and appointment keeping, however, CVD knowledge and self-efficacy related to diet and weight management all improved significantly (P<.01). Qualitative findings provided additional information on the acceptability, feasibility, and efficacy of the intervention. This pilot CHW intervention showed evidence of feasibility, as well as efficacy, in improving hypertension management and reducing CVD factors in Filipino Americans.

  6. [Feasibility and effectiveness of mindfulness training in adults with ADHD: a pilot study].

    PubMed

    Hepark, S; Kan, C C; Speckens, A

    2014-01-01

    Attention deficit hyperactivity disorder (ADHD) is a developmental disorder that often continues into adulthood. Stimulant medication is the common treatment for ADHD. However, there is a need for psychosocial interventions in addition to medication. To conduct a pilot study which examines the feasibility and effectiveness of mindfulness training for adults with ADHD. Eleven adults with ADHD participated in a mindfulness training scheme lasting 10 weeks. ADHD symptoms, anxiety and depressive symptoms, quality of life, mindfulness skills and attentional tasks were measured before and after the period of mindfulness training. Nine participants completed the mindfulness training and were satisfied with the training. Eight of these reported improvement in their ADHD symptoms. For all participants, their quality of life, awareness of their actions and executive control had also improved. Mindfulness is a feasible treatment strategy for adults with ADHD and seems to have a positive effect on ADHD symptoms and executive control.

  7. Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

    ERIC Educational Resources Information Center

    Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

    2014-01-01

    It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

  8. A simulator evaluation of an automatic terminal approach system

    NASA Technical Reports Server (NTRS)

    Hinton, D. A.

    1983-01-01

    The automatic terminal approach system (ATAS) is a concept for improving the pilot/machine interface with cockpit automation. The ATAS can automatically fly a published instrument approach by using stored instrument approach data to automatically tune airplane avionics, control the airplane's autopilot, and display status information to the pilot. A piloted simulation study was conducted to determine the feasibility of an ATAS, determine pilot acceptance, and examine pilot/ATAS interaction. Seven instrument-rated pilots each flew four instrument approaches with a base-line heading select autopilot mode. The ATAS runs resulted in lower flight technical error, lower pilot workload, and fewer blunders than with the baseline autopilot. The ATAS status display enabled the pilots to maintain situational awareness during the automatic approaches. The system was well accepted by the pilots.

  9. Using an individualised consultation and activPAL™ feedback to reduce sedentary time in older Scottish adults: results of a feasibility and pilot study.

    PubMed

    Fitzsimons, Claire F; Kirk, Alison; Baker, Graham; Michie, Fraser; Kane, Catherine; Mutrie, Nanette

    2013-11-01

    Sedentary behaviours have been linked to poor health, independent of physical activity levels. The objective of this study was to explore an individualised intervention strategy aimed at reducing sedentary behaviours in older Scottish adults. This feasibility and pilot study was a pre-experimental (one group pretest-posttest) study design. Participants were enrolled into the study in January-March 2012 and data analysis was completed April-October 2012. The study was based in Glasgow, Scotland. Participants received an individualised consultation targeting sedentary behaviour incorporating feedback from an activPAL activity monitor. Outcome measures were objectively (activPAL) and subjectively measured (Sedentary Behaviour Questionnaire) sedentary time. Twenty four participants received the intervention. Objectively measured total time spent sitting/lying was reduced by 24 min/day (p=0.042), a reduction of 2.2%. Total time spent in stepping activities, such as walking increased by 13 min/day (p=0.044). Self-report data suggested participants achieved behaviour change by reducing time spent watching television and/or using motorised transport. Interventions to reduce sedentary behaviours in older people are urgently needed. The results of this feasibility and pilot study suggest a consultation approach may help individuals reduce time spent in sedentary behaviours. A larger, controlled trial is warranted with a diverse sample to increase generalisability. © 2013.

  10. Congestive heart failure adherence redesign trial: a pilot study

    PubMed Central

    Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

    2014-01-01

    Objective Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. Setting A large tertiary care medical centre in Chicago. Participants Low-income patients (80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. Conclusions This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. PMID:25475245

  11. INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

    PubMed Central

    2011-01-01

    Background Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness. The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. Methods/design This is a mixed methods pragmatic multicentre feasibility pilot study with four components:- (a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial. (b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience. (c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial. (d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. Discussion The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim. Trial registration number Current Controlled Trials ISRCTN71327395 assigned 7th June 2010. PMID:21733166

  12. 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.

  13. A remotely piloted aircraft system in major incident management: concept and pilot, feasibility study.

    PubMed

    Abrahamsen, Håkon B

    2015-06-10

    Major incidents are complex, dynamic and bewildering task environments characterised by simultaneous, rapidly changing events, uncertainty and ill-structured problems. Efficient management, communication, decision-making and allocation of scarce medical resources at the chaotic scene of a major incident is challenging and often relies on sparse information and data. Communication and information sharing is primarily voice-to-voice through phone or radio on specified radio frequencies. Visual cues are abundant and difficult to communicate between teams and team members that are not co-located. The aim was to assess the concept and feasibility of using a remotely piloted aircraft (RPA) system to support remote sensing in simulated major incident exercises. We carried out an experimental, pilot feasibility study. A custom-made, remotely controlled, multirotor unmanned aerial vehicle with vertical take-off and landing was equipped with digital colour- and thermal imaging cameras, a laser beam, a mechanical gripper arm and an avalanche transceiver. We collected data in five simulated exercises: 1) mass casualty traffic accident, 2) mountain rescue, 3) avalanche with buried victims, 4) fisherman through thin ice and 5) search for casualties in the dark. The unmanned aerial vehicle was remotely controlled, with high precision, in close proximity to air space obstacles at very low levels without compromising work on the ground. Payload capacity and tolerance to wind and turbulence were limited. Aerial video, shot from different altitudes, and remote aerial avalanche beacon search were streamed wirelessly in real time to a monitor at a ground base. Electromagnetic interference disturbed signal reception in the ground monitor. A small remotely piloted aircraft can be used as an effective tool carrier, although limited by its payload capacity, wind speed and flight endurance. Remote sensing using already existing remotely piloted aircraft technology in pre-hospital environments is feasible and can be used to support situation assessment and information exchange at a major incident scene. Regulations are needed to ensure the safe use of unmanned aerial vehicles in major incidents. Ethical issues are abundant.

  14. Development and feasibility of Inlife: A pilot study of an online social support intervention for informal caregivers of people with dementia

    PubMed Central

    Dam, Alieske E. H.; van Boxtel, Martin P. J.; Rozendaal, Nico; Verhey, Frans R. J.; de Vugt, Marjolein E.

    2017-01-01

    Background Informal caregivers of individuals with dementia have an increased risk to face social isolation due to progression of the disease. Online social media interventions might offer a new opportunity to increase access to social support and enhance positive interactions and openness in dementia care networks. Objective This explorative pilot study describes (1) the development of an online social support intervention Inlife, and (2) the evaluation of the feasibility of this intervention and the measurements to assess its effectiveness. Methods The Medical Research Council (MRC) framework guided the development of the online social support intervention. This is a stepwise approach that integrates potential users’ views with the development and validation of the program content. The program was developed by combining (1) individual caregiver interviews (n = 10), (2) focus group sessions with experts and web designers (n = 6), and (3) individual think-aloud tests (n = 2). Subsequently, a pilot study with informal caregivers was conducted (n = 25) to examine the program’s feasibility and preliminary effectiveness. Online self-report measures were completed at baseline and at four follow-up time points. Results In total, 23 participants completed the newly developed Inlife intervention. Despite the high number of low-active users (17/23, 73%), Inlife had a good feasibility score of 7.1 (range: 1–10). The Calendar and Timeline were used most frequently and contributed to better care coordination and positive interactions. Conclusions Although the Inlife platform received a sufficient feasibility rating, the uptake was not optimal. Therefore, the Inlife platform was adapted to limit the number of low-active users and improve user friendliness. Recommendations for additional treatment adherence were provided. The development according to the MRC framework and the sufficient feasibility rating of Inlife formed the basis for a future effectiveness study. PMID:28886056

  15. Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study.

    PubMed

    Singh, Rameet H; Espey, Eve; Carr, Shannon; Pereda, Brenda; Ogburn, Tony; Leeman, Lawrence

    2015-02-01

    The objective was to determine feasibility of a study comparing mean pain scores between women randomized to nitrous oxide/oxygen (NO) versus oxygen+oral analgesics for trimester surgical abortion. Pilot randomized controlled trial comparing NO (n=10) versus oxygen+oral analgesics (n=10). Feasibility of subject recruitment, and pain and satisfaction scores on a visual analog scale were evaluated. Fifty-seven percent of eligible women participated. Mean pain scores were similar between groups, and mean satisfaction scores were higher for the NO group (77.5 vs. 46.7, P=.048). The majority of eligible women agreed to participate in this study evaluating an uncommon pain control intervention. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

    ERIC Educational Resources Information Center

    Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

    2013-01-01

    Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

  17. Leap motion controlled videogame-based therapy for rehabilitation of elderly patients with subacute stroke: a feasibility pilot study.

    PubMed

    Iosa, Marco; Morone, Giovanni; Fusco, Augusto; Castagnoli, Marcello; Fusco, Francesca Romana; Pratesi, Luca; Paolucci, Stefano

    2015-08-01

    The leap motion controller (LMC) is a new optoelectronic system for capturing motion of both hands and controlling a virtual environment. Differently from previous devices, it optoelectronically tracks the fine movements of fingers neither using glows nor markers. This pilot study explored the feasibility of adapting the LMC, developed for videogames, to neurorehabilitation of elderly with subacute stroke. Four elderly patients (71.50 ± 4.51 years old) affected by stroke in subacute phase were enrolled and tested in a cross-over pilot trial in which six sessions of 30 minutes of LMC videogame-based therapy were added on conventional therapy. Measurements involved participation to the sessions, evaluated by means of the Pittsburgh Rehabilitation Participation Scale, hand ability and grasp force evaluated respectively by means of the Abilhand Scale and by means of the dynamometer. Neither adverse effects nor spasticity increments were observed during LMC training. Participation to the sessions was excellent in three patients and very good in one patient during the LMC trial. In this period, patients showed a significantly higher improvement in hand abilities (P = 0.028) and grasp force (P = 0.006). This feasibility pilot study was the first one using leap motion controller for conducting a videogame-based therapy. This study provided a proof of concept that LMC can be a suitable tool even for elderly patients with subacute stroke. LMC training was in fact performed with a high level of active participation, without adverse effects, and contributed to increase the recovery of hand abilities.

  18. Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency.

    PubMed

    August, Gerald J; Piehler, Timothy F; Bloomquist, Michael L

    2016-01-01

    The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Toward this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. The SMART feasibility pilot study includes a sample of 100 youth (13-17 years of age) identified by law enforcement as early stage offenders and referred for precourt juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems.

  19. A Human Resource Inventory and Information System for Selected Illinois Community Colleges and Upper-Division Universities: A Feasibility Study.

    ERIC Educational Resources Information Center

    Wesley, Robert M.; And Others

    This report presents the results of a pilot study designed to test the feasibility and desirability of establishing a statewide human resources inventory and information system to support the community service role of Illinois community colleges and upper division universities. The information system would provide a centralized source of data on…

  20. Telephone Administration of the Aberrant Behavior Checklist: A Pilot Study of Feasibility in Children with Intellectual Disability and Autism

    ERIC Educational Resources Information Center

    Siegel, Matthew; Milligan, Briana; Stein, Hannah; Teer, Olivia; Smith, Kahsi A.

    2013-01-01

    To advance clinical care and research in children with intellectual disability and autism there is a growing need for efficient means to measure behavioral severity and response to treatment. The objective of this study was to assess the feasibility of telephone administration of the Aberrant Behavior Checklist-Irritability Subscale (ABC-I). The…

  1. Problem Solving in Relation to Resources in Everyday Life in Families of Children with Disabilities: A Pilot Study

    ERIC Educational Resources Information Center

    Ylven, Regina; Granlund, Mats; Persson, Carina

    2012-01-01

    Problem solving is recognized as a skill, helping families of children with disabilities to manage problems in everyday life. Family problem-solving skills may therefore be seen as an important outcome of a child and youth habilitation service. The aim of this pilot feasibility study was to examine the design of a future web-based questionnaire…

  2. Outcomes of an Acceptance and Commitment Therapy-Based Skills Training Group for Students with High-Functioning Autism Spectrum Disorder: A Quasi-Experimental Pilot Study

    ERIC Educational Resources Information Center

    Pahnke, Johan; Lundgren, Tobias; Hursti, Timo; Hirvikoski, Tatja

    2014-01-01

    Autism spectrum disorder is characterized by social impairments and behavioural inflexibility. In this pilot study, the feasibility and outcomes of a 6-week acceptance and commitment therapy-based skills training group were evaluated in a special school setting using a quasi-experimental design (acceptance and commitment therapy/school classes as…

  3. 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.

  4. Pilot study of enhanced tobacco-cessation services coverage for low-income smokers.

    PubMed

    Doescher, Mark P; Whinston, Melicent A; Goo, Alvin; Cummings, Diane; Huntington, Jane; Saver, Barry G

    2002-01-01

    This study explored the feasibility of covering nicotine replacement therapy (NRT) and paying for pharmacist-delivered smoking cessation counseling at the time of NRT pick-up for low-income, managed Medicaid and Basic Health Plan (a state insurance program) enrollees. A prospective pilot intervention was used at two community health centers (CHCs) and two community pharmacies. Participants were adult managed-Medicaid or Basic Health Plan enrollees who attended the pilot CHCs and smoked. An innovative insurance benefit that included coverage for NRT and $15 payment to the pharmacist to deliver cessation counseling with each prescription fill. Proportion of eligible patients who used the cessation benefit and patient and pharmacist satisfaction with the intervention. During the 9-month intervention, 32 patients at the pilot clinics were referred for NRT and pharmacist-delivered counseling. This number represented roughly 5% of eligible smokers. Of these, 26 received NRT with concomitant pharmacist-delivered cessation counseling at least once. Recipients reported a high level of satisfaction with this intervention. Pharmacists indicated they would continue providing counseling if reimbursement remained adequate and if counseling lasted no longer than 5-10 min. However, 12 (38%) who were referred were no longer insured by the sponsoring plan by the end of the 9-month pilot period. Pharmacist-delivered cessation counseling may be feasible and merits further study. More importantly, this pilot reveals two key obstacles in our low-income, culturally diverse setting: low participation and rapid turnover of insureds. Future interventions will need to address these barriers.

  5. Testing the Feasibility of Fidelity Evaluation in a Multisite, Multiprogram Initiative

    ERIC Educational Resources Information Center

    Cornish, Disa Lubker; Losch, Mary E.; Avery, Mitchell

    2016-01-01

    Monitoring fidelity of implementation is a critical task when initiating evidence-based programs. This pilot study sought to identify best practices in a fidelity monitoring process and determine the feasibility of continuing a fidelity monitoring process with a multisite, multiprogram initiative. A fidelity log was created for each of 11…

  6. A Pilot Study of Adjunctive Family Psychoeducation in Adolescent Major Depression: Feasibility and Treatment Effect

    ERIC Educational Resources Information Center

    Sanford, Mark; Boyle, Michael; McCleary, Lynn; Miller, Jennifer; Steele, Margaret; Duku, Eric; Offord, David

    2006-01-01

    Objective: To obtain preliminary evidence of the feasibility and effectiveness of adjunctive family psychoeducation in adolescent major depressive disorder. Method: Participants were from outpatient clinics in Hamilton and London, Ontario. Over 24 months, 41 adolescents ages 13 through 18 years meeting major depressive disorder criteria were…

  7. The Feasibility of Using the BrightHearts Biofeedback-Assisted Relaxation Application for the Management of Pediatric Procedural Pain: A Pilot Study.

    PubMed

    Burton, Karen L O; Morrow, Angela M; Beswick, Brooke V; Khut, George P

    2018-04-17

    The objective of this pilot study was to assess the acceptability and feasibility of using BrightHearts, a biofeedback-assisted relaxation application (app), in children undergoing painful procedures. Thirty children 7 to 18 years of age undergoing a medical procedure (peripheral blood collection, botulinum toxin injection, or intravenous cannula insertion) participated. Participants used BrightHearts, a heart rate-controlled biofeedback-assisted relaxation training app delivered via an iPad with heart rate measured through a pulse oximeter worn on the ear or thumb. Feasibility was assessed through observations and patient, parent/carer, and healthcare professional feedback. Patient, parent/carer, and healthcare professional satisfaction with BrightHearts was rated using investigator-developed surveys. Eighty-three percent of child participants reported that they found BrightHearts helpful during the procedure and that they would use BrightHearts again. All parents and 96% of healthcare professionals indicated they would use BrightHearts again. Sixty-four percent of healthcare providers perceived that BrightHearts assisted with the ease of performing the procedure. Qualitative analyses found 2 themes: (1) BrightHearts calms through providing distraction and biofeedback and (2) the impact of BrightHearts on the procedure. This pilot study demonstrates the feasibility of using biofeedback-assisted relaxation delivered via the BrightHearts app in children undergoing peripheral blood collection and cannulation. Future studies are required to evaluate BrightHearts' efficacy in reducing pain and anxiety during painful procedures and distinguish the effects of a biofeedback-mediated app from distraction. © 2018 World Institute of Pain.

  8. Centering prayer for women receiving chemotherapy for recurrent ovarian cancer: a pilot study.

    PubMed

    Johnson, Mary E; Dose, Ann M; Pipe, Teri Britt; Petersen, Wesley O; Huschka, Mashele; Gallenberg, Mary M; Peethambaram, Prema; Sloan, Jeff; Frost, Marlene H

    2009-07-01

    To explore the feasibility of implementing centering prayer in chemotherapy treatment and assess its influence on mood, spiritual well-being, and quality of life in women with recurrent ovarian cancer. Descriptive pilot study. Outpatient chemotherapy treatment suite in a large cancer center in the midwestern United States. A convenience sample of 10 women receiving outpatient chemotherapy for recurrent ovarian cancer. A centering prayer teacher led participants through three one-hour sessions over nine weeks. Data were collected prior to the first session, at the conclusion of the final session, and at three and six months after the final session. Feasibility and influence of centering prayer on mood, spiritual well-being, and quality of life. Most participants identified centering prayer as beneficial. Emotional well-being, anxiety, depression, and faith scores showed improvement. Centering prayer can potentially benefit women with recurrent ovarian cancer. Additional research is needed to assess its feasibility and effectiveness. Nurses may promote or suggest centering prayer as a feasible intervention for the psychological and spiritual adjustment of patients with recurrent ovarian cancer.

  9. Feasibility and Initial Effectiveness of Home Exercise During Maintenance Therapy for Childhood Acute Lymphoblastic Leukemia

    PubMed Central

    Esbenshade, Adam J.; Friedman, Debra L.; Smith, Webb A.; Jeha, Sima; Pui, Ching-Hon; Robison, Leslie L.; Ness, Kirsten K.

    2014-01-01

    Purpose Children with acute lymphoblastic leukemia (ALL) are at increased risk of obesity and deconditioning from cancer therapy. This pilot study assessed feasibility/initial efficacy of an exercise intervention for ALL patients undergoing maintenance therapy. Methods Participants were children with ALL, age 5-10 years, receiving maintenance therapy, in first remission. A 6-month home-based intervention, with written and video instruction, was supervised with weekly calls from an exercise coach. Pre- and post-study testing evaluated strength, flexibility, fitness and motor function. Results Seventeen patients enrolled (participation 63%). Twelve (71%) finished the intervention, completing 81.7±7.2% of prescribed sessions. Improvements ≥5% occurred in 67% for knee and 75% for grip strength, 58% for hamstring/low-back and 83% for ankle flexibility, 75% for the 6-minute-walk-test, and 33% for performance on the Bruininks-Oseretsky Test of Motor Proficiency Version 2. Conclusions This pilot study demonstrated that exercise intervention during ALL therapy is feasible and has promise for efficacy. PMID:24979081

  10. 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…

  11. Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

    ERIC Educational Resources Information Center

    Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

    2015-01-01

    Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses'…

  12. Impact of a pilot walking school bus intervention on children's pedestrian safety behaviors: a pilot study

    USDA-ARS?s Scientific Manuscript database

    Walking school buses (WSB) increased children's physical activity, but impact on pedestrian safety behaviors (PSB) is unknown. We tested the feasibility of a protocol evaluating changes to PSB during a WSB program. Outcomes were school-level street crossing PSB prior to (Time 1) and during weeks 4–5...

  13. Open-Trial Pilot of "Mind Reading" and in Vivo Rehearsal for Children with HFASD

    ERIC Educational Resources Information Center

    Thomeer, Marcus L.; Rodgers, Jonathan D.; Lopata, Christopher; McDonald, Christin A.; Volker, Martin A.; Toomey, Jennifer A.; Smith, Rachael A.; Gullo, Gaetano

    2011-01-01

    In this pilot study, the authors evaluated a manualized administration of the "Mind Reading" (MR) program with in vivo rehearsal to determine the effects on emotion recognition and autism features of eleven 7- to 12-year-old children with High-Functioning Autism Spectrum Disorders (HFASD), and to determine the overall feasibility of the…

  14. Mentoring in the Juvenile Justice System: Findings from Two Pilot Programs.

    ERIC Educational Resources Information Center

    Mecartney, Crystal A.; And Others

    This study examined two pilot mentoring programs which were designed to provide information on the feasibility of integrating mentoring relationships into the juvenile justice system. Each program, one in St. Louis, Missouri and one in Atlanta, Georgia, sought to recruit, train, and match 100 adult volunteers (half over the age of 55) with 100…

  15. 77 FR 18793 - Spectrum Sharing Innovation Test-Bed Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    .... 120322212-2212-01] Spectrum Sharing Innovation Test-Bed Pilot Program AGENCY: National Telecommunications... Innovation Test-Bed pilot program to assess whether devices employing Dynamic Spectrum Access techniques can... Spectrum Sharing Innovation Test-Bed (Test-Bed) pilot program to examine the feasibility of increased...

  16. Direct Verification of School Meal Applications with Medicaid Data: A Pilot Evaluation of Feasibility, Effectiveness and Costs

    ERIC Educational Resources Information Center

    Logan, Christopher W.; Cole, Nancy; Kamara, Sheku G.

    2010-01-01

    Purpose/Objectives: The Direct Verification Pilot tested the feasibility, effectiveness, and costs of using Medicaid and State Children's Health Insurance Program (SCHIP) data to verify applications for free and reduced-price (FRP) school meals instead of obtaining documentation from parents and guardians. Methods: The Direct Verification Pilot…

  17. Developing and pilot testing a shared decision-making intervention for dialysis choice.

    PubMed

    Finderup, Jeanette; Jensen, Jens K D; Lomborg, Kirsten

    2018-04-17

    Evidence is inconclusive on how best to guide the patient in decision-making around haemodialysis and peritoneal dialysis choice. International guidelines recommend involvement of the patient in the decision to choose the dialysis modality most suitable for the individual patient. Nevertheless, studies have shown lack of involvement of the patient in decision-making. To develop and pilot test an intervention for shared decision-making targeting the choice of dialysis modality. This study reflects the first two phases of a complex intervention design: phase 1, the development process and phase 2, feasibility and piloting. Because decision aids were a part of the intervention, the International Patient Decision Aid Standards were considered. The pilot test included both the intervention and the feasibility of the validated shared decision-making questionnaire (SDM Q9) and the Decision Quality Measure (DQM) applied to evaluate the intervention. A total of 137 patients tested the intervention. After the intervention, 80% of the patients chose dialysis at home reflecting an increase of 23% in starting dialysis at home prior to the study. The SDM Q9 showed the majority of the patients experienced this intervention as shared decision-making. An intervention based on shared decision-making supported by decision aids seemed to increase the number of patients choosing home dialysis. The SDM Q9 and DQM were feasible evaluation tools. Further research is needed to gain insight into the patients' experiences of involvement and the implications for their choice of dialysis modality. © 2018 European Dialysis and Transplant Nurses Association/European Renal Care Association.

  18. Pilot Testing of the NURSE Stress Management Intervention.

    PubMed

    Delaney, Colleen; Barrere, Cynthia; Robertson, Sue; Zahourek, Rothlyn; Diaz, Desiree; Lachapelle, Leeanne

    2016-12-01

    Student nurses experience significant stress during their education, which may contribute to illness and alterations in health, poor academic performance, and program attrition. The aim of this pilot study was to evaluate the feasibility and potential efficacy of an innovative stress management program in two baccalaureate nursing programs in Connecticut, named NURSE (Nurture nurse, Use resources, foster Resilience, Stress and Environment management), that assists nursing students to develop stress management plans. An explanatory sequential mixed-methods design was used to evaluate the effects of the intervention with 40 junior nursing students. Results from this study provide evidence that the NURSE intervention is highly feasible, and support further testing to examine the effect of the intervention in improving stress management in nursing students. © The Author(s) 2015.

  19. Development and feasibility study of very brief interventions for physical activity in primary care.

    PubMed

    Pears, Sally; Morton, Katie; Bijker, Maaike; Sutton, Stephen; Hardeman, Wendy

    2015-04-08

    There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which 'active ingredients' (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. Current Controlled Trials ISRCTN02863077. Registered 5 October 2012.

  20. Steps to Enhance Early Recovery After Hematopoietic Stem Cell Transplantation: Lessons Learned From a Physical Activity Feasibility Study.

    PubMed

    Hacker, Eileen Danaher; Peters, Tara; Patel, Pritesh; Rondelli, Damiano

    This pilot study tested and refined a free-living physical activity intervention. The investigators evaluated the acceptability and feasibility of the intervention after hematopoietic stem cell transplantation and determined preliminary effects on physical activity, fatigue, muscle strength, functional ability, and quality of life. This pilot study used a 1-group, pretest-posttest design. The free-living physical activity intervention consisted of an education component and 6 weeks of gradually increasing physical activity after discharge from the hospital. The intervention was designed to increase steps by 10% weekly. Subjects were assessed before transplantation and during the seventh week after discharge from the hospital after completing the intervention. Pretest-posttest scores were analyzed with paired t tests. Subject wore the physical activity tracker for an average of 38 of 42 days and met their physical activity goals 57% of the time. Subjects reported significantly less physical fatigue after the free-living physical activity intervention compared with baseline (P = .05). Improvements in quality of life approached significance (P = .06). The findings demonstrate that the free-living physical activity intervention implemented during the very early recovery period after transplantation is feasible and acceptable. The intervention potentially reduces fatigue and improves quality of life. The positive results must be interpreted cautiously given the pilot nature of the study. The evidence supports continued investigation.

  1. Web-Based Evidence Based Practice Educational Intervention to Improve EBP Competence among BSN-Prepared Pediatric Bedside Nurses: A Mixed Methods Pilot Study

    ERIC Educational Resources Information Center

    Laibhen-Parkes, Natasha

    2014-01-01

    For pediatric nurses, their competence in EBP is critical for providing high-quality care and maximizing patient outcomes. The purpose of this pilot study was to assess and refine a Web-based EBP educational intervention focused on improving EBP beliefs and competence in BSN-prepared pediatric bedside nurses, and to examine the feasibility,…

  2. 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…

  3. Bristol girls dance project feasibility study: using a pilot economic evaluation to inform design of a full trial

    PubMed Central

    Powell, Jane E; Carroll, Fran E; Sebire, Simon J; Haase, Anne M; Jago, Russell

    2013-01-01

    Background There is currently little guidance for pilot trial economic evaluation where health outcomes and costs are influenced by a range of wider determinants and factors. Objectives This article presents the findings of a pilot economic evaluation study running alongside the Bristol Girls Dance Project (BGDP) feasibility study. Design 3-arm, cluster randomised, controlled pilot trial and economic evaluation. 7 schools (n=210) from the Bristol and greater Bristol area, UK were randomly allocated to the intervention arm 3 schools (n=90) and the control arm 4 schools (n=120). Intervention Girls aged 11–12 years with parental consent were provided with two, 90 min dance sessions per week for 9 weeks at school facilities. Economic outcome measures Programme costs and girls’ preferences for attributes of dance and preferences for competing leisure time activities were measured. Results The mainstream average cost of the BGDP programme (not including research, control and dance teacher training costs) per school was $2126.40, £1329 and €1555 and per participant was $70.90, £44.31 and €51.84 in 2010–2011 prices. Discrete choice experiment (DCE) methods are acceptable to girls of this age indicating time available for other leisure activities on dance class days is the attribute girls valued most and 2 h leisure time remaining preferred to 3 h. Conclusions This pilot study indicates that providing full cost data for a future trial of the BGDP programme is feasible and practical. There is no evidence from preference data to support adjustment to intervention design. A future economic evaluation is likely to be successful utilising the resource use checklist developed. The importance of categorising separately resources used to develop, prepare, deliver and maintain the programme to estimate mainstream costs accurately is demonstrated. PMID:24362013

  4. Formative research on the feasibility of hygiene interventions for influenza control in UK primary schools.

    PubMed

    Schmidt, Wolf-Peter; Wloch, Catherine; Biran, Adam; Curtis, Val; Mangtani, Punam

    2009-10-15

    Interventions to increase hand washing in schools have been advocated as a means to reduce the transmission of pandemic influenza and other infections. However, the feasibility and acceptability of effective school-based hygiene interventions is not clear. A pilot study in four primary schools in East London was conducted to establish the current need for enhanced hand hygiene interventions, identify barriers to their implementation and to test their acceptability and feasibility. The pilot study included key informant interviews with teachers and school nurses, interviews, group discussions and essay questions with the children, and testing of organised classroom hand hygiene activities. In all schools, basic issues of personal hygiene were taught especially in the younger age groups. However, we identified many barriers to implementing intensive hygiene interventions, in particular time constraints and competing health issues. Teachers' motivation to teach hygiene and enforce hygienic behaviour was primarily educational rather than immediate infection control. Children of all age groups had good knowledge of hygiene practices and germ transmission. The pilot study showed that intensive hand hygiene interventions are feasible and acceptable but only temporarily during a period of a particular health threat such as an influenza pandemic, and only if rinse-free hand sanitisers are used. However, in many settings there may be logistical issues in providing all schools with an adequate supply. In the absence of evidence on effectiveness, the scope for enhanced hygiene interventions in schools in high income countries aiming at infection control appears to be limited in the absence of a severe public health threat.

  5. Formative research on the feasibility of hygiene interventions for influenza control in UK primary schools

    PubMed Central

    Schmidt, Wolf-Peter; Wloch, Catherine; Biran, Adam; Curtis, Val; Mangtani, Punam

    2009-01-01

    Background Interventions to increase hand washing in schools have been advocated as a means to reduce the transmission of pandemic influenza and other infections. However, the feasibility and acceptability of effective school-based hygiene interventions is not clear. Methods A pilot study in four primary schools in East London was conducted to establish the current need for enhanced hand hygiene interventions, identify barriers to their implementation and to test their acceptability and feasibility. The pilot study included key informant interviews with teachers and school nurses, interviews, group discussions and essay questions with the children, and testing of organised classroom hand hygiene activities. Results In all schools, basic issues of personal hygiene were taught especially in the younger age groups. However, we identified many barriers to implementing intensive hygiene interventions, in particular time constraints and competing health issues. Teachers' motivation to teach hygiene and enforce hygienic behaviour was primarily educational rather than immediate infection control. Children of all age groups had good knowledge of hygiene practices and germ transmission. Conclusion The pilot study showed that intensive hand hygiene interventions are feasible and acceptable but only temporarily during a period of a particular health threat such as an influenza pandemic, and only if rinse-free hand sanitisers are used. However, in many settings there may be logistical issues in providing all schools with an adequate supply. In the absence of evidence on effectiveness, the scope for enhanced hygiene interventions in schools in high income countries aiming at infection control appears to be limited in the absence of a severe public health threat. PMID:19832971

  6. Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

    PubMed Central

    Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

    2015-01-01

    Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses’ utilization of evidence-based engagement practices when referring youth to MHS. Participants were six school nurses and twenty-five adolescents in a large, urban school district. School nurses reported positive attitudes towards the EP, suggesting that they found it feasible and acceptable. Though there were small increases in school nurses’ use of engagement practices and in adolescents’ readiness for services following training, due to limited sample size, differences were not statistically significant. Still, pilot results suggest preliminary efficacy of training school nurses to strategically implement evidence-based engagement practices to increase adolescents’ engagement in MHS. PMID:26251671

  7. Being “SMART” about Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency

    PubMed Central

    August, Gerald J.; Piehler, Timothy F.; Bloomquist, Michael L.

    2014-01-01

    OBJECTIVE The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Towards this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. METHOD The SMART feasibility pilot study includes a sample of 100 youth (13–17 years of age) identified by law enforcement as early stage offenders and referred for pre-court juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. RESULTS Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. CONCLUSIONS The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems. PMID:25256135

  8. Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

    PubMed

    Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

    2014-12-23

    The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. ChiCTR-TRC-13003911. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  9. 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.

  10. Development of a tobacco cessation intervention for Alaska Native youth

    PubMed Central

    Patten, Christi A.; Fadahunsi, Oluwole; Hanza, Marcelo; Smith, Christina M.; Hughes, Christine A.; Brockman, Tabetha A.; Boyer, Rahnia; Decker, Paul A.; Luger, Elizabeth; Sinicrope, Pamela S.; Offord, Kenneth P.

    2013-01-01

    Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and acceptability of a targeted cessation intervention developed for AN youth. Intervention components were informed by prior focus groups assessing treatment preferences among AN youth, a social cognitive theoretical framework and feedback obtained from a teen advisory group. The intervention consisted of a weekend program where youth traveled by small airplane from their villages to stay overnight with other adolescents who quit tobacco use together. The program included recreational activities, talking circles, personal stories from elders and teen advisors, and cognitive behavioral counseling. Two intervention pilots were conducted from October 2010 to January 2011 using a non-randomized, uncontrolled study design with assessments at baseline and six-week follow-up. One village in Western Alaska was selected for each pilot with a targeted enrollment of 10 adolescents each. Participants were recruited for each pilot within five days, but recruitment challenges and ‘‘lessons learned’’ are described. The first pilot enrolled nine adolescents (all female) aged 13–16 years; all nine attended the intervention program and 78% (7/9) completed follow-up. The second pilot enrolled 12 adolescents (eight females, four males) aged 12–17 years, of which seven attended the intervention program. Six of these seven participants (86%) completed follow-up. In both pilots, participants rated the intervention as highly acceptable. A targeted cessation intervention was feasible and acceptable to AN youth. The intervention will be tested for efficacy in a subsequent randomized controlled trial. PMID:24058327

  11. Results of a Pilot Study to Ameliorate Psychological and Behavioral Outcomes of Minority Stress Among Young Gay and Bisexual Men.

    PubMed

    Smith, Nathan Grant; Hart, Trevor A; Kidwai, Ammaar; Vernon, Julia R G; Blais, Martin; Adam, Barry

    2017-09-01

    Project PRIDE (Promoting Resilience In Discriminatory Environments) is an 8-session small group intervention aimed at reducing negative mental and behavioral health outcomes resulting from minority stress. This study reports the results of a one-armed pilot test of Project PRIDE, which aimed to examine the feasibility and potential for efficacy of the intervention in a sample of 33 gay and bisexual men aged 18 to 25. The intervention appeared feasible to administer in two different sites and all participants who completed posttreatment (n = 22) or follow-up (n = 19) assessments reported high satisfaction with the intervention. Small to large effect sizes were observed for increases in self-esteem; small effect sizes were found for decreases in loneliness and decreases in minority stress variables; and small and medium effect sizes were found for reductions in alcohol use and number of sex partners, respectively. Overall, Project PRIDE appears to be a feasible intervention with promise of efficacy. Copyright © 2017. Published by Elsevier Ltd.

  12. Feasibility of interdisciplinary community-based fall risk screening.

    PubMed

    Elliott, Sharon J; Ivanescu, Andrada; Leland, Natalie E; Fogo, Jennifer; Painter, Jane A; Trujillo, Leonard G

    2012-01-01

    This pilot study examined the feasibility of (1) conducting interdisciplinary fall risk screens at a communitywide adult fall prevention event and (2) collecting preliminary follow-up data from people screened at the event about balance confidence and home and activity modifications made after receiving educational information at the event. We conducted a pilot study with pre- and posttesting (4-mo follow-up) with 35 community-dwelling adults ≥55 yr old. Approximately half the participants were at risk for falls. Most participants who anticipated making environmental or activity changes to reduce fall risk initiated changes (n = 8/11; 72.7%) during the 4-mo follow-up period. We found no significant difference in participants' balance confidence between baseline (median = 62.81) and follow-up (median = 64.06) as measured by the Activities-specific Balance Confidence scale. Conducting interdisciplinary fall risk screens at an adult fall prevention event is feasible and can facilitate environmental and behavior changes to reduce fall risk. Copyright © 2012 by the American Occupational Therapy Association, Inc.

  13. A pilot to examine the logistical and feasibility issues in testing deceased tissue donors for vCJD using tonsil as the analyte.

    PubMed

    Warwick, Ruth M; Armitage, W John; Chandrasekar, Akila; Mallinson, Gary; Poniatowski, Stefan; Clarkson, Anthony

    2012-03-01

    Transplanted tissues have transmitted transmissible spongiform encephalopathies and in the UK there have been more cases of variant Creutzfeldt-Jakob disease (vCJD) than elsewhere in the world. A pilot study was undertaken to look at the feasibility of testing for vCJD in deceased donors using tonsillar tissue. This pilot showed that obtaining consent for removal and testing tonsil tissue was feasible. Donor eligibility for inclusion in the pilot was limited to tissue donors from the National Health Service Blood and Transplant, Tissue Services and to donors shared with the Corneal Transplant Service Eye Banks. Obtaining tonsillar tissue in the immediate post-mortem period was limited by the presence of rigor mortis. Tonsillar tissue was suitable for routine analysis for the presence of prion associated with vCJD in deceased tissue donors. Production and processing of tissue was straightforward and a low assay background was obtained from most samples. Since palatine and lingual tonsil tissue can be obtained in pairs it was possible, in the majority of cases, to set aside an intact sample for confirmatory testing if required. In one instance a sample was reactive by Western blot. However, the pattern of reactivity was not typical for that obtained from vCJD patients. Unfortunately the sample was not of sufficient quality for the confirmatory test to provide a conclusive result.

  14. Pilot social feasibility study for the establishment of a public human umbilical cord blood stem cell bank in South Africa.

    PubMed

    Meissner-Roloff, Madelein; Young, Wendy; Rangaka, Isabella; Lombaard, Hennie; Dhai, Ames; Tsotsi, Norma; Pepper, Michael S

    2012-12-01

    There is a large unmet need in South Africa for bone marrow transplantation. Umbilical cord blood (UCB) is an important source of stem cells for the treatment of haematological and non-haematological diseases. Access to the two existing private umbilical cord blood stem cell banks (UCB SCBs) in South Africa is limited to individuals that can afford it, which further aggravates the ever increasing divide between families from different socio-economic classes. The problem is compounded by a severe global shortage of genetically compatible samples, representative of the South African demographics. Establishing a public human UCB SCB in South Africa would provide more South Africans with access to previously unavailable treatment in the form of affordable, genetically compatible stem cells for bone marrow transplantation. A public UCB SCB has many facets to consider, one of which is public preparedness and support for the bank. This was assessed in a social feasibility pilot study which is reported here. In addition to the findings of this social feasibility study, other important considerations for establishing a public human UCB SCB in SA include; (a) testing the samples for HIV and other infectious diseases (required for compliance with international regulatory standards); (b) flow cytometric analysis for enumeration of CD34+ UCB stem cells; (c) mapping of HLA genotypes/alleles; and (d) a study of the economic feasibility of this endeavour.The social feasibility study was conducted to gauge public preparedness and support for a public SCB through patient interviews and questionnaires. The process was dynamic due to its novel nature for interviewers and interviewees alike. Many obstacles were met and dealt with which lead to the compilation of results discussed here in the form of a pilot social feasibility study.In the South African context, we are faced with unique and rich challenges relating to cultural and religious differences that are further augmented by linguistic constraints, educational insufficiencies and logistical and administrative limitations. Complicating factors encountered during the informed consent process included cultural differences, religious practices, traditions and superstitions together with language constraints and an educational disparity.Despite many initial obstacles, preliminary results from the informed consent questionnaire were favourable with regard to the establishment of a public UCB SCB. These initial results prompted the revision of the questionnaire and interview process and the compilation of a more succinct and coherent definitive social feasibility study which will form a separate study and which we hope will ultimately assist in the decision of whether or not to establish a public UCB SCB in South Africa. Nevertheless, results from this pilot study appear to be favourable and highlight particular areas which could influence community support for a public SCB. Educating the general public with regard to the workings and benefits of public stem cell banking is the first step in determining the viability of such an undertaking-a unique and rich challenge in the South African context.

  15. A Pilot Study of an Intervention Designed to Promote Walking, Balance, and Self-Efficacy in Older Adults with Fear of Falling

    ERIC Educational Resources Information Center

    Dattilo, John; Martire, Lynn; Gottschall, Jinger; Weybright, Elizabeth

    2014-01-01

    There is a need to provide interventions that are of interest to older adults who are not inclined to participate in conventional exercise programs and that can improve balance and fear of falling. One purpose of this pilot study was to assess feasibility and acceptability of an eight-week (3x/wk, 90-minute sessions) multifaceted, small group,…

  16. Development and pilot testing of an intervention to promote care engagement and adherence among HIV-positive Kenyan MSM.

    PubMed

    Graham, Susan M; Micheni, Murugi; Kombo, Bernadette; Van Der Elst, Elisabeth M; Mugo, Peter M; Kivaya, Esther; Aunon, Frances; Kutner, Bryan; Sanders, Eduard J; Simoni, Jane M

    2015-12-01

    In many African settings, MSM are a stigmatized group whose access to and engagement in HIV care may be challenging. Our aim was to design a targeted, culturally appropriate intervention to promote care engagement and antiretroviral therapy (ART) adherence for MSM in coastal Kenya, and describe intervention safety, feasibility, and acceptability based upon a small pilot study. Based on qualitative work including in-depth interviews with HIV-positive MSM and focus groups with providers, we developed a tailored intervention and conducted a pilot test to refine intervention materials and procedures. The Shikamana intervention combines modified Next-Step Counseling by trained providers, support from a trained peer navigator, and tailored use of SMS messaging, phone calls, and discrete pill carriers. Providers, including counselors and clinicians, work together with peer navigators as a case management team. Forty HIV-positive MSM aged 19-51 participated in intervention development and testing. Six counselors, three clinical officers, and four MSM peers were trained in intervention procedures. Of 10 ART-naïve participants who enrolled in the pilot, eight completed follow-up with no adverse events reported. One participant was lost to follow-up after 2 months and another failed to initiate ART despite ongoing counseling. No adverse events were reported. Staff feedback and exit interviews rated the intervention as feasible and acceptable. This adherence support intervention tailored for Kenyan MSM was well tolerated, feasible, and acceptable in the pilot phase. A randomized controlled trial of a scaled-up programme to estimate intervention efficacy is ongoing.

  17. 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…

  18. Engaging Overweight Adolescents in a Health and Fitness Program Using Wearable Activity Trackers.

    PubMed

    Wilson, Marian; Ramsay, Samantha; Young, Kimberly J

    Our objectives were to (a) examine feasibility and receptivity of overweight adolescents joining a community-based group fitness program and (b) test preliminary efficacy of a 12-week pilot intervention designed to promote health, fitness, and self-efficacy for the identified teens. The 12-week fitness program for overweight adolescents was developed and included planned physical activities, nutrition classes, and goal-setting sessions. A one-group pre-/posttest study design evaluated 20 participants from grades 10 through 12 who enrolled in the program pilot study. Participants were given a wearable activity tracker that captured data using an Internet-based platform. Outcome measures included body mass index, screen time, fitness, and cardiovascular measures. A community fitness program for overweight adolescents was successfully implemented. High school students were receptive to the intervention and reported high program satisfaction. Positive effects included measurements of strength, systolic blood pressure, weight, and screen time behaviors. This study provides evidence to support the feasibility, acceptance, and preliminary effects of the pilot program with overweight adolescents. Copyright © 2017 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

  19. Patient-led training on patient safety: a pilot study to test the feasibility and acceptability of an educational intervention.

    PubMed

    Jha, V; Winterbottom, A; Symons, J; Thompson, Z; Quinton, N; Corrado, O J; Melville, C; Watt, I; Torgerson, D; Wright, J

    2013-09-01

    Training in patient safety is an important element of medical education. Most educational interventions on patient safety training adopt a 'health-professional lens' with limited consideration on the impact of safety lapses on the patient and their families and little or no involvement of patients in the design or delivery of the training. This paper describes a pilot study to test the feasibility and acceptability of implementing a patient-led educational intervention to facilitate safety training amongst newly qualified doctors. Patients and/or carers who had experienced harm during their care shared narratives of their stories with trainees; this was followed by a focused discussion on patient safety issues exploring the causes and consequences of safety incidents and lessons to be learned from these. The intervention, which will be further tested in an NIHR-funded randomised controlled trial (RCT), was successfully implemented into an existing training programme and found acceptance amongst the patients and trainees. The pilot study proved to be a useful step in refining the intervention for the RCT including identifying appropriate outcome measures and highlighting organisational issues.

  20. 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.

  1. An Educational Intervention to Train Professional Nurses in Promoting Patient Engagement: A Pilot Feasibility Study.

    PubMed

    Barello, Serena; Graffigna, Guendalina; Pitacco, Giuliana; Mislej, Maila; Cortale, Maurizio; Provenzi, Livio

    2016-01-01

    Introduction: Growing evidence recognizes that patients who are motivated to take an active role in their care can experience a range of health benefits and reduced healthcare costs. Nurses play a critical role in the effort to make patients fully engaged in their disease management. Trainings devoted to increase nurses' skills and knowledge to assess and promote patient engagement are today a medical education priority. To address this goal, we developed a program of nurse education training in patient engagement strategies (NET-PES). This paper presents pilot feasibility study and preliminary participants outcomes for NET-PES. Methods: This is a pilot feasibility study of a 2-session program on patient engagement designed to improve professional nurses' ability to engage chronic patients in their medical journey; the training mainly focused on passing patient engagement assessment skills to clinicians as a crucial mean to improve care experience. A pre-post pilot evaluation of NET-PES included 46 nurses working with chronic conditions. A course specific competence test has been developed and validated to measure patient engagement skills. The design included self-report questionnaire completed before and after the training for evaluation purposes. Participants met in a large group for didactic presentations and then they were split into small groups in which they used role-play and case discussion to reflect upon the value of patient engagement measurement in relation to difficult cases from own practice. Results: Forty-six nurses participated in the training program. The satisfaction questionnaire showed that the program met the educational objectives and was considered to be useful and relevant by the participants. Results demonstrated changes on clinicians' attitudes and skills in promoting engagement. Moreover, practitioners demonstrated increases on confidence regarding their ability to support their patients' engagement in the care process. Conclusions: Learning programs teaching nurses about patient engagement strategies and assessment measures in clinical practice are key in supporting the realization of patient engagement in healthcare. Training nurses in this area is feasible and accepted and might have an impact on their ability to engage patients in the chronic care journey. Due to the limitation of the research design, further research is needed to assess the effectiveness of such a program and to verify if the benefits envisaged in this pilot are maintained on a long-term perspective and to test results by employing a randomized control study design.

  2. Development and pilot evaluation of a clinic-based mHealth app referral service to support adult cancer survivors increase their participation in physical activity using publicly available mobile apps.

    PubMed

    Short, Camille E; Finlay, Amy; Sanders, Ilea; Maher, Carol

    2018-01-16

    Participation in regular physical activity holds key benefits for cancer survivors, yet few cancer survivors meet physical activity recommendations. This study aimed to develop and pilot test a mHealth app referral service aimed at assisting cancer survivors to increase their physical activity. In particular, the study sought to examine feasibility and acceptability of the service and determine preliminary efficacy for physical activity behaviour change. A systematic search identified potentially appropriate Apple (iOS) and Android mHealth apps. The apps were audited regarding the type of physical activity encouraged, evidence-based behavioural strategies and other characteristics, to help match apps to users' preferences and characteristics. A structured service was devised to deliver the apps and counselling, comprising two face-to-face appointments with a mid-week phone or email check-up. The mHealth app referral service was piloted using a pre-post design among 12 cancer survivors. Participants' feedback regarding the service's feasibility and acceptability was sought via purpose-designed questionnaire, and analysed using inductive thematic analysis and descriptive statistics. Change in physical activity was assessed using a valid and reliable self-report tool and analysed using paired t-tests. In line with recommendations for pilot studies, confidence intervals and effect sizes were reported to aid interpretation of clinical significance, with an alpha of 0.2 used to denote statistical significance. Of 374 mHealth apps identified during the systematic search, 54 progressed to the audit (iOS = 27, Android = 27). The apps consistently scored well for aesthetics, engagement and functionality, and inconsistently for gamification, social and behaviour change features. Ten participants completed the pilot evaluation and provided positive feedback regarding the service's acceptability and feasibility. On average, participants increased their moderate-vigorous physical activity by 236 min per week (d = 0.73; 95% CI = -49 to 522; p = 0.09). This study offered initial evidence that a mHealth app referral service for cancer survivors is feasible and acceptable and may increase physical activity levels. The large increase in physical activity is promising, but should be interpreted with caution given the small sample size and lack of control group. Further research is warranted on a larger scale to investigate generalisability, long-term compliance and application in clinical settings.

  3. Peer Mentoring for Male Parolees: A CBPR Pilot Study.

    PubMed

    Marlow, Elizabeth; Grajeda, William; Lee, Yema; Young, Earthy; Williams, Malcolm; Hill, Karen

    2015-01-01

    Formerly incarcerated adults are impoverished, have high rates of substance use disorders, and have long histories of imprisonment. This article describes the development of a peer mentoring program for formerly incarcerated adults and the pilot study designed to evaluate it. The research team, which included formerly incarcerated adults and academic researchers, developed the peer mentoring program to support formerly incarcerated adults' transition to the community after prison. The purposes of the pilot evaluation study were to (1) assess the feasibility of implementing a peer-based intervention for recently released men developed using a community-based participatory research (CBPR) approach; (2) establish preliminary data on the program's impact on coping, self-esteem, abstinence self-efficacy, social support, and participation in 12-step meetings; and (3) establish a CBPR team of formerly incarcerated adults and academic researchers to develop, implement, and test interventions for this population. This pilot evaluation study employed a mixed-methods approach with a single group pretest/posttest design with 20 men on parole released from prison within the last 30 days. Quantitative findings showed significant improvement on two abstinence self-efficacy subscales, negative affect and habitual craving. Qualitative findings revealed the relevance and acceptance of peer mentoring for this population. This study demonstrated the feasibility and import of involving formerly incarcerated adults in the design, implementation, and testing of interventions intended to support their reintegration efforts.

  4. Congestive heart failure adherence redesign trial: a pilot study.

    PubMed

    Mangla, Ashvarya; Doukky, Rami; Powell, Lynda H; Avery, Elizabeth; Richardson, DeJuran; Calvin, James E

    2014-12-04

    Heart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study. A large tertiary care medical centre in Chicago. Low-income patients (80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention. This pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. Task Order 7. Use of activated carbon for treatment of explosives-contaminated groundwater at the Milan Army Ammunition Plant (MAAP). Final report, Apr 89-May 90

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dennis, R.M.; Wujcik, W.J.; Lowe, W.L.

    1990-05-01

    The primary objective of this task was to determine the feasibility of using GAC to treat ground water contaminated by explosives at the Milan Army Ammunition Plant (MAAP) in Milan, Tennessee. Laboratory GAC isotherm studies were conducted and two carbons, Atochem, Inc. GAC 830 and Calgon Filtrasorb 300, were selected for further testing in continuous flow GAC columns. Three pilot scale continuous flow GAC column tests were performed at MAAP using the two carbons selected from the laboratory GAC isotherm studies. The results from the laboratory and pilot studies are presented in this report. They show that concurrent removal ofmore » explosives such as TNT, RDX, HMX, Tetryl, and nitrobenzenes from ground water using continuous flow granular activated carbon is feasible.« less

  6. Low-dose aspirin in polycythaemia vera: a pilot study. Gruppo Italiano Studio Policitemia (GISP).

    PubMed

    1997-05-01

    In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males. aged 17-80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 +/- 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.

  7. "Body Morph": Feasibility Testing of an Interactive CD-ROM to Teach Young Adolescents about Puberty

    ERIC Educational Resources Information Center

    Cousineau, Tara M.; Franko, Debra L.; Green, Traci C.; Watt, Meredith; Rancourt, Diana

    2006-01-01

    The aim of this pilot study was to examine the feasibility of an interactive computer program among 34 sixth and seventh grade children and to assess the potential for knowledge acquisition about puberty. Based on a developmental self-esteem approach to teach children about their bodies, the "Body Morph" program was designed to maximize the…

  8. Brief Report: The Feasibility and Effectiveness of an Advocacy Program for Latino Families of Children with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Burke, Meghan M.; Magaña, Sandra; Garcia, Marlene; Mello, Maria P.

    2016-01-01

    Latino, Spanish-speaking families of children with autism spectrum disorder (ASD) face unique barriers in special education advocacy. Although advocacy programs are becoming more common in the United States, none of these programs target Latino families. This is a pilot study to examine the feasibility and effectiveness of an advocacy program for…

  9. Pregnancy Prevention at Her Fingertips: A Text- and Mobile Video-Based Pilot Intervention to Promote Contraceptive Methods among College Women

    ERIC Educational Resources Information Center

    Walsh-Buhi, Eric R.; Helmy, Hannah; Harsch, Kristin; Rella, Natalie; Godcharles, Cheryl; Ogunrunde, Adejoke; Lopez Castillo, Humberto

    2016-01-01

    Objective: This paper reports on a pilot study evaluating the feasibility and acceptability of a text- and mobile video-based intervention to educate women and men attending college about non-daily contraception, with a particular focus on long-acting reversible contraception (LARC). A secondary objective is to describe the process of intervention…

  10. Results of the promoting effective advance care planning for elders (PEACE) randomized pilot study.

    PubMed

    Radwany, Steven M; Hazelett, Susan E; Allen, Kyle R; Kropp, Denise J; Ertle, Denise; Albanese, Teresa H; Fosnight, Susan M; Moore, Pamela S

    2014-04-01

    The specific aim of the PEACE pilot study was to determine the feasibility of a fully powered study to test the effectiveness of an in-home geriatrics/palliative care interdisciplinary care management intervention for improving measures of utilization, quality of care, and quality of life in enrollees of Ohio's community-based long-term care Medicaid waiver program, PASSPORT. This was a randomized pilot study (n=40 intervention [IG], n=40 usual care) involving new enrollees into PASSPORT who were >60 years old. This was an in-home interdisciplinary chronic illness care management intervention by PASSPORT care managers collaborating with a hospital-based geriatrics/palliative care specialist team and the consumer's primary care physician. This pilot was not powered to test hypotheses; instead, it was hypothesis generating. Primary outcomes measured symptom control, mood, decision making, spirituality, and quality of life. Little difference was seen in primary outcomes; however, utilization favored the IG. At 12 months, the IG had fewer hospital visits (50% vs. 55%, P=0.65) and fewer nursing facility admissions (22.5% vs. 32.5%, P=0.32). Using hospital-based specialists interfacing with a community agency to provide a team-based approach to care of consumers with chronic illnesses was found to be feasible. Lack of change in symptom control or quality of life outcome measures may be related to the tools used, as these were validated in populations closer to the end of life. Data from this pilot study will be used to calculate the sample size needed for a fully powered trial.

  11. Perceptions of Adolescents With Cancer Related to a Pain Management App and Its Evaluation: Qualitative Study Nested Within a Multicenter Pilot Feasibility Study

    PubMed Central

    Stevens, Bonnie J; Nathan, Paul C; Seto, Emily; Cafazzo, Joseph A; Johnston, Donna L; Hum, Vanessa; Stinson, Jennifer N

    2018-01-01

    Background Pain in adolescents with cancer is common and negatively impacts health-related quality of life. The Pain Squad+ smartphone app, capable of providing adolescents with real-time pain management support, was developed to enhance pain management using a phased approach (ie, systematic review, consensus conference and vetting, iterative usability testing cycles). A 28-day Pain Squad+ pilot was conducted with 40 adolescents with cancer to evaluate the feasibility of implementing the app in a future clinical trial and to obtain estimates of treatment effect. Objective The objective of our nested qualitative study was to elucidate the perceptions of adolescents with cancer to determine the acceptability and perceived helpfulness of Pain Squad+, suggestions for app improvement, and satisfaction with the pilot study protocol. Methods Post pilot study participation, telephone-based, semistructured, and audio-recorded exit interviews were conducted with 20 adolescents with cancer (12-18 years). All interviews were transcribed and independently coded by 2 study team members. Content analysis was conducted to identify data categories and overarching themes. Results Five major themes comprising multiple categories and codes emerged. These themes focused on the acceptability of the intervention, acceptability of the study, the perceived active ingredients of the intervention, the suitability of the intervention to adolescents’ lives, and recommendations for intervention improvement. Conclusions Overall, Pain Squad+ and the pilot study protocol were acceptable to adolescents with cancer. Suggestions for intervention and study improvements will be incorporated into the design of a future randomized clinical trial (RCT) aimed at assessing the effectiveness of Pain Squad+ on adolescents with cancer health outcomes. PMID:29625951

  12. An eHealth Intervention for Patients in Rural Areas: Preliminary Findings From a Pilot Feasibility Study

    PubMed Central

    Schrader, Geoffrey; Harris, Melanie; Newman, Lareen; Lynn, Sarah; Peterson, Leigh; Battersby, Malcolm

    2014-01-01

    Background eHealth facilitation of chronic disease management has potential to increase engagement and effectiveness and extend access to care in rural areas. Objective The objective of this study was to demonstrate the feasibility and acceptability of an eHealth system for the management of chronic conditions in a rural setting. Methods We developed an online management program which incorporated content from the Flinders Chronic Condition Management Program (Flinders Program) and used an existing software platform (goACT), which is accessible by patients and health care workers using either Web-enabled mobile phone or Internet, enabling communication between patients and clinicians. We analyzed the impact of this eHealth system using qualitative and simple quantitative methods. Results The eHealth system was piloted with 8 recently hospitalized patients from rural areas, average age 63 (SD 9) years, each with an average of 5 chronic conditions and high level of psychological distress with an average K10 score of 32.20 (SD 5.81). Study participants interacted with the eHealth system. The average number of logins to the eHealth system by the study participants was 26.4 (SD 23.5) over 29 weeks. The login activity was higher early in the week. Conclusions The pilot demonstrated the feasibility of implementing and delivering a chronic disease management program using a Web-based patient-clinician application. A qualitative analysis revealed burden of illness and low levels of information technology literacy as barriers to patient engagement. PMID:24927511

  13. An eHealth Intervention for Patients in Rural Areas: Preliminary Findings From a Pilot Feasibility Study.

    PubMed

    Schrader, Geoffrey; Bidargaddi, Niranjan; Harris, Melanie; Newman, Lareen; Lynn, Sarah; Peterson, Leigh; Battersby, Malcolm

    2014-06-12

    eHealth facilitation of chronic disease management has potential to increase engagement and effectiveness and extend access to care in rural areas. The objective of this study was to demonstrate the feasibility and acceptability of an eHealth system for the management of chronic conditions in a rural setting. We developed an online management program which incorporated content from the Flinders Chronic Condition Management Program (Flinders Program) and used an existing software platform (goACT), which is accessible by patients and health care workers using either Web-enabled mobile phone or Internet, enabling communication between patients and clinicians. We analyzed the impact of this eHealth system using qualitative and simple quantitative methods. The eHealth system was piloted with 8 recently hospitalized patients from rural areas, average age 63 (SD 9) years, each with an average of 5 chronic conditions and high level of psychological distress with an average K10 score of 32.20 (SD 5.81). Study participants interacted with the eHealth system. The average number of logins to the eHealth system by the study participants was 26.4 (SD 23.5) over 29 weeks. The login activity was higher early in the week. The pilot demonstrated the feasibility of implementing and delivering a chronic disease management program using a Web-based patient-clinician application. A qualitative analysis revealed burden of illness and low levels of information technology literacy as barriers to patient engagement.

  14. Advanced Low Temperature Geothermal Power Cycles (The ENTIV Organic Project) Final Report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mugerwa, Michael

    2015-11-18

    Feasibility study of advanced low temperature thermal power cycles for the Entiv Organic Project. Study evaluates amonia-water mixed working fluid energy conversion processes developed and licensed under Kalex in comparison with Kalina cycles. Both cycles are developed using low temperature thermal resource from the Lower Klamath Lake Geothermal Area. An economic feasibility evaluation was conducted for a pilot plant which was deemed unfeasible by the Project Sponsor (Entiv).

  15. Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK

    PubMed Central

    Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

    2017-01-01

    Objectives To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Design Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. Setting 2 private herbal practices in the UK. Participants 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. Intervention 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Main outcome measures Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Results Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. Conclusions A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. Trial registration number ISRCTN 31072075; Results. PMID:28159846

  16. Comprehension of confidence intervals - development and piloting of patient information materials for people with multiple sclerosis: qualitative study and pilot randomised controlled trial.

    PubMed

    Rahn, Anne C; Backhus, Imke; Fuest, Franz; Riemann-Lorenz, Karin; Köpke, Sascha; van de Roemer, Adrianus; Mühlhauser, Ingrid; Heesen, Christoph

    2016-09-20

    Presentation of confidence intervals alongside information about treatment effects can support informed treatment choices in people with multiple sclerosis. We aimed to develop and pilot-test different written patient information materials explaining confidence intervals in people with relapsing-remitting multiple sclerosis. Further, a questionnaire on comprehension of confidence intervals was developed and piloted. We developed different patient information versions aiming to explain confidence intervals. We used an illustrative example to test three different approaches: (1) short version, (2) "average weight" version and (3) "worm prophylaxis" version. Interviews were conducted using think-aloud and teach-back approaches to test feasibility and analysed using qualitative content analysis. To assess comprehension of confidence intervals, a six-item multiple choice questionnaire was developed and tested in a pilot randomised controlled trial using the online survey software UNIPARK. Here, the average weight version (intervention group) was tested against a standard patient information version on confidence intervals (control group). People with multiple sclerosis were invited to take part using existing mailing-lists of people with multiple sclerosis in Germany and were randomised using the UNIPARK algorithm. Participants were blinded towards group allocation. Primary endpoint was comprehension of confidence intervals, assessed with the six-item multiple choice questionnaire with six points representing perfect knowledge. Feasibility of the patient information versions was tested with 16 people with multiple sclerosis. For the pilot randomised controlled trial, 64 people with multiple sclerosis were randomised (intervention group: n = 36; control group: n = 28). More questions were answered correctly in the intervention group compared to the control group (mean 4.8 vs 3.8, mean difference 1.1 (95 % CI 0.42-1.69), p = 0.002). The questionnaire's internal consistency was moderate (Cronbach's alpha = 0.56). The pilot-phase shows promising results concerning acceptability and feasibility. Pilot randomised controlled trial results indicate that the patient information is well understood and that knowledge gain on confidence intervals can be assessed with a set of six questions. German Clinical Trials Register: DRKS00008561 . Registered 8th of June 2015.

  17. A pilot study of delivering peer health messages in an HIV clinic via mobile media.

    PubMed

    Winstead-Derlega, Christopher; Rafaly, Mary; Delgado, Sarah; Freeman, Jason; Cutitta, Katherine; Miles, Tony; Ingersoll, Karen; Dillingham, Rebecca

    2012-01-01

    This pilot study tested the feasibility and impact of using mobile media devices to present peer health messages to human immunodeficiency virus (HIV)-positive patients. A convenience sample of 30 adult patients from an outpatient HIV clinic serving a mostly rural catchment area in central Virginia volunteered for the study. Participants viewed short videos of people discussing HIV health topics on an Apple (Cupertino, CA) iPod® touch® mobile device. Pre- and post-intervention surveys assessed attitudes related to engagement in care and disease disclosure. Participants found delivery of health information by the mobile device acceptable in a clinic setting. They used the technology without difficulty. Participants reported satisfaction with and future interest in viewing such videos after using the mobile devices. The majority of participants used the device to access more videos than requested, and many reported the videos "hit home." There were no significant changes in participant perceptions about engagement in care or HIV disclosure after the intervention. This pilot study demonstrates the feasibility and acceptability of using mobile media technology to deliver peer health messages. Future research should explore how to best use mobile media to improve engagement in care and reduce perceptions of stigma.

  18. Using video feedback to improve early father-infant interaction: a pilot study.

    PubMed

    Lawrence, Peter J; Davies, Beverley; Ramchandani, Paul G

    2013-01-01

    Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child's thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers' feedback was generally positive. The flexibility to conduct sessions at home (or at fathers' places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers.

  19. Travel Virginia

    DOT National Transportation Integrated Search

    2000-01-01

    Prepared ca. 2000. This report summarizes the results of a fifteen-month study to assess the feasibility of expanding Travel Shenandoah, a pilot rural ATIS service developed for Virginia's Northern Shenandoah Valley, into a comprehensive, statewide s...

  20. Feasibility and Acceptability of a Gardening-Based Nutrition Education Program in Preschoolers from Low-Income, Minority Populations

    ERIC Educational Resources Information Center

    Sharma, Shreela V.; Hedberg, Ann Marie; Skala, Katherine A.; Chuang, Ru-Jye; Lewis, Tamara

    2015-01-01

    Garden-based lessons are gaining popularity as a means of increasing fruit and vegetable intake among children. The study objective was to pilot test a garden-based preschool curriculum for feasibility and acceptability in Harris County Department of Education Head Start using qualitative and quantitative methods. A total of 103, 3- to 5-year-old…

  1. Feasibility of a home-based program to improve handwriting after stroke: a pilot study.

    PubMed

    Simpson, Bronwyn; McCluskey, Annie; Lannin, Natasha; Cordier, Reinie

    2016-01-01

    To test the feasibility of a handwriting retraining program with adults after stroke; specifically the feasibility of: (i) recruiting people with stroke to the study, (ii) delivering the handwriting retraining program and (iii) outcome measures of handwriting performance. A quasi-experimental pre-test post-test design was used. A four-week, home-based handwriting retraining program was delivered by an occupational therapist using task-specific practice. Legibility, speed, pen control and self-perception of handwriting were measured at baseline and completion of the program. Legibility was scored by a blinded rater. Seven adults with stroke were recruited (eligibility fraction 43% of those screened, and enrolment fraction 78% of those eligible). There were no dropouts. Although, recruitment was slow the intervention was feasible and acceptable to adults with stroke. No statistically or clinically significant changes in legibility were reported in this small sample, but a ceiling effect was evident for some outcome measures. The study was not powered to determine efficacy. Delivery of a four-week handwriting intervention with eight supervised sessions in the community was feasible; however, recruitment of an adequate sample size would require greater investment than the single site used in this pilot. Handwriting difficulty is common following hemiparesis after stroke, however research addressing handwriting retraining for adults with stroke is lacking. A four-week home-based handwriting program using task-specific practice and feedback was feasible to deliver and appropriate for adults with stroke. Improving handwriting legibility and neatness across a range of tasks were important goals for adults with handwriting impairment.

  2. Model driver screening and evaluation program. Volume 2, Maryland pilot older driver study

    DOT National Transportation Integrated Search

    2003-05-01

    This research project studied the feasibility as well as the scientific validity and utility of performing functional capacity screening with older drivers. A Model Program was described encompassing procedures to detect functionally impaired drivers...

  3. Impact of a pilot walking school bus intervention on children's pedestrian safety behaviors: a pilot study.

    PubMed

    Mendoza, Jason A; Watson, Kathy; Chen, Tzu-An; Baranowski, Tom; Nicklas, Theresa A; Uscanga, Doris K; Hanfling, Marcus J

    2012-01-01

    Walking school buses (WSB) increased children's physical activity, but impact on pedestrian safety behaviors (PSB) is unknown. We tested the feasibility of a protocol evaluating changes to PSB during a WSB program. Outcomes were school-level street crossing PSB prior to (Time 1) and during weeks 4-5 (Time 2) of the WSB. The protocol collected 1252 observations at Time 1 and 2548 at Time 2. Mixed model analyses yielded: intervention schoolchildren had 5-fold higher odds (p<0.01) of crossing at the corner/crosswalk but 5-fold lower odds (p<0.01) of stopping at the curb. The protocol appears feasible for documenting changes to school-level PSB. Copyright © 2011 Elsevier Ltd. All rights reserved.

  4. Promoting self-transcendence and well-being in community-dwelling older adults: A pilot study of a psychoeducational intervention.

    PubMed

    McCarthy, Valerie Lander; Ling, Jiying; Bowland, Sharon; Hall, Lynne A; Connelly, Jennifer

    2015-01-01

    Self-transcendence changes how older adults perceive themselves, their relationships with others, the material world, and the metaphysical or spiritual dimension. It is associated with multiple indicators of well-being. The purpose of this pilot study (N = 20) was to examine the feasibility and effectiveness of a psychoeducational intervention to increase self-transcendence and well-being in older adults. Data were analyzed using generalized estimating equations. All variables trended in the directions hypothesized. Self-transcendence increased in the intervention group and decreased in the control group but not significantly. The group × time interaction for life satisfaction was significant (z = 2.89, p = .004). This feasibility study supports further investigation to assess the effectiveness of the intervention in a larger sample. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study.

    PubMed

    Reese, Hannah E; Vallejo, Zayda; Rasmussen, Jessica; Crowe, Katherine; Rosenfield, Elizabeth; Wilhelm, Sabine

    2015-03-01

    In this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD. Eighteen individuals age 16-67 completed an uncontrolled open trial of MBSR-tics. The intervention consisted of 8 weekly 2-hour classes and one 4hour retreat in the fifth or sixth week of the program. Symptomatic assessments were performed at baseline, post-treatment, and one-month follow-up. MBSR-tics proved to be a feasible and acceptable intervention. It resulted in significant improvement in tic severity and tic-related impairment. 58.8% of subjects were deemed treatment responders. Therapeutic gains were maintained at 1-month follow-up. Improvements in tic severity were correlated with increases in self-reported levels of mindfulness. This small open pilot study provides preliminary support for the feasibility, acceptability, and efficacy of MBSR-tics for individuals 16 or older with TS or CTD. A larger randomized controlled trial with blind assessment is necessary to confirm these initial, promising findings. Trial Registration Partners Clinical Trials Registry Number 2011P000606 (clinicaltrials.partners.org). Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Feasibility of a combined aerobic and strength training program and its effects on cognitive and physical function in institutionalized dementia patients. A pilot study.

    PubMed

    Bossers, Willem J R; Scherder, Erik J A; Boersma, Froukje; Hortobágyi, Tibor; van der Woude, Lucas H V; van Heuvelen, Marieke J G

    2014-01-01

    We examined the feasibility of a combined aerobic and strength training program in institutionalized dementia patients and studied the effects on cognitive and physical function. Thirty-three patients with dementia, recruited from one nursing home, participated in this non-randomized pilot study (25 women; age = 85.2±4.9 years; Mini Mental State Examination = 16.8±4.0). In phase 1 of the study, seventeen patients in the Exercise group (EG) received a combined aerobic and strength training program for six weeks, five times per week, 30 minutes per session, in an individually supervised format and successfully concluded the pre and posttests. In phase 2 of the study, sixteen patients in the Social group (SG) received social visits at the same frequency, duration, and format and successfully concluded the pre and posttests. Indices of feasibility showed that the recruitment and adherence rate, respectively were 46.2% and 86.3%. All EG patients completed the exercise program according to protocol without adverse events. After the six-week program, no significant differences on cognitive function tests were found between the EG and SG. There was a moderate effect size in favor for the EG for the Visual Memory Span Forward; a visual attention test. There were significant differences between groups in favor for the EG with moderate to large effects for the physical tests Walking Speed (p = .003), Six-Minute Walk Test (p = .031), and isometric quadriceps strength (p = .012). The present pilot study showed that it is feasible to conduct a combined aerobic and strength training program in institutionalized patients with dementia. The selective cognitive visual attention improvements and more robust changes in motor function in favor of EG vs. SG could serve as a basis for large randomized clinical trials. trialregister.nl 1230.

  7. Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

    PubMed

    Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

    2014-01-01

    Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Joint distraction for thumb carpometacarpal osteoarthritis: a feasibility study with 1-year follow-up.

    PubMed

    Spaans, Anne J; Minnen, L Paul van; Braakenburg, Assa; Mink van der Molen, Aebele B

    2017-08-01

    The purpose of this pilot study was to evaluate the feasibility of joint distraction of the first carpometacarpal (CMC1) joint in patients with CMC1 osteoarthritis (OA). An external joint distractor was placed over the CMC1 joint by K-wire fixation in the trapezium and the metacarpal. The joint was distracted 3 mm during surgery. The device was then kept in place for 8 weeks. Disabilities of the Arm, Shoulder, and Hand (DASH) score, Michigan Hand Outcome Questionnaire (MHQ), Visual Analogue Scale (VAS), and grip strength were recorded preoperatively and at set postoperative intervals. Five female patients with an average age of 53 years (range = 41-61) were included. One year postoperatively, average DASH, MHQ, and VAS scores improved compared to preoperative values; DASH 53 to 27, MHQ 48 to 76, and VAS pain 48 to 14. There were no technical problems associated with the device. One patient had a local pin site infection treated successfully with oral antibiotics. This study concludes that joint distraction of the osteoarthritic CMC1 joint is technically feasible. In this small, prospective pilot study the majority of the results were favourable during short-term follow-up.

  9. Feasibility and Pilot Study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) Project

    PubMed Central

    Sun, Lena S.; Li, Guohua; DiMaggio, Charles J.; Byrne, Mary W.; Ing, Caleb; Miller, Tonya LK; Bellinger, David C.; Han, Sena; McGowan, Francis X.

    2012-01-01

    Background Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induce neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been performed using existing datasets, and produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at Columbia University Medical Center (CUMC) and Children’s Hospital of Boston (CHB) for the PANDA project. Methods The PANDA project uses an ambi-directional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs ages 6–11 years old. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair prior to age 36 months and the unexposed siblings had no anesthesia before age 36 months. All sibling pairs were English speaking and were 36 weeks gestational age or greater. Each sibling pair underwent direct testing using WASI and NEPSY II, and the parents completed questionnaires related to behavior using CBCL and Conners’ rating. Data are presented as means ± SD. We conducted descriptive analyses of demographic data. We compared exposed and unexposed sibling groups on WASI and NEPSY II, and total and T-scores from CBCL and Conners’ as continuous data by paired t test between. A P< 0.05 was considered significant. Results Following IRB approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. Scores for verbal IQ (Exposed=106.1±16.3,Unexposed=109.2±17.9), performance IQ (Exposed=109.1±16.0, Unexposed=113.9±15.9) and full IQ (Exposed=108.2±14.0, Unexposed=112.8±16.8) were comparable between siblings. There were no differences between the two groups in T scores for any of the NEPSY II sub-domains, CBCL or Conners’. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). Conclusions The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach, and yielded pilot data from neuropsychological testing. PMID:23076226

  10. “Is Your Man Stepping Out?” An online pilot study to evaluate acceptability of a guide-enhanced HIV prevention soap opera video series and feasibility of recruitment by Facebook© advertising

    PubMed Central

    Jones, Rachel; Lacroix, Lorraine J.; Nolte, Kerry

    2015-01-01

    Love, Sex, and Choices (LSC) is a 12-episode soap opera video series developed to reduce HIV risk among at-risk Black urban women. We added a video guide commentator to offer insights at critical dramatic moments. An online pilot study evaluated acceptability of the Guide Enhanced LSC (GELSC) and feasibility of Facebook© advertising, streaming to smartphones, and retention. Facebook© ads targeted high HIV-prevalence areas. In 30 days, Facebook© ads generated 230 screening interviews; 84 were high risk, 40 watched GELSC, and 39 followed up at 30 days. Recruitment of high-risk participants was 10 per week compared to 7 per week in previous field recruitment. Half the sample was Black; 12% were Latina. Findings suggest GELSC influenced sex scripts and behaviors. It was feasible to recruit young urban women from a large geographic area via Facebook© and to retain the sample. We extended the reach to at-risk women by streaming to mobile devices. PMID:26066692

  11. Moms growing together: Piloting action methods and expressive arts in a therapeutic group for teen mothers.

    PubMed

    SmithBattle, Lee; Chantamit-O-Pas, Chutima; Freed, Patricia; McLaughlin, Dorcas; Schneider, Joanne K

    2017-05-01

    The purpose of this pilot study was to test the safety, acceptability, feasibility, and effectiveness of Moms Growing Together (MGT), an intervention to prevent and reduce psychological distress in teen mothers. A mixed method design was used. The primary outcomes were reported satisfaction with MGT (acceptance); successful recruitment and retention of teen mothers (feasibility); and prevention or reduction of psychological distress (safety and effectiveness). Summary scores on each of three symptom measures operationally defined psychological distress. Sixteen African-American teen mothers participated in the study: eight in MGT and eight in a comparison group. MGT was considered safe and acceptable. MGT had a negative small effect (effect size [ES] = -0.028) on decreasing depression in participants and a moderate effect in reducing anxiety (ES = 0.395) and trauma symptoms (ES = 0.521-0.554) relative to the comparison group. Prolonged recruitment limited feasibility. Because psychological distress casts a long shadow on teen mothers' well-being, developing teen-friendly clinical programs that address their mental health is a high priority. © 2017 Wiley Periodicals, Inc.

  12. Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care.

    PubMed

    Avery, Leah; Sniehotta, Falko F; Denton, Sarah J; Steen, Nick; McColl, Elaine; Taylor, Roy; Trenell, Michael I

    2014-02-03

    Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012.

  13. Feasibility Pilot Study: Training Soft Skills in Virtual Worlds.

    PubMed

    Abshier, Patricia

    2012-04-01

    In a world where funding is limited, training for healthcare professionals is turning more and more to distance learning in an effort to maintain a knowledgeable and skilled work force. In 2010, Cicatelli Associates, Inc. began exploring the feasibility of using games and virtual worlds as an alternative means to teach skills-training in a distance-learning environment. The pilot study was conducted with six individuals familiar with general counseling and communication skills used by the healthcare industry to promote behavior change. Participants reported that the venue, although challenging at first, showed great potential for use with healthcare providers, as it allowed for more interaction and activities than traditional Webinars. However, there are significant limitations that must be overcome in order for this healthcare training modality to be utilized on a large scale. These limitations included a lack of microgestures and issues regarding the technology being used. In spite of the limitations, however, the potential use of virtual worlds for the training of healthcare providers exists and should be researched further. This article discusses the need and intended benefits of virtual world training as well as the results and conclusions of the pilot study.

  14. Adapting and Pilot Testing a Parenting Intervention for Homeless Families in Transitional Housing.

    PubMed

    Holtrop, Kendal; Holcomb, Jamila E

    2018-01-24

    Intervention adaptation is a promising approach for extending the reach of evidence-based interventions to underserved families. One highly relevant population in need of services are homeless families. In particular, homeless families with children constitute more than one third of the total homeless population in the United States and face several unique challenges to parenting. The purpose of this study was to adapt and pilot test a parenting intervention for homeless families in transitional housing. An established adaptation model was used to guide this process. The systematic adaptation efforts included: (a) examining the theory of change in the original intervention, (b) identifying population differences relevant to homeless families in transitional housing, (c) adapting the content of the intervention, and (d) adapting the evaluation strategy. Next, a pilot test of the adapted intervention was conducted to examine implementation feasibility and acceptability. Feasibility data indicate an intervention spanning several weeks may be difficult to implement in the context of transitional housing. Yet, acceptability of the adapted intervention among participants was consistently high. The findings of this pilot work suggest several implications for informing continued parenting intervention research and practice with homeless families in transitional housing. © 2018 Family Process Institute.

  15. Examining the Hospital Elder Life Program in a rehabilitation setting: a pilot feasibility study.

    PubMed

    Huson, Kelsey; Stolee, Paul; Pearce, Nancy; Bradfield, Corrie; Heckman, George A

    2016-07-18

    The Hospital Elder Life Program (HELP) has been shown to effectively prevent delirium and functional decline in older patients in acute care, but has not been examined in a rehabilitation setting. This pilot study examined potential successes and implementation factors of the HELP in a post-acute rehabilitation hospital setting. A mixed methods (quantitative and qualitative) evaluation, incorporating a repeated measures design, was used. A total of 100 patients were enrolled; 58 on the pilot intervention unit and 42 on a usual care unit. Group comparisons were made using change scores (pre-post intervention) on outcome measures between pilot unit patients and usual care patients (separate analyses compared usual care patients with pilot unit patients who did or did not receive the HELP). Qualitative data were collected using focus group and individual interviews, and analyzed using emergent coding procedures. Delirium prevalence reduced from 10.9 % (n = 6) to 2.5 % (n = 1) in the intervention group, while remaining the same in the usual care group (2.5 % at both measurement points). Those who received the HELP showed greater improvement on cognitive and functional outcomes, particularly short-term memory and recall, and a shorter average length of stay than patients who did not. Participant groups discussed perceived barriers, benefits, and recommendations for further implementation of the HELP in a rehabilitation setting. This study adds to the limited research on delirium and the effectiveness of the HELP in post-acute rehabilitation settings. The HELP was found to be feasible and have potential benefits for reduced delirium and improved outcomes among rehabilitation patients.

  16. Continuous GPS : pilot applications - Phase II

    DOT National Transportation Integrated Search

    2003-08-01

    The primary objective of this research was to evaluate the feasibility of applying Global Positioning System (GPS) technology in the study of geotechnical phenomenon by developing, integrating, and test deploying a GPS-based instrumentation package u...

  17. 77 FR 28889 - Center for Scientific Review; Notice of Closed Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-16

    ... Panel; RFA Panel: System Science and Health in the Behavioral and Social Sciences. Date: June 6-7, 2012... Special Emphasis Panel; Pilot and Feasibility Clinical Research Studies in Digestive Diseases and...

  18. TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

    PubMed Central

    Pearce, Patricia F.; Chirico, Cristina; Etchevarria, Mirta; Cardinale, Daniel; Rubinstein, Fernando

    2013-01-01

    Objective. To assess a text messaging intervention to promote tuberculosis (TB) treatment adherence. Methods. A mixed-methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina. Patients newly diagnosed with TB who were 18 or older, and had mobile phone access were recruited and randomized to usual care plus either medication calendar (n = 19) or text messaging intervention (n = 18) for the first two months of treatment. Primary outcomes were feasibility and acceptability; secondary outcomes explored initial efficacy. Results. Feasibility was evidenced by high access to mobile phones, familiarity with texting, most phones limited to basic features, a low rate of participant refusal, and many describing suboptimal TB understanding. Acceptability was evidenced by participants indicating feeling cared for, supported, responsible for their treatment, and many self-reporting adherence without a reminder. Participants in the texting group self-reported adherence on average 77% of the days whereas only 53% in calendar group returned diaries. Exploring initial efficacy, microscopy testing was low and treatment outcomes were similar in both groups. Conclusion. The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary. Further evaluation of the texting intervention is warranted. PMID:24455238

  19. Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

    PubMed

    Bakitas, Marie; Dionne-Odom, J Nicholas; Pamboukian, Salpy V; Tallaj, Jose; Kvale, Elizabeth; Swetz, Keith M; Frost, Jennifer; Wells, Rachel; Azuero, Andres; Keebler, Konda; Akyar, Imatullah; Ejem, Deborah; Steinhauser, Karen; Smith, Tasha; Durant, Raegan; Kono, Alan T

    2017-08-31

    Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

  20. An educational game for teaching clinical practice guidelines to Internal Medicine residents: development, feasibility and acceptability

    PubMed Central

    Akl, Elie A; Mustafa, Reem; Slomka, Thomas; Alawneh, Alia; Vedavalli, Abhishek; Schünemann, Holger J

    2008-01-01

    Background Adherence to Clinical Practice Guidelines (CPGs) remains suboptimal among internal medicine trainees. Educational games are of growing interest and have the potential to improve adherence to CPGs. The objectives of this study were to develop an educational game to teach CPGs in Internal Medicine residency programs and to evaluate its feasibility and acceptability. Methods We developed the Guide-O-Game© in the format of a TV game show with questions based on recommendations of CPGs. The development of the Guide-O-Game© consisted of the creation of a multimedia interactive tool, the development of recommendation-based questions, and the definition of the game's rules. We evaluated its feasibility through pilot testing and its acceptability through a qualitative process. Results The multimedia interactive tool uses a Macromedia Flash web application and consists of a manager interface and a user interface. The user interface allows the choice of two game styles. We created so far 16 sets of questions relating to 9 CPGs. The pilot testing proved that the game was feasible. The qualitative evaluation showed that residents considered the game to be acceptable. Conclusion We developed an educational game to teach CPGs to Internal Medicine residents that is both feasible and acceptable. Future work should evaluate its impact on educational outcomes. PMID:19017400

  1. The development and feasibility of an online aphasia group intervention and networking program - TeleGAIN.

    PubMed

    Pitt, Rachelle; Theodoros, Deborah; Hill, Anne J; Russell, Trevor

    2017-09-04

    Aphasia group therapy offers many benefits, however people with aphasia report difficulty accessing groups and speech-language pathologists are faced with many challenges in providing aphasia group therapy. Telerehabilitation may offer an alternative service delivery option. An online aphasia group therapy program - Telerehabilitation Group Aphasia Intervention and Networking (TeleGAIN) - has been developed according to the guidelines of the Medical Research Council (MRC) framework for complex interventions. The purpose of this paper is to describe the development of TeleGAIN and the results of a pilot trial to determine feasibility and acceptability. The development of TeleGAIN was informed through literature reviews in relevant topic areas, consideration of expert opinion and application of the social cognitive theory. TeleGAIN was then modelled through a feasibility pilot trial with four people with aphasia. TeleGAIN appeared to be feasible and acceptable to participants and able to be implemented as planned. Participant satisfaction with treatment was high and results suggested some potential for improvements in language functioning and communication-related quality of life. TeleGAIN appeared to be feasible and acceptable, however the study highlighted issues related to technology, clinical implementation and participant-specific factors that should be addressed prior to a larger trial.

  2. A pilot study of rhythm and timing training as a supplement to occupational therapy in stroke rehabilitation.

    PubMed

    Hill, Valerie; Dunn, Leah; Dunning, Kari; Page, Stephen J

    2011-01-01

    Stroke is the leading cause of disability. A need exists for an effective intervention to enhance upper extremity (UE) motor abilities and activities of daily living (ADL) performance. The objectives of this pilot study were to (1) determine the feasibility of adding Interactive Metronome (IM) to an occupational therapy (OT) program; and (2) determine changes in UE impairments, function, quality of life, and perceived physical performance ability and satisfaction using a combined IM + OT regimen compared with OT alone for adults with chronic stroke. This pilot study (n=10) used a 2-group (OT or IM+OT) pretest-posttest design. The intervention involved 60 minutes of IM + OT or OT alone, 3 days a week for 10 weeks. Outcome measures included the UE Fugl-Meyer (impairment), the Arm Motor Ability Test (function), the Box and Block Test (function), Stroke Impact Scale (quality of life), and the Canadian Occupational Performance Measure (perceived performance ability and satisfaction). It was feasible to add IM to OT. The IM+OT group demonstrated decreased impairment and increased quality of life. However, the OT-alone group demonstrated greater gains in function, perceived physical performance ability, and satisfaction. These findings suggest that rhythm and timing training using the IM is a feasible intervention to consider as part of therapy treatment. However, IM may fit best for prefunctional treatment, as it seemed to primarily decrease impairment. It may also serve as a supplement before or after treatment in order to maximize rehabilitation potential. Clinical implications and suggestions for future studies are provided.

  3. An Educational Intervention to Train Professional Nurses in Promoting Patient Engagement: A Pilot Feasibility Study

    PubMed Central

    Barello, Serena; Graffigna, Guendalina; Pitacco, Giuliana; Mislej, Maila; Cortale, Maurizio; Provenzi, Livio

    2017-01-01

    Introduction: Growing evidence recognizes that patients who are motivated to take an active role in their care can experience a range of health benefits and reduced healthcare costs. Nurses play a critical role in the effort to make patients fully engaged in their disease management. Trainings devoted to increase nurses' skills and knowledge to assess and promote patient engagement are today a medical education priority. To address this goal, we developed a program of nurse education training in patient engagement strategies (NET-PES). This paper presents pilot feasibility study and preliminary participants outcomes for NET-PES. Methods: This is a pilot feasibility study of a 2-session program on patient engagement designed to improve professional nurses' ability to engage chronic patients in their medical journey; the training mainly focused on passing patient engagement assessment skills to clinicians as a crucial mean to improve care experience. A pre-post pilot evaluation of NET-PES included 46 nurses working with chronic conditions. A course specific competence test has been developed and validated to measure patient engagement skills. The design included self-report questionnaire completed before and after the training for evaluation purposes. Participants met in a large group for didactic presentations and then they were split into small groups in which they used role-play and case discussion to reflect upon the value of patient engagement measurement in relation to difficult cases from own practice. Results: Forty-six nurses participated in the training program. The satisfaction questionnaire showed that the program met the educational objectives and was considered to be useful and relevant by the participants. Results demonstrated changes on clinicians' attitudes and skills in promoting engagement. Moreover, practitioners demonstrated increases on confidence regarding their ability to support their patients' engagement in the care process. Conclusions: Learning programs teaching nurses about patient engagement strategies and assessment measures in clinical practice are key in supporting the realization of patient engagement in healthcare. Training nurses in this area is feasible and accepted and might have an impact on their ability to engage patients in the chronic care journey. Due to the limitation of the research design, further research is needed to assess the effectiveness of such a program and to verify if the benefits envisaged in this pilot are maintained on a long-term perspective and to test results by employing a randomized control study design. PMID:28119644

  4. 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.

  5. Piloted Simulator Tests of a Guidance System which Can Continously Predict Landing Point of a Low L/D Vehicle During Atmosphere Re-Entry

    NASA Technical Reports Server (NTRS)

    Wingrove, Rodney C.; Coate, Robert E.

    1961-01-01

    The guidance system for maneuvering vehicles within a planetary atmosphere which was studied uses the concept of fast continuous prediction of the maximum maneuver capability from existing conditions rather than a stored-trajectory technique. used, desired touchdown points are compared with the maximum range capability and heating or acceleration limits, so that a proper decision and choice of control inputs can be made by the pilot. In the method of display and control a piloted fixed simulator was used t o demonstrate the feasibility od the concept and to study its application to control of lunar mission reentries and recoveries from aborts.

  6. GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

    PubMed

    Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine

    2018-01-01

    Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. ISRCTN46869894; retrospectively registered 25th May 2016.

  7. An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study

    PubMed Central

    2017-01-01

    Background Sport participation is associated with a risk of sports-related injuries and illnesses, and Paralympic athletes’ additional medical issues can be a challenge to health care providers and medical staff. However, few prospective studies have assessed sports-related injuries and illnesses in Paralympic sport (SRIIPS) over time. Advances in mobile phone technology and networking systems offer novel opportunities to develop innovative eHealth applications for collection of athletes’ self-reports. Using eHealth applications for collection of self-reported SRIIPS is an unexplored area, and before initiation of full-scale research of SRIIPS, the feasibility and usability of such an approach needs to be ascertained. Objective The aim of this study was to perform a 4-week pilot study and (1) evaluate the monitoring feasibility and system usability of a novel eHealth application for self-reported SRIIPS and (2) report preliminary data on SRIIPS. Methods An eHealth application for routine collection of data from athletes was developed and adapted to Paralympic athletes. A 4-week pilot study was performed where Paralympic athletes (n=28) were asked to weekly self-report sport exposure, training load, general well-being, pain, sleep, anxiety, and possible SRIIPS. The data collection was followed by a poststudy use assessment survey. Quantitative data related to the system use (eg, completed self-reports, missing responses, and errors) were analyzed using descriptive statistics. The qualitative feasibility and usability data provided by the athletes were condensed and categorized using thematic analysis methods. Results The weekly response rate was 95%. The athletes were of the opinion that the eHealth application was usable and feasible but stated that it was not fully adapted to Paralympic athletes and their impairments. For example, it was difficult to understand how a new injury or illness should be identified when the impairment was involved. More survey items related to the impairments were requested, as the athletes perceived that injuries and illnesses often occurred because of the impairment. Options for description of multifactorial incidents including an injury, an illness, and the impairment were also insufficient. Few technical issues were encountered, but athletes with visual impairment reported usability difficulties with the speech synthesizer. An incidence rate of 1.8 injuries and 1.7 illnesses per 100 hours of athlete exposure were recorded. The weekly pain prevalence was 56% and the impairment contributed to 20% of the reported incidents. Conclusions The novel eHealth-based application for self-reported SRIIPS developed and tested in this pilot study was generally feasible and usable. With some adaptation to accommodate Paralympic athletes’ prerequisites and improved technical support for athletes with visual impairment, this application can be recommended for use in prospective studies of SRIIPS. Trial Registration ClinicalTrials.gov NCT02788500; https://clinicaltrials.gov/ct2/show/NCT02788500 (Archived by WebCite at http://www.webcitation.org/6v56OqTeP) PMID:29187343

  8. A pilot feasibility study of virtual patient simulation to enhance social work students' brief mental health assessment skills.

    PubMed

    Washburn, Micki; Bordnick, Patrick; Rizzo, Albert Skip

    2016-10-01

    This study presents preliminary feasibility and acceptability data on the use of virtual patient (VP) simulations to develop brief assessment skills within an interdisciplinary care setting. Results support the acceptability of technology-enhanced simulations and offer preliminary evidence for an association between engagement in VP practice simulations and improvements in diagnostic accuracy and clinical interviewing skills. Recommendations and next steps for research on technology-enhanced simulations within social work are discussed.

  9. 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 ).

  10. Autonomous Aircraft Operations using RTCA Guidelines for Airborne Conflict Management

    NASA Technical Reports Server (NTRS)

    Krishnamurthy, Karthik; Wing, David J.; Barmore, Bryan E.; Barhydt, Richard; Palmer, Michael T.; Johnson, Edward J.; Ballin, Mark G.; Eischeid, Todd M.

    2003-01-01

    A human-in-the-loop experiment was performed at the NASA Langley Research Center to study the feasibility of DAG-TM autonomous aircraft operations in highly constrained airspace. The airspace was constrained by a pair of special-use airspace (SUA) regions on either side of the pilot's planned route. Traffic flow management (TFM) constraints were imposed as a required time of arrival and crossing altitude at an en route fix. Key guidelines from the RTCA Airborne Conflict Management (ACM) concept were applied to autonomous aircraft operations for this experiment. These concepts included the RTCA ACM definitions of distinct conflict detection and collision avoidance zones, and the use of a graded system of conflict alerts for the flight crew. Three studies were conducted in the course of the experiment. The first study investigated the effect of hazard proximity upon pilot ability to meet constraints and solve conflict situations. The second study investigated pilot use of the airborne tools when faced with an unexpected loss of separation (LOS). The third study explored pilot interactions in an over-constrained conflict situation, with and without priority rules dictating who should move first. Detailed results from these studies were presented at the 5th USA/Europe Air Traffic Management R&D Seminar (ATM2003). This overview paper focuses on the integration of the RTCA ACM concept into autonomous aircraft operations in highly constrained situations, and provides an overview of the results presented at the ATM2003 seminar. These results, together with previously reported studies, continue to support the feasibility of autonomous aircraft operations.

  11. Impact of a daily 10-minute strength and flexibility program in a manufacturing plant.

    PubMed

    Pronk, S J; Pronk, N P; Sisco, A; Ingalls, D S; Ochoa, C

    1995-01-01

    In summary, employees' flexibility and mood showed modest improvements following the implementation of a plant-wide, 10-minute, daily flexibility and strength program. The initial six-week pilot study, administered prior to the plant-wide program implementation, successfully assessed program feasibility, assessed the efficiency of program implementation, identified administrative and logistical concerns, and generated pilot data needed to secure managerial support. Despite the noted significant increases in grip strength in the pilot study, no increases were observed following the six months of plant-wide implementation. This may be related to the differences in low average pretest grip strength for the pilot study compared to the higher scores for the main study population. The pilot study subjects may have received a sufficient exercise stimulus to increase grip strength over the course of six weeks. In contrast, this may not have been the case for the main study subjects due to their higher initial mean grip strength. An increased number of exercises designed to directly impact grip strength may be needed to improve this parameter.

  12. Canada-U.S. Border Air Quality Strategy Border Reports

    EPA Pesticide Factsheets

    View reports on two airshed pilot studies that explored the human health effects of air pollution in the United States and Canada, plus a report on the feasibility of transboundary emissions cap and trade program.

  13. EMERGING TECHNOLOGY SUMMARY: DEMONSTRATION OF AMBERSORB 563 ADSORBENT TECHNOLOGY

    EPA Science Inventory

    A field pilot study was conducted to demonstrate the technical feasibility and cost-effectiveness of Ambersorb® 5631 carbonaceous adsorbent for remediating groundwater contaminated with volatile organic compounds (VOCs). The Ambersorb adsorbent technology demonstration consist...

  14. A Piloted Flight to a Near-Earth Object: A Feasibility Study

    NASA Technical Reports Server (NTRS)

    Landis, Rob; Korsmeyer, Dave; Abell, Paul; Adamo, Dan; Morrison, Dave; Lu, Ed; Lemke, Larry; Gonzales, Andy; Jones, Tom; Gershman, Bob; hide

    2007-01-01

    This viewgraph presentation examines flight hardware elements of the Constellation Program (CxP) and the utilization of the Crew Exploration Vehicle (CEV), Evolvable Expendable Launch Vehicles (EELVs) and Ares launch vehicles for NEO missions.

  15. Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial.

    PubMed

    Dudley, L; Kettle, C; Thomas, P W; Ismail, K M K

    2017-02-10

    To establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds. A multicentre pilot and feasibility RCT. Ten UK maternity units from July 2011 to July 2013. Eligible women with a dehisced perineal wound within 2 weeks of childbirth. The interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat. The primary outcome measure was wound healing at 6-8 weeks. The study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6-8 weeks all but one wound in both groups had healed. PREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months. ISRCTN05754020. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. 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.

  17. Feasibility and acceptability of a nursing intervention with family caregiver on self-care among heart failure patients: a randomized pilot trial.

    PubMed

    Cossette, Sylvie; Belaid, Hayet; Heppell, Sonia; Mailhot, Tanya; Guertin, Marie-Claude

    2016-01-01

    Self-care practices in heart failure (HF) contribute to quality of life, symptom stabilization, and extended life expectancy. However, adherence to practices such as liquid and salt restriction or symptom monitoring require high motivation on a daily basis. The aim was to assess the feasibility, acceptability, and potential effectiveness of a nursing intervention with family caregivers, aimed at improving self-care practice of HF patients. This pilot study involved 32 HF patient-caregiver dyads (16/group) randomized to an experimental (EG) or control group (CG). The intervention, based on the Self-Determination Theory, was designed to enhance patients' autonomy and motivation in self-care practices, by involving their caregivers' support. Five encounters were planned with the EG dyads-two face-to-face during hospitalization and three by telephone after discharge. The feasibility of delivering the protocol was evaluated as well as the acceptability of the intervention. The potential effectiveness of the intervention was assessed based on patient outcomes, including general self-care management and self-care specific to HF, perceived competence to manage HF, autonomous motivation (A-motivation, external extrinsic motivation, internal extrinsic motivation, and intrinsic motivation), and perceived support from the caregiver. Caregiver outcomes included level of support provided to the patient. Despite recruitment challenges, the intervention was feasible, with 12 of the 16 dyads receiving all 5 encounters delivered per protocol. The 4 other dyads received the two hospital encounters, but at least 1 of the 3 post-discharge planned telephone encounters was not feasible because the patients had been re-hospitalized or was deceased. Participant's satisfaction with the intervention was high. Outcomes favoring the EG include self-care specific to HF, internal extrinsic motivation, intrinsic motivation, and caregiver's feeling that they provide a higher level of support. Caregiver involvement was found to be both a feasible and acceptable means of supporting self-care practice in HF patients. This approach presents a potential avenue for enhancing patients' efforts in this regard. However, this pilot study offers preliminary findings only, which need to be replicated in a phase 3 clinical trial.

  18. A pilot study of the feasibility of long-term human bone balance during perimenopause using a 41Ca tracer

    NASA Astrophysics Data System (ADS)

    Hui, S. K.; Prior, J.; Gelbart, Z.; Johnson, R. R.; Lentle, B. C.; Paul, M.

    2007-06-01

    The mechanisms governing calcium fluxes during bone remodeling processes in perimenopausal women are poorly known. Despite higher, albeit erratic, estradiol levels in perimenopause, spine bone loss is greater than during the first five years past the final menstrual flow when estradiol becomes low. Understanding changes during this dynamic transition are important to prevent fragility fractures in midlife and older women. The exploration of long-lived 41Ca (T1/2 = 1.04 × 105 yrs) tracer measurements using accelerator mass spectrometry (AMS) leads to the possibility of monitoring bone remodeling balance. With this new technology, we explored a pilot long-term feasibility study of bone health by measuring the 41Ca trace element in urine for six years from premenopausal to later perimenopausal phases in one midlife woman. We measured bone mineral density in parallel.

  19. Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

    PubMed Central

    Thompson, Stephanie; Klarenbach, Scott; Molzahn, Anita; Lloyd, Anita; Gabrys, Iwona; Haykowsky, Mark; Tonelli, Marcello

    2016-01-01

    Objectives For people with end-stage renal disease requiring haemodialysis, exercise can improve aspects of quality of life (QoL). However, the relative benefits and risks of different types of exercise in this population are unknown. Therefore, this pilot study aimed to evaluate the feasibility of a main study evaluating the efficacy of cycling and resistance exercise each performed during the haemodialysis treatment on QoL. Methods In this factorial (2×2) pilot trial, 31 haemodialysis patients were randomised to cycling, resistance, cycling and resistance, or an attention control. Feasibility was defined a priori by criteria on recruitment, fidelity to the protocol and patient response to the intervention. To better understand feasibility, we conducted interviews with dialysis unit staff and trial participants. As secondary outcomes, we estimated the main effect of cycling and weights each compared with control on QoL, physical function and strength. Findings We exceeded the target accrual of 28 participants over 12 weeks. Irrespective of exercise group allocation, adherence was high; of the 1038 training sessions offered, 87% were initiated and over 80% of exercise sessions were performed as per protocol. Progression based on perceived exertion, individual instruction and interactions with the kinesiologist facilitated acceptability across exercise groups. Using an attention control, measures of contamination and attrition were low. Important barriers to unit staff readiness for the intervention were initial safety and workflow concerns, unit workload and onerous data collection. Secondary outcomes were not statistically significant. Adverse events were low and did not increase with a higher volume of exercise. Conclusions The main study is feasible with minor modifications. In addition to practical assistance, involvement from unit staff could increase patient participation and improve trial implementation. Strategies to increase acceptability of the intervention for staff include improving workflow integration and using a prestudy demonstration phase to introduce the intervention. Trial registration number NCT02234232. Results PMID:27601500

  20. 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.

  1. Remote Ambulatory Management of Veterans with Obstructive Sleep Apnea

    PubMed Central

    Fields, Barry G.; Behari, Pratima Pathak; McCloskey, Susan; True, Gala; Richardson, Diane; Thomasson, Arwin; Korom-Djakovic, Danijela; Davies, Keith; Kuna, Samuel T.

    2016-01-01

    Study Objectives: Despite significant medical sequelae of obstructive sleep apnea (OSA), the condition remains undiagnosed and untreated in many affected individuals. We explored the feasibility of a comprehensive, telemedicine-based OSA management pathway in a community-based Veteran cohort. Methods: This prospective, parallel-group randomized pilot study assessed feasibility of a telemedicine-based pathway for OSA evaluation and management in comparison to a more traditional, in-person care model. The study included 60 Veterans at the Philadelphia Veterans Affairs Medical Center and two affiliated community-based outpatient clinics. Telemedicine pathway feasibility, acceptability, and outcomes were assessed through a variety of quantitative (Functional Outcomes of Sleep Questionnaire, dropout rates, positive airway pressure [PAP] adherence rates, participant satisfaction ratings) and qualitative (verbal feedback) metrics. Results: There was no significant difference in functional outcome changes, patient satisfaction, dropout rates, or objectively measured PAP adherence between groups after 3 months of treatment. Telemedicine participants showed greater improvement in mental health scores, and their feedback was overwhelmingly positive. Conclusions: Our pilot study suggests that telemedicine-based management of OSA patients is feasible in terms of patient functional outcomes and overall satisfaction with care. Future studies should include larger populations to further elucidate these findings while assessing provider- and patient-related cost effectiveness. Citation: Fields BG, Behari PP, McCloskey S, True G, Richardson D, Thomasson A, Korom-Djakovic D, Davies K, Kuna ST. Remote ambulatory management of veterans with obstructive sleep apnea. SLEEP 2016;39(3):501–509. PMID:26446115

  2. 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

  3. 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

  4. 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.

  5. The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

    PubMed

    Rombeek, Meghan; De Jesus, Stefanie; Altamirano-Diaz, Luis; Welisch, Eva; Prapavessis, Harry; Seabrook, Jamie A; Norozi, Kambiz

    2017-01-01

    Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

  6. Quality Measures for Hospice and Palliative Care: Piloting the PEACE Measures

    PubMed Central

    Rokoske, Franziska S.; Durham, Danielle; Cagle, John G.; Hanson, Laura C.

    2014-01-01

    Abstract Background: The Carolinas Center for Medical Excellence launched the PEACE project in 2006, under contract with the Centers for Medicare & Medicaid Services (CMS), to identify, develop, and pilot test quality measures for hospice and palliative care programs. Objectives: The project collected pilot data to test the usability and feasibility of potential quality measures and data collection processes for hospice and palliative care programs. Settings/subjects: Twenty-two hospices participating in a national Quality Improvement Collaborative (QIC) submitted data from 367 chart reviews for pain care and 45 chart reviews for nausea care. Fourteen additional hospices completed a one-time data submission of 126 chart reviews on 60 potential patient-level quality measures across eight domains of care and an organizational assessment evaluating structure and processes of care. Design: Usability was assessed by examining the range, variability and size of the populations targeted by each quality measure. Feasibility was assessed during the second pilot study by surveying data abstractors about the abstraction process and examining the rates of missing data. The impact of data collection processes was assessed by comparing results obtained using different processes. Results: Measures shown to be both usable and feasible included: screening for physical symptoms on admission and documentation of treatment preferences. Methods of data collection and measure construction appear to influence observed rates of quality of care. Conclusions: We successfully identified quality measures with potential for use in hospices and palliative care programs. Future research is needed to understand whether these measures are sensitive to quality improvement interventions. PMID:24921162

  7. 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.

  8. Diagnosing upper extremity deep vein thrombosis with non-contrast-enhanced Magnetic Resonance Direct Thrombus Imaging: A pilot study.

    PubMed

    Dronkers, C E A; Klok, F A; van Haren, G R; Gleditsch, J; Westerlund, E; Huisman, M V; Kroft, L J M

    2018-03-01

    Diagnosing upper extremity deep vein thrombosis (UEDVT) can be challenging. Compression ultrasonography is often inconclusive because of overlying anatomic structures that hamper compressing veins. Contrast venography is invasive and has a risk of contrast allergy. Magnetic Resonance Direct Thrombus Imaging (MRDTI) and Three Dimensional Turbo Spin-echo Spectral Attenuated Inversion Recovery (3D TSE-SPAIR) are both non-contrast-enhanced Magnetic Resonance Imaging (MRI) sequences that can visualize a thrombus directly by the visualization of methemoglobin, which is formed in a fresh blood clot. MRDTI has been proven to be accurate in diagnosing deep venous thrombosis (DVT) of the leg. The primary aim of this pilot study was to test the feasibility of diagnosing UEDVT with these MRI techniques. MRDTI and 3D TSE-SPAIR were performed in 3 pilot patients who were already diagnosed with UEDVT by ultrasonography or contrast venography. In all patients, UEDVT diagnosis could be confirmed by MRDTI and 3D TSE-SPAIR in all vein segments. In conclusion, this study showed that non-contrast MRDTI and 3D TSE-SPAIR sequences may be feasible tests to diagnose UEDVT. However diagnostic accuracy and management studies have to be performed before these techniques can be routinely used in clinical practice. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. Using video feedback to improve early father–infant interaction: A pilot study

    PubMed Central

    Davies, Beverley; Ramchandani, Paul G.

    2013-01-01

    Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child’s thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers’ feedback was generally positive. The flexibility to conduct sessions at home (or at fathers’ places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers. PMID:22434935

  10. WASHING STUDIES FOR PCP AND CREOSOTE-CONTAMINATED SOIL

    EPA Science Inventory

    The Environmental Protection Agency has conducted a series of bench-scale and pilot-scale studies to evaluate the feasibility of washing pentachlorophenol (PCP) and creosote from the soil at an abandoned wood-treatment Superfund site in Pensacola, FL. The high sand content and lo...

  11. Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans

    DTIC Science & Technology

    2012-10-01

    pilot tested a viable Internet-based intervention to assist veterans with Post -Traumatic Stress symptoms to progress toward changing negative...veterans’ health and recovery. The three-month feasibility test was designed to assess acceptability and viability of the CTI system and the...aim of the study was to adapt and test the feasibility of a multiple behavior TTM-based CTI designed for the general adult population so that it

  12. Can a brief two-hour interdisciplinary communication skills training be successful in undergraduate medical education?

    PubMed

    Bachmann, Cadja; Barzel, Anne; Roschlaub, Silke; Ehrhardt, Maren; Scherer, Martin

    2013-11-01

    To pilot-test feasibility, acceptance and learning-outcomes of a brief interdisciplinary communication skills training program in undergraduate medical education. A two-hour interdisciplinary communication skills program with simulated patients was developed and pilot-tested with clinical students at Hamburg University. Five psychosocial specialties facilitated the training. Composite effects were measured qualitatively and quantitatively. Eighty students volunteered to participate in the pilot-program (intervention-group). Their evaluations of the program were very positive (1.1 on a six-point scale). Benefits were seen in feedback, increase of self-confidence, cross-disciplinary clinical and communication experience. Students who did not volunteer (n=206) served as the control-group. The intervention-group performed significantly better (p=0.023) in a primary care communication examination and female students performed better than males. Clinical teachers evaluated the pilot-training very positively with regard to learning-outcomes and feasibility. The positive results from the pilot-training led to implementation into the regular curriculum. A two-hour interdisciplinary communication skills training program is beneficial for medical students with regard to communication competencies, self-confidence and learning-outcomes. The training is feasible within given time-frames and limited staff resources. The high teaching load for small-group-training are split between five specialties. The concept might be an interesting option for other faculties. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  13. 100-OL-1 Operable Unit Field Portable X-Ray Fluorescence (XRF) Analyzer Pilot Study Plans

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bunn, Amoret L.; Fritz, Brad G.; Wellman, Dawn M.

    A pilot study is being conducted to support the approval of the Remedial Investigation/Feasibility Study (RI/FS) Work Plan to evaluate the 100-OL-1 Operable Unit (OU) pre-Hanford orchard lands. Based on comments received by the U.S. Environmental Protection Agency (EPA) and Washington State Department of Ecology, the pilot study will evaluate the use of field portable X-ray fluorescence (XRF) spectrometry measurements for evaluating lead and arsenic concentrations on the soil surface as an indicator of past use of lead arsenate pesticide residue in the OU. The work will be performed in the field during the summer of 2014, and assist inmore » the planning for the characterization activities in the RI/FS.« less

  14. Cognitive Existential Couple Therapy for newly diagnosed prostate cancer patients and their partners: a descriptive pilot study.

    PubMed

    Collins, Anna L; Love, Anthony W; Bloch, Sidney; Street, Annette F; Duchesne, Gillian M; Dunai, Judy; Couper, Jeremy W

    2013-02-01

    This paper aims to describe 'Cognitive Existential Couple Therapy' (CECT), a novel couples-based intervention for men with early stage prostate cancer (PCa) and their partners, and to report preliminary findings from a pilot study that investigated the acceptability and feasibility of the intervention and the measures to be used in a subsequent randomised controlled trial. A manualised CECT programme was delivered to 12 couples facing a diagnosis of PCa within the previous 12 months by psychiatrists and clinical psychologists. Participants completed measures of psychological distress, marital function and coping pattern before and after CECT. Semi-structured interviews were conducted with nine couples shortly after the completion of CECT. The application of CECT was both feasible and acceptable as indicated by favourable participant compliance (10 of the 12 couples attended all six designated sessions), completion of measures before and after CECT and participation in semi-structured interviews by nine couples. Preliminary results included reduced levels of avoidance and hyperarousal after the programme, with this effect stronger in partners than in patients. Interviews demonstrated that couples valued the therapist's contribution to their overall care. Previous research suggests that a couple-focused psychological intervention is desirable in the context of early stage PCa. This pilot study has established that CECT is acceptable, feasible and valued by couples facing a recent PCa diagnosis and demonstrates a potential for reduced psychological distress following CECT. A randomised controlled trial is currently being undertaken to validate the efficacy of this novel approach. Copyright © 2011 John Wiley & Sons, Ltd.

  15. Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center: Results of the Pilot Study.

    PubMed

    Lai, Xiaobin; Wong, Frances Kam Yuet; Leung, Carenx Wai Yee; Lee, Lai Ha; Wong, Jessica Shuk Yin; Lo, Yim Fan; Ching, Shirley Siu Yin

    2015-01-01

    The increasing number of cancer patients and inadequate communication in clinics are posing challenges to cancer patients receiving outpatient-based chemotherapy and healthcare providers. A nurse-led care program was proposed as one way of dealing with at least some of these challenges. The objectives of the pilot study were to assess the feasibility of the subject recruitment, care, and data collection procedures and to explore the acceptability of this program. A pilot study with a 1-group pretest-posttest design was conducted. Five cancer patients receiving chemotherapy in a chemotherapy day center participated. Each patient had a nurse consultation before chemotherapy and received 2 telephone calls after the first and second cycles of chemotherapy. Four questionnaires were adopted to evaluate the subjects' quality of life, self-efficacy, symptom experiences, and satisfaction with care. Questionnaires were completed before the chemotherapy and after the second cycle. The subjects were also interviewed to understand their comments on the service. The recruitment, care, and data collection procedures were completed smoothly. Slight changes were observed in quality of life and self-efficacy. All 5 subjects were highly satisfied with the care. The nurse-led care program is feasible and acceptable. The effect of the nurse-led care program will be evaluated in a single-center, open, randomized controlled trial. If the encouraging results can be confirmed, it may be an effective approach to improving the quality of ambulatory chemotherapy care. It would also shed light on the development of nurse-led care in other areas.

  16. Feasibility, acceptance and long-term exercise behaviour in cancer patients: an exercise intervention by using a swinging-ring system.

    PubMed

    Crevenna, Richard; Cenik, Fadime; Galle, Anton; Komanadj, Tanya Sedghi; Keilani, Mohammad

    2015-10-01

    Aim of this pilot study was to describe feasibility and acceptance of an exercise intervention by using an unique swinging-ring system with the goal to promote long-term exercise behaviour in cancer patients. The included cancer patients (n = 13, male:f emale (m:f) = 7:6, age = 56 ± 11, range 38-74a) were invited to perform a home-based exercise intervention. All participants of this pilot study were instructed how to use the smovey® Vibroswing. They could choose how to use the swinging-ring system, for example only indoor or only outdoor (single or in a group) or both. Feasibility and acceptance were assessed after 12 months (T2). Handgrip strength (Jamar hand dynamometer) and health-related quality of life (QOL, SF-36 Health survey) were assessed at baseline (T1) and after 12 months (T2). A total of 10 (77%) patients (m:f = 5:5, 59 ± 9 years, range = 46-74) could be assessed at baseline and after 12 months. The exercise intervention showed no adverse events and was well accepted. Approximately 77% of patients of the study population have been exercising for more than 12 months. Furthermore, this intervention was able to increase handgrip strength in the participants. QOL improved as well in all domains. The results of this small pilot study indicate that regular physical exercise with this swinging-ring system seems to be safe, and to promote long-term exercise behaviour of the included patients. Furthermore, this study population showed benefits in terms of increased handgrip strength and of improved QOL.

  17. Safety and feasibility of transcranial direct current stimulation (tDCS) combined with sensorimotor retraining in chronic low back pain: a protocol for a pilot randomised controlled trial.

    PubMed

    Ouellette, Adam Louis; Liston, Matthew B; Chang, Wei-Ju; Walton, David M; Wand, Benedict Martin; Schabrun, Siobhan M

    2017-08-21

    Chronic low back pain (LBP) is a common and costly health problem yet current treatments demonstrate at best, small effects. The concurrent application of treatments with synergistic clinical and mechanistic effects may improve outcomes in chronic LBP. This pilot trial aims to (1) determine the feasibility, safety and perceived patient response to a combined transcranial direct current stimulation (tDCS) and sensorimotor retraining intervention in chronic LBP and (2) provide data to support a sample size calculation for a fully powered trial should trends of effectiveness be present. A pilot randomised, assessor and participant-blind, sham-controlled trial will be conducted. Eighty participants with chronic LBP will be randomly allocated to receive either (1) active tDCS + sensorimotor retraining or (2) sham tDCS + sensorimotor retraining. tDCS (active or sham) will be applied to the primary motor cortex for 20 min immediately prior to 60 min of supervised sensorimotor retraining twice per week for 10 weeks. Participants in both groups will complete home exercises three times per week. Feasibility, safety, pain, disability and pain system function will be assessed immediately before and after the 10-week intervention. Analysis of feasibility and safety will be performed using descriptive statistics. Statistical analyses will be conducted based on intention-to-treat and per protocol and will be used to determine trends for effectiveness. Ethical approval has been gained from the institutional human research ethics committee (H10184). Written informed consent will be provided by all participants. Results from this pilot study will be submitted for publication in peer-reviewed journals. ACTRN12616000624482. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Teenagers and Texting: Use of a Youth Ecological Momentary Assessment System in Trajectory Health Research With Latina Adolescents

    PubMed Central

    Hardeman, Rachel R; Kwon, Gyu; Lando-King, Elizabeth; Zhang, Lei; Genis, Therese; Brady, Sonya S; Kinder, Elizabeth

    2014-01-01

    Background Adolescent females send and receive more text messages than any others, with an average of 4050 texts a month. Despite this technological inroad among adolescents, few researchers are utilizing text messaging technology to collect real time, contextualized data. Temporal variables (ie, mood) collected regularly over a period of time could yield useful insights, particularly for evaluating health intervention outcomes. Use of text messaging technology has multiple benefits, including capacity of researchers to immediately act in response to texted information. Objective The objective of our study was to custom build a short messaging service (SMS) or text messaging assessment delivery system for use with adolescents. The Youth Ecological Momentary Assessment System (YEMAS) was developed to collect automated texted reports of daily activities, behaviors, and attitudes among adolescents, and to examine the feasibility of YEMAS. This system was created to collect and transfer real time data about individual- and social-level factors that influence physical, mental, emotional, and social well-being. Methods YEMAS is a custom designed system that interfaces with a cloud-based communication system to automate scheduled delivery of survey questions via text messaging; we designed this university-based system to meet data security and management standards. This was a two-phase study that included development of YEMAS and a feasibility pilot with Latino adolescent females. Relative homogeneity of participants was desired for the feasibility pilot study; adolescent Latina youth were sought because they represent the largest and fastest growing ethnic minority group in the United States. Females were targeted because they demonstrate the highest rate of text messaging and were expected to be interested in participating. Phase I involved development of YEMAS and Phase II involved piloting of the system with Latina adolescents. Girls were eligible to participate if they were attending one of the participating high schools and self-identified as Latina. We contacted 96 adolescents; of these, 24 returned written parental consent forms, completed assent processes, and enrolled in the study. Results YEMAS was collaboratively developed and implemented. Feasibility was established with Latina adolescents (N=24), who responded to four surveys daily for two two-week periods (four weeks total). Each survey had between 12 and 17 questions, with responses including yes/no, Likert scale, and open-ended options. Retention and compliance rates were high, with nearly 18,000 texts provided by the girls over the course of the pilot period. Conclusions Pilot results support the feasibility and value of YEMAS, an automated SMS-based text messaging data collection system positioned within a secure university environment. This approach capitalizes on immediate data transfer protocols and enables the documentation of participants’ thoughts, feelings, and behaviors in real time. Data are collected using mobile devices that are familiar to participants and nearly ubiquitous in developed countries. PMID:25098355

  19. Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

    PubMed

    Lai, Lily; Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

    2017-02-03

    To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. 2 private herbal practices in the UK. 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. ISRCTN 31072075; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients

    PubMed Central

    Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

    2016-01-01

    Introduction Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. Methods and analysis 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0–4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1–2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Ethics and dissemination Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. Trial registration number NCT02377830; Pre-results. PMID:27059469

  1. Exceptional Responders Initial Feasibility Results

    Cancer.gov

    A pilot study evaluating identification of cancer patients who respond to treatment that is ineffective in at least 90 percent of patients found that it was indeed able to confirm a majority of proposed patients as exceptional responders based on clinical

  2. An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment.

    PubMed

    Hall, Sue; Lewith, George; Brien, Sarah; Little, Paul

    2008-12-01

    Kinesiology is a complementary therapy assessing subtle change in manual muscle testing results to select individualised treatments. We report the exploratory 2-stage development and pilot of a sham kinesiology treatment for use in a clinical trial to evaluate the specific effects of this intervention. 1. To design, pilot and assess the credibility of a sham kinesiology treatment in a kinesiology-aware population. 2. To pilot the sham kinesiology in a cross-over study of sham versus real kinesiology, and to make an exploratory assessment of its credibility in a kinesiology-naïve population. 1. 10 kinesiology-aware volunteers received a specially designed sham treatment weekly for 5 weeks which was subject to a credibility assessment. 2. 10 kinesiology-naïve patients with low back pain were randomised to receive 4 real and 4 sham treatments in a cross-over design; the treatments were subject to a credibility assessment. 100% of participants found the sham protocol a credible treatment as measured by the credibility questionnaire. 100% of patients having real treatment first did not recognise that the second set of treatments were sham. Small numbers precluded the use of formal statistical tests. In this small sample it appeared feasible to deliver an apparently credible sham kinesiology treatment. This feasibility study has allowed us to develop a sham treatment for use in a larger prospective clinical trial of kinesiology in patients with low back pain. 2008 S. Karger AG, Basel.

  3. Sleep among bereaved caregivers of patients admitted to hospice: a 1-year longitudinal pilot study

    PubMed Central

    Slåtten, Kari; Saghaug, Elisabeth; Grov, Ellen Karine; Normann, Are Peder; Lee, Kathryn A; Bjorvatn, Bjørn; Gay, Caryl L

    2016-01-01

    Objectives This pilot study aimed to describe the sleep of partners and other family caregivers prior to and in the first year after a hospice patient's death. The study also evaluated the feasibility of the study protocol and determined the effect sizes in preparation for a full-scale study. Design The pilot study used a longitudinal, descriptive and comparative design. Setting and participants Participants included primary family caregivers of patients admitted to a hospice in Oslo, Norway. Primary outcome Caregiver sleep was measured subjectively with the Pittsburgh Sleep Quality Index (PSQI) and objectively using wrist actigraphy for 4 nights and 3 days at three different times: during the hospice stay, and at 6 and 12 months after the patient's death. Results 16 family caregivers (10 partners and 6 other family members) completed the 1-year study protocol. Overall, sleep quality and quantity were stable over time and at each assessment, approximately half of the sample had poor sleep quality, both by self-report and objective measures. However, the sleep trajectories differed significantly over time, with older caregivers (≥65 years) having significantly longer sleep durations than younger caregivers (<65 years). Furthermore, sleep quality also differed over time depending on the caregiver's relationship to the patient, with partner caregivers having significantly worse sleep quality than other family caregivers. Conclusions Caring for a dying family member is known to interfere with sleep, yet little is known about bereaved caregivers. The results of this pilot study demonstrate the feasibility of the longitudinal study protocol and indicate that sleep problems are common for caregivers and continue into the bereavement period, particularly for partner caregivers. The caregiver's relationship to the patient may be an important factor to consider in future studies. PMID:26729383

  4. Feasibility and effectiveness of an automated bilingual text message intervention for weight loss: pilot study.

    PubMed

    Kolodziejczyk, Julia K; Norman, Gregory J; Barrera-Ng, Angelica; Dillon, Lindsay; Marshall, Simon; Arredondo, Elva; Rock, Cheryl L; Raab, Fred; Griswold, William G; Sullivan, Mark; Patrick, Kevin

    2013-11-06

    Little is known about the feasibility and acceptability of tailored text message based weight loss programs for English and Spanish-language speakers. This pilot study evaluated the feasibility, acceptability, and estimated impact of a tailored text message based weight loss program for English and Spanish-language speakers. The purpose of this pilot study was to inform the development of a full-scale randomized trial. There were 20 overweight or obese participants (mean age 40.10, SD 8.05; 8/20, 40% male; 9/20, 45% Spanish-speakers) that were recruited in San Diego, California, from March to May 2011 and evaluated in a one-group pre/post clinical trial. For 8 weeks, participants received and responded to 3-5 text messages daily sent from a fully automated text messaging system. They also received printed weight loss materials and brief 10-15 minute weekly counseling calls. To estimate the impact of the program, the primary outcome was weight (kg) measured during face-to-face measurement visits by trained research staff. Pre and post differences in weight were analyzed with a one-way repeated measures analysis of variance. Differences by language preference at both time points were analyzed with t tests. Body mass index and weight management behaviors also were examined. Feasibility and acceptability were determined by recruitment success, adherence (ie, percentage of replies to interactive text messages and attrition), and participant satisfaction. Participants who completed the final assessment (N=18) decreased body weight by 1.85 kg (F1,17=10.80, P=.004, CI∆ 0.66-3.03, η(2)=0.39). At both time points, there were no differences in weight by language preference. Participants responded to 88.04% (986/1120) of interactive text messages, attrition rate was 10% (2/20), and 94% (19/20) of participants reported satisfaction with the program. This fully automated text message based weight program was feasible with English and Spanish-speakers and may have promoted modest weight loss over an 8-week period. Clinicaltrials.gov NCT01171586; http://clinicaltrials.gov/ct2/show/NCT01171586 (Archived by WebCite at http://www.webcitation.org/6Ksr6dl7n).

  5. Randomised controlled pilot study to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: TOPIC feasibility study protocol.

    PubMed

    Yeung, Joyce; Melody, Teresa; Kerr, Amy; Naidu, Babu; Middleton, Lee; Tryposkiadis, Kostas; Daniels, Jane; Gao, Fang

    2016-12-01

    Open chest surgery (thoracotomy) is considered the most painful of surgical procedures. Forceful wound retraction, costochondral dislocation, posterior costovertebral ligament disruption, intercostal nerve trauma and wound movement during respiration combine to produce an acute, severe postoperative pain insult and persistent chronic pain many months after surgery is common. Three recent systematic reviews conclude that unilateral continuous paravertebral blockade (PVB) provides analgesia at least equivalent to thoracic epidural blockade (TEB) in the postoperative period, has a lower failure rate, and symptom relief that lasted months. Crucially, PVB may reduce the development of subsequent chronic pain by intercostal nerve protection or decreased nociceptive input. The overall aim is to determine in patients who undergo thoracotomy whether perioperative PVB results in reducing chronic post-thoracotomy pain (CPTP) compared with TEB. This pilot study will evaluate feasibility of a substantive trial. TOPIC is a randomised controlled trial comparing the effectiveness of TEB and PVB in reducing CPTP. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 2 adult thoracic centres, Heart of England NHS Foundation Trust (HEFT) and University Hospital of South Manchester NHS Foundation Trust (UHSM). The primary objective is to establish the number of patients randomised as a proportion of those eligible. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will primarily take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs. The study has obtained ethical approval from NHS Research Ethics Committee (REC number 14/EM/1280). Dissemination plan includes: informing patients and health professionals; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full HTA application dependent on the success of the study. ISRCTN45041624; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse–Family Partnership in Canadian public health settings

    PubMed Central

    Jack, S. M.; Catherine, N.; Gonzalez, A.; MacMillan, H. L.; Sheehan, D.; Waddell, C.

    2015-01-01

    Abstract Introduction: The Nurse–Family Partnership (NFP) is a home-visit program for young and first-time, socially and economically disadvantaged mothers. Evidence from three United States randomized controlled trials (RCTs) on the effectiveness of this intervention at improving pregnancy outcomes, improving child health and development, and increasing maternal economic self-sufficiency is robust. However, the effectiveness of the NFP in Canada, with its different health and social care context, needs to be determined. The purpose of this article is to describe the complex process for moving the NFP from the research arena to full implementation in Canada. Methods: This process of evaluation in Canada includes (1) adapting the intervention; (2) piloting the intervention in small-scale feasibility and acceptability studies; and (3) conducting an RCT and process evaluation through a study called the British Columbia Healthy Connections Project (BCHCP). This large-scale evaluation also creates an opportunity to expand the NFP evidence base by conducting an additional study to examine potential biological mechanisms linking intervention and behavioural outcomes in children. Results: Adaptation of the NFP home-visit materials is a continuous process. A pilot project determined that it was feasible to enrol eligible women into the NFP. This pilot also determined that, in Canada, it was most appropriate for public health agencies to implement the NFP and for public health nurses to deliver the intervention. Finally, the pilot showed that this intensive home-visit program was acceptable to clients, their family members and health care providers. Through the BCHCP, the next steps—the RCT and process evaluation—are currently underway. The BCHCP will also set the foundation for long-term evaluation of key public health outcomes in a highly vulnerable population of families. PMID:26605564

  7. Adapting, piloting and evaluating complex public health interventions: lessons learned from the Nurse-Family Partnership in Canadian public health settings.

    PubMed

    Jack, S M; Catherine, N; Gonzalez, A; MacMillan, H L; Sheehan, D; Waddell, D

    2015-01-01

    The Nurse-Family Partnership (NFP) is a home-visit program for young and first-time, socially and economically disadvantaged mothers. Evidence from three United States randomized controlled trials (RCTs) on the effectiveness of this intervention at improving pregnancy outcomes, improving child health and development, and increasing maternal economic self-sufficiency is robust. However, the effectiveness of the NFP in Canada, with its different health and social care context, needs to be determined. The purpose of this article is to describe the complex process for moving the NFP from the research arena to full implementation in Canada. This process of evaluation in Canada includes (1) adapting the intervention; (2) piloting the intervention in small-scale feasibility and acceptability studies; and (3) conducting an RCT and process evaluation through a study called the British Columbia Healthy Connections Project (BCHCP). This large-scale evaluation also creates an opportunity to expand the NFP evidence base by conducting an additional study to examine potential biological mechanisms linking intervention and behavioural outcomes in children. Adaptation of the NFP home-visit materials is a continuous process. A pilot project determined that it was feasible to enrol eligible women into the NFP. This pilot also determined that, in Canada, it was most appropriate for public health agencies to implement the NFP and for public health nurses to deliver the intervention. Finally, the pilot showed that this intensive home-visit program was acceptable to clients, their family members and health care providers. Through the BCHCP, the next steps - the RCT and process evaluation - are currently underway. The BCHCP will also set the foundation for long-term evaluation of key public health outcomes in a highly vulnerable population of families.

  8. Feasibility and pilot study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project.

    PubMed

    Sun, Lena S; Li, Guohua; DiMaggio, Charles J; Byrne, Mary W; Ing, Caleb; Miller, Tonya L K; Bellinger, David C; Han, Sena; McGowan, Francis X

    2012-10-01

    Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induces neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been analyzed using existing data sets, and these studies produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at the Columbia University Medical Center (CUMC) and Children's Hospital of Boston (CHB) for the PANDA project. The PANDA project uses an ambidirectional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs from 6 to 11 years of age. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair before the age of 36 months and the unexposed siblings had no anesthesia before the age of 36 months. All the sibling pairs were English speaking and were 36 weeks of gestational age or older. Each sibling pair underwent a direct testing using the Wechsler Abbreviated Scale of Intelligence (WASI) and the NEuroPSYchological Assessment, second edition (NEPSY II), and the parents completed questionnaires related to behavior using CBCL and Conners rating. Data are presented as means±SD. We conducted descriptive analyses of the demographic data. We compared both the exposed and the unexposed sibling groups on WASI and NEPSY II, and total and T scores from CBCL and Conners rating were analyzed as continuous data using the paired t test between the two groups. A P<0.05 was considered significant. After the Institutional Review Board approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. The scores for verbal IQ (exposed=106.1±16.3, unexposed=109.2±17.9), performance IQ (exposed=109.1±16.0, unexposed=113.9±15.9), and full IQ (exposed=108.2±14.0, unexposed=112.8±16.8) were comparable between the siblings. There were no differences between the two groups in T scores for any of the NEPSY II subdomains, CBCL, or Conners rating. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach and yielded pilot data from neuropsychological testing.

  9. A pilot randomised control trial of the effectiveness of a biofeedback mouse in reducing self-reported pain among office workers.

    PubMed

    King, Trevor K; Severin, Colette N; Van Eerd, Dwayne; Ibrahim, Selahadin; Cole, Donald; Amick, Ben; Steenstra, Ivan A

    2013-01-01

    A pilot study examined the effectiveness of a biofeedback mouse in reducing upper extremity pain and discomfort in office workers; in addition, relative mouse use (RMU), satisfaction and the feasibility of running a randomised controlled trial (RCT) in a workplace setting were evaluated. The mouse would gently vibrate if the hand was idle for more than 12 s. The feedback reminded users to rest the arm in neutral, supported postures. Analysis showed a statistically significant reduction in shoulder pain and discomfort for the intervention group at T2 (38.7% lower than controls). Statistically significant differences in RMU time between groups were seen post intervention (-7% at T1 and +15% at T2 for the intervention group). Fifty-five percent of the intervention group was willing to continue using the mouse. It appears feasible to perform an RCT for this type of intervention in a workplace setting. Further study including more participants is suggested. The study findings support the feasibility of conducting randomised control trials in office settings to evaluate ergonomics interventions. The intervention resulted in reduced pain and discomfort in the shoulder. The intervention could be a relevant tool in the reduction of upper extremity musculoskeletal disorder. Further research will better explain the study's preliminary findings.

  10. A brief cognitive-behavioural group therapy programme for the treatment of depression in adolescent outpatients: a pilot study

    PubMed Central

    2014-01-01

    Background The goal of this pilot study was to examine the feasibility and clinical outcomes of a brief (6-session) group therapy programme in adolescent outpatients with depression. The programme had previously been assessed in in-patients, with positive results. Methods A total of 15 outpatients aged 13 to 18 years took part in the programme between October 2010 and May 2011, in 3 separate groups of 4–6 participants each. The outcomes measured were feasibility of the programme, as assessed by attendance rate, user feedback, fidelity of implementation, and response to treatment, as assessed by pre- and post-intervention measurement of depressive symptoms, quality of life, and suicidal ideation. Results The programme demonstrated good feasibility, with a mean attendance rate of 5.33 out of 6 sessions, a mean rating by participants on overall satisfaction with the programme of 7.21 out of 10 (SD = 1.89), and a 93% concurrence between the contents of the sessions and the contents of the treatment manual. Compared to baseline scores, depressive symptoms at follow-up test were significantly reduced, as assessed by the Children’s Depression Rating Scale Revised (F(1, 12) = 11.76, p < .01) and the Beck Depression Inventory Revision (F(1, 32) = 11.19, p < .01); quality of life improved, as assessed by the Inventory of Quality of Life (F(1, 31) = 5.27, p < .05); and suicidal ideation was reduced. No significant changes were seen on the measures of the Parent Rating Scale for Depression and the Clinical Global Impression scale. Conclusions Based on the results of this pilot study, it is feasible to further assess this brief outpatient treatment programme in a randomized controlled trial without further modifications. PMID:24655595

  11. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    PubMed Central

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial registration number ISRCTN84528320. PMID:27412105

  12. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting.

    PubMed

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-07-13

    Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3-4 physiotherapists) and a focus group (n=6-8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). ISRCTN84528320. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  13. Feasibility of developing a pilot car training and certification program in Alabama.

    DOT National Transportation Integrated Search

    2010-09-01

    The State of Alabama does not currently require certification for the pilot car drivers who escort : oversize/overweight vehicles. The Alabama Department of Transportation contracted with The University : Transportation Center for Alabama (UTCA) to i...

  14. Feasibility of developing a pilot car training and certification program in Alabama

    DOT National Transportation Integrated Search

    2010-09-01

    The State of Alabama does not currently require certification for the pilot car drivers who escort : oversize/overweight vehicles. The Alabama Department of Transportation contracted with The University : Transportation Center for Alabama (UTCA) to i...

  15. Web-based family intervention for overweight children: a pilot study.

    PubMed

    Delamater, Alan M; Pulgaron, Elizabeth R; Rarback, Sheah; Hernandez, Jennifer; Carrillo, Adriana; Christiansen, Steven; Severson, Herbert H

    2013-02-01

    Research has shown the efficacy of family-based behavioral interventions for overweight children, but a major difficulty is access to effective treatment programs. The objective of this study was to develop and test the initial feasibility and efficacy of a web-based family program for overweight 8- to 12-year-old children. A website was created using concepts from effective family-based behavioral programs and input from focus groups with overweight children, parents, and pediatricians. The website provided information about obesity and healthy lifestyles, assessment of dietary and physical activity habits, interactive dietary and physical activity games, and instruction in goal-setting and monitoring of goals. Children selected a dietary and physical activity goal and a daily step goal with pedometers. Feasibility and pilot testing over 4 weeks was conducted with 24 overweight children referred by a physician. Outcomes were z-BMI, healthy eating and physical activity, and intrinsic motivation and self-efficacy for weight control. Mean number of logins over the study period was 11.4 for the study sample. Eighteen families (75%) returned for the follow-up assessment. Pre-post analyses for these participants showed improvements in intrinsic motivation, (p=0.05), self-efficacy (p=0.025), physical activity (p=0.005), and healthy lifestyle behaviors (p=0.001). Comparisons between high and low users of the program indicated that high users reduced their BMI while low users increased their BMI over time (p=0.02); high users also improved their dietary intake relative to low users (p=0.04). Consumer satisfaction ratings were high. These pilot findings suggest this is a feasible approach for treatment of overweight children and that children who used the web program frequently improved their BMI and dietary intake.

  16. A self-care, problem-solving and mindfulness intervention for informal caregivers of people with motor neurone disease: A pilot study.

    PubMed

    Ugalde, Anna; Mathers, Susan; Hennessy Anderson, Nicole; Hudson, Peter; Orellana, Liliana; Gluyas, Cathy

    2018-04-01

    Informal caregivers of people with motor neurone disease (MND) take on an extensive role. Caregivers are at increased risk of experiencing psychological distress and burden, yet, there is a lack of intervention programmes to support them. The aim of this study was to investigate the feasibility and acceptability of a therapeutic group intervention promoting self-care, problem-solving and mindfulness to informal caregivers of people with MND. Pilot study that utilised a one-arm pre- and post-design. Acceptability of the intervention was assessed 2 weeks post intervention with a questionnaire designed specifically for this study. Feasibility was assessed with consent, adherence and reasons for non-participation, refusal and attrition. Participants completed baseline and follow-up (6-week post intervention) questionnaires for psychological morbidity, burden, problem-solving, mindfulness and preparedness. Settings/participants: Caregivers of people with a diagnosis of MND within the past 12 months who were 18 years or older; who could speak, read and write in English and who were attending a progressive neurological diseases clinic were eligible. A total of 13 caregivers participated in one of three group intervention sessions which were focused on self-care, problem-solving and mindfulness. The intervention appeared to be feasible and acceptable. All participants stated that they would recommend the intervention to others. The group format appeared to be highly valued. There was no significant change in measures between pre-intervention and 6 weeks post intervention. This pilot serves as an initial step for examining interventions for MND caregivers, with the hope of identifying effective, efficient and sustainable strategies to best support this group.

  17. Can the coverage of screening for cancer of the cervix be improved using the Electoral Register? A pilot study.

    PubMed

    Cook, G A; Wald, N J

    1985-09-30

    We conducted a pilot study to assess the feasibility using the Electoral Register to carry out a cervical cancer screening programme on a Health District basis. A random sample of 500 names and addresses were drawn from a computerised list of the Electoral Register from three Electoral Wards in Oxford. A pilot study showed that the Electoral Register could be used successfully in this way and that the proportion of women aged 35-64 years who had a cervical smear examination as a result of the screening initiative was increased by a quarter, from 64% to 79%. The numbers of women involved at each step of the screening process were determined, and these may provide a useful guide to others considering implementing similar schemes.

  18. Brain response to taste in overweight children: A pilot feasibility study.

    PubMed

    Bohon, Cara

    2017-01-01

    Understanding the neural response to food and food cues during early stages of weight gain in childhood may help us determine the drive processes involved in unhealthy eating behavior and risk for obesity. Healthy weight and overweight children ages 6-8 (N = 18; 10 with BMI between 5th and 85th %ile and 8 with BMI >85th %ile) underwent fMRI scans while anticipating and receiving tastes of chocolate milkshake. Parents completed a Children's Eating Behaviour Questionnaire. Results reveal greater response to milkshake taste receipt in overweight children in the right insula, operculum, precentral gyrus, and angular gyrus, and bilateral precuneus and posterior cingulate. No group differences were found for brain response to a visual food cue. Exploratory analyses revealed interactions between self-report measures of eating behavior and weight status on brain response to taste. This pilot study provides preliminary evidence of feasibility of studying young children's taste processing and suggests a possible developmental shift in brain response to taste.

  19. Brain response to taste in overweight children: A pilot feasibility study

    PubMed Central

    Bohon, Cara

    2017-01-01

    Understanding the neural response to food and food cues during early stages of weight gain in childhood may help us determine the drive processes involved in unhealthy eating behavior and risk for obesity. Healthy weight and overweight children ages 6–8 (N = 18; 10 with BMI between 5th and 85th %ile and 8 with BMI >85th %ile) underwent fMRI scans while anticipating and receiving tastes of chocolate milkshake. Parents completed a Children’s Eating Behaviour Questionnaire. Results reveal greater response to milkshake taste receipt in overweight children in the right insula, operculum, precentral gyrus, and angular gyrus, and bilateral precuneus and posterior cingulate. No group differences were found for brain response to a visual food cue. Exploratory analyses revealed interactions between self-report measures of eating behavior and weight status on brain response to taste. This pilot study provides preliminary evidence of feasibility of studying young children’s taste processing and suggests a possible developmental shift in brain response to taste. PMID:28235080

  20. A pilot trial of a videogame-based exercise program for methadone maintained patients

    PubMed Central

    Cutter, Christopher J.; Schottenfeld, Richard S.; Moore, Brent A.; Ball, Samuel A.; Beitel, Mark; Savant, Jonathan D.; Stults-Kolehmainen, Matthew A.; Doucette, Christopher; Barry, Declan T.

    2014-01-01

    Few studies have examined exercise as a substance use disorder treatment. This pilot study investigated the feasibility and acceptability of an exercise intervention comprising the Wii Fit Plus™ and of a time-and-attention sedentary control comprising Wii™ videogames. We also explored their impact on physical activity levels, substance use, and psychological wellness. Twenty-nine methadone-maintained patients enrolled in an 8-week trial were randomly assigned to either Active Game Play (Wii Fit Plus™ videogames involving physical exertion) or Sedentary Game Play (Wii™ videogames played while sitting). Participants had high satisfaction and study completion rates. Active Game Play participants reported greater physical activity outside the intervention than Sedentary Game Play participants despite no such differences at baseline. Substance use decreased and stress and optimism improved in both conditions. Active Game Play is a feasible and acceptable exercise intervention, and Sedentary Game Play is a promising time-and-attention control. Further investigations of these interventions are warranted. PMID:25012555

  1. A pilot trial of a videogame-based exercise program for methadone maintained patients.

    PubMed

    Cutter, Christopher J; Schottenfeld, Richard S; Moore, Brent A; Ball, Samuel A; Beitel, Mark; Savant, Jonathan D; Stults-Kolehmainen, Matthew A; Doucette, Christopher; Barry, Declan T

    2014-10-01

    Few studies have examined exercise as a substance use disorder treatment. This pilot study investigated the feasibility and acceptability of an exercise intervention comprising the Wii Fit Plus™ and of a time-and-attention sedentary control comprising Wii™ videogames. We also explored their impact on physical activity levels, substance use, and psychological wellness. Twenty-nine methadone-maintained patients enrolled in an 8-week trial were randomly assigned to either Active Game Play (Wii Fit Plus™ videogames involving physical exertion) or Sedentary Game Play (Wii™ videogames played while sitting). Participants had high satisfaction and study completion rates. Active Game Play participants reported greater physical activity outside the intervention than Sedentary Game Play participants despite no such differences at baseline. Substance use decreased and stress and optimism improved in both conditions. Active Game Play is a feasible and acceptable exercise intervention, and Sedentary Game Play is a promising time-and-attention control. Further investigations of these interventions are warranted. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. The Girlfriends Project: Results of a pilot study assessing feasibility of an HIV testing and risk reduction intervention developed, implemented, and evaluated in community settings.

    PubMed

    Hawk, Mary

    2013-12-01

    African American women in the United States experience significant HIV health disparities. The majority of evidence-based risk reduction interventions do not incorporate HIV testing, and most are targeted only to narrow segments of the population such as women who are pregnant or seen in STI clinics. This pilot study assessed the feasibility and efficacy of The Girlfriends Project (TGP), a community developed and community evaluated HIV risk reduction and testing intervention. A group randomized wait-list design was used to recruit 149 women and to compare findings for intervention group versus control group participants. Women in the intervention group demonstrated statistically-significant increases in HIV knowledge scores and in condom use during vaginal sex. Eighty-seven percent of participants accessed HIV testing with a 100% return rate for results. Study findings suggest that TGP has the potential to be an effective intervention and to increase number of African American women who access HIV testing.

  3. Maintaining Cognitive Functioning in Healthy Seniors with a Technology-Based Foreign Language Program: A Pilot Feasibility Study.

    PubMed

    Ware, Caitlin; Damnee, Souad; Djabelkhir, Leila; Cristancho, Victoria; Wu, Ya-Huei; Benovici, Judith; Pino, Maribel; Rigaud, Anne-Sophie

    2017-01-01

    Researchers have hypothesized that learning a foreign language could be beneficial for seniors, as language learning requires the use of extensive neural networks. We developed and qualitatively evaluated an English training program for older French adults; our principal objective was to determine whether a program integrating technology is feasible for this population. We conducted a 4-month pilot study (16, 2-h sessions) with 14 French participants, (nine women, five men, average age 75). Questionnaires were administered pre- and post-intervention to measure cognitive level and subjective feelings of loneliness or social isolation; however, these scores did not improve significantly. Post-intervention, semi-directive interviews were carried out with participants, and a content/theme analysis was performed. Five main themes were identified from the interviews: Associations with school, attitudes toward English, motivation for learning English, attitudes toward the program's organization, and social ties. The program was found to be feasible for this age group, yet perceived as quite difficult for participants who lacked experience with English. Nonetheless, most participants found the program to be stimulating and enjoyable. We discuss different suggestions for future programs and future directions for foreign-language learning as a therapeutic and cognitive intervention.

  4. Mindfulness for adolescent chronic pain: a pilot feasibility study.

    PubMed

    Lovas, David Adam; Pajer, Kathleen; Chorney, Jill MacLaren; Vo, Dzung X; Howlett, Melissa; Doyle, Ashley; Huber, Adam

    2017-09-01

    Chronic pain is common in paediatric populations and many patients do not respond to the currently available evidence-based treatments. Mindfulness-based interventions (MBIs) have a growing evidence-base in adults, but evidence is limited in youth with chronic pain. We conducted an open-label pilot study to test the feasibility of an 8-week MBI for this population. Seven adolescents (age range 14-17; median age 15; six female) completed the intervention. There were no dropouts. Median class attendance was seven of eight total sessions (SD = 0.76). Only one (14.3%) participant reported not finding it useful; five (71.4%) reported that they would recommend it to a friend; and the remaining two (28.6%) reported "maybe". There was no worsening of internalizing symptoms. Secondary outcomes included significant reduction of pain intensity, which was maintained at three-month follow-up. Somatic symptoms and functional disability were both non-significantly lower immediately following the intervention; but were significantly improved at three-month follow-up. An eight-week group MBI is a feasible intervention for adolescents with chronic pain, and warrants further investigation as a potential alternative to cognitive behavioural therapy in this population.

  5. "Is Your Man Stepping Out?" An Online Pilot Study to Evaluate Acceptability of a Guide-Enhanced HIV Prevention Soap Opera Video Series and Feasibility of Recruitment by Facebook Advertising.

    PubMed

    Jones, Rachel; Lacroix, Lorraine J; Nolte, Kerry

    2015-01-01

    Love, Sex, and Choices (LSC) is a 12-episode soap opera video series developed to reduce HIV risk among at-risk Black urban women. We added a video guide commentator to offer insights at critical dramatic moments. An online pilot study evaluated acceptability of the Guide-Enhanced LSC (GELSC) and feasibility of Facebook advertising, streaming to smartphones, and retention. Facebook ads targeted high-HIV-prevalence areas. In 30 days, Facebook ads generated 230 screening interviews: 84 were high risk, 40 watched GELSC, and 39 followed up at 30 days. Recruitment of high-risk participants was 10 per week, compared to seven per week in previous field recruitment. Half the sample was Black; 12% were Latina. Findings suggest GELSC influenced sex scripts and behaviors. It was feasible to recruit young urban women from a large geographic area via Facebook and to retain the sample. We extended the reach to at-risk women by streaming to mobile devices. Copyright © 2015 Association of Nurses in AIDS Care. Published by Elsevier Inc. All rights reserved.

  6. Tai Chi: moving for better balance -- development of a community-based falls prevention program.

    PubMed

    Li, Fuzhong; Harmer, Peter; Mack, Karin A; Sleet, David; Fisher, K John; Kohn, Melvin A; Millet, Lisa M; Xu, Junheng; Yang, Tingzhong; Sutton, Beth; Tompkins, Yvaughn

    2008-05-01

    This study was designed to develop an evidence- and community based falls prevention program -- Tai Chi: Moving for Better Balance. A mixed qualitative and quantitative approach was used to develop a package of materials for program implementation and evaluation. The developmental work was conducted in 2 communities in the Pacific Northwest. Participants included a panel of experts, senior service program managers or activity coordinators, and older adults. Outcome measures involved program feasibility and satisfaction. Through an iterative process, a program package was developed. The package contained an implementation plan and class training materials (ie, instructor's manual, videotape, and user's guidebook). Pilot testing of program materials showed that the content was appropriate for the targeted users (community-living older adults) and providers (local senior service organizations). A feasibility survey indicated interest and support from users and providers for program implementation. A 2-week pilot evaluation showed that the program implementation was feasible and evidenced good class attendance, high participant satisfaction, and interest in continuing Tai Chi. The package of materials developed in this study provides a solid foundation for larger scale implementation and evaluation of the program in community settings.

  7. 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

  8. Pilot Comparisons of Temporary Open Revascularization Using Stent Grafts vs. Standard Shunts in a Sheep (Ovis aries) Model

    DTIC Science & Technology

    2016-03-14

    using stent grafts vs. standard shunts in a sheep (Ovis aries) model." PRINCIPAL INVESTIGATOR (Pl) I TRAINING COORDINATOR (TC): Lt Col James Sampson...Objectives: Pilot study and development of an experimental model to test and compare the performance of endovascular stent -graft as an arterial shunt...FDG2015001 OA 2 Results: Exposure and placement of vascular stent -grafts and shunts into the common carotid artery was feasible. Stent -graft and

  9. Use of waste tires (crumb rubber) on Colorado highways.

    DOT National Transportation Integrated Search

    2014-12-01

    The objective of this study was to determine the feasibility of using waste tires (crumb rubber) in the : construction of asphalt pavements in Colorado. Two pilot test sections and one control section were constructed : and observed over a five-year ...

  10. Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study

    PubMed Central

    Maggiani, Alberto; Tremolizzo, Lucio; Valentina, Andrea Della; Mapelli, Laurent; Sosio, Silvia; Milano, Valeria; Bianchi, Manuel; Badi, Francesco; Lavazza, Carolina; Grandini, Marco; Corna, Giovanni; Prometti, Paola; Lunetta, Christian; Riva, Nilo; Ferri, Alessandra; Lanfranconi, Francesca

    2016-01-01

    Background: Current interventions in amyotrophic lateral sclerosis (ALS) are focused on supporting quality of life (QoL) and easing pain with a multidisciplinary approach. Objective: Primary aim of this pilot work assessed feasibility, safety, tolerability and satisfaction of osteopathic manual treatment (OMT) in 14 ALS outpatients. Methods: Patients were randomized according to an initial single-blind design (12 weeks, T0-T1), in order to receive OMT (weekly for 4 weeks, and fortnightly for the following 8 weeks) versus usual-care (n=7 each group), followed by an OMT open period (T1-T2, once a week for 8 weeks, n=10). Secondary aims included blind osteopathic assessment of somatic dysfunctions (SD) for goal attainment scale (GAS) calculation, Brief Pain Inventory-short form and McGill QoL-16 items. Results: OMT was demonstrated feasible and safe and patients displayed high satisfaction (T1-VAS=8.34 ± 0.46; T2-VAS=8.52 ± 0.60). Considering secondary aims no significant differences emerged. Finally, at study entry (T0), a cervico-dorsal SD was found in 78% of ALS patients versus 28% of healthy matched controls (p<0.01). Conclusion: OMT was found feasible, safe and satisfactory in ALS. The lack of secondary aim differences can be due to the limited sample size. OMT could be an interesting option to explore in ALS. PMID:27651843

  11. Building Resiliency in a Palliative Care Team: A Pilot Study.

    PubMed

    Mehta, Darshan H; Perez, Giselle K; Traeger, Lara; Park, Elyse R; Goldman, Roberta E; Haime, Vivian; Chittenden, Eva H; Denninger, John W; Jackson, Vicki A

    2016-03-01

    Palliative care clinicians (PCCs) are vulnerable to burnout as a result of chronic stress related to working with seriously ill patients. Burnout can lead to absenteeism, ineffective communication, medical errors, and job turnover. Interventions that promote better coping with stress are needed in this population. This pilot study tested the feasibility of the Relaxation Response Resiliency Program for Palliative Care Clinicians, a program targeted to decrease stress and increase resiliency, in a multidisciplinary cohort of PCCs (N = 16) at a major academic medical center. A physician delivered the intervention over two months in five sessions (12 hours total). Data were collected the week before the program start and two months after completion. The main outcome was feasibility of the program. Changes in perceived stress, positive and negative affect, perspective taking, optimism, satisfaction with life, and self-efficacy were examined using nonparametric statistical tests. Effect size was quantified using Cohen's d. The intervention was feasible; all participants attended at least four of the five sessions, and there was no attrition. After the intervention, participants showed reductions in perceived stress and improvements in perspective taking. Our findings suggest that a novel team-based resiliency intervention based on elicitation of the relaxation response was feasible and may help promote resiliency and protect against the negative consequences of stress for PCCs. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  12. Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care

    PubMed Central

    2014-01-01

    Background Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. Methods This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and faithfully delivered in routine primary care. Discussion Movement as Medicine for Type 2 Diabetes will address an important gap in the evidence-base, that is, the need for interventions to increase free-living PA behaviour in adults with Type 2 diabetes. The multifaceted intervention incorporates an online accredited training programme for primary healthcare professionals and represents, to the best of our knowledge, the first of its kind in the United Kingdom. This study will establish whether the multifaceted behavioural intervention is acceptable and feasible in routine primary care. Trial registration Movement as Medicine for Type 2 Diabetes (MaMT2D) was registered with Current Controlled Trials on the 14th January 2012: ISRCTN67997502. The first primary care practice was randomised on the 5th October 2012. PMID:24491134

  13. Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

    PubMed

    Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

    2017-01-01

    The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population. The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary outcomes for the main study, and the feasibility of their measurement will be determined in this pilot trial. The manuscript describes the protocol for a pilot study to determine the feasibility of a behavioral intervention to improve consistent condom use among BB FSWs. The results of this pilot will inform a larger intervention for HIV prevention for this target group in Nigeria. The Institutional Review Board (IRB) of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.

  14. Individual Learning Account Pilot Initiative: A Learning Tool for the 21st Century. Report to the OPM Director.

    ERIC Educational Resources Information Center

    President's Task Force on Federal Training Technology, Washington, DC.

    The U.S. Office of Personnel Management (OPM) evaluated the feasibility of individual learning accounts (ILAs) as an approach to workforce development. Thirteen federal agencies volunteered to participate in the initiative. Together, they conducted a total of 17 pilot tests. Some pilot tests included all employees in the agency. Others targeted…

  15. Effect of chiropractic manipulation on vertical jump height in young female athletes with talocrural joint dysfunction: a single-blind randomized clinical pilot trial.

    PubMed

    Hedlund, Sofia; Nilsson, Hans; Lenz, Markus; Sundberg, Tobias

    2014-02-01

    The main objective of this pilot study was to explore the effect of chiropractic high-velocity, low-amplitude (HVLA) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction. This was a randomized assessor-blind clinical pilot trial. Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation (n = 11) or sham treatment (n = 11) once a week during a 3-week period. The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks. Nineteen athletes completed the study. After 3 weeks, the group receiving HVLA manipulation (n = 11) had a statistically significant mean (SD) improvement in vertical jump height of 1.07 (1.23) cm (P = .017). The sham treatment group (n = 8) improved their vertical jump height by 0.59 (2.03) cm (P = .436). The between groups' change was 0.47 cm (95% confidence interval, -1.31 to 2.26; P = .571) in favor of the group receiving HVLA manipulation. Blinding and sham procedures were feasible, and there were no reported adverse events. The results of this pilot study show that a larger-scale study is feasible. Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction. However, the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  16. PILOT STUDIES OF IN-SITU BIO-TRANSFORMATION OF MERCURY-CONTAMINATED GROUNDWATER IN KAZAKHSTAN UTILIZING NATIVE BACTERIA

    EPA Science Inventory

    Several regions in the Republic of Kazakhstan and throughout the former USSR are contaminated with mercury resulting from industrial releases. Our studies directed towards determining the feasibility of developing a biological filter, which when placed into the path the groundwat...

  17. SCHOOL INTEGRATION CONTROVERSIES IN NEW YORK CITY, A PILOT STUDY.

    ERIC Educational Resources Information Center

    SWANSON, BERT E.

    THE MAJOR PROBLEM OF THIS PREPARATORY RESEARCH PROGRAM WAS TO ASCERTAIN THE FEASIBILITY OF MAKING A FULL-SCALE STUDY OF THE DYNAMICS OF SCHOOL INTEGRATION CONTROVERSIES IN NEW YORK CITY. METHODS INVOLVED INTERVIEWING AND OBSERVING LEADERS AT CITYWIDE AND NEIGHBORHOOD LEVELS, INCLUDING SCHOOL ADMINISTRATORS, SCHOOL BOARD MEMBERS, TEACHERS, PARENT…

  18. WET OXIDATION OF MUNICIPAL SLUDGE BY THE VERTICAL TUBE REACTOR

    EPA Science Inventory

    A study was undertaken to assess the feasibility of carrying out oxidation of dilute sewage sludge by means of the vertical tube reactor (VTR) system. A pilot scale facility along with a laboratory reactor were used for this study. Dilute sewage sludge was oxidized in the laborat...

  19. Pilot Study of a School-Based Parent Training Program for Preschoolers with ASD

    ERIC Educational Resources Information Center

    Ingersoll, Brooke R; Wainer, Allison L

    2013-01-01

    This study investigated the feasibility and preliminary effectiveness of a parenting training program designed for early intervention and early childhood special education (EI/ESCE) programs serving students with autistic spectrum disorders. Thirteen teachers representing three intermediate school districts implemented the intervention with 27…

  20. 77 FR 35466 - Pilot Project Grants in Support of Railroad Safety Risk Reduction Programs

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-13

    ... mobile telephones and laptop computers. This subpart was codified in response to an increase in the... FRA funding. Applications should include feasibility studies and cost estimates, if completed. FRA will more favorably consider applications that include these types of studies and estimates, as they...

  1. Carbon sequestration pilot program : estimated land available for carbon sequestration in the national highway system

    DOT National Transportation Integrated Search

    2010-05-01

    The Federal Highway Administration (FHWA) established the Carbon Sequestration Pilot Program (CSPP) in 2008 to assess whether a roadside carbon sequestration effort through modified maintenance and management practices is appropriate and feasible for...

  2. Feasibility and Effectiveness of Nutritional Telemonitoring for Home Care Clients: A Pilot Study.

    PubMed

    van Doorn-van Atten, Marije N; Haveman-Nies, Annemien; Heery, Daniel; de Vries, Jeanne H M; de Groot, Lisette C P G M

    2018-06-01

    Undernutrition has unfavorable consequences for health and quality of life. This pilot study aimed to evaluate the feasibility of a telemonitoring intervention to improve the nutritional status of community-dwelling older adults. The study involved a one-group pretest post-test design, complemented by a qualitative study. The 3-month intervention included 20 Dutch home care clients aged >65 years and consisted of nutritional telemonitoring, television messages, and dietary advice. A process evaluation provided insight into intervention delivery and acceptability. Changes in behavioral determinants, diet quality, appetite, nutritional status, physical functioning, and quality of life were assessed. Researchers and health care professionals implemented the intervention as intended and health care professionals accepted the intervention well. However, 9 participants dropped out, and participants' acceptance was low, mainly due to the low usability of the telemonitoring television channel. Adherence to the telemonitoring measurements was good, although participants needed more help from nurses than anticipated. Participants increased compliance to several Dutch dietary guidelines and no effects on nutritional status, physical functioning, and quality of life were found. Successful telemonitoring of nutritional parameters in community-dwelling older adults starts with optimal usability and acceptability by older adults and their health care professionals. This pilot study provides insight into how to optimize telemonitoring interventions for older adults for maximum impact on behavior and health.

  3. Feasibility of a Humor Training to Promote Humor and Decrease Stress in a Subclinical Sample: A Single-Arm Pilot Study

    PubMed Central

    Tagalidou, Nektaria; Loderer, Viola; Distlberger, Eva; Laireiter, Anton-Rupert

    2018-01-01

    The present study investigates the feasibility of a humor training for a subclinical sample suffering from increased stress, depressiveness, or anxiety. Based on diagnostic interviews, 35 people were invited to participate in a 7-week humor training. Evaluation measures were filled in prior training, after training, and at a 1-month follow-up including humor related outcomes (coping humor and cheerfulness) and mental health-related outcomes (perceived stress, depressiveness, anxiety, and well-being). Outcomes were analyzed using repeated-measures ANOVAs. Within-group comparisons of intention-to-treat analysis showed main effects of time with large effect sizes on all outcomes. Post hoc tests showed medium to large effect sizes on all outcomes from pre to post and results remained stable until follow-up. Satisfaction with the training was high, attrition rate low (17.1%), and participants would highly recommend the training. Summarizing the results, the pilot study showed promising effects for people suffering from subclinical symptoms. All outcomes were positively influenced and showed stability over time. Humor trainings could be integrated more into mental health care as an innovative program to reduce stress whilst promoting also positive emotions. However, as this study was a single-arm pilot study, further research (including also randomized controlled trials) is still needed to evaluate the effects more profoundly. PMID:29740368

  4. Knee ultrasound from research to real practice: a systematic literature review of adult knee ultrasound assessment feasibility studies.

    PubMed

    Peltea, Alexandra; Berghea, Florian; Gudu, Tania; Ionescu, Ruxandra

    2016-12-05

    To identify and analyse existing data regarding knee ultrasound (US) feasibility in clinical practice. Material and methods: A systematic literature review was performed using the terms: ("knee") AND ("ultrasound" OR "ultrasonography") AND ("feasibility" OR "pilot" OR "proof of concept"). Feasibility studies regarding knee US or US aided maneuver involving knee joint, published during 2005-2015, were selected and evaluated against a complex framework constructed around mandatory key areas for feasibility studies: acceptability, demand, implementation, practicality, adaptation, integration and expansion. One hundred and fifty-nine publications were identified, of which 9 were included in the final analysis: 6 dealt with the development and implementation of novel US scores, while the rest focused on implementing MSUS in clinical practice, evaluating the usefulness of articular cartilage US assessment and the feasibility of sonography for intra-articular knee injections, respectively. Six studies quantified feasibility as time spent for the evaluation, with only two addressing areassuch as acceptability, implementation and practicality, although none of these systematically assessed all feasibility domains. Knee US feasibility is still poorly addressed; the time required for US assessment is the main area addressed. This information gap should be properly addressed in future works, in order to ensure the right place for this technique.

  5. Feasibility and Acceptability of Nurse-Led Primary Palliative Care for Older Adults with Chronic Conditions: A Pilot Study.

    PubMed

    Izumi, Shigeko Seiko; Basin, Basilia; Presley, Margo; McCalmont, Jean; Furuno, Jon P; Noble, Brie; Baggs, Judith G; Curtis, J Randall

    2018-05-24

    Many older adults live with serious illness for years before their death. Nurse-led primary palliative care could improve their quality of life and ability to stay in their community. To assess feasibility and acceptability of a nurse-led Transitional Palliative Care (TPC) program for older adults with serious illness. The study was a pilot trial of the TPC program in which registered nurses assisted patients with symptom management, communication with care providers, and advance care planning. Forty-one older adults with chronic conditions were enrolled in TPC or standard care groups. Feasibility was assessed through enrollment and attrition rates and degree of intervention execution. Acceptability was assessed through surveys and exit interviews with participants and intervention nurses. Enrollment rate for those approached was 68%, and completion rate for those enrolled was 71%. The TPC group found the intervention acceptable and helpful and was more satisfied with care received than the control group. However, one-third of participants perceived that TPC was more than they needed, despite the number of symptoms they experienced and the burdensomeness of their symptoms. More than half of the participants had little to no difficulty participating in daily activities. This study demonstrated that the nurse-led TPC program is feasible, acceptable, and perceived as helpful. However, further refinement is needed in selection criteria to identify the population who would most benefit from primary palliative care before future test of the efficacy of this intervention.

  6. 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.

  7. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt

    PubMed Central

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-01-01

    Objectives Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness. Setting Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)). Participants 460 participants (46.6% female; 13.2 (0.4) years old). Interventions 8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition. Primary and secondary outcome measures Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline. Results All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive ‘fun’; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1.8 (0.1 to 3.4) p=0.04 but no difference in shyness/sociability. Participation in activity types approached significance (intervention group 2.3 (−0.2 to 4.7) p=0.07 more activity types). Conclusions Results suggest feasibility and indicate potential effectiveness of GoActive to increase MVPA and support a fully powered evaluation of effectiveness and cost-effectiveness. Process evaluation data were used to refine GoActive prior to a full trial. Trial registration number ISRCTN31583496; pre-results. PMID:27836873

  8. Australasian brachytherapy audit: results of the 'end-to-end' dosimetry pilot study.

    PubMed

    Haworth, Annette; Wilfert, Lisa; Butler, Duncan; Ebert, Martin A; Todd, Stephen; Bucci, Joseph; Duchesne, Gillian M; Joseph, David; Kron, Tomas

    2013-08-01

    We present the results of a pilot study to test the feasibility of a brachytherapy dosimetry audit. The feasibility study was conducted at seven sites from four Australian states in both public and private centres. A purpose-built cylindrical water phantom was imaged using the local imaging protocol and a treatment plan was generated to deliver 1 Gy to the central (1 of 3) thermoluminescent dosimeter (TLD) from six dwell positions. All centres completed the audit, consisting of three consecutive irradiations, within a 2-h time period, with the exception of one centre that uses a pulsed dose rate brachytherapy unit. All TLD results were within 4.5% of the predicted value, with the exception of one subset where the dwell position step size was incorrectly applied. While the limited data collected in the study demonstrated considerable heterogeneity in clinical practice, the study proved a brachytherapy dosimetry audit to be feasible. Future studies should include verification of source strength using a Standard Dosimetry Laboratory calibrated chamber, a phantom that more closely mimics the clinical situation, a more comprehensive review of safety and quality assurance (QA) procedures including source dwell time and position accuracy, and a review of patient treatment QA procedures such as applicator position verification. © 2013 The Authors. Journal of Medical Imaging and Radiation Oncology © 2013 The Royal Australian and New Zealand College of Radiologists.

  9. 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.

  10. An eHealth Application of Self-Reported Sports-Related Injuries and Illnesses in Paralympic Sport: Pilot Feasibility and Usability Study.

    PubMed

    Fagher, Kristina; Jacobsson, Jenny; Dahlström, Örjan; Timpka, Toomas; Lexell, Jan

    2017-11-29

    Sport participation is associated with a risk of sports-related injuries and illnesses, and Paralympic athletes' additional medical issues can be a challenge to health care providers and medical staff. However, few prospective studies have assessed sports-related injuries and illnesses in Paralympic sport (SRIIPS) over time. Advances in mobile phone technology and networking systems offer novel opportunities to develop innovative eHealth applications for collection of athletes' self-reports. Using eHealth applications for collection of self-reported SRIIPS is an unexplored area, and before initiation of full-scale research of SRIIPS, the feasibility and usability of such an approach needs to be ascertained. The aim of this study was to perform a 4-week pilot study and (1) evaluate the monitoring feasibility and system usability of a novel eHealth application for self-reported SRIIPS and (2) report preliminary data on SRIIPS. An eHealth application for routine collection of data from athletes was developed and adapted to Paralympic athletes. A 4-week pilot study was performed where Paralympic athletes (n=28) were asked to weekly self-report sport exposure, training load, general well-being, pain, sleep, anxiety, and possible SRIIPS. The data collection was followed by a poststudy use assessment survey. Quantitative data related to the system use (eg, completed self-reports, missing responses, and errors) were analyzed using descriptive statistics. The qualitative feasibility and usability data provided by the athletes were condensed and categorized using thematic analysis methods. The weekly response rate was 95%. The athletes were of the opinion that the eHealth application was usable and feasible but stated that it was not fully adapted to Paralympic athletes and their impairments. For example, it was difficult to understand how a new injury or illness should be identified when the impairment was involved. More survey items related to the impairments were requested, as the athletes perceived that injuries and illnesses often occurred because of the impairment. Options for description of multifactorial incidents including an injury, an illness, and the impairment were also insufficient. Few technical issues were encountered, but athletes with visual impairment reported usability difficulties with the speech synthesizer. An incidence rate of 1.8 injuries and 1.7 illnesses per 100 hours of athlete exposure were recorded. The weekly pain prevalence was 56% and the impairment contributed to 20% of the reported incidents. The novel eHealth-based application for self-reported SRIIPS developed and tested in this pilot study was generally feasible and usable. With some adaptation to accommodate Paralympic athletes' prerequisites and improved technical support for athletes with visual impairment, this application can be recommended for use in prospective studies of SRIIPS. ClinicalTrials.gov NCT02788500; https://clinicaltrials.gov/ct2/show/NCT02788500 (Archived by WebCite at http://www.webcitation.org/6v56OqTeP). ©Kristina Fagher, Jenny Jacobsson, Örjan Dahlström, Toomas Timpka, Jan Lexell. Originally published in JMIR Human Factors (http://humanfactors.jmir.org), 29.11.2017.

  11. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

    PubMed

    Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

    2016-06-01

    Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Pilot parallel three-arm randomised controlled trial nested within feasibility work. Two UK NHS departments of upper gastrointestinal surgery. Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing, allowing a seamless transition into the definitive trial. Consequently, the database is unlocked at the time of writing and data presented here are for patients recruited by 31 August 2014. Random allocation achieved a good balance between the arms of the study, which, as a high proportion of patients underwent their allocated surgery (69/79, 87%), ensured a fair comparison between the interventions. Dressing patients with large bandages, covering all possible incisions, was successful in keeping patients blind while pain was assessed during the first week post surgery. Postsurgical length of stay and risk of adverse events were within the typical range for this group of patients, with one death occurring within 30 days among 76 patients. There were good completion rates for the assessment of pain at 6 days post surgery (88%) and of the patient-reported outcomes at 6 weeks post randomisation (74%). Rapid recruitment to the pilot trial and the successful refinement of methodology indicated the feasibility of a definitive trial comparing different approaches to oesophagectomy. Although we have shown a full trial of open compared with minimally invasive oesophagectomy to be feasible, this is necessarily based on our findings from the two clinical centres that we could include in this small preliminary study. Current Controlled Trials ISRCTN59036820. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 48. See the NIHR Journals Library website for further project information.

  12. A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

    PubMed

    Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

    2013-01-01

    An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

  13. 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.

  14. Feasibility and Effectiveness of a Pilot Health Promotion Program for Adults With Type 2 Diabetes

    PubMed Central

    Kluding, Patricia M.; Singh, Rupali; Goetz, Jeanine; Rucker, Jason; Bracciano, Sarah; Curry, Natasha

    2013-01-01

    Purpose The purpose of this pilot study was to assess the feasibility and effectiveness of an intense health promotion program in older adults with diabetes. The program combined individually prescribed and supervised exercise with nutrition and education programs on glycemic control and aerobic fitness. Methods Various recruitment and retention strategies were analyzed for effectiveness. Out of 28 potential subjects assessed for eligibility, 6 subjects with type 2 diabetes (2 male and 4 female; all white; age, 60.2 ± 4.7 years) participated in the 10-week intervention. Aerobic and resistance exercise was performed on alternate days (3-4 days per week), with individualized nutrition counseling and diabetes health education sessions once weekly. The primary outcome measures were aerobic fitness and glycemic control (A1C), and secondary outcome measures included body mass index (BMI), self-efficacy, and symptoms of neuropathy. Changes in outcomes were assessed using descriptive statistics and paired t test analysis (α = .05). Results Following the intervention, subjects had improvements that approached significance in A1C and pain, with significant improvements in self-efficacy. Conclusions A systematic approach to analysis of feasibility revealed issues with recruitment and retention that would need to be addressed for future studies or clinical implementation of this program. However, for the subset of subjects who did complete the intervention, adherence was excellent, and satisfaction with the program was confirmed by exit interview comments. Following participation in this pilot health promotion program, subjects had meaningful improvements in glycemic control, pain, and self-efficacy. PMID:20530663

  15. Feasibility of a home-delivered Internet obesity prevention program for fourth-grade students.

    PubMed

    Owens, Scott; Lambert, Laurel; McDonough, Suzanne; Green, Kenneth; Loftin, Mark

    2009-08-01

    This pilot study examined the feasibility of an interactive obesity prevention program delivered to a class of fourth-grade students utilizing daily e-mail messages sent to the students' home computers. The study involved a single intact class of 22 students, 17 (77%) of whom submitted parental permission documentation and received e-mail messages each school day over the course of one month. Concerns regarding Internet safety and children's use of e-mail were addressed fairly easily. Cost/benefit issues for the school did not seem prohibitive. Providing e-mail access to students without a home computer was accomplished by loaning them personal digital assistant (PDA) devices. In larger interventions, loaning PDAs is probably not feasible economically, although cell phones may be an acceptable alternative. It was concluded that this type of interactive obesity prevention program is feasible from most perspectives. Data from a larger scale effectiveness study is still needed.

  16. Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

    PubMed Central

    Manshanden, Johan S.J.; Gielen, Chantal L.I.; de Borgie, Corianne A.J.M.; Klautz, Robert J.M.; de Mol, Bas A.J.M.; Koolbergen, David R.

    2015-01-01

    Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

  17. Pilot study of the impact sacroiliac joint manipulation has on walking kinematics using motion analysis technology

    PubMed Central

    Ward, John S.; Coats, Jesse; Sorrels, Kenneth; Walters, Mathew; Williams, Trevor

    2013-01-01

    Objective The purpose of this study was to evaluate the feasibility of engaging in a series of larger studies measuring the effect of sacroiliac joint manipulation on walking kinematics using motion analysis technology. Methods Twelve college students engaged in a baseline 90-second gait analysis at 1.5 mph using infrared VICON cameras. Following this, they underwent a prone heel comparison test for functional leg length inequality. Upon examination, participants were then classified as follows: left short leg, right short leg, or no short leg. Participants in each of the 2 short leg branches of this study were then randomized to receive either chiropractic manipulative therapy to the posterior superior iliac spine on the short limb side or no manipulation. Recruitment was ongoing for this pilot study until 1 participant was recruited in each of the following 5 comparative study groups: left short leg—manipulation, left short leg—no manipulation (control 1), right short leg—manipulation, right short leg—no manipulation (control 2), and no short leg (control 3). All participants then underwent another 90-second gait analysis. Data were then grouped and submitted to a blinded biomechanist to determine if there were any unique biomechanical differences between the groups. Results No statistically significant differences were measured because of this being a pilot study with a small sample size. Conclusions The data from this study indicate that a series of larger studies with this design is feasible. PMID:24396314

  18. A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy.

    PubMed

    Brulé, David; Gillmeister, Biljana; Lee, Michelle; Alexander, Sarah; Gassas, Adam; Hendershot, Eleanor; Zupanec, Sue; Dupuis, Lee; Sung, Lillian

    2016-12-01

    Fatigue is a major problem in children with cancer. The objective was to examine the feasibility of performing a clinical trial of homeopathic treatment for fatigue in children receiving chemotherapy. This was a single-institution, open-label, pilot study. Children 2 to 18 years old, diagnosed with cancer, and receiving chemotherapy were eligible. Participants were given individualized homeopathic treatment for a maximum of 14 days. In-home or clinic assessments were conducted up to 3 times weekly. Feasibility was defined as the ability to recruit and administer homeopathy to 10 participants within 1 year. Fatigue was measured using the Symptom Distress Scale daily and the PedsQL Multidimensional Fatigue Module weekly. Between April 2012 and April 2014, 155 potential participants were identified. There were 45 eligible and contacted patients; 36 declined participation, 30 because they were not interested; 9 agreed to participate, but 1 participant withdrew prior to treatment initiation. Median length of homeopathic treatment was 10.5 (range = 6 to 14) days. All parents found homeopathic treatment to be easy or very easy to follow. Trials of individualized homeopathy for fatigue reduction in pediatric cancer are not feasible in this context; lack of interest was a primary reason. Alternative approaches to evaluating homeopathy efficacy are needed. © The Author(s) 2015.

  19. 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.

  20. Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST): A Pilot Randomized Trial.

    PubMed

    Kosa, S Daisy; Gafni, Amiram; House, Andrew A; Lawrence, JulieAnn; Moist, Louise; Nathoo, Bharat; Tam, Paul; Sarabia, Alicia; Thabane, Lehana; Wu, George; Lok, Charmaine E

    2017-03-01

    We developed the Hemodialysis Infection Prevention Protocols Ontario-Shower Technique (HIPPO-ST) to permit hemodialysis (HD) patients with central venous catheters (catheters) to shower without additional infection risk. Our primary objective was to determine the feasibility of conducting a parallel randomized controlled trial (RCT) to evaluate the impact of HIPPO-ST on catheter-related bacteremia (CRB) in adult HD patients. Adult HD patients using catheters were recruited from 11 HD units. Patients were randomized to receive HIPPO-ST or standard care and were followed up for 6 months. Only CRB-outcome assessors were blinded. For the study to be considered feasible, 4 of 5 feasibility outcomes, each with its own statistical threshold for success, must have been achieved. A total of 68 patients were randomized (33 HIPPO-ST and 35 control) and were followed up to 6 months. Of 5 measures of feasibility, 4 were achieved: (1) accurate CRB rate documented (threshold: κ level >0.80); (2) 97.8% (279/285) of satellite HD patients with catheters were screened (threshold: >95%); (3) 88% (23/26) in the HIPPO-ST arm were successfully educated by 6 months (threshold: >80%); and (4) 0% (0/29) patients in the control arm were "contaminated," that is, using HIPPO-ST (threshold: <5%). However, only 44.2% (72/163) of eligible patients consented to participate (threshold: >80%). The rate of CRB was similarly low in HIPPO-ST and control groups (0.68 vs. 0.88/1000 catheter days). This HIPPO-ST pilot study demonstrated the feasibility of the larger HIPPO-ST study, especially given the high levels of education success with the HIPPO-ST arm and the low levels of contamination in the control arm.

  1. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth.

    PubMed

    Byrne, Jean; Hauck, Yvonne; Fisher, Colleen; Bayes, Sara; Schutze, Robert

    2014-01-01

    This pilot study tested the feasibility and effectiveness of using Mindfulness-Based Childbirth Education (MBCE), a novel integration of mindfulness meditation and skills-based childbirth education, for mental health promotion with pregnant women. The MBCE protocol aimed to reduce fear of birth, anxiety, and stress and improve maternal self-efficacy. This pilot study also aimed to determine the acceptability and feasibility of the MBCE protocol. A single-arm pilot study of the MBCE intervention using a repeated-measures design was used to analyze data before and after the MBCE intervention to determine change trends with key outcome variables: mindfulness; depression, anxiety, and stress; childbirth self-efficacy; and fear of childbirth. Pregnant women (18-28 weeks' gestation) and their support companions attended weekly MBCE group sessions over 8 weeks in an Australian community setting. Of the 18 women who began and completed the intervention, missing data allowed for complete data from 12 participants to be analyzed. Statistically significant improvements and large effect sizes were observed for childbirth self-efficacy and fear of childbirth. Improvements in depression, mindfulness, and birth outcome expectations were underpowered. At postnatal follow-up significant improvements were found in anxiety, whereas improvements in mindfulness, stress, and fear of birth were significant at a less conservative alpha level. This pilot study demonstrated that a blended mindfulness and skills-based childbirth education intervention was acceptable to women and was associated with improvements in women's sense of control and confidence in giving birth. Previous findings that low self-efficacy and high childbirth fear are linked to greater labor pain, stress reactivity, and trauma suggest the observed improvements in these variables have important implications for improving maternal mental health and associated child health outcomes. Ways in which these outcomes can be achieved through improved childbirth education are discussed. © 2013 by the American College of Nurse-Midwives.

  2. Pilot study of a smartphone application designed to socially motivate cardiovascular disease patients to improve medication adherence.

    PubMed

    Fujita, Saki; Pitaktong, Isaree; Steller, Graeme Vosit; Dadfar, Victor; Huang, Qinwen; Banerjee, Sindhu; Guo, Richard; Nguyen, Hien Tan; Allen, Robert Harry; Martin, Seth Shay

    2018-01-01

    Social support received by patients from family and community has been identified as a key factor for success in improving medication adherence in those patients. This pilot study aimed to investigate the usability and feasibility of PillPal, a smartphone application that uses video-chatting as a social motivation medium to encourage medication adherence in cardiovascular disease (CVD) patients. We additionally gathered feedback on the Physician Calendar, an accompanying web platform that allows clinicians to view patient adherence data generated from the app. Thirty patients were recruited from the Johns Hopkins Hospital (JHH) Lipid Clinic (n=14) and Inpatient Cardiology Service (n=16) to pilot test the app. Data were obtained through in-person interviews in which patients tested out the app and answered standardized questions regarding the app's feasibility as a means to enhance social support, as well as its usability measured in terms of ease of use and patient comfort level with the video-chat technology. Cardiologists (n=10) from JHH were interviewed to gain feedback on the Physician Calendar. We recorded 43.4% participants who stated that PillPal would increase their motivation to take their medications; 96.7% stated the app was easy to use; and 70% stated they were comfortable with video-chatting while taking their medications. Patient factors such as current adherence level, disease severity, and personality were more predictive of positive app reviews than the perceived level of social support. Clinicians generally approved of the Physician Calendar, as they would be able to quickly screen for non-adherence and begin conversations with patients to address the root cause of their non-adherence. Based on pilot testing and interviews, using a smartphone app for video-chatting as a social support medium to improve patient medication adherence is feasible and has potential to increase medication adherence depending on certain patient characteristics. The Physician Calendar was deemed a useful tool by clinicians to quickly identify and understand reasons for medication non-adherence.

  3. Retraining function in people with Parkinson's disease using the Microsoft kinect: game design and pilot testing.

    PubMed

    Galna, Brook; Jackson, Dan; Schofield, Guy; McNaney, Roisin; Webster, Mary; Barry, Gillian; Mhiripiri, Dadirayi; Balaam, Madeline; Olivier, Patrick; Rochester, Lynn

    2014-04-14

    Computer based gaming systems, such as the Microsoft Kinect (Kinect), can facilitate complex task practice, enhance sensory feedback and action observation in novel, relevant and motivating modes of exercise which can be difficult to achieve with standard physiotherapy for people with Parkinson's disease (PD). However, there is a current need for safe, feasible and effective exercise games that are appropriate for PD rehabilitation. The aims of this study were to i) develop a computer game to rehabilitate dynamic postural control for people with PD using the Kinect; and ii) pilot test the game's safety and feasibility in a group of people with PD. A rehabilitation game aimed at training dynamic postural control was developed through an iterative process with input from a design workshop of people with PD. The game trains dynamic postural control through multi-directional reaching and stepping tasks, with increasing complexity across 12 levels of difficulty. Nine people with PD pilot tested the game for one session. Participant feedback to identify issues relating to safety and feasibility were collected using semi-structured interviews. Participants reported that they felt safe whilst playing the game. In addition, there were no adverse events whilst playing. In general, the participants stated that they enjoyed the game and seven of the nine participants said they could imagine themselves using the game at home, especially if they felt it would improve their balance. The Flow State Scale indicated participants were immersed in the gameplay and enjoyed the experience. However, some participants reported that they found it difficult to discriminate between different types and orientations of visual objects in the game and some also had difficulty with the stepping tasks, especially when performed at the same time as the reaching tasks. Computer-based rehabilitation games using the Kinect are safe and feasible for people with PD although intervention trials are needed to test their safety, feasibility and efficacy in the home.

  4. Retraining function in people with Parkinson’s disease using the Microsoft kinect: game design and pilot testing

    PubMed Central

    2014-01-01

    Background Computer based gaming systems, such as the Microsoft Kinect (Kinect), can facilitate complex task practice, enhance sensory feedback and action observation in novel, relevant and motivating modes of exercise which can be difficult to achieve with standard physiotherapy for people with Parkinson’s disease (PD). However, there is a current need for safe, feasible and effective exercise games that are appropriate for PD rehabilitation. The aims of this study were to i) develop a computer game to rehabilitate dynamic postural control for people with PD using the Kinect; and ii) pilot test the game’s safety and feasibility in a group of people with PD. Methods A rehabilitation game aimed at training dynamic postural control was developed through an iterative process with input from a design workshop of people with PD. The game trains dynamic postural control through multi-directional reaching and stepping tasks, with increasing complexity across 12 levels of difficulty. Nine people with PD pilot tested the game for one session. Participant feedback to identify issues relating to safety and feasibility were collected using semi-structured interviews. Results Participants reported that they felt safe whilst playing the game. In addition, there were no adverse events whilst playing. In general, the participants stated that they enjoyed the game and seven of the nine participants said they could imagine themselves using the game at home, especially if they felt it would improve their balance. The Flow State Scale indicated participants were immersed in the gameplay and enjoyed the experience. However, some participants reported that they found it difficult to discriminate between different types and orientations of visual objects in the game and some also had difficulty with the stepping tasks, especially when performed at the same time as the reaching tasks. Conclusion Computer-based rehabilitation games using the Kinect are safe and feasible for people with PD although intervention trials are needed to test their safety, feasibility and efficacy in the home. PMID:24731758

  5. Development and Feasibility of a Virtual Reality Task for the Cognitive Assessment of Older Adults: The ECO-VR.

    PubMed

    Oliveira, Camila R; Lopes Filho, Brandel José P; Sugarman, Michael A; Esteves, Cristiane S; Lima, Margarida Maria B M P; Moret-Tatay, Carmen; Irigaray, Tatiana Q; Argimon, Irani Iracema L

    2016-12-13

    Cognitive assessment with virtual reality (VR) may have superior ecological validity for older adults compared to traditional pencil-and-paper cognitive assessment. However, few studies have reported the development of VR tasks. The aim of this study was to present the development, feasibility, content validity, and preliminary evidence of construct validity of an ecological task of cognitive assessment for older adults in VR (ECO-VR). The tasks were prepared based on theoretical and clinical backgrounds. We had 29 non-expert judges identify virtual visual stimuli and three-dimensional scenarios, and five expert judges assisted with content analysis and developing instructions. Finally, six older persons participated in three pilot studies and thirty older persons participated in the preliminary study to identify construct validity evidence. Data were analyzed by descriptive statistics and partial correlation. Target stimuli and three-dimensional scenarios were judged adequate and the content analysis demonstrated that ECO-VR evaluates temporo-spatial orientation, memory, language and executive functioning. We made significant changes to the instructions after the pilot studies to increase comprehensibility and reduce the completion time. The total score of ECO-VR was positively correlated mainly with performance in executive function (r = .172, p < .05) and memory tests (r = .488, p ≤ .01). The ECO-VR demonstrated feasibility for cognitive assessment in older adults, as well as content and construct validity evidences.

  6. E-learning to improve the drug prescribing in the hospitalized elderly patients: the ELICADHE feasibility pilot study.

    PubMed

    Franchi, C; Mari, D; Tettamanti, M; Pasina, L; Djade, C D; Mannucci, P M; Onder, G; Bernabei, R; Gussoni, G; Bonassi, S; Nobili, A

    2014-08-01

    E-learning is an efficient and cost-effective educational method. This study aimed at evaluating the feasibility of an educational e-learning intervention, focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment, to improve drug prescribing to hospitalized elderly patients. Eight geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control. Clinicians of the two groups had to complete a specific per group e-learning program in 30 days. Then, ten patients (aged ≥75 years) had to be consecutively enrolled collecting clinical data at hospital admission, discharge, and 3 months later. The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer's criteria and of potential drug-drug interactions through a specific computerized database. The study feasibility was confirmed by the high percentage (90 %) of clinicians who completed the e-learning program, the recruitment, and follow-up of all planned patients. The intervention was well accepted by all participating clinicians who judged positively (a mean score of >3 points on a scale of 5 points: 0 = useless; 5 = most useful) the specific contents, the methodology applied, the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing. The pilot study met all the requested goals. The main study is currently ongoing and is planned to finish on July 2015.

  7. Expanding Horizons: A Pilot Mentoring Program Linking College/Graduate Students and Teens With ASD.

    PubMed

    Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C

    2016-02-01

    A small pilot program of 9 youth 13 to 18 years old with high-functioning autism spectrum disorder (ASD) or Asperger's syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local boys and girls club. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants' social connectedness. Although the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. © The Author(s) 2015.

  8. EXPANDING HORIZONS: A PILOT MENTORING PROGRAM LINKING COLLEGE/GRADUATE STUDENTS AND TEENS WITH ASD

    PubMed Central

    Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C.

    2015-01-01

    A small pilot program of nine youth ages 13–18 with high functioning autism spectrum disorder (ASD) or Asperger’s syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local Boys and Girls Clubs. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants’ social connectedness. While the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. PMID:26016838

  9. A cognitive-behavioural program for adolescents with chronic pain-a pilot study.

    PubMed

    Merlijn, Vivian P B M; Hunfeld, Joke A M; van der Wouden, Johannes C; Hazebroek-Kampschreur, Alice A J M; van Suijlekom-Smit, Lisette W A; Koes, Bart W; Passchier, Jan

    2005-11-01

    The purpose of this pilot study is to evaluate the feasibility of a cognitive-behavioural training program for adolescents with chronic pain irrespective of pain localisation. A secondary aim was to give an impression of the effect of the program on pain and quality of life. Eight adolescents (14-18 years) with chronic non-organic pain recruited from the general population (and their parents) participated in this pilot study. The intervention included five group meetings alternated with four telephone contacts (during the self-management weeks) over a period of 9 weeks. The training aimed to change pain behaviour through pain education, relaxation strategies, problem-solving techniques, assertiveness training, cognitive restructuring and by stimulating the adolescent's physical activity level. The training further addresses the social context of pain by inviting parents to attend two meetings for the parents only, and by asking the adolescents to bring a peer to one of the meetings. Adolescents and their parents were positive about the program. Adolescents felt they were more in control of their pain and parents valued the support they experienced in helping their children to master the pain. The training was considered to be feasible in daily life. Further, the preliminary data showed an effect on pain and quality of life in the expected direction. The results underline the need for a definitive study with a larger sample size and a random controlled design.

  10. [Mini-KiSS--a multimodal group therapy intervention for parents of young children with sleep disorders: a pilot study].

    PubMed

    Schlarb, Angelika Anita; Brandhorst, Isabel; Hautzinger, Martin

    2011-05-01

    Sleep disorders in early childhood tend to be chronic and almost always a burden for the parents. This study developed and evaluated a multimodal parent training program for children 0.5 to 4 years of age suffering from sleep disorders (Mini-KiSS). We hypothesized that there would be specific improvements following the structured group training (reduction of sleep problems, improvement of parental well-being). The pilot study consisted of a pre-post test design without control group. Participants were n = 17 parents of children 0.5 to 4 years of age with sleep disorders determined according to the ICSD-II. Each of the six sessions was evaluated, and changes were assessed by sleep diary and CBCL. Behavioral and emotional problems of the child were assessed by CBCL, parental well-being, and SCL-90-R. The results showed high acceptance of Mini-KiSS and satisfactory feasibility. Children showed significant improvements of the sleep disturbances such as nightly awakenings as well as sleeping in parents' bed. Furthermore, improvements were found for children's emotional and behavioral problems and for parental well-being, in particular for the depression scale of the mother. This pilot study shows a high acceptance and good feasibility of the multimodal short-time parent-training program Mini-KiSS. Sleep problems were significantly reduced.

  11. A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

    PubMed

    Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

    2018-04-01

    Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

  12. Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population.

    PubMed

    Dick, Jonathan J; Nundy, Shantanu; Solomon, Marla C; Bishop, Keisha N; Chin, Marshall H; Peek, Monica E

    2011-09-01

    We pilot-tested a text message-based diabetes care program in an urban African-American population in which automated text messages were sent to participants with personalized medication, foot care, and appointment reminders and text messages were received from participants on adherence. Eighteen patients participated in a 4-week pilot study. Baseline surveys collected data about demographics, historical cell phone usage, and adherence to core diabetes care measures. Exit interview surveys (using close-coded and open-ended questions) were administered to patients at the end of the program. A 1-month follow-up interview was conducted surveying patients on perceived self-efficacy. Wilcoxon signed-rank tests were used to compare baseline survey responses about self-management activities to those at the pilot's end and at 1-month follow-up. Eighteen urban African-American participants completed the pilot study. The average age was 55 and the average number of years with diabetes was 8. Half the participants were initially uncomfortable with text messaging. Example messages include "Did you take your diabetes medications today" and "How many times did you check your feet for wounds this week?" Participants averaged 220 text messages with the system, responded to messages 80% of the time, and on average responded within 6 minutes. Participants strongly agreed that text messaging was easy to perform and helped with diabetes self-care. Missed medication doses decreased from 1.6 per week to 0.6 (p = .003). Patient confidence in diabetes self-management was significantly increased during and 1 month after the pilot (p = .002, p = .008). Text messaging may be a feasible and useful approach to improve diabetes self-management in urban African Americans. © 2011 Diabetes Technology Society.

  13. The feasibility of paper-based Tracking Codes and electronic medical record systems to monitor tobacco-use assessment and intervention in an Individual Practice Association (IPA) Model health maintenance organization (HMO).

    PubMed

    Bentz, Charles J; Davis, Nancy; Bayley, Bruce

    2002-01-01

    Despite evidence of its effectiveness, tobacco cessation is not systematically addressed in routine healthcare settings. Its measurement is part of the problem. A pilot study was designed to develop and implement two different tobacco tracking systems in two independent primary care offices that participated in an IPA Model health maintenance organization in Portland, Oregon. The first clinic, which utilized a paper-based charting system, implemented CPT-like tracking codes to measure and report tobacco-cessation activities, which were eventually included in the managed-care organization's (MCO) claims database. The second clinic implemented an electronic tracking system based on its computerized electronic medical record (EMR) charting system. This paper describes the pilot study, including the processes involved in building provider acceptance for the new tracking systems in these two clinics, the barriers and successes encountered during implementation, and the resources expended by the clinics and by the MCO during the pilot. The findings from the 3-month implementation period were that documentation of tobacco-use status remained stable at 42-45% in the paper-based clinic and increased from 79% to 88% in the EMR clinic. This pilot study demonstrated that Tracking Codes are a feasible preventive-care tracking system in paper-based medical offices. However, high levels of effort and support are needed, and a critical mass of insurers and health plans would need to adopt Tracking Codes before widespread use could be expected. Results of the EMR-based tracking system are also reviewed and discussed.

  14. Development and pilot study of an essential set of indicators for general surgery services.

    PubMed

    Soria-Aledo, Victor; Angel-Garcia, Daniel; Martinez-Nicolas, Ismael; Rebasa Cladera, Pere; Cabezali Sanchez, Roger; Pereira García, Luis Francisco

    2016-11-01

    At present there is a lack of appropriate quality measures for benchmarking in general surgery units of Spanish National Health System. The aim of this study is to present the selection, development and pilot-testing of an initial set of surgical quality indicators for this purpose. A modified Delphi was performed with experts from the Spanish Surgeons Association in order to prioritize previously selected indicators. Then, a pilot study was carried out in a public hospital encompassing qualitative analysis of feasibility for prioritized indicators and an additional qualitative and quantitative three-rater reliability assessment for medical record-based indicators. Observed inter-rater agreement, prevalence adjusted and bias adjusted kappa and non-adjusted kappa were performed, using a systematic random sample (n=30) for each of these indicators. Twelve out of 13 proposed indicators were feasible: 5 medical record-based indicators and 7 indicators based on administrative databases. From medical record-based indicators, 3 were reliable (observed agreement >95%, adjusted kappa index >0.6 or non-adjusted kappa index >0.6 for composites and its components) and 2 needed further refinement. Currently, medical record-based indicators could be used for comparison purposes, whilst further research must be done for validation and risk-adjustment of outcome indicators from administrative databases. Compliance results in the adequacy of informed consent, diagnosis-to-treatment delay in colorectal cancer, and antibiotic prophylaxis show room for improvement in the pilot-tested hospital. Copyright © 2016 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. 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.

  16. Using Family-Focused Garden, Nutrition, and Physical Activity Programs To Reduce Childhood Obesity: The Texas! Go! Eat! Grow! Pilot Study.

    PubMed

    Spears-Lanoix, Erica C; McKyer, E Lisako J; Evans, Alexandra; McIntosh, William Alex; Ory, Marcia; Whittlesey, Lisa; Kirk, Alice; Hoelscher, Deanna M; Warren, Judith L

    2015-12-01

    The TEXAS! GROW! EAT! GO! (TGEG) randomized, control trial is a 5-year study to measure the impact of a nutrition and gardening intervention and/or physical activity (PA) intervention on the weight status of third-grade students. This article describes the results of the pilot study to test the feasibility of two interventions and test the measures to be used in the main trial. The pilot study was conducted in one school with third-grade students and their parents or guardians. The Junior Master Gardner (JMG) and Walk Across Texas (WAT) interventions were implemented over a 5-month period in three third-grade classrooms during spring 2012. The respective interventions focused on improving healthy eating and PA behaviors of children and their families. Baseline and immediate post-test data were collected from students and parents/guardians to measure four child, four parent, and four parent-child interaction behaviors. Process data regarding implementation were also collected from teachers and school administration. Forty-four students and 34 parents or guardians provided both pre- and post-test data. Paired-sample t-tests showed statistically significant changes in student knowledge, vegetable preferences, vegetable consumption, and home food availability (all p < 0.05). At baseline, participants' weight status categories included 57% obese, 10% overweight, and 31% normal weight. Postintervention, weight status categories included 39% obese, 16% overweight, and normal 45%. Data collected from teachers indicated high levels of implementation fidelity. Implementation of both interventions occurred at a very high fidelity level, which led to positive changes in BMI status, and several dietary and PA behaviors. Although the pilot study indicated feasibility of the two interventions for school implementation, results guided revisions to the TGEG program and its survey instruments.

  17. A randomised controlled pilot trial evaluating feasibility and acceptability of a computer-based tool to identify and reduce harmful and hazardous drinking among adolescents with alcohol-related presentations in Canadian pediatric emergency departments.

    PubMed

    Newton, Amanda S; Dow, Nadia; Dong, Kathryn; Fitzpatrick, Eleanor; Cameron Wild, T; Johnson, David W; Ali, Samina; Colman, Ian; Rosychuk, Rhonda J

    2017-08-11

    This study piloted procedures and obtained data on intervention acceptability to determine the feasibility of a definitive randomised controlled trial (RCT) of the effectiveness of a computer-based brief intervention in the emergency department (ED). Two-arm, multi-site, pilot RCT. Adolescents aged 12-17 years presenting to three Canadian pediatric EDs from July 2010 to January 2013 for an alcohol-related complaint. Standard medical care plus computer-based screening and personalised assessment feedback (experimental group) or standard care plus computer-based sham (control group). ED and research staff, and adolescents were blinded to allocation. Main: change in alcohol consumption from baseline to 1- and 3 months post-intervention. Secondary: recruitment and retention rates, intervention acceptability and feasibility, perception of group allocation among ED and research staff, and change in health and social services utilisation. Of the 340 adolescents screened, 117 adolescents were eligible and 44 participated in the study (37.6% recruitment rate). Adolescents allocated to the intervention found it easy, quick and informative, but were divided on the credibility of the feedback provided (agreed it was credible: 44.4%, disagreed: 16.7%, unsure: 16.7%, no response: 22.2%). We found no evidence of a statistically significant relationship between which interventions adolescents were allocated to and which interventions staff thought they received. Alcohol consumption, and health and social services data were largely incomplete due to modest study retention rates of 47.7% and 40.9% at 1- and 3 months post-intervention, respectively. A computer-based intervention was acceptable to adolescents and delivery was feasible in the ED in terms of time to use and ease of use. However, adjustments are needed to the intervention to improve its credibility. A definitive RCT will be feasible if protocol adjustments are made to improve recruitment and retention rates; and increase the number of study sites and research staff. clinicaltrials.gov NCT01146665. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. 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.

  19. Identifying the support needs of fathers affected by post-partum depression: a pilot study.

    PubMed

    Letourneau, N; Duffett-Leger, L; Dennis, C-L; Stewart, M; Tryphonopoulos, P D

    2011-02-01

    The purpose of this pilot study was to describe the experiences, support needs, resources, and barriers to support for fathers whose partners had post-partum depression (PPD) in preparation for a larger study. Qualitative methods and community-based research approaches were used in this exploratory/descriptive multi-site study, conducted in New Brunswick and Alberta. Telephone interviews were conducted with a total of 11 fathers in New Brunswick (n= 7) and Alberta (n= 4). Fathers experienced a number of depressive symptoms including: anxiety, lack of time and energy, irritability, feeling sad or down, changes in appetite, and thoughts of harm to self or baby. The most common barriers for fathers were lack of information regarding PPD resources and difficulty seeking support. This pilot study establishes the feasibility of the larger-scale exploration of fathers' experiences in supporting their spouses affected by PPD. © 2010 Blackwell Publishing.

  20. 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.

  1. 30 CFR 582.23 - Testing Plan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OPERATIONS IN THE OUTER... detailed Mining Plan than is obtainable under an approved Delineation Plan, to prepare feasibility studies, to carry out a pilot program to evaluate processing techniques or technology or mining equipment, or...

  2. 30 CFR 582.23 - Testing Plan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OPERATIONS IN THE OUTER... detailed Mining Plan than is obtainable under an approved Delineation Plan, to prepare feasibility studies, to carry out a pilot program to evaluate processing techniques or technology or mining equipment, or...

  3. 30 CFR 582.23 - Testing Plan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Resources BUREAU OF OCEAN ENERGY MANAGEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OPERATIONS IN THE OUTER... detailed Mining Plan than is obtainable under an approved Delineation Plan, to prepare feasibility studies, to carry out a pilot program to evaluate processing techniques or technology or mining equipment, or...

  4. Composting Begins at Home.

    ERIC Educational Resources Information Center

    Dreckman, George P.

    1994-01-01

    Reports the results of a year-long home composting pilot program run by the city of Madison, Wisconsin. The study was designed to gather data on the amount and type of materials composted by 300 volunteer households and to determine the feasibility of a full-scale program. (LZ)

  5. ENGAGE: Guided Activity-Based Gaming in Neurorehabilitation after Stroke: A Pilot Study

    PubMed Central

    Reinthal, Ann; Szirony, Kathy; Clark, Cindy; Swiers, Jeffrey; Kellicker, Michelle; Linder, Susan

    2012-01-01

    Introduction. Stroke is a leading cause of disability in healthy adults. The purpose of this pilot study was to assess the feasibility and outcomes of a novel video gaming repetitive practice paradigm, (ENGAGE) enhanced neurorehabilitation: guided activity-based gaming exercise. Methods. Sixteen individuals at least three months after stroke served as participants. All participants received concurrent outpatient therapy or took part in a stroke exercise class and completed at least 500 minutes of gaming. Primary baseline and posttest outcome measures included the Wolf motor function test (WMFT) and the Fugl-Meyer assessment (FMA). ENGAGE uses a game selection algorithm providing focused, graded activity-based repetitive practice that is highly individualized and directed. The Wilcoxon signed ranks test was used to determine statistical significance. Results. There were improvements in the WMFT (P = 0.003) and the FMA (P = 0.002) that exceeded established values of minimal clinically important difference. Conclusions. ENGAGE was feasible and an effective adjunct to concurrent therapy after stroke. PMID:22593835

  6. Resourcefulness training intervention: a promising approach to improve mental health of mothers with technology-dependent children.

    PubMed

    Toly, Valerie Boebel; Musil, Carol M; Zauszniewski, Jaclene A

    2014-02-01

    The population of children dependent on medical technology such as mechanical ventilation, feeding tubes, and supplemental oxygen continues to grow in the United States. These children are frequently cared for by their mothers at home following hospital discharge. Research indicates that these mothers are at high risk for negative mental health outcomes that affect both caregiver and care recipient. The purpose of this randomized controlled pilot trial was to determine the feasibility, acceptability, and efficacy of resourcefulness training (RT), a cognitive-behavioral intervention, among mothers of technology-dependent children. RT was found to be a feasible and acceptable intervention with this population during the 6 week study. The effect size in this pilot study demonstrates initial efficacy and indicates areas for strengthening the intervention protocol. RT is a promising intervention that can be employed by pediatric nurses to assist mothers in the home management of technology-dependent children. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. 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.

  8. A pilot study to explore the feasibility of using theClinical Care Classification System for developing a reliable costing method for nursing services.

    PubMed

    Dykes, Patricia C; Wantland, Dean; Whittenburg, Luann; Lipsitz, Stuart; Saba, Virginia K

    2013-01-01

    While nursing activities represent a significant proportion of inpatient care, there are no reliable methods for determining nursing costs based on the actual services provided by the nursing staff. Capture of data to support accurate measurement and reporting on the cost of nursing services is fundamental to effective resource utilization. Adopting standard terminologies that support tracking both the quality and the cost of care could reduce the data entry burden on direct care providers. This pilot study evaluated the feasibility of using a standardized nursing terminology, the Clinical Care Classification System (CCC), for developing a reliable costing method for nursing services. Two different approaches are explored; the Relative Value Unit RVU and the simple cost-to-time methods. We found that the simple cost-to-time method was more accurate and more transparent in its derivation than the RVU method and may support a more consistent and reliable approach for costing nursing services.

  9. Immediate Effects of a Program to Promote School Readiness in Low-Income Children: Results of a Pilot Study

    PubMed Central

    Pears, Katherine C.; Healey, Cynthia V.; Fisher, Philip A.; Braun, Drew; Gill, Colt; Conte, Holly Mar; Newman, Judy; Ticer, Sara

    2014-01-01

    Children from low-income backgrounds demonstrate poorer school readiness skills than their higher-income peers. The Kids in Transition to School (KITS) Program was developed to increase early literacy, social skills, and self-regulatory skills among children with inadequate school readiness. In the present study, 39 families participated in a pilot efficacy trial conducted through a community collaboration to examine the feasibility and impact of the KITS program with families from disadvantaged neighborhoods. Participating families were demographically representative of the larger populations in the participating school districts. Children who received the intervention demonstrated significantly greater improvements in letter naming, initial sound fluency, and understanding of concepts about print than their peers who did not participate in the intervention, as well as decreases in aggressive responses to peer provocation and increases in self-regulation skills. Results suggest that a brief, focused school readiness intervention is feasible to conduct with low-income families and may improve critical skills. PMID:25382932

  10. HYDration and Bicarbonate to Prevent Acute Renal Injury After Endovascular Aneurysm Repair With Suprarenal Fixation: Pilot/Feasibility Randomised Controlled Study (HYDRA Pilot Trial).

    PubMed

    Saratzis, Athanasios; Chiocchia, Virginia; Jiffry, Ahmad; Hassanali, Neelam; Singh, Surjeet; Imray, Christopher H; Bown, Matthew J; Mahmood, Asif

    2018-05-01

    Up to 25% of patients undergoing elective endovascular aneurysm repair (EVAR) develop acute kidney injury (AKI), which is associated with short and long-term morbidity and mortality. There is no high quality randomised evidence regarding prevention of EVAR related AKI. A novel AKI prevention strategy for EVAR was devised, based on best evidence and an expert consensus group. This included a bolus of high dose sodium bicarbonate (NaHCO 3 ) immediately before EVAR (1 mL/kg of 8.4% NaHCO 3 ) and standardised crystalloid based hydration pre- and post-EVAR. A pilot/feasibility randomised controlled trial (RCT) was performed in two centres to assess the safety of the intervention, potential impact on AKI prevention, and feasibility of a national RCT; the primary end point was the proportion of eligible patients recruited into the study. AKI was defined using "Kidney Disease Improving Global Outcomes" and "Acute Kidney Injury Network" criteria based on National Institute for Health and Clinical Excellence AKI recommendations, using serum creatinine and hourly urine output. Fifty-eight patients (84% of those screened; median age 75 years [range 57-89 years], 10% female) were randomised to receive the standardised intravenous hydration with (intervention) or without (control) NaHCO 3 . Groups were comparable in terms of AKI risk factors; 56 of 58 participants had a device with suprarenal fixation. Overall, 33% of patients in the control arm developed AKI versus 7% in the intervention arm (as treated analysis). None of the patients receiving NaHCO 3 developed a serious intervention related adverse event; five patients did not attend their 30 day follow-up. Bolus high dose NaHCO 3 and hydration is a promising EVAR related AKI prevention method. This trial has confirmed the feasibility of delivering a definitive large RCT to confirm the efficacy of this novel intervention, in preventing EVAR related AKI. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

  11. Critique of a practice-based pilot study in chiropractic practices in Western Australia.

    PubMed

    Amorin-Woods, Lyndon G; Parkin-Smith, Gregory F; Nedkoff, Lee; Fisher, Colleen

    2016-01-01

    Practice-based data collection can offer insight into the nature of chiropractic practice and contribute to resolving the conundrum of the chiropractic profession's role in contemporary healthcare, subsequently informing care service policy. However, there is little formal data available about chiropractic practice to inform decision-makers about the nature and role of chiropractic within the context of a modern multidisciplinary healthcare context in Australia, particularly at a local and regional level. This was a mixed-methods data transformation model (qualitative to quantitative) pilot study the purpose of which was to provide a critique of the research design and collect data from a selected sample of chiropractic practices in Western Australia, with a view to offer recommendations related to the design, feasibility and implementation of a future confirmatory study. A narrative critique of the research methods of this pilot study is offered in this paper covering: (a) practice and patient recruitment, (b) enrollment of patients, (c) data collection methods, (d) acceptability of the study methods, (e) sample size calculations, and (f) design critique. The result of this critique provides a sensible sample size estimate and recommendations as to the design and implementation of a future confirmatory study. Furthermore, we believe that a confirmatory study is not only feasible, but indeed necessary, with a view to offer meaningful insight into chiropractic practice in Western Australia. ACTRN12616000434493 Australian New Zealand Clinical Trials Registry (ANZCTR). Registered 5 April 2016. First participant enrolled 01 July 2014, retrospectively registered.

  12. Pilot of a Tailored Dance Intervention to Support Function in People With Cognitive Impairment Residing in Long-Term Care: A Brief Report

    PubMed Central

    O’Rourke, Hannah M.; Sidani, Souraya; Chu, Charlene H.; Fox, Mary; McGilton, Katherine S.; Collins, Jhonna

    2017-01-01

    Older adults who live in long-term care settings are at risk for functional decline, which may be mitigated by regular exercise. Using a single-group repeated measures design, this pilot study explored the feasibility, acceptability, and preliminary effects of a Waltz-based dance intervention delivered to 13 Canadian, English-speaking, long-term care residents with mild to moderate cognitive impairment. The findings supported intervention feasibility, based on a high completion rate (93%), level of attendance (M = 7.15 of 10 sessions) and level of engagement during dance sessions (M = 1.75 to 1.97 out of 2.00). On average, residents perceived dance sessions positively, and staff and family participants (N = 26) rated them as somewhat acceptable overall (M = 2.37, 0 to 4 scale). Additional research is needed to assess intervention efficacy in a larger sample. PMID:29085863

  13. Pilot of a computer-based brief multiple-health behavior intervention for college students.

    PubMed

    Moore, Michele J; Werch, Chudley E; Bian, Hui

    2012-01-01

    Given the documented multiple health risks college students engage in, and the dearth of effective programs addressing them, the authors developed a computer-based brief multiple-health behavior intervention. This study reports immediate outcomes and feasibility of a pilot of this program. Two hundred students attending a midsized university participated. Participants were randomly assigned to the intervention or control program, both delivered via computer. Immediate feedback was collected with the computer program. Results indicate that the intervention had an early positive impact on alcohol and cigarette use intentions, as well as related constructs underlying the Behavior-Image Model specific to each of the 3 substances measured. Based on the implementation process, the program proved to be feasible to use and acceptable to the population. Results support the potential efficacy of the intervention to positively impact behavioral intentions and linkages between health promoting and damaging behaviors among college students.

  14. Pilot of a Tailored Dance Intervention to Support Function in People With Cognitive Impairment Residing in Long-Term Care: A Brief Report.

    PubMed

    O'Rourke, Hannah M; Sidani, Souraya; Chu, Charlene H; Fox, Mary; McGilton, Katherine S; Collins, Jhonna

    2017-01-01

    Older adults who live in long-term care settings are at risk for functional decline, which may be mitigated by regular exercise. Using a single-group repeated measures design, this pilot study explored the feasibility, acceptability, and preliminary effects of a Waltz-based dance intervention delivered to 13 Canadian, English-speaking, long-term care residents with mild to moderate cognitive impairment. The findings supported intervention feasibility, based on a high completion rate (93%), level of attendance ( M = 7.15 of 10 sessions) and level of engagement during dance sessions ( M = 1.75 to 1.97 out of 2.00). On average, residents perceived dance sessions positively, and staff and family participants ( N = 26) rated them as somewhat acceptable overall ( M = 2.37, 0 to 4 scale). Additional research is needed to assess intervention efficacy in a larger sample.

  15. Aerobic nonaseptic growth of Verticillium on coffee waste waters and cane blackstrap molasses at a pilot plant scale

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Espinosa, R.; Maldonado, O.; Menchu, J.F.

    1977-01-01

    An evaluation is made of the pilot plant studies on the biosynthesis of Verticillium sp. both on coffee waste waters and blackstrap molasses. The purpose of the study was two-fold: the first to produce a filamentous fungi as a source of protein and the second to alleviate the serious water pollution resulting from the processing of coffee berries. The molasses was studied as an alternative medium to enable year-round operation of the plant since coffee is a seasonal crop. The results indicated that the growth of Verticillium is technically feasible in a batch operation. (JSR)

  16. Recall of Fertility Discussion by Adolescent Female Cancer Patients: A Survey-Based Pilot Study.

    PubMed

    Zarnegar, Sara; Gosiengfiao, Yasmin; Rademaker, Alfred; Casey, Robert; Albritton, Karen H

    2018-04-01

    Many adolescent female cancer patients will survive into their reproductive years. Pediatric oncologists are advised to discuss oncofertility during treatment planning. In this pilot study, 19 adolescent females completed a retrospective survey assessing recall of a fertility discussion, satisfaction with fertility knowledge, and multiple factors that may influence recall, including parental involvement in decision-making. Eleven respondents (58%) remembered a discussion about infertility risk and 9 (47%) about fertility preservation. Most who recalled a discussion were satisfied with their fertility knowledge (10/11, 90.9%). In this study, we validated the feasibility of survey administration and identified trends in oncofertility counseling at our center.

  17. A pilot study of an online workplace nutrition program: the value of participant input in program development.

    PubMed

    Cousineau, Tara; Houle, Brian; Bromberg, Jonas; Fernandez, Kathrine C; Kling, Whitney C

    2008-01-01

    Tailored nutrition Web programs constitute an emerging trend in obesity prevention. Initial investment in innovative technology necessitates that the target population be well understood. This pilot study's purpose was to determine the feasibility of a workplace nutrition Web program. Formative research was conducted with gaming industry employees and benefits managers to develop a consensus on workplace-specific nutrition needs. A demonstration Web program was piloted with stakeholders to determine feasibility. Indiana, Mississippi, Nevada, and New Jersey gaming establishments. 86 employees, 18 benefits managers. Prototype Web program. Concept mapping; 16-item nutrition knowledge test; satisfaction. Concept mapping was used to aggregate importance ratings on programmatic content, which informed Web program curriculum. Chi-square tests were performed postintervention to determine knowledge improvement. (1) Employees and benefits managers exhibited moderate agreement about content priorities for the program (r = 0.48). (2) There was a significant increase in employees' nutrition knowledge scores postintervention (t = 7.16, df = 36, P < .001); those with less knowledge exhibited the greatest gains in knowledge scores (r = -0.647, P < .001). Employees and benefit managers do not necessarily agree on the priority of nutrition-related content, suggesting a need for programs to appeal to various stakeholders. Computer-based approaches can address various stakeholder health concerns via tailored, customized programming.

  18. Developing the Translational Research Workforce: A Pilot Study of Common Metrics for Evaluating the Clinical and Translational Award KL2 Program

    PubMed Central

    Guerrero, Lourdes; Jones, Lisa B.; Tong, Greg; Ireland, Christine; Dumbauld, Jill; Rainwater, Julie

    2015-01-01

    Abstract Purpose This pilot study describes the career development programs (i.e., NIH KL2 awards) across five Clinical and Translational Science Award (CTSA) institutions within the University of California (UC) system, and examines the feasibility of a set of common metrics for evaluating early outcomes. Methods A survey of program administrators provided data related to the institutional environment within which each KL2 program was implemented. Application and progress report data yielded a combined data set that characterized KL2 awardees, their initial productivity, and early career outcomes. Results The pilot project demonstrated the feasibility of aggregating common metrics data across multiple institutions. The data indicated that KL2 awardees were an accomplished set of investigators, both before and after the award period, representing a wide variety of disciplines. Awardees that had completed their trainee period overwhelmingly remained active in translational research conducted within an academic setting. Early indications also suggest high rates of success with obtaining research funding subsequent to the KL2 award. Conclusion This project offers a model for how to collect and analyze common metrics related to the education and training function of the CTSA Consortium. Next steps call for expanding participation to other CTSA sites outside of the University of California system. PMID:26602332

  19. 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.

  20. 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.

  1. Pilot study on the feasibility of a computerized speech recognition charting system.

    PubMed

    Feldman, C A; Stevens, D

    1990-08-01

    The objective of this study was to determine the feasibility of developing and using a voice recognition computerized charting system to record dental clinical examination data. More specifically, the study was designed to analyze the time and error differential between the traditional examiner/recorder method (ASSISTANT) and computerized voice recognition method (VOICE). DMFS examinations were performed twice on 20 patients using the traditional ASSISTANT and the VOICE charting system. A statistically significant difference was found when comparing the mean ASSISTANT time of 2.69 min to the VOICE time of 3.72 min (P less than 0.001). No statistically significant difference was found when comparing the mean ASSISTANT recording errors of 0.1 to VOICE recording errors of 0.6 (P = 0.059). 90% of the patients indicated they felt comfortable with the dentist talking to a computer and only 5% of the sample indicated they opposed VOICE. Results from this pilot study indicate that a charting system utilizing voice recognition technology could be considered a viable alternative to traditional examiner/recorder methods of clinical charting.

  2. Feasibility of a Manualized Occupation-Based Diabetes Management Intervention.

    PubMed

    Carandang, Kristine M; Pyatak, Elizabeth A

    We investigated the feasibility and acceptability of an occupational therapy intervention targeting diabetes management for underserved young adults. Eight participants completed the intervention and a battery of assessments at baseline and after the intervention. At completion, the participants and occupational therapist were interviewed about their experiences with the study. Four categories of assessment questions were used to guide the study: process, resource, management, and scientific. Successes included recruitment; fulfillment of tasks by staff and partnering clinics; adequate space, financial support, and equipment; and meaningfulness of the intervention for participants. Challenges included scheduling participants for the intervention and follow-up focus groups and providing client centeredness and flexibility while reducing burden on the intervener. This feasibility study allowed us to make necessary revisions to our study protocol before implementing a larger pilot study. Copyright © 2018 by the American Occupational Therapy Association, Inc.

  3. Interpersonal Psychotherapy with Pregnant Adolescents: Two Pilot Studies

    ERIC Educational Resources Information Center

    Miller, Lisa; Gur, Merav; Shanok, Arielle; Weissman, Myrna

    2008-01-01

    The objective of this study was to test the feasibility, acceptability and helpfulness of group Interpersonal Psychotherapy (IPT-PA) for depression in pregnant adolescents. Method: Two open clinical trials were conducted of IPT-PA delivered in group format in a New York City public school for pregnant girls. Study 1 tests IPT-PA for management of…

  4. Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study.

    PubMed

    Sherwood, Nancy E; JaKa, Meghan M; Crain, A Lauren; Martinson, Brian C; Hayes, Marcia G; Anderson, Julie D

    2015-12-01

    The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ≤ BMI < 95th percentile). The aim of this randomized, controlled pilot study was to evaluate the feasibility, acceptability, and potential efficacy of the HHHK-Preschool intervention. Sixty parent-child dyads recruited from pediatric primary care clinics were randomized to: (1) the Busy Bodies/Better Bites Obesity Prevention Arm or the (2) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm. Baseline and 6-month data were collected, including measured height and weight, accelerometry, previous day dietary recalls, and parent surveys. Intervention process data (e.g., call completion) were also collected. High intervention completion and satisfaction rates were observed. Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score, post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity (p = 0.04). HHHK-Preschool pilot study results support the feasibility, acceptability, and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching. What's New: Implementing pediatric primary care-based obesity interventions is challenging. Previous interventions have primarily involved in-person sessions, a barrier to sustained parent involvement. HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach.

  5. Illness Management & Recovery (IMR) in the Netherlands; a naturalistic pilot study to explore the feasibility of a randomized controlled trial.

    PubMed

    Roosenschoon, Bert-Jan; van Weeghel, Jaap; Bogaards, Moniek; Deen, Mathijs L; Mulder, Cornelis L

    2016-11-09

    Illness Management & Recovery (IMR) is a curriculum-based program for people with severe and persistent mental illness. To date, four randomized controlled trials (RCTs) have been published on it. As these produced mixed results, we conducted a pilot study to test the feasibility of conducting a new RCT in a Dutch psychiatric institute. Because our primary objective was to evaluate support for implementing IMR on a broader scale, we examined participant recruitment, client outcomes, and clients' and clinicians' satisfaction. Secondary objectives were to evaluate fidelity, trainers' training and supervision, and to explore program duration, dropout, and client characteristics related to dropout. For reporting, we used the checklist for pilot studies adopted from the CONSORT Statement. This program evaluation included a process-evaluation and an outcome evaluation with a One Group Pre-Posttest Design (N = 81). Interviews and internal reports were used to monitor participant numbers, program duration, dropout, and completers' characteristics. Clients' and clinicians' satisfaction and provision of trainers' training and supervision were assessed through interviews. Fidelity was assessed on the IMR Fidelity Scale; client outcomes were assessed on the IMR scale (client and clinician versions) and the Recovery Markers Questionnaire (RMQ). Eighty-one participants were recruited of 167 people who were assessed for eligibility. Completers and clinicians were satisfied, and scores for completers improved significantly on the IMR scale (clinician version) (d = 0.84) and RMQ (d = 0.52), and not significantly on the IMR scale client version (d = 0.41). Mean fidelity was good, but three groups had only moderate fidelity. Our feasibility criterion for trainers' education and supervision was partly attained. Dropout from treatment was 51 %; female participants and people who scored higher on both IMR-scales at baseline had a significantly lower chance of dropping out. The duration of IMR varied (M = 12.7 months, SD = 2.87). Results suggested that feasibility of conducting an RCT on IMR was good. Special attention is required to fidelity, IMR duration, trainers' education and supervision, and dropout, especially of men. One study limitation was our inability to conduct follow-up measurements of non-completers.

  6. A pilot trial of ambulatory monitoring of gastric motility using a modified magnetic capsule endoscope.

    PubMed

    Kim, Hee Man; Choi, Ja Sung; Cho, Jae Hee

    2014-04-30

    The magnetic capsule endoscope has been modified to be fixed inside the stomach and to monitor the gastric motility. This pilot trial was designed to investigate the feasibility of the magnetic capsule endoscope for monitoring gastric motility. The magnetic capsule endoscope was swallowed by the healthy volunteer and maneuvered by the external magnet on his abdomen surface inside the stomach. The magnetic capsule endoscope transmitted image of gastric peristalsis. This simple trial suggested that the real-time ambulatory monitoring of gastric motility should be feasible by using the magnetic capsule endoscope.

  7. Quantum Physics Principles and Communication in the Acute Healthcare Setting: A Pilot Study.

    PubMed

    Helgeson, Heidi L; Peyerl, Colleen Kraft; Solheim-Witt, Marit

    This pilot study explores whether clinician awareness of quantum physics principles could facilitate open communication between patients and providers. In the spirit of action research, this study was conceptualized with a holistic view of human health, using a mixed method design of grounded theory as an emergent method. Instrumentation includes surveys and a focus group discussion with twelve registered nurses working in an acute care hospital setting. Findings document that the preliminary core phenomenon, energy as information, influences communication in the healthcare environment. Key emergent themes include awareness, language, validation, open communication, strategies, coherence, incoherence and power. Research participants indicate that quantum physics principles provide a language and conceptual framework for improving their awareness of communication and interactions in the healthcare environment. Implications of this pilot study support the feasibility of future research and education on awareness of quantum physics principles in other clinical settings. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. 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.

  9. Measures of pilot performance during V/TOL aircraft landings on ships at sea

    NASA Technical Reports Server (NTRS)

    Howard, J. C.

    1977-01-01

    Simulation experiments to determine the feasibility of landing V/TOL aircraft on ships at sea were studied. The motion and attitude of the aircraft relative to the landing platform was known at the instant of touchdown. The success of these experiments depended on the ability of the experimenter to measure the pilot's performance during the landing maneuver. To facilitate these measurements, the equations describing the motion of the aircraft and its attitude relative to the landing platform are presented in a form which is suitable for simulation purposes.

  10. 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.

  11. Pilot study to investigate the feasibility of the Home Falls and Accidents Screening Tool (HOME FAST) to identify older Malaysian people at risk of falls

    PubMed Central

    Romli, Muhammad Hibatullah; Mackenzie, Lynette; Lovarini, Meryl; Tan, Maw Pin

    2016-01-01

    Objective The relationship between home hazards and falls in older Malaysian people is not yet fully understood. No tools to evaluate the Malaysian home environment currently exist. Therefore, this study aimed to pilot the Home Falls and Accidents Screening Tool (HOME FAST) to identify hazards in Malaysian homes, to evaluate the feasibility of using the HOME FAST in the Malaysian Elders Longitudinal Research (MELoR) study and to gather preliminary data about the experience of falls among a small sample of Malaysian older people. Design A cross-sectional pilot study was conducted. Setting An urban setting in Kuala Lumpur. Participants 26 older people aged 60 and over were recruited from the control group of a related research project in Malaysia, in addition to older people known to the researchers. Primary outcome measure The HOME FAST was applied with the baseline survey for the MELoR study via a face-to-face interview and observation of the home by research staff. Results The majority of the participants were female, of Malay or Chinese ethnicity and living with others in a double-storeyed house. Falls were reported in the previous year by 19% and 80% of falls occurred at home. Gender and fear of falling had the strongest associations with home hazards. Most hazards were detected in the bathroom area. A small number of errors were detected in the HOME FAST ratings by researchers. Conclusions The HOME FAST is feasible as a research and clinical tool for the Malaysian context and is appropriate for use in the MELoR study. Home hazards were prevalent in the homes of older people and further research with the larger MELoR sample is needed to confirm the validity of using the HOME FAST in Malaysia. Training in the use of the HOME FAST is needed to ensure accurate use by researchers. PMID:27531736

  12. Distributed Practicum Supervision in a Managed Learning Environment (MLE)

    ERIC Educational Resources Information Center

    Carter, David

    2005-01-01

    This evaluation-research feasibility study piloted the creation of a technology-mediated managed learning environment (MLE) involving the implementation of one of a new generation of instructionally driven management information systems (IMISs). The system, and supporting information and communications technology (ICT) was employed to support…

  13. TREATABILITY STUDY BULLETIN: MOBILE VOLUME REDUCTION UNIT AT THE SAND CREEK SUPERFUND SITE

    EPA Science Inventory

    The Risk Reduction Engineering Laboratory (RREL) Releases Control Branch (RCB) has developed a pilot-scale Mobile Volume Reduction Unit (VRU) to determine the feasibility of soil washing for the remediation of contaminated soils. This mobile unit, mounted on two trailers, can pro...

  14. Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression.

    PubMed

    Loo, C K; Gálvez, V; O'Keefe, E; Mitchell, P B; Hadzi-Pavlovic, D; Leyden, J; Harper, S; Somogyi, A A; Lai, R; Weickert, C S; Glue, P

    2016-07-01

    This pilot study assessed the feasibility, efficacy and safety of an individual dose-titration approach, and of the intravenous (IV), intramuscular (IM) and subcutaneous (SC) routes for treating depression with ketamine. Fifteen treatment-refractory depressed participants received ketamine or midazolam (control treatment) in a multiple crossover, double-blind study. Ketamine was administered by IV (n = 4), IM (n = 5) or SC (n = 6) injection. Dose titration commenced at 0.1 mg/kg, increasing by 0.1 mg/kg up to 0.5 mg/kg, given in separate treatment sessions separated by ≥1 week, with one placebo control treatment randomly inserted. Mood, psychotomimetic and hemodynamic effects were assessed and plasma ketamine concentrations assayed. Twelve participants achieved response and remission criteria, achieved at doses as low as 0.1 mg/kg. All three routes of administration resulted in comparable antidepressant effects. Fewest adverse effects were noted with the SC route. Antidepressant response, adverse effects and ketamine concentrations were dose-related. Antidepressant response occurred at a range of doses and at <0.5 mg/kg. The dose-titration approach is a practical method for optimizing the efficacy - side-effects trade-off on an individual patient basis. This pilot study provides preliminary evidence for SC injection as a practical, feasible and efficacious treatment approach. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. 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.

  16. Assessing the feasibility and fidelity of an intervention for women with violent offenses.

    PubMed

    Kubiak, Sheryl Pimlott; Fedock, Gina; Tillander, Elizabeth; Kim, Woo Jong; Bybee, Deborah

    2014-02-01

    Women convicted of assaultive or violent offenses represent a small but important subpopulation of adults involved in the criminal justice system. The limited treatment and rehabilitation programs that are available for these women are usually developed for male offenders and do not consider factors that are especially relevant to women, such as higher rates of mental health and substance use disorders as well as their likely histories of interpersonal violence. Moreover, women's trajectories into violent behavior - as well as their trajectories out - may differ from their male counterparts. Due to the absence of programs available for this unique population, a new gender-specific and trauma informed intervention, Beyond Violence, was developed. This paper describes a pilot study with a mixed-methods approach that assesses the feasibility and fidelity of the intervention within a state prison for women. Overall, various components of feasibility (i.e. engaging the target population, gaining institutional support, and finding skilled treatment staff), were realized, as were fidelity elements such as adherence to the intervention material, and high attendance and satisfaction by participants. The positive results of this pilot study increase the likelihood of dissemination of the intervention and a randomized control trial is currently underway. Copyright © 2013 Elsevier Ltd. All rights reserved.

  17. A small group aerobic exercise programme that reduces body weight is feasible in adults with severe chronic schizophrenia: a pilot study.

    PubMed

    Dodd, Karen J; Duffy, Sean; Stewart, Jan A; Impey, Jennifer; Taylor, Nicholas

    2011-01-01

    To evaluate the feasibility and effects of an exercise programme on people with severe, chronic schizophrenia. A single-group, pre-post pilot study incorporating a baseline familiarisation phase was followed by a 24-week, small-group aerobic exercise programme for up to 30-min each session, twice a week and a 30-min weekly walking session. Adherence was assessed by attendance, and by analysing the exercise supervisor's comments in a programme diary and in each participant's exercise logbook. Body weight, cardio-respiratory fitness (VO₂ max), walking endurance (6-min walk test) and psychiatric symptoms (the Positive and Negative Syndrome Scale) were measured at each time point. Eight participants (6 men, 2 women; mean age 45 years, 9 months (SD 10 years, 1 month); mean body mass index 27.0 (SD 4.2)) attended a mean of 73% of the scheduled exercise sessions, and 83% of the walking sessions, with no adverse events and no dropouts. All participants displayed positive and negative behaviours during training sessions. There were significant reductions in weight (2.4%) and body mass index (2.2%), but no changes in other measures. It was feasible and safe to conduct a small-group aerobic exercise programme for adults with severe chronic schizophrenia that reduced body weight.

  18. Maintaining Cognitive Functioning in Healthy Seniors with a Technology-Based Foreign Language Program: A Pilot Feasibility Study

    PubMed Central

    Ware, Caitlin; Damnee, Souad; Djabelkhir, Leila; Cristancho, Victoria; Wu, Ya-Huei; Benovici, Judith; Pino, Maribel; Rigaud, Anne-Sophie

    2017-01-01

    Researchers have hypothesized that learning a foreign language could be beneficial for seniors, as language learning requires the use of extensive neural networks. We developed and qualitatively evaluated an English training program for older French adults; our principal objective was to determine whether a program integrating technology is feasible for this population. We conducted a 4-month pilot study (16, 2-h sessions) with 14 French participants, (nine women, five men, average age 75). Questionnaires were administered pre- and post-intervention to measure cognitive level and subjective feelings of loneliness or social isolation; however, these scores did not improve significantly. Post-intervention, semi-directive interviews were carried out with participants, and a content/theme analysis was performed. Five main themes were identified from the interviews: Associations with school, attitudes toward English, motivation for learning English, attitudes toward the program’s organization, and social ties. The program was found to be feasible for this age group, yet perceived as quite difficult for participants who lacked experience with English. Nonetheless, most participants found the program to be stimulating and enjoyable. We discuss different suggestions for future programs and future directions for foreign-language learning as a therapeutic and cognitive intervention. PMID:28298892

  19. Feasibility and Acceptability of a Text Message-Based Smoking Cessation Program for Young Adults in Lima, Peru: Pilot Study

    PubMed Central

    Zevallos, Karine; Samolski, M Reuven; Requena, David; Velarde, Chaska; Briceño, Patricia; Piazza, Marina; Ybarra, Michele L

    2017-01-01

    Background In Peru’s urban communities, tobacco smoking generally starts during adolescence and smoking prevalence is highest among young adults. Each year, many attempt to quit, but access to smoking cessation programs is limited. Evidence-based text messaging smoking cessation programs are an alternative that has been successfully implemented in high-income countries, but not yet in middle- and low-income countries with limited tobacco control policies. Objective The objective was to assess the feasibility and acceptability of an short message service (SMS) text message-based cognitive behavioral smoking cessation program for young adults in Lima, Peru. Methods Recruitment included using flyers and social media ads to direct young adults interested in quitting smoking to a website where interested participants completed a Google Drive survey. Inclusion criteria were being between ages 18 and 25 years, smoking at least four cigarettes per day at least 6 days per week, willing to quit in the next 30 days, owning a mobile phone, using SMS text messaging at least once in past year, and residing in Lima. Participants joined one of three phases: (1) focus groups and in-depth interviews whose feedback was used to develop the SMS text messages, (2) validating the SMS text messages, and (3) a pilot of the SMS text message-based smoking cessation program to test its feasibility and acceptability among young adults in Lima. The outcome measures included adherence to the SMS text message-based program, acceptability of content, and smoking abstinence self-report on days 2, 7, and 30 after quitting. Results Of 639 participants who completed initial online surveys, 42 met the inclusion criteria and 35 agreed to participate (focus groups and interviews: n=12; validate SMS text messages: n=8; program pilot: n=15). Common quit practices and beliefs emerged from participants in the focus groups and interviews informed the content, tone, and delivery schedule of the messages used in the SMS text message smoking cessation program. A small randomized controlled pilot trial was performed to test the program’s feasibility and acceptability; nine smokers were assigned to the SMS text message smoking cessation program and six to a SMS text message nutrition program. Participant retention was high: 93% (14/15) remained until day 30 after quit day. In all, 56% of participants (5/9) in the SMS text message smoking cessation program reported remaining smoke-free until day 30 after quit day and 17% of participants (1/6) in the SMS text message nutrition program reported remaining smoke-free during the entire program. The 14 participants who completed the pilot reported that they received valuable health information and approved the delivery schedule of the SMS text messages. Conclusions This study provides initial evidence that a SMS text message smoking cessation program is feasible and acceptable for young adults residing in Lima. PMID:28778850

  20. Anaerobic Digestion of Laminaria japonica Waste from Industrial Production Residues in Laboratory- and Pilot-Scale.

    PubMed

    Barbot, Yann Nicolas; Thomsen, Claudia; Thomsen, Laurenz; Benz, Roland

    2015-09-18

    The cultivation of macroalgae to supply the biofuel, pharmaceutical or food industries generates a considerable amount of organic residue, which represents a potential substrate for biomethanation. Its use optimizes the total resource exploitation by the simultaneous disposal of waste biomaterials. In this study, we explored the biochemical methane potential (BMP) and biomethane recovery of industrial Laminaria japonica waste (LJW) in batch, continuous laboratory and pilot-scale trials. Thermo-acidic pretreatment with industry-grade HCl or industrial flue gas condensate (FGC), as well as a co-digestion approach with maize silage (MS) did not improve the biomethane recovery. BMPs between 172 mL and 214 mL g(-1) volatile solids (VS) were recorded. We proved the feasibility of long-term continuous anaerobic digestion with LJW as sole feedstock showing a steady biomethane production rate of 173 mL g(-1) VS. The quality of fermentation residue was sufficient to serve as biofertilizer, with enriched amounts of potassium, sulfur and iron. We further demonstrated the upscaling feasibility of the process in a pilot-scale system where a CH₄ recovery of 189 L kg(-1) VS was achieved and a biogas composition of 55% CH₄ and 38% CO₂ was recorded.

  1. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Franzese, Oscar; Lascurain, Mary Beth; Capps, Gary J

    The Federal Motor Carrier Safety Administration (FMCSA) Wireless Roadside Inspection (WRI) Program is researching the feasibility and value of electronically assessing truck and bus driver and vehicle safety at least 25 times more often than is possible using only roadside physical inspections. The WRI program is evaluating the potential benefits to both the motor carrier industry and to government. These potential benefits include reduction in accidents, fatalities and injuries on our highways and keeping safe and legal drivers and vehicles moving on the highways. WRI Pilot tests were conducted to prototype, test and demonstrate the feasibility and benefits of electronicallymore » collecting safety data message sets from in-service commercial vehicles and performing wireless roadside inspections using three different communication methods. This report summarizes the design, conduct and results of the Tennessee CMRS WRI Pilot Test. The purpose of this Pilot test was to demonstrate the implementation of commercial mobile radio services to electronically request and collect safety data message sets from a limited number of commercial vehicles operating in Tennessee. The results of this test have been used in conjunction with the results of the complimentary pilot tests to support an overall assessment of the feasibility and benefits of WRI in enhancing motor carrier safety (reduction in accidents) due to increased compliance (change in motor carrier and driver behavior) caused by conducting frequent safety inspections electronically, at highway speeds, without delay or need to divert into a weigh station« less

  2. 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.

  3. Feasibility of dietary assessment methods, other tools and procedures for a pan-European food consumption survey among infants, toddlers and children.

    PubMed

    Ocké, Marga; Brants, Henny; Dofkova, Marcela; Freisling, Heinz; van Rossum, Caroline; Ruprich, Jiri; Slimani, Nadia; Temme, Elisabeth; Trolle, Ellen; Vandevijvere, Stefanie; Huybrechts, Inge; de Boer, Evelien

    2015-08-01

    To test the feasibility of tools and procedures for a pan-European food consumption survey among children 0-10 years and to recommend one of two tested dietary assessment methods. Two pilot studies including 378 children were conducted in Belgium and the Czech Republic in the Pilot studies for Assessment of Nutrient intake and food Consumption among Kids in Europe. One protocol included a 3-day food diary which was checked with a parent, and data were entered afterwards using EPIC-Soft. The alternative protocol consisted of two non-consecutive 1-day food diaries followed by EPIC-Soft completion interviews. Both protocols included general and food propensity questionnaires and anthropometric measurements. The protocols were compared using evaluation questionnaires among the participating parents and study personnel. The parents found the questionnaires and instructions for filling in the food diaries understandable. Food description and food quantification was evaluated as problematic by 29 and 15% of the participants for the 3-day diaries versus 15 and 12% for the 1-day diaries. The protocol with 1-day food diaries was evaluated as less burdensome by the parents and logistically more challenging by the interviewers. Both dietary assessment methods with related tools and administration protocols were evaluated as feasible. The administration protocol with two 1-day food diaries with completion interviews offers more advantages for the future pan-European survey in children 0-10 years. The positive evaluation of feasibility of tools and materials is an important step towards harmonised food consumption data at European level among the younger age groups.

  4. The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

    PubMed

    Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

    2018-01-05

    The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

  5. 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.

  6. 78 FR 43263 - Paperless Hazard Communications Pilot Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-19

    ... Research Division (PHH-23), Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue... materials by air, highway, rail, and water) to test the feasibility and then evaluate both the feasibility... times and locations.'' On September 12, 2001, the Research and Special Programs Administration (the...

  7. A Computer-Based Private Pilot (Airplane) Certification Exam: A First Step Toward Nation-Wide Computer-Administration of FAA Certification Exams.

    ERIC Educational Resources Information Center

    Anderson, Richard I.; Trollip, Stanley R.

    1982-01-01

    To assess the feasibility of computer-assisted Federal Aviation Administration certification examinations, a system for administering the Private Pilot Certification Examination was implemented using PLATO. Characteristics, reactions, and guidelines for use of the test are included. (Author/JJD)

  8. Cockpit voice recognition program at Princeton University

    NASA Technical Reports Server (NTRS)

    Huang, C. Y.

    1983-01-01

    Voice recognition technology (VRT) is applied to aeronautics, particularly on the pilot workload alleviation. The VRT does not have to prove its maturity any longer. The feasibility of voice tuning of radio and DME are demonstrated since there are immediate advantages to the pilot and can be completed in a reasonable time.

  9. A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

    PubMed

    Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

    2014-05-01

    This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

  10. 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.

  11. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients.

    PubMed

    Kho, Michelle E; Molloy, Alexander J; Clarke, France; Herridge, Margaret S; Koo, Karen K Y; Rudkowski, Jill; Seely, Andrew J E; Pellizzari, Joseph R; Tarride, Jean-Eric; Mourtzakis, Marina; Karachi, Timothy; Cook, Deborah J

    2016-04-08

    Early exercise with in-bed cycling as part of an intensive care unit (ICU) rehabilitation programme has the potential to improve physical and functional outcomes following critical illness. The objective of this study is to determine the feasibility of enrolling adults in a multicentre pilot randomised clinical trial (RCT) of early in-bed cycling versus routine physiotherapy to inform a larger RCT. 60-patient parallel group pilot RCT in 7 Canadian medical-surgical ICUs. We will include all previously ambulatory adult patients within the first 0-4 days of mechanical ventilation, without exclusion criteria. After informed consent, patients will be randomised using a web-based, centralised electronic system, to 30 min of in-bed leg cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay (28 days maximum) or routine physiotherapy alone. We will measure patients' muscle strength (Medical Research Council Sum Score, quadriceps force) and function (Physical Function in ICU Test (scored), 30 s sit-to-stand, 2 min walk test) at ICU awakening, ICU discharge and hospital discharge. Our 4 feasibility outcomes are: (1) patient accrual of 1-2 patients per month per centre, (2) protocol violation rate <20%, (3) outcome measure ascertainment >80% at the 3 time points and (4) blinded outcomes ascertainment >80% at hospital discharge. Hospital outcome assessors are blinded to group assignment, whereas participants, ICU physiotherapists, ICU caregivers, research coordinators and ICU outcome assessors are not blinded to group assignment. We will analyse feasibility outcomes with descriptive statistics. Each participating centre will obtain local ethics approval, and results of the study will be published to inform the design and conduct of a future multicentre RCT of in-bed cycling to improve physical outcomes in ICU survivors. NCT02377830; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  12. EXercising with Computers in Later Life (EXCELL) - pilot and feasibility study of the acceptability of the Nintendo® WiiFit in community-dwelling fallers.

    PubMed

    Williams, Marie A; Soiza, Roy L; Jenkinson, Alison McE; Stewart, Alison

    2010-09-13

    Falls management programmes have been instituted to attempt to reduce falls. This pilot study was undertaken to determine whether the Nintendo® WiiFit was a feasible and acceptable intervention in community-dwelling older fallers. Community-dwelling fallers over 70 years were recruited and attended for computer-based exercises (n = 15) or standard care (n = 6). Balance and fear of falling were assessed at weeks 0, 4 and 12. Participants were interviewed on completion of the study to determine whether the intervention was acceptable.Eighty percent of participants attended 75% or more of the exercise sessions. An improvement in Berg Score was seen at four weeks (p = 0.02) and in Wii Age at 12 weeks (p = 0.03) in the intervention group. There was no improvement in balance scores in the standard care group. WiiFit exercise is acceptable in self-referred older people with a history of falls. The WiiFit has the potential to improve balance but further work is required. ClinicalTrials.gov - NCT01082042.

  13. 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.

  14. Development and pilot test of a new set of good practice indicators for chronic cancer pain management.

    PubMed

    Saturno, P J; Martinez-Nicolas, I; Robles-Garcia, I S; López-Soriano, F; Angel-García, D

    2015-01-01

    Pain is among the most important symptoms in terms of prevalence and cause of distress for cancer patients and their families. However, there is a lack of clearly defined measures of quality pain management to identify problems and monitor changes in improvement initiatives. We built a comprehensive set of evidence-based indicators following a four-step model: (1) review and systematization of existing guidelines to list evidence-based recommendations; (2) review and systematization of existing indicators matching the recommendations; (3) development of new indicators to complete a set of measures for the identified recommendations; and (4) pilot test (in hospital and primary care settings) for feasibility, reliability (kappa), and usefulness for the identification of quality problems using the lot quality acceptance sampling (LQAS) method and estimates of compliance. Twenty-two indicators were eventually pilot tested. Seventeen were feasible in hospitals and 12 in all settings. Feasibility barriers included difficulties in identifying target patients, deficient clinical records and low prevalence of cases for some indicators. Reliability was mostly very good or excellent (k > 0.8). Four indicators, all of them related to medication and prevention of side effects, had acceptable compliance at 75%/40% LQAS level. Other important medication-related indicators (i.e., adjustment to pain intensity, prescription for breakthrough pain) and indicators concerning patient-centred care (i.e., attention to psychological distress and educational needs) had very low compliance, highlighting specific quality gaps. A set of good practice indicators has been built and pilot tested as a feasible, reliable and useful quality monitoring tool, and underscoring particular and important areas for improvement. © 2014 European Pain Federation - EFIC®

  15. Development and pilot of an internationally standardized measure of cardiovascular risk management in European primary care

    PubMed Central

    2011-01-01

    Background Primary care can play an important role in providing cardiovascular risk management in patients with established Cardiovascular Diseases (CVD), patients with a known high risk of developing CVD, and potentially for individuals with a low risk of developing CVD, but who have unhealthy lifestyles. To describe and compare cardiovascular risk management, internationally valid quality indicators and standardized measures are needed. As part of a large project in 9 European countries (EPA-Cardio), we have developed and tested a set of standardized measures, linked to previously developed quality indicators. Methods A structured stepwise procedure was followed to develop measures. First, the research team allocated 106 validated quality indicators to one of the three target populations (established CVD, at high risk, at low risk) and to different data-collection methods (data abstraction from the medical records, a patient survey, an interview with lead practice GP/a practice survey). Secondly, we selected a number of other validated measures to enrich the assessment. A pilot study was performed to test the feasibility. Finally, we revised the measures based on the findings. Results The EPA-Cardio measures consisted of abstraction forms from the medical-records data of established Coronary Heart Disease (CHD)-patients - and high-risk groups, a patient questionnaire for each of the 3 groups, an interview questionnaire for the lead GP and a questionnaire for practice teams. The measures were feasible and accepted by general practices from different countries. Conclusions An internationally standardized measure of cardiovascular risk management, linked to validated quality indicators and tested for feasibility in general practice, is now available. Careful development and pilot testing of the measures are crucial in international studies of quality of healthcare. PMID:21473758

  16. Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

    PubMed

    Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

    2018-05-01

    To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

  17. 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.

  18. Effects of sculpture based art therapy in dementia patients-A pilot study.

    PubMed

    Seifert, Kathrin; Spottke, Annika; Fliessbach, Klaus

    2017-11-01

    Art and art therapy open up interesting possibilities for dementia patients. However, it has not been evaluated scientifically so far, whether the art of sculpting has any benefits. In this non-randomized pilot study with twelve participants, we investigated the feasibility and acceptance of sculptural activity in patients with dementia and the effects on their well-being. A questionnaire was custom-designed to investigate five key aspects of well-being: mental state and concentration, corporeal memory, self-reliance, self-esteem and physicality. Remarkable improvements were seen in several subscales in the sculptural activity group, but not the control group: Mental state and concentration (nine of thirteen key aspects), self-reliance (four of five), self-esteem (one of one) and physicality (two of two). The results of this pilot study indicate the multidimensional effects of sculptural activity on patients living with dementia. The field would benefit greatly from further research.

  19. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music.

    PubMed

    Rennick, Janet E; Stremler, Robyn; Horwood, Linda; Aita, Marilyn; Lavoie, Tanya; Majnemer, Annette; Antonacci, Marie; Knox, Alyssa; Constantin, Evelyn

    2018-04-13

    To examine the feasibility and acceptability of a PICU Soothing intervention using touch, reading, and music. Nonblinded, pilot randomized controlled trial. The PICU and medical-surgical wards of one Canadian pediatric hospital. Twenty PICU patients age 2-14 years old and their parents, randomized to an intervention group (n = 10) or control group (n = 10). PICU Soothing consisted of: 1) parental comforting (touch and reading), followed by 2) a quiet period with music via soft headbands, administered once daily throughout hospitalization. Acceptability and feasibility of the intervention and methods were assessed via participation rates, observation, measurement completion rates, semistructured interviews, and telephone calls. Psychological well-being was assessed using measures of distress, sleep, and child and parent anxiety in the PICU, on the wards and 3 months post discharge. Forty-four percent of parents agreed to participate. Seventy percent and 100% of intervention group parents responded positively to comforting and music, respectively. Most intervention group parents (70%) and all nurses felt children responded positively. All nurses found the intervention acceptable and feasible. Measurement completion rates ranged from 70% to 100%. Pilot data suggested lower intervention group child and parent anxiety after transfer to hospital wards. PICU Soothing is acceptable and feasible to conduct. Results support the implementation of a full-scale randomized controlled trial to evaluate intervention effectiveness.

  20. Parental Involvement in Language and Literacy Acquisition: A Bilingual Journaling Approach

    ERIC Educational Resources Information Center

    Caesar, Lena G.; Nelson, Nickola Wolf

    2014-01-01

    This pilot study examined the feasibility of a home-school partnership for improving emergent literacy skills in Spanish-speaking pre-school children of migrant farmworkers. Parents were requested to send labeled drawings of family activities to their children's classroom for supplementing bilingual language and literacy instruction. Participants…

  1. 77 FR 5519 - Agency Forms Undergoing Paperwork Reduction Act Review

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... sample frame will be generated from the U.S. Census of Governments. The proposed pilot study is designed to address three key methodological objectives. The first objective is to test the feasibility of the proposed sampling frame and to answer sample design issues related to determining sampling criteria for...

  2. Photographic Data Extraction Feasibility and Pilot Study in Support of Roadside Safety and Roadway Departure Research

    DOT National Transportation Integrated Search

    2014-05-01

    This work represents the first phase of an ongoing low-cost in-house effort to perform data analysis, optimize internal data gathering in an informed fashion, make data requests to organizations, and obtain needed information. The work also calls on ...

  3. TREATABILITY STUDY BULLETIN: MOBILE VOLUME REDUCTION UNIT AT THE ESCAMBIA SUPERFUND SITE

    EPA Science Inventory

    The RREL has developed a pilot-scale Mobile Volume Reduction Unit (VRU) to determine the feasibility of soil washing for the remediation of contaminated soils. This mobile unit, mounted on two trailers, can process 100 lb/hr of soil feed. Soil washing is a cost effective technolo...

  4. Depression in Adolescents with ASD: A Pilot RCT of a Group Intervention

    ERIC Educational Resources Information Center

    Santomauro, Damian; Sheffield, Jeanie; Sofronoff, Kate

    2016-01-01

    Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the…

  5. Modular Cognitive-Behavioral Therapy for Body Dysmorphic Disorder

    ERIC Educational Resources Information Center

    Wilhelm, Sabine; Phillips, Katharine A.; Fama, Jeanne M.; Greenberg, Jennifer L.; Steketee, Gail

    2011-01-01

    This study pilot tested a newly developed modular cognitive-behavioral therapy (CBT) treatment manual for body dysmorphic disorder (BDD). We tested feasibility, acceptability, and treatment outcome in a sample of 12 adults with primary BDD. Treatment was delivered in weekly individual sessions over 18 or 22 weeks. Standardized clinician ratings…

  6. USE OF RADIOPHONIC TEACHING IN FUNDAMENTAL EDUCATION.

    ERIC Educational Resources Information Center

    RHOADS, WILLIAM G.; AND OTHERS

    A PILOT STUDY WAS CONDUCTED IN EL SALVADOR AND HONDURAS TO TEST THE FEASIBILITY OF MULTINATIONAL EVALUATION OF THE RADIOPHONIC SCHOOL SYSTEM IN LATIN AMERICA. RADIO SCHOOL PROGRAMS WERE EXAMINED IN TERMS OF THEIR EFFECT ON PARTICIPANT ACHIEVEMENT, SATISFACTION, AND APPLICATION OF ACQUIRED SKILLS AND KNOWLEDGE. ATTITUDINAL, SOCIAL, AND CULTURAL…

  7. The feasibility and acceptability of screening for hypertension in private drug retail outlets: a pilot study in Mwanza region, Tanzania.

    PubMed

    Michael, Denna; Kezakubi, Dotto; Juma, Adinan; Todd, Jim; Reyburn, Hugh; Renju, Jenny

    2016-09-01

    Hypertension is a major contributor to ill health in sub-Saharan Africa. Developing countries need to increase access for screening. This study assesses the feasibility and acceptability of using private sector drug retail outlets to screen for hypertension in Mwanza region, Tanzania. A pilot study took place in eight drug retail outlets from August 2013 to February 2014. Customers ≥18 years were invited for screening. Socio-demographic characteristics, hypertension knowledge, hypertension screening and treatment history were collected. Subjects with systolic blood pressure over 140 mmHg were referred for follow up. Referral slips captured attendance. Mystery client visits and follow up phone calls were conducted to assess service quality. A total of 971 customers were screened, one person refused; 109 (11.2%) had blood pressure over 140/90 mmHg and were referred for ongoing assessment; 85/109 (78.0%) were newly diagnosed. Customers reported that the service was acceptable. Service providers were able to follow the protocol. Only 18/85 (21%) newly diagnosed participants visited the referral clinic within two weeks. Blood pressure screening was feasible and acceptable to customers of private drug retail outlets. However many who were referred failed to attend at a referral centre and further research is needed in this area. © The Author 2016. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

  8. Use of an Anti-Gravity Treadmill for Early Postoperative Rehabilitation After Total Knee Replacement: A Pilot Study to Determine Safety and Feasibility.

    PubMed

    Bugbee, William D; Pulido, Pamela A; Goldberg, Timothy; D'Lima, Darryl D

    2016-01-01

    The objective was to determine the safety, feasibility, and effects of anti-gravity gait training on functional outcomes (Knee Injury and Osteoarthritis Outcome Score [KOOS], the Timed Up and Go test [TUG], Numerical Rating Scale [NRS] for pain) with the AlterG® Anti-Gravity Treadmill® device for total knee arthroplasty (TKA) rehabilitation. Subjects (N = 30) were randomized to land-based vs anti-gravity gait training over 4 weeks of physical therapy after TKA. Adverse events, complications, and therapist satisfaction were recorded. All patients completed rehabilitation protocols without adverse events. KOOS, TUG, and NRS scores improved in both groups with no significant differences between groups. For the AlterG group, Sports/Recreation and Quality of Life subscales of the KOOS had the most improvement. At the end of physical therapy, TUG and NRS pain scores improved from 14 seconds to 8 seconds and from 2.8 to 1.1, respectively. Subjectively, therapists reported 100% satisfaction with the AlterG. This initial pilot study demonstrated that the AlterG Anti-Gravity Treadmill device was safe and feasible. While functional outcomes improved over time with use of the anti-gravity gait training, further studies are needed to define the role of this device as an alternative or adjunct to established rehabilitation protocols.

  9. Repertory Grid Technique in Early Childhood as a Tool for Reflective Conversations in Arts Education.

    ERIC Educational Resources Information Center

    Karppinen, Seija

    The repertory grid is a technique used in psychological and behavioral studies to elicit individuals' personal constructs. This pilot study examined the feasibility of using this technique with young children in early childhood education settings with regard to visual art education, based on the view that listening to, and appreciating children's…

  10. Facilitated Playgroups to Promote Speech and Language Skills of Young Children with Communication Delays: A Pilot Study

    ERIC Educational Resources Information Center

    Green, Katherine B.; Towson, Jacqueline A.; Head, Cynthia; Janowski, Brittany; Smith, Laura

    2018-01-01

    Family-centered practices that build caregiver capacity are a central focus of early intervention services for young children with disabilities. The purpose of this study was to evaluate the feasibility of adapting the "Parents Interacting with Infants" (PIWI) facilitated playgroup model to target effective communication strategies for…

  11. Educational Applications of Vision Therapy: A Pilot Study on Children with Autism.

    ERIC Educational Resources Information Center

    Lovelace, Kelly; Rhodes, Heidi; Chambliss, Catherine

    This report discusses the outcomes of a study that explored the feasibility of using vision therapy (VT) as part of an interdisciplinary approach to the education of children with autism. Traditional research on VT has explored its usefulness in helping patients to use both eyes together, improve depth perception, and enhance visual acuity.…

  12. Open-Trial Pilot Study of a Comprehensive Outpatient Psychosocial Treatment for Children with High-Functioning Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Lopata, Christopher; Lipinski, Alanna M.; Thomeer, Marcus L.; Rodgers, Jonathan D.; Donnelly, James P.; McDonald, Christin A.; Volker, Martin A.

    2017-01-01

    This study examined the feasibility and initial outcomes of a comprehensive outpatient psychosocial treatment (MAXout) for children aged 7-12 years with high-functioning autism spectrum disorder. The 18-week treatment, two 90-minute sessions per week, included instruction and therapeutic activities targeting social/social communication skills,…

  13. Developing a health and human rights training program for french speaking Africa: lessons learned, from needs assessment to a pilot program

    PubMed Central

    2009-01-01

    Background The importance of human rights education has widely been recognized as one of the strategies for their protection and promotion of health. Yet training programs have not always taken into account neither local needs, nor public health relevance, nor pedagogical efficacy. The objectives of our study were to assess, in a participative way, educational needs in the field of health and human rights among potential trainees in six French-speaking African countries and to test the feasibility of a training program through a pilot test. Ultimately the project aims to implement a health and human rights training program most appropriate to the African context. Methods Needs assessment was done according to four approaches: Revue of available data on health and human rights in the targeted countries; Country visits by one of the authors meeting key institutions; Focus group discussions with key-informants in each country; A questionnaire-based study targeting health professionals and human rights activists. Pilot training program: an interactive e-learning pilot program was developed integrating training needs expressed by partner institutions and potential trainees. Results Needs assessment showed high public health and human rights challenges that the target countries have to face. It also showed precise demands of partner institutions in regard to a health and human rights training program. It further allowed defining training objectives and core competencies useful to potential employers and future students as well as specific training contents. A pilot program allowed testing the motivation of students, the feasibility of an interactive educational approach and identifying potential difficulties. Conclusion In combining various approaches our study was able to show that training needs concentrate around tools allowing the identification of basic human rights violations in the health system, the analysis of their causes and coordinated responses through specific intervention projects. PMID:19703303

  14. Developing a health and human rights training program for french speaking Africa: lessons learned, from needs assessment to a pilot program.

    PubMed

    Chastonay, Philippe; Klohn, Axel Max; Zesiger, Véronique; Freigburghaus, Franziska; Mpinga, Emmanuel Kabengele

    2009-08-24

    The importance of human rights education has widely been recognized as one of the strategies for their protection and promotion of health. Yet training programs have not always taken into account neither local needs, nor public health relevance, nor pedagogical efficacy.The objectives of our study were to assess, in a participative way, educational needs in the field of health and human rights among potential trainees in six French-speaking African countries and to test the feasibility of a training program through a pilot test. Ultimately the project aims to implement a health and human rights training program most appropriate to the African context. Needs assessment was done according to four approaches: Revue of available data on health and human rights in the targeted countries; Country visits by one of the authors meeting key institutions; Focus group discussions with key-informants in each country; A questionnaire-based study targeting health professionals and human rights activists.Pilot training program: an interactive e-learning pilot program was developed integrating training needs expressed by partner institutions and potential trainees. Needs assessment showed high public health and human rights challenges that the target countries have to face. It also showed precise demands of partner institutions in regard to a health and human rights training program. It further allowed defining training objectives and core competencies useful to potential employers and future students as well as specific training contents.A pilot program allowed testing the motivation of students, the feasibility of an interactive educational approach and identifying potential difficulties. In combining various approaches our study was able to show that training needs concentrate around tools allowing the identification of basic human rights violations in the health system, the analysis of their causes and coordinated responses through specific intervention projects.

  15. Effect of shaping sensor data on pilot response

    NASA Technical Reports Server (NTRS)

    Bailey, Roger M.

    1990-01-01

    The pilot of a modern jet aircraft is subjected to varying workloads while being responsible for multiple, ongoing tasks. The ability to associate the pilot's responses with the task/situation, by modifying the way information is presented relative to the task, could provide a means of reducing workload. To examine the feasibility of this concept, a real time simulation study was undertaken to determine whether preprocessing of sensor data would affect pilot response. Results indicated that preprocessing could be an effective way to tailor the pilot's response to displayed data. The effects of three transformations or shaping functions were evaluated with respect to the pilot's ability to predict and detect out-of-tolerance conditions while monitoring an electronic engine display. Two nonlinear transformations, on being the inverse of the other, were compared to a linear transformation. Results indicate that a nonlinear transformation that increases the rate-or-change of output relative to input tends to advance the prediction response and improve the detection response, while a nonlinear transformation that decreases the rate-of-change of output relative to input tends to lengthen the prediction response and make detection more difficult.

  16. Estimation of nonlinear pilot model parameters including time delay.

    NASA Technical Reports Server (NTRS)

    Schiess, J. R.; Roland, V. R.; Wells, W. R.

    1972-01-01

    Investigation of the feasibility of using a Kalman filter estimator for the identification of unknown parameters in nonlinear dynamic systems with a time delay. The problem considered is the application of estimation theory to determine the parameters of a family of pilot models containing delayed states. In particular, the pilot-plant dynamics are described by differential-difference equations of the retarded type. The pilot delay, included as one of the unknown parameters to be determined, is kept in pure form as opposed to the Pade approximations generally used for these systems. Problem areas associated with processing real pilot response data are included in the discussion.

  17. Psychoeducation against depression, anxiety, alexithymia and fibromyalgia: a pilot study in primary care for patients on sick leave.

    PubMed

    Melin, Eva O; Svensson, Ralph; Thulesius, Hans O

    2018-06-01

    Feasibility testing of a psychoeducational method -The Affect School and Script Analyses (ASSA) - in a Swedish primary care setting. Exploring associations between psychological, and medically unexplained physical symptoms (MUPS). Pilot study. Three Swedish primary care centers serving 20,000 people. 8 weekly 2-hour sessions with a 5-7 participant group led by two instructors - followed by 10 individual hour-long sessions. Thirty-six patients, 29 women (81%), on sick-leave due to depression, anxiety, or fibromyalgia. Feasibility in terms of participation rates and expected improvements of psychological symptoms and MUPS, assessed by self-report instruments pre-, one-week post-, and 18 months post-intervention. Regression coefficients between psychological symptoms and MUPS. The entire 26-hour psychoeducational intervention was completed by 30 patients (83%), and 33 patients (92%) completed the 16-hour Affect School. One-week post-intervention median test score changes were significantly favorable for 27 respondents, with p < .05 after correction for multiple testing for 9 of 11 measures (depression, anxiety, alexithymia, MUPS, general health, self-affirmation, self-love, self-blame, and self-hate); 18 months post intervention the results remained significantly favorable for 15 respondents for 7 of 11 measures (depression, alexithymia, MUPS, general health, self-affirmation, self-love, and self-hate). A psychoeducational method previously untested in primary care for mostly women patients on sick-leave due to depression, anxiety, or fibromyalgia had >80% participation rates, and clear improvements of self-assessed psychological symptoms and MUPS. The ASSA intervention thus showed adequate feasibility in a Swedish primary care setting. Key Points  A pilot study of a psychoeducational intervention - The Affect School and Script Analyses (ASSA) - was performed in primary care   • The intervention showed feasibility for patients on sick-leave due to depression, anxiety, or fibromyalgia   • 92% completed the 8 weeks/16 hours Affect School and 83% completed the entire 26-hour ASSA intervention   • 9 of 11 self-reported measures improved significantly one-week post intervention   • 7 of 11 self-reported measures improved significantly 18 months post-intervention.

  18. Pilot feasibility of an mHealth system for conducting ecological momentary assessment of mood-related symptoms following traumatic brain injury.

    PubMed

    Juengst, Shannon B; Graham, Kristin M; Pulantara, I Wayan; McCue, Michael; Whyte, Ellen M; Dicianno, Brad E; Parmanto, Bambang; Arenth, Patricia M; Skidmore, Elizabeth R D; Wagner, Amy K

    2015-01-01

    This study assessed pilot feasibility and validity of a mobile health (mHealth) system for tracking mood-related symptoms after traumatic brain injury (TBI). A prospective, repeated measures design was used to assess compliance with daily ecological momentary assessments (EMA) conducted via a smartphone application over an 8-week period. An mHealth system was developed specifically for individuals with TBI and utilized previously validated tools for depressive and anxiety symptoms (Patient Health Questionnaire-9, Generalized Anxiety Disorder-7). Feasibility was assessed in 20 community-dwelling adults with TBI via an assessment of compliance, satisfaction and usability of the smartphone applications. The authors also developed and implemented a clinical patient safety management mechanism for those endorsing suicidality. Participants correctly completed 73.4% of all scheduled assessments, demonstrating good compliance. Daily assessments took <2 minutes to complete. Participants reported high satisfaction with smartphone applications (6.3 of 7) and found them easy to use (6.2 of 7). Comparison of assessments obtained via telephone-based interview and EMA demonstrated high correlations (r = 0.81-0.97), supporting the validity of conducting these assessments via smartphone application in this population. EMA conducted via smartphone demonstrates initial feasibility among adults with TBI and presents numerous opportunities for long-term monitoring of mood-related symptoms in real-world settings.

  19. A feasibility study of valerian extract for sleep disturbance in person with arthritis.

    PubMed

    Taibi, Diana M; Bourguignon, Cheryl; Gill Taylor, Ann

    2009-04-01

    To present a pilot study of valerian to explore issues of feasibility and efficacy in studies of sedative herbs for arthritis-related sleep disturbance. Fifteen persons with arthritis and mild sleep disturbance were randomized to receive 600 mg valerian (Valeriana officinalis, n = 7) or placebo (n = 8) for five nights. Protocol adherence (dosing and data collection) was high. Allocation concealment was successful using a novel approach for matching the placebo on the distinctive odor of valerian. Nonsignificant differences between the groups were found on all sleep outcomes, measured by daily diaries and wrist actigraphy. The study methods were feasible, except for recruitment issues (addressed in the discussion), and may guide the testing of other sedative herbs for persons with arthritis. Although efficacy outcomes were inconclusive due to the small sample size of this study, recent evidence from larger trials of valerian also does not support its efficacy.

  20. Cognitive behavioural therapy for psychopathology in relatives of missing persons: study protocol for a pilot randomised controlled trial.

    PubMed

    Lenferink, Lonneke I M; Wessel, Ineke; de Keijser, Jos; Boelen, Paul A

    2016-01-01

    It is hypothesized that the grieving process of relatives of missing persons is complicated by having to deal with uncertainty about the fate of their loved one. We developed a cognitive behavioural therapy (CBT) with mindfulness that focuses on dealing with this uncertainty. In this article, we elucidate the rationale of a pilot randomised controlled trial (RCT) for testing the feasibility and potential effectiveness of this CBT for reducing symptoms of psychopathology in relatives of missing persons. A pilot RCT comparing participants of the CBT condition ( n  = 15) with waiting list controls ( n  = 15) will be executed. Individuals suffering from psychopathology related to the long-term disappearance of a loved one are eligible to participate. The treatment consists of eight individual sessions. Questionnaires tapping psychological constructs will be administered before, during, and after the treatment. The feasibility of the treatment will be evaluated using descriptive statistics (e.g., attrition rate). The primary analysis consists of a within-group analysis of changes in mean scores of persistent complex bereavement disorder from baseline to immediately post-treatment and follow-up (12 and 24 weeks post-treatment). A significant number of people experience the disappearance of a loved one. Surprisingly, an RCT to evaluate a treatment for psychopathology among relatives of missing persons has never been conducted. Knowledge about treatment effects is needed to improve treatment options for those in need of help. The strengths of this study are the development of a tailored treatment for relatives of missing persons and the use of a pilot design before exposing a large sample to a treatment that has yet to be evaluated. Future research could benefit from the results of this study. NTR4732 (The Netherlands National Trial Register (NTR)).

  1. Moderate-to-high intensity aerobic exercise in patients with mild to moderate Alzheimer's disease: a pilot study.

    PubMed

    Frederiksen, Kristian S; Sobol, Nanna; Beyer, Nina; Hasselbalch, Steen; Waldemar, Gunhild

    2014-12-01

    Physical exercise may modulate neuropathology and symptoms of Alzheimer's disease (AD). This pilot study assessed the feasibility of conducting a study of moderate-to-high intensity aerobic exercise in home-dwelling patients with mild AD. An uncontrolled preintervention-postintervention test design with a single group receiving the same intervention. A total of eight patients with mild to moderate AD from the Copenhagen Memory clinic were included in the study. The intervention lasted for 14 weeks and consisted of supervised, 1-h sessions of aerobic exercise three times per week (50-60% of heart rate reserve for a two-week adaptation period and 70-80 % of heart rate reserve for the remaining 12 weeks) Feasibility was assessed based on acceptability, including attendance and drop-out, safety, and patients' and caregivers' attitudes towards the intervention as well as other relevant parameters. Attendance (mean, range: 90 %, 70-100 %) and retention (seven out of eight) rates were very high. No serious adverse events were observed. In general, patients and caregivers were positive towards the intervention. This study shows that it is feasible to conduct moderate-to-high intensity aerobic exercise in community-dwelling patients with mild AD. Our findings indicate that aspects such as a longer adaptation period, information about injury prevention, and need for involvement and support from caregivers should be addressed when planning an exercise intervention in an AD population. Copyright © 2014 John Wiley & Sons, Ltd.

  2. Feasibility of remote administration of the Fundamentals of Laparoscopic Surgery (FLS) skills test.

    PubMed

    Okrainec, Allan; Vassiliou, Melina; Kapoor, Andrew; Pitzul, Kristen; Henao, Oscar; Kaneva, Pepa; Jackson, Timothy; Ritter, E Matt

    2013-11-01

    Fundamentals of Laparoscopic Surgery (FLS) certification testing currently is offered at accredited test centers or at select surgical conferences. Maintaining these test centers requires considerable investment in human and financial resources. Additionally, it can be challenging for individuals outside North America to become FLS certified. The objective of this pilot study was to assess the feasibility of remotely administering and scoring the FLS examination using live videoconferencing compared with standard onsite testing. This parallel mixed-methods study used both FLS scoring data and participant feedback to determine the barriers to feasibility of remote proctoring for the FLS examination. Participants were tested at two accredited FLS testing centers. An official FLS proctor administered and scored the FLS exam remotely while another onsite proctor provided a live score of participants' performance. Participant feedback was collected during testing. Interrater reliabilities of onsite and remote FLS scoring data were compared using intraclass correlation coefficients (ICCs). Participant feedback was analyzed using modified grounded theory to identify themes for barriers to feasibility. The scores of the remote and onsite proctors showed excellent interrater reliability in the total FLS (ICC 0.995, CI [0.985-0.998]). Several barriers led to critical errors in remote scoring, but most were accompanied by a solution incorporated into the study protocol. The most common barrier was the chain of custody for exam accessories. The results of this pilot study suggest that remote administration of the FLS has the potential to decrease costs without altering test-taker scores or exam validity. Further research is required to validate protocols for remote and onsite proctors and to direct execution of these protocols in a controlled environment identical to current FLS test administration.

  3. Feasibility and safety of early lower limb robot-assisted training in sub-acute stroke patients: a pilot study.

    PubMed

    Gandolfi, Marialuisa; Geroin, Christian; Tomelleri, Christopher; Maddalena, Isacco; Kirilova Dimitrova, Eleonora; Picelli, Alessandro; Smania, Nicola; Waldner, Andreas

    2017-12-01

    So far, the development of robotic devices for the early lower limb mobilization in the sub-acute phase after stroke has received limited attention. To explore the feasibility of a newly robotic-stationary gait training in sub-acute stroke patients. To report the training effects on lower limb function and muscle activation. A pilot study. Rehabilitation ward. Two sub-acute stroke inpatients and ten age-matched healthy controls were enrolled. Healthy controls served as normative data. Patients underwent 10 robot-assisted training sessions (20 minutes, 5 days/week) in alternating stepping movements (500 repetitions/session) on a hospital bed in addition to conventional rehabilitation. Feasibility outcome measures were compliance, physiotherapist time, and responses to self-report questionnaires. Efficacy outcomes were bilateral lower limb muscle activation pattern as measured by surface electromyography (sEMG), Motricity Index (MI), Medical Research Council (MRC) grade, and Ashworth Scale (AS) scores before and after training. No adverse events occurred. No significant differences in sEMG activity between patients and healthy controls were observed. Post-training improvement in MI and MRC scores, but no significant changes in AS scores, were recorded. Post-treatment sEMG analysis of muscle activation patterns showed a significant delay in rectus femoris offset (P=0.02) and prolonged duration of biceps femoris (P=0.04) compared to pretreatment. The robot-assisted training with our device was feasible and safe. It induced physiological muscle activations pattern in both stroke patients and healthy controls. Full-scale studies are needed to explore its potential role in post-stroke recovery. This robotic device may enrich early rehabilitation in subacute stroke patients by inducing physiological muscle activation patterns. Future studies are warranted to evaluate its effects on promoting restorative mechanisms involved in lower limb recovery after stroke.

  4. Transcontinental anaesthesia: a pilot study.

    PubMed

    Hemmerling, T M; Arbeid, E; Wehbe, M; Cyr, S; Giunta, F; Zaouter, C

    2013-05-01

    Although telemedicine is one of the key initiatives of the World Health Organization, no study has explored the feasibility and efficacy of teleanaesthesia. This bi-centre pilot study investigates the feasibility of transcontinental anaesthesia. Twenty patients aged ≥ 18 yr undergoing elective thyroid surgery for ≥ 30 min were enrolled in this study. The remote and local set-up was composed of a master-computer (Montreal) and a slave-computer (Pisa). Standard Internet connection, remote desktop control, and video conference software were used. All patients received total i.v. anaesthesia controlled remotely (Montreal). The main outcomes were feasibility, clinical performance, and controller performance of transcontinental anaesthesia. The clinical performance of hypnosis control was the efficacy to maintain bispectral index (BIS) at 45: 'excellent', 'good', 'poor', and 'inadequate' control represented BIS values within 10, from 11 to 20, from 21 to 30, or >30% from target. The clinical performance of analgesia was the efficacy to maintain Analgoscore values at 0 (-9 to 9); -3 to +3 representing 'excellent' pain control, -3 to -6 and +3 to +6 representing 'good' pain control, and -6 to -9 and +6 to +9 representing 'insufficient' pain control. The controller performance was evaluated using Varvel parameters. Transcontinental anaesthesia was successful in all 20 consecutive patients. The clinical performance of hypnosis showed an 'excellent and good' control for 69% of maintenance time, and the controller performance showed an average global performance index of 57. The clinical performance of analgesia was 'excellent and good' for 92% of maintenance time, and the controller performance showed a global performance index of 1118. Transcontinental anaesthesia is feasible; control of anaesthesia shows good performance indexes. Clinical registration number NCT01331096.

  5. Technology-based functional assessment in early childhood intervention: a pilot study.

    PubMed

    Khetani, Mary A; McManus, Beth M; Arestad, Kristen; Richardson, Zachary; Charlifue-Smith, Renee; Rosenberg, Cordelia; Rigau, Briana

    2018-01-01

    Electronic patient-reported outcomes (e-PROs) may provide valid and feasible options for obtaining family input on their child's functioning for care planning and outcome monitoring, but they have not been adopted into early intervention (EI). The purpose of this pilot study was to evaluate the feasibility of implementing technology-based functional assessment into EI practice and to examine child, family, service, and environmental correlates of caregiver-reported child functioning in the home. In a cross-sectional design, eight individual EI providers participated in a 90-min technology-based functional assessment training to recruit participants and a 60-min semi-structured focus group post data collection. Participants completed the Young Children's Participation and Environment Measure (YC-PEM) home section online and Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) via iPad. Participants' EI service use data were obtained from administrative records. A total of 37 caregivers of children between 6 and 35 months old (mean age = 19.4, SD = 7.7) enrolled, a rate of 44% (37/84) in 2.5 months. Providers suggested expanding staff training, gathering data during scheduled evaluations, and providing caregivers and providers with access to assessment summaries. Caregivers wanted their child's participation to change in 56% of home activities. Lower caregiver education and higher EI intensity were related to less child involvement in home activities. Implementing technology-based functional assessment is feasible with modifications, and these data can be useful for highlighting child, family, and EI service correlates of caregiver-reported child functioning that merit further study. Feasibility results informed protocol modifications related to EI provider training, timing of data collection, and management of EI service use data extraction, as preparation for a subsequent scale-up study that is underway.

  6. A feasibility study of the provision of a personalized interdisciplinary audiovisual summary to facilitate care transfer care at hospital discharge: Care Transfer Video (CareTV).

    PubMed

    Newnham, Harvey H; Gibbs, Harry H; Ritchie, Edward S; Hitchcock, Karen I; Nagalingam, Vathy; Hoiles, Andrew; Wallace, Ed; Georgeson, Elizabeth; Holton, Sara

    2015-04-01

    To assess the feasibility and patient acceptance of a personalized interdisciplinary audiovisual record to facilitate effective communication with patients, family, carers and other healthcare workers at hospital discharge. Descriptive pilot study utilizing a study-specific patient feedback questionnaire conducted from October 2013 to June 2014. Twenty General Medical inpatients being discharged from an Acute General Medical Ward in a metropolitan teaching hospital. Audiovisual record of a CareTV filmed at the patient's bedside by a consultant-led interdisciplinary team, within 24 h prior to discharge from the ward, provided immediately for the patient to take home. Patient surveys were completed within 2 weeks of discharge. Technical quality, utilization, acceptability, patient satisfaction and recall of diagnosis, medication changes and post-discharge review arrangements. All patients had watched their CareTV either alone or in the presence of a variety of others: close family, their GP, a medical specialist, friends or other health personnel. Participating patients had good understanding of the video content and recall of their diagnosis, medication changes and post-discharge plans. Patient feedback was overwhelmingly positive. In the context of a General Medical Unit with extensive experience in interdisciplinary bedside rounding and teamwork, CareTV is simple to implement, inexpensive, technically feasible, requires minimal staff training and is acceptable to patients. The results of this pilot study will inform and indicate the feasibility of conducting a larger randomized control trial of the impact of CareTV on patient satisfaction, medication adherence and recall of key information, and primary healthcare provider satisfaction. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

  7. Development and Feasibility of a COPD Self-Management Intervention Delivered with Motivational Interviewing Strategies

    PubMed Central

    Benzo, Roberto; Vickers, Kristin; Ernst, Denise; Tucker, Sharon; McEvoy, Charlene; Lorig, Kate

    2013-01-01

    BACKGROUND Self-management (SM) is proposed as the standard of care in chronic obstructive pulmonary disease (COPD) but details of the process and training required to deliver effective SM are not widely available. In addition, recent data suggest that patient engagement and motivation are critical ingredients for effective self-management. This manuscript carefully describes a self-management intervention using Motivational Interviewing skills, aimed to increase engagement and commitment in severe COPD patients. METHODS The intervention was developed and pilot tested for fidelity to protocol, for patient and interventionist feedback (qualitative) and effect on quality of life. Engagement between patient and interventionists was measured by the Working Alliance Inventory. The intervention was refined based in the results of the pilot study and delivered in the active arm of a prospective randomized study. RESULTS The pilot study suggested improvements in quality of life, fidelity to theory and patient acceptability. The refined self-management intervention was delivered 540 times in the active arm of a randomized study. We observed a retention rate of 86% (patients missing or not available for only 14% the scheduled encounters). CONCLUSIONS A self-management intervention, that includes motivational interviewing as the way if guiding patient into behavior change, is feasible in severe COPD and may increase patient engagement and commitment to self-management. This provides a very detailed description of the SM process for (the specifics of training and delivering the intervention) that facilitates replicability in other settings and could be translated to cardiac rehabilitation. PMID:23434613

  8. Developing a tool for observing group critical thinking skills in first-year medical students: a pilot study using physiology-based, high-fidelity patient simulations.

    PubMed

    Nguyen, Khoa; Ben Khallouq, Bertha; Schuster, Amanda; Beevers, Christopher; Dil, Nyla; Kay, Denise; Kibble, Jonathan D; Harris, David M

    2017-12-01

    Most assessments of physiology in medical school use multiple choice tests that may not provide information about a student's critical thinking (CT) process. There are limited performance assessments, but high-fidelity patient simulations (HFPS) may be a feasible platform. The purpose of this pilot study was to determine whether a group's CT process could be observed over a series of HFPS. An instrument [Critical Thinking Skills Rating Instrument CTSRI)] was designed with the IDEAS framework. Fifteen groups of students participated in three HFPS that consisted of a basic knowledge quiz and introduction, HFPS session, and debriefing. HFPS were video recorded, and two raters reviewed and scored all HFPS encounters with the CTSRI independently. Interrater analysis suggested good reliability. There was a correlation between basic knowledge scores and three of the six observations on the CTSRI providing support for construct validity. The median CT ratings significantly increased for all observations between the groups' first and last simulation. However, there were still large percentages of video ratings that indicated students needed substantial prompting during the HFPS. The data from this pilot study suggest that it is feasible to observe CT skills in HFPS using the CTSRI. Based on the findings from this study, we strongly recommend that first-year medical students be competent in basic knowledge of the relevant physiology of the HFPS before participating, to minimize the risk of a poor learning experience. Copyright © 2017 the American Physiological Society.

  9. 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.

  10. Assessing the Feasibility of a Social Media to Promote Weight Management Engagement in Adolescents with Severe Obesity: Pilot Study

    PubMed Central

    Moore, Reneé H; Li, Ziyi; Bishop-Gilyard, Chanelle T; Garrett, Andrew R; Hill, Douglas L; Bruton, Yasmeen P; Sarwer, David B

    2018-01-01

    Background Severe obesity in adolescents has deleterious physical and psychological complications necessitating frequent multi-disciplinary clinic visits. Greater treatment engagement has been equated with weight-loss. However, traditional medical weight-loss programs for adolescents have high attrition rates. Social media is widely used by adolescents and may enhance medical weight management engagement and success. Objective The first objective was to examine the acceptability and feasibility of using a private social media group as an adjunct to medical weight management in youth ages 14 to 20 years with severe obesity [body mass index (BMI) ≥ 35 kg/m2]. The second objective was to pilot test the use of social media to improve treatment engagement and decrease attrition rates. Methods In this single arm, 12 week pre-post study, participants attended individual clinic visits and participated in a moderated private social media group that received nutrition, exercise, and behavior change social media communications or “posts” 3 to 4 times/week. Youth commented and/or liked posts from the moderator and each other. Social media engagement was measured with the number of likes and comments on social media. Clinic attrition was compared, measuring clinic visit attendance 12 weeks prior, during, and after the intervention with mixed linear regression models. Correlations of social media engagement with changes from baseline for BMI, BMI-z score, and psychosocial measures were fit. Results All 13 enrolled youth completed the study and reported that the group was enjoyable, helpful, reinforced their weight management program, and would recommend using social media to support other youth. The pilot trial was acceptable and feasible. Youth mean weekly engagement (likes + comments) in social media was greater than once a day (8.6 ±3.6). Compared to 12 weeks prior to the intervention, there was no significant decrease in clinic visit attendance at the end of the intervention (M=.231, P=.69) or 12 weeks at the conclusion of the intervention (M=.589, P=.28). Increased social media comments correlated with weight change (r=–.633, P=.04). Conclusions This pilot trial demonstrated that the use of social media as an adjunct to medical weight management was feasible and acceptable to adolescents with severe obesity. Based upon these preliminary findings, social media may be an effective way to mitigate attrition from obesity treatment programs, and improve health outcomes in this high-risk population. PMID:29555623

  11. Feasibility study and pilot cluster-randomised controlled trial of the GoActive intervention aiming to promote physical activity among adolescents: outcomes and lessons learnt.

    PubMed

    Corder, Kirsten; Brown, Helen E; Schiff, Annie; van Sluijs, Esther M F

    2016-11-11

    Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness. Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)). 460 participants (46.6% female; 13.2 (0.4) years old). 8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition. Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline. All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive 'fun'; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1.8 (0.1 to 3.4) p=0.04 but no difference in shyness/sociability. Participation in activity types approached significance (intervention group 2.3 (-0.2 to 4.7) p=0.07 more activity types). Results suggest feasibility and indicate potential effectiveness of GoActive to increase MVPA and support a fully powered evaluation of effectiveness and cost-effectiveness. Process evaluation data were used to refine GoActive prior to a full trial. ISRCTN31583496; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. A Computerized Asthma Outcomes Measure Is Feasible for Disease Management.

    PubMed

    Turner-Bowker, Diane M; Saris-Baglama, Renee N; Anatchkova, Milena; Mosen, David M

    2010-04-01

    OBJECTIVE: To develop and test an online assessment referred to as the ASTHMA-CAT (computerized adaptive testing), a patient-based asthma impact, control, and generic health-related quality of life (HRQOL) measure. STUDY DESIGN: Cross-sectional pilot study of the ASTHMA-CAT's administrative feasibility in a disease management population. METHODS: The ASTHMA-CAT included a dynamic or static Asthma Impact Survey (AIS), Asthma Control Test, and SF-8 Health Survey. A sample of clinician-diagnosed adult asthmatic patients (N = 114) completed the ASTHMA-CAT. Results were used to evaluate administrative feasibility of the instrument and psychometric performance of the dynamic AIS relative to the static AIS. A prototype aggregate (group-level) report was developed and reviewed by care providers. RESULTS: Online administration of the ASTHMA-CAT was feasible for patients in disease management. The dynamic AIS functioned well compared with the static AIS in preliminary studies evaluating response burden, precision, and validity. Providers found reports to be relevant, useful, and applicable for care management. CONCLUSION: The ASTHMA-CAT may facilitate asthma care management.

  13. Usability and feasibility of a mobile health system to provide comprehensive antenatal care in low-income countries: PANDA mHealth pilot study in Madagascar.

    PubMed

    Benski, Anne Caroline; Stancanelli, Giovanna; Scaringella, Stefano; Herinainasolo, Josea Léa; Jinoro, Jéromine; Vassilakos, Pierre; Petignat, Patrick; Schmidt, Nicole C

    2017-06-01

    Background Madagascar's maternal health mortality ratio in 2013 was 478 deaths per 100,000 live births. Most deaths are related to direct complications during pregnancy and childbirth and could be reduced by providing comprehensive antenatal care (ANC). Objective The objective of the study was to assess the usability and feasibility of a mobile health system (mHealth) to provide high-quality ANC, according to World Health Organization (WHO) recommendations. Methods PANDA (Pregnancy And Newborn Diagnostic Assessment) is an easy-to-use mHealth system that uses affordable communications technology to support diagnosis and health care worker decision-making regarding ANC. From January to March 2015, a cross-sectional pilot study was conducted in Ambanja District, Madagascar, in which ANC using PANDA was provided to 100 pregnant women. The collected data were transmitted to a database in the referral hospital to create individual electronic patient records. Accuracy and completeness of the data were closely controlled. The PANDA software was assessed and the number of abnormal results, treatments performed, and participants requiring referral to health care facilities were monitored. Results The PANDA system facilitated creation of individual electronic patient records that included socio-demographic and medical data for 100 participants. Duration of ANC visits averaged 29.6 min. Health care providers were able to collect all variables (100%) describing personal and medical data. No major technical problems were encountered and no data were lost. During 17 ANC visits (17%), an alert function was generated to highlight abnormal clinical results requiring therapy or referral to an affiliated hospital. Participants' acceptability of the system was very high. Conclusion This pilot study proved the usability and feasibility of the PANDA mHealth system to conduct complete and standardised ANC visits according to WHO guidelines, thus providing a promising solution to increase access to high-quality and standardised ANC for pregnant women in remote areas.

  14. West End Walkers 65+: a randomised controlled trial of a primary care-based walking intervention for older adults: study rationale and design.

    PubMed

    Macmillan, Freya; Fitzsimons, Claire; Black, Karen; Granat, Malcolm H; Grant, Margaret P; Grealy, Madeleine; Macdonald, Hazel; McConnachie, Alex; Rowe, David A; Shaw, Rebecca; Skelton, Dawn A; Mutrie, Nanette

    2011-02-19

    In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged 65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group) or a 12-week waiting list control group (delayed group) who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor), mood (Positive and Negative Affect Schedule), functional ability (Perceived Motor-Efficacy Scale for Older Adults), quality of life (Short-Form (36) Health Survey version 2) and loneliness (UCLA Loneliness Scale) were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged 65 years. The study will also examine the effect of the intervention on the well-being of participants and gain an insight into both participant and research team member experiences of the intervention.

  15. Experiences from a pilot study on how to conduct a qualitative multi-country research project regarding use of antibiotics in Southeast Europe.

    PubMed

    Kaae, Susanne; Sporrong, Sofia Kälvemark; Traulsen, Janine Morgall; Wallach Kildemoes, Helle; Nørgaard, Lotte Stig; Jakupi, Arianit; Raka, Denis; Gürpinar, Emre Umut; Alkan, Ali; Hoxha, Iris; Malaj, Admir; Cantarero, Lourdes Arevalo

    2016-01-01

    In 2014, a qualitative multi-country research project was launched to study the reasons behind the high use of antibiotics in regions of Southeast Europe by using previously untrained national interviewers (who were engaged in other antibiotic microbial resistance-related investigations) to conduct qualitative interviews with local patients, physicians and pharmacists. Little knowledge exists about how to implement qualitative multi-country research collaborations involving previously untrained local data collectors. The aim of this paper was therefore to contribute to the knowledge regarding how to conduct these types of research projects by evaluating a pilot study of the project. Local data collectors conducted the study according to a developed protocol and evaluated the study with the responsible researcher-team from University of Copenhagen. The pilot study focused on 'local ownership', 'research quality' and 'feasibility' with regard to successful implementation and evaluation. The evaluation was achieved by interpreting 'Skype' and 'face to face' meetings and email correspondence by applying 'critical common sense'. Local data collectors achieved a sense of joint ownership. Overall, the protocol worked well. Several minor challenges pertaining to research quality and feasibility were identified, in particular obtaining narratives when conducting interviews and recruiting patients for the study. Furthermore, local data collectors found it difficult to allocate sufficient time to the project. Solutions were discussed and added to the protocol. Despite the challenges, it was possible to achieve an acceptable scientific level of research when conducting qualitative multi-country research collaboration under the given circumstances. Specific recommendations to achieve this are provided by the authors.

  16. Technical Report of: Assessing Teacher Preparation Program Effectiveness--A Pilot Examination of Value Added Approaches

    ERIC Educational Resources Information Center

    Noell, George H.

    2005-01-01

    Analyses were conducted replicating pilot work examining the feasibility of using the Louisiana's educational assessment data in concert with the Louisiana Educational Assessment Data System (LEADS) database and other associated databases to assess teacher preparation programs. The degree of matching across years and the degree of matching between…

  17. Improving maternity care in the Dominican Republic: a pilot study of a community-based participatory research action plan by an international healthcare team.

    PubMed

    Foster, Jennifer; Gossett, Sarah; Burgos, Rosa; Cáceres, Ramona; Tejada, Carmen; Dominguez García, Luis; Ambrosio Rosario, Angel; Almonte, Asela; Perez, Lydia J

    2015-05-01

    This article is a report of the process and results of a feasibility pilot study to improve the quality of maternity care in a sample of 31 women and their newborns delivering in a public, tertiary hospital in the Dominican Republic. The pilot study was the first "action step" taken as a result of a formative, community-based participatory research (CBPR) study conducted between 2008 and 2010 by an interdisciplinary, international partnership of U.S. academic researchers, Dominican medical/nursing personnel, and Dominican community health workers. Health personnel and community health workers separately identified indicators most important to measure quality of antepartum maternity care: laboratory and diagnostic studies and respectful, interpersonal communication. At the midpoint and the completion of data collection, the CBPR team evaluated the change in quality indicators to assess improvement in care. The pilot study supports the idea that joint engagement of community health workers, health personnel, and academic researchers with data creation and patient monitoring is motivating for all to continue to improve services in the cultural context of the Dominican Republic. © The Author(s) 2014.

  18. e-TC: Development and pilot testing of a web-based intervention to reduce anxiety and depression in survivors of testicular cancer.

    PubMed

    Heiniger, L E; Smith, A B; Olver, I; Grimison, P; Klein, B; Wootten, A; Abbott, J-A M; Price, M A; McJannett, M; Tran, B; Stockler, M R; Gurney, H; Butow, P N

    2017-11-01

    e-TC is an online intervention designed to address common psychosocial concerns of testicular cancer survivors. It aims to reduce anxiety, depression and fear of cancer recurrence by providing evidence-based information and psychological intervention. This paper details the development and pilot testing of e-TC. During pilot testing, 25 men (with varying psychological profiles) who had completed treatment for testicular cancer, 6 months to 5 years ago (which had not recurred), used e-TC over a 10-week period and provided quantitative and qualitative feedback on the feasibility and acceptability of the programme. Six men also completed a qualitative interview to provide detailed feedback on their experiences using e-TC. Fourteen men (56%) completed at least 80% of the programme. Participants reported a high level of satisfaction with the programme. Men's limited time was a barrier to programme use and completion, and participants suggested that men with a more recent diagnosis and a higher level of distress may be more likely to engage with the programme. e-TC appears to be a feasible and acceptable online intervention for survivors of testicular cancer. Findings from this study are currently being used to refine e-TC and guide the design of a larger efficacy study. © 2017 John Wiley & Sons Ltd.

  19. Project IMPACT Pilot Report: Feasibility of Implementing a Hospital-to-Home Transition Bundle.

    PubMed

    Mallory, Leah A; Osorio, Snezana Nena; Prato, B Stephen; DiPace, Jennifer; Schmutter, Lisa; Soung, Paula; Rogers, Amanda; Woodall, William J; Burley, Kayla; Gage, Sandra; Cooperberg, David

    2017-03-01

    To improve hospital to home transitions, a 4-element pediatric patient-centered transition bundle was developed, including: a transition readiness checklist; predischarge teach-back education; timely and complete written handoff to the primary care provider; and a postdischarge phone call. The objective of this study was to demonstrate the feasibility of bundle implementation and report initial outcomes at 4 pilot sites. Outcome measures included postdischarge caregiver ability to teach-back key home management information and 30-day reuse rates. A multisite, observational time series using multiple planned sequential interventions to implement bundle components with non-technology-supported and technology-supported patients. Data were collected via electronic health record reviews and during postdischarge phone calls. Statistical process control charts were used to assess outcomes. Four pilot sites implemented the bundle between January 2014 and May 2015 for 2601 patients, of whom 1394 had postdischarge telephone encounters. Improvement was noted in the implementation of all bundle elements with the transitions readiness checklist posing the greatest feasibility challenge. Phone contact connection rates were 69%. Caregiver ability to teach-back essential home management information postdischarge improved from 18% to 82%. No improvement was noted in reuse rates, which differed dramatically between technology-supported and non-technology-supported patients. A pediatric care transition bundle was successfully tested and implemented, as demonstrated by improvement in all process measures, as well as caregiver home management skills. Important considerations for successful implementation and evaluation of the discharge bundle include the role of local context, electronic health record integration, and subgroup analysis for technology-supported patients. Copyright © 2017 by the American Academy of Pediatrics.

  20. 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.

  1. Trials, tribulations, and triumphs of a pilot initiative to optimize the management of wounds complicated by diabetes within the home.

    PubMed

    Hodgins, Marilyn J; Logan, Susan M; Price, Karla; Thompson, Carol

    2014-01-01

    To support home health care nurses in their efforts to optimize the management of patients with wounds complicated by diabetes, an initiative was introduced that incorporated a standardized assessment tool, electronic data entry, and the provision of written treatment recommendations with supporting rationale prepared by nurses with expertise in diabetes and wound care. A pilot study was conducted that provided preliminary evidence of the feasibility of this initiative as well as its potential effect on outcomes for patients, nurses, and the home care program.

  2. Pilot interaction with cockpit automation 2: An experimental study of pilots' model and awareness of the Flight Management System

    NASA Technical Reports Server (NTRS)

    Sarter, Nadine B.; Woods, David D.

    1994-01-01

    Technological developments have made it possible to automate more and more functions on the commercial aviation flight deck and in other dynamic high-consequence domains. This increase in the degrees of freedom in design has shifted questions away from narrow technological feasibility. Many concerned groups, from designers and operators to regulators and researchers, have begun to ask questions about how we should use the possibilities afforded by technology skillfully to support and expand human performance. In this article, we report on an experimental study that addressed these questions by examining pilot interaction with the current generation of flight deck automation. Previous results on pilot-automation interaction derived from pilot surveys, incident reports, and training observations have produced a corpus of features and contexts in which human-machine coordination is likely to break down (e.g., automation surprises). We used these data to design a simulated flight scenario that contained a variety of probes designed to reveal pilots' mental model of one major component of flight deck automation: the Flight Management System (FMS). The events within the scenario were also designed to probe pilots' ability to apply their knowledge and understanding in specific flight contexts and to examine their ability to track the status and behavior of the automated system (mode awareness). Although pilots were able to 'make the system work' in standard situations, the results reveal a variety of latent problems in pilot-FMS interaction that can affect pilot performance in nonnormal time critical situations.

  3. A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

    PubMed

    Hampson, Lisa V; Williamson, Paula R; Wilby, Martin J; Jaki, Thomas

    2017-01-01

    Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials. Progression criteria are usually specified and agreed with the funder ahead of time. To date, however, the progression rules used are typically ad hoc. In addition, rules routinely permit adaptations to recruitment strategies but do not stipulate criteria for evaluating their effectiveness. In this paper, we develop a framework for planning and designing internal pilot studies which permit a trial to be stopped early if recruitment is disappointing or to continue to full recruitment if enrolment during the feasibility phase is adequate. This framework enables a progression rule to be pre-specified and agreed upon prior to starting a trial. The novel two-stage designs stipulate that if neither of these situations arises, adaptations to recruitment should be made and subsequently evaluated to establish whether they have been successful. We derive optimal progression rules for internal pilot studies which minimise the expected trial overrun and maintain a high probability of completing the study when the recruitment rate is adequate. The advantages of this procedure are illustrated using a real trial example.

  4. Piloting a mHealth intervention to improve newborn care awareness among rural Cambodian mothers: a feasibility study.

    PubMed

    Huang, Shan; Li, Mu

    2017-10-16

    Globally, the World Health Organization reports that the chances of a child dying is highest in the first month of life, the neonatal period. The neonatal mortality rate in Cambodia is 18 per 1000 live births. In the province of Kampong Chhnang, that rate is the fifth highest among the 24 provinces of Cambodia at 27 per 1000 live births. We piloted a project to determine the feasibility of using a mHealth intervention (the use of mobile devices to improve health outcomes) to increase mothers' awareness about neonatal care and promote the government policy 'Safe Motherhood Protocols for Health Centres' which are in line with WHO recommendations for neonatal care. Between September and December 2013, we piloted an Interactive Voice Response system that sent pre-recorded messages to mothers of newborns using the theme 'It takes a village to raise a baby'. Four hundred fifty-five mothers were registered onto this program and the intervention involved delivering seven periodic 60 to 90 s voice messages directly to the mobile phones of these mothers from day three of their neonate's life to day 28. An evaluation of the pilot was conducted in December 2013. One hundred twenty-nine mothers were randomly selected from the 455 registered mothers and interviewed using a quantitative questionnaire. We also held two focus group discussions with three mothers and seven health workers. Quantitative and qualitative results of 126 respondents were included for analysis. They indicate that the intervention was well accepted. Seventy-one percent of respondents reported that they would recommend the intervention to other mothers, and 83% reported that they would be willing to pay for the service. This type of mHealth intervention is an acceptable and feasible way of promoting the awareness of newborn care to rural Cambodian mothers.

  5. Alcohol Brand Use and Injury in the Emergency Department: A Pilot Study.

    PubMed

    Jernigan, David H; Cukier, Samantha; Ross, Craig; Ahmed, Syed Rafay; Stolbach, Andrew

    2013-08-01

    In an urban emergency department on weekend nights in 2010 and 2011, 105 interviews assessed feasibility of collecting alcohol brand consumption data from injured patients who drank within 6 h of presentation, with responses to the orally administered survey specifying 331 alcohol brands recorded on a netbook computer. A Kruskal-Wallis test adjusted for tied ranks assessed demographic differences; confidence intervals were created around comparisons with national brand shares. The study found collection of such information feasible; limitations include comparison of national brand market share data with a local sample of drinkers. Funding was provided by the Centers for Disease Control and Prevention.

  6. Shared Medical Appointments: A Portal for Nutrition and Culinary Education in Primary Care-A Pilot Feasibility Project.

    PubMed

    Delichatsios, Helen K; Hauser, Michelle E; Burgess, Jonathan D; Eisenberg, David M

    2015-11-01

    Diseases linked to obesity such as cardiovascular disease, diabetes, degenerative joint disease, gastroesophageal reflux, and sleep apnea constitute a large portion of primary care visits. Patients with these conditions often lack knowledge, skills, and support needed to maintain health. Shared medical appointments (SMAs) that include culinary skills and nutrition education offer a novel, cost-effective way to address these diseases in primary care. Adult patients in a primary care practice at a large academic hospital in Boston, Massachusetts, who had at least 1 cardiovascular risk factor were invited to participate in SMAs that included cooking demonstrations and teaching about nutrition in addition to medical management of their conditions. Sessions were conducted by a physician and an assistant in a conference room of a traditional primary care practice as part of a pilot feasibility project. Seventy patients, contributing a total of 156 patient visits, attended 17 nutrition-focused SMAs over a 4-year period. Patients were surveyed after each visit and indicated that they enjoyed the SMAs, would consider alternating SMAs with traditional one-on-one visits, and would recommend SMAs to others. Half would pay out of pocket or a higher copay to attend SMAs. Financially, the practice broke even compared with traditional one-onone office visits. In this feasibility study, chronic disease SMAs conducted with a culinary/nutrition focus were feasible, cost-effective, and well received by patients. Follow-up studies are needed to evaluate short- and long-term outcomes of this SMA model on obesity-related diseases.

  7. Shared Medical Appointments: A Portal for Nutrition and Culinary Education in Primary Care—A Pilot Feasibility Project

    PubMed Central

    Hauser, Michelle E.; Burgess, Jonathan D.; Eisenberg, David M.

    2015-01-01

    Introduction: Diseases linked to obesity such as cardiovascular disease, diabetes, degenerative joint disease, gastroesophageal reflux, and sleep apnea constitute a large portion of primary care visits. Patients with these conditions often lack knowledge, skills, and support needed to maintain health. Shared medical appointments (SMAs) that include culinary skills and nutrition education offer a novel, cost-effective way to address these diseases in primary care. Methods: Adult patients in a primary care practice at a large academic hospital in Boston, Massachusetts, who had at least 1 cardiovascular risk factor were invited to participate in SMAs that included cooking demonstrations and teaching about nutrition in addition to medical management of their conditions. Sessions were conducted by a physician and an assistant in a conference room of a traditional primary care practice as part of a pilot feasibility project. Results: Seventy patients, contributing a total of 156 patient visits, attended 17 nutrition-focused SMAs over a 4-year period. Patients were surveyed after each visit and indicated that they enjoyed the SMAs, would consider alternating SMAs with traditional one-on-one visits, and would recommend SMAs to others. Half would pay out of pocket or a higher copay to attend SMAs. Financially, the practice broke even compared with traditional one-onone office visits. Conclusion: In this feasibility study, chronic disease SMAs conducted with a culinary/nutrition focus were feasible, cost-effective, and well received by patients. Follow-up studies are needed to evaluate short- and long-term outcomes of this SMA model on obesity-related diseases. PMID:26665019

  8. COPE: A Pilot Study with Urban-Dwelling Minority Sixth-Grade Youth to Improve Physical Activity and Mental Health Outcomes

    ERIC Educational Resources Information Center

    Hoying, Jacqueline; Melnyk, Bernadette Mazurek

    2016-01-01

    Approximately one in three preadolescents (34%) is obese/overweight and one in four (25%) experience a mental health issue. Urban youth suffer from higher rates of these problems, and at earlier ages than their peers. This study's purpose was to determine feasibility/acceptability and preliminary effects of the COPE (Creating Opportunities for…

  9. INTEGRATING BIOLOGICAL PRINCIPLES WITH INSTRUCTION IN VOCATIONAL AGRICULTURE, A RESEARCH REPORT OF A GRADUATE STUDY. RESEARCH SERIES IN AGRICULTURAL EDUCATION.

    ERIC Educational Resources Information Center

    BENDER, RALPH E.; STARLING, JOHN T.

    TO DETERMINE THE FEASIBILITY OF INTEGRATING BIOLOGICAL PRINCIPLES WITH INSTRUCTION IN VOCATIONAL AGRICULTURE IN OHIO HIGH SCHOOLS, 15 PILOT SCHOOLS AND 8 CONTROL SCHOOLS WERE STUDIED. PRETESTS ADMINISTERED TO STUDENTS IN OCTOBER 1963 WERE AN AGRICULTURAL ACHIEVEMENT TEST, A BIOLOGICAL PRINCIPLES TEST, THE CALIFORNIA SHORT-FORM TEST OF MENTAL…

  10. Working Memory Training for Children with Cochlear Implants: A Pilot Study

    ERIC Educational Resources Information Center

    Kronenberger, William G.; Pisoni, David B.; Henning, Shirley C.; Colson, Bethany G.; Hazzard, Lindsey M.

    2011-01-01

    Purpose: This study investigated the feasibility and efficacy of a working memory training program for improving memory and language skills in a sample of 9 children who are deaf (age 7-15 years) with cochlear implants (CIs). Method: All children completed the Cogmed Working Memory Training program on a home computer over a 5-week period.…

  11. Problem-Solving Skills Training for Mothers of Children Recently Diagnosed with Autism Spectrum Disorder: A Pilot Feasibility Study

    ERIC Educational Resources Information Center

    Nguyen, Cathina T.; Fairclough, Diane L.; Noll, Robert B.

    2016-01-01

    Problem-solving skills training is an intervention designed to teach coping skills that has shown to decrease negative affectivity (depressive symptoms, negative mood, and post-traumatic stress symptoms) in mothers of children with cancer. The objective of this study was to see whether mothers of children recently diagnosed with autism spectrum…

  12. Telemedicine for Peer-to-Peer Psychiatry Learning between U.K. and Somaliland Medical Students

    ERIC Educational Resources Information Center

    Keynejad, Roxanne; Ali, Faisal R.; Finlayson, Alexander E. T.; Handuleh, Jibriil; Adam, Gudon; Bowen, Jordan S. T.; Leather, Andrew; Little, Simon J.; Whitwell, Susannah

    2013-01-01

    Objective: The proportion of U.K. medical students applying for psychiatry training continues to decline, whereas, in Somaliland, there are no public-sector psychiatrists. This pilot study assessed the usefulness and feasibility of online, instant messenger, peer-to-peer exchange for psychiatry education between cultures. Method: Twenty medical…

  13. Supporting Self-Regulated Learning for College Students with Asperger Syndrome: Exploring the "Strategies for College Learning" Model

    ERIC Educational Resources Information Center

    Ness, Bryan M.

    2013-01-01

    In this study, I piloted the feasibility, effects, and perceived acceptability of a peer mentoring intervention targeting academic achievement and self-regulated learning (SRL) for three college students with Asperger syndrome. The approach, dubbed Strategies for College Learning (SCL), features individualized assessment of academic performance in…

  14. Issues Related to Assessing Listening Ability.

    ERIC Educational Resources Information Center

    Mead, Nancy A.

    The National Assessment of Educational Progress (NAEP) and the Speech Communication Association (SCA) initiated a pilot study to test the feasibility of assessing speaking and listening skills. A pool of 56 items was developed and then field tested at four sites which represented a variety of national regions, of size and type of cities, and of…

  15. A Pilot Demonstration of Comprehensive Mental Health Services in Inner-City Public Schools

    ERIC Educational Resources Information Center

    Walter, Heather J.; Gouze, Karen; Cicchetti, Colleen; Arend, Richard; Mehta, Tara; Schmidt, Janet; Skvarla, Madelynn

    2011-01-01

    Background: National policy statements increasingly espouse the delivery of comprehensive mental health services in schools. In response to the limited evidence supporting this recommendation, the purpose of this study was to assess the need for, and feasibility, desirability, and outcomes of a full model of comprehensive mental health services in…

  16. Embedding Community Engagement in South African Higher Education

    ERIC Educational Resources Information Center

    Lazarus, Josef; Erasmus, Mabel; Hendricks, Denver; Nduna, Joyce; Slamat, Jerome

    2008-01-01

    Community engagement was a relatively unknown concept in South African higher education until the late 1990s. In response to the call of the White Paper on the Transformation of Higher Education (1997) for "feasibility studies and pilot programmes which explore the potential of community service in higher education" the Joint Education…

  17. An Examination of the Feasibility of Integrating Motivational Interviewing Techniques into FCS Cooperative Extension Programming

    ERIC Educational Resources Information Center

    Radunovich, Heidi Liss; Ellis, Sarah; Spangler, Taylor

    2017-01-01

    Demonstrating program impact through behavior change is critical for the continued success of Family and Consumer Sciences (FCS) Cooperative Extension programming. However, the literature suggests that simply providing information to participants does not necessarily lead to behavior change. This study pilot tested the integration of Motivational…

  18. Using Simulation to Train Junior Psychiatry Residents to Work with Agitated Patients: A Pilot Study

    ERIC Educational Resources Information Center

    Zigman, Daniel; Young, Meredith; Chalk, Colin

    2013-01-01

    Objective: This article examines the benefit and feasibility of introducing a new, simulation-based learning intervention for junior psychiatry residents. Method: Junior psychiatry residents were invited to participate in a new simulation-based learning intervention focusing on agitated patients. Questionnaires were used to explore the success of…

  19. A pilot study of the photoprotective effect of almond phytochemicals in a 3D human skin equivalent

    USDA-ARS?s Scientific Manuscript database

    UV exposure causes oxidative stress, inflammation, erythema, and skin cancer. Alpha-Tocopherol (AT) and polyphenols (AP) present in almonds may serve as photoprotectants. Our objectives were to assess the feasibility of using a 3D human skin equivalent (HSE) in photoprotectant research and to deter...

  20. Maternal Work Status and Pregnancy Outcomes: A Pilot.

    ERIC Educational Resources Information Center

    Pitzer, Martha S.

    Investigated were effects of maternal work status and parity on specific outcomes in maternal psychology and physiology and infant physiology. In addition, the study design and the usefulness of instruments were evaluated, and the feasibility of subject recruitment and retention was assessed. Subjects were 20 women between 18 and 35 years of age…

  1. Can the IROMEC robot support play in children with severe physical disabilities? A pilot study.

    PubMed

    van den Heuvel, Renée J F; Lexis, Monique A S; de Witte, Luc P

    2017-03-01

    The aim of this study was to explore the application of the IROMEC (Interactive social RObotic Mediators as Companions) robot to support play for children with severe physical disabilities in rehabilitation and special education. Within a 2-month pilot study, physically disabled children with a developmental age between 2 and 8 years participated in sessions with the robot. A combination of qualitative and quantitative outcome measures was used to collect data on aspects of feasibility, usability, barriers for the child as well as the therapist and an indication of the effects on playfulness and the achievement of therapeutic and educational goals. A total of 11 children participated in this study (four boys, seven girls). Individually Prioritized Problem Assessment scores indicated a positive effect of the IROMEC robot on the achievement of goals for the children. Professionals did observe meaningful application possibilities, but the lacking adaptability, expandability and technical stability of the robot platform make application in daily care practice impossible. The application of a robot like IROMEC for children with severe physical disabilities seems to be positive and worthwhile, but usability and feasibility aspects are crucial for success.

  2. Priority setting for the prevention and control of cardiovascular diseases: multi-criteria decision analysis in four eastern Mediterranean countries.

    PubMed

    Ghandour, Rula; Shoaibi, Azza; Khatib, Rana; Abu Rmeileh, Niveen; Unal, Belgin; Sözmen, Kaan; Kılıç, Bülent; Fouad, Fouad; Al Ali, Radwan; Ben Romdhane, Habiba; Aissi, Wafa; Ahmad, Balsam; Capewell, Simon; Critchley, Julia; Husseini, Abdullatif

    2015-01-01

    To explore the feasibility of using a simple multi-criteria decision analysis method with policy makers/key stakeholders to prioritize cardiovascular disease (CVD) policies in four Mediterranean countries: Palestine, Syria, Tunisia and Turkey. A simple multi-criteria decision analysis (MCDA) method was piloted. A mixed methods study was used to identify a preliminary list of policy options in each country. These policies were rated by different policymakers/stakeholders against pre-identified criteria to generate a priority score for each policy and then rank the policies. Twenty-five different policies were rated in the four countries to create a country-specific list of CVD prevention and control policies. The response rate was 100% in each country. The top policies were mostly population level interventions and health systems' level policies. Successful collaboration between policy makers/stakeholders and researchers was established in this small pilot study. MCDA appeared to be feasible and effective. Future applications should aim to engage a larger, representative sample of policy makers, especially from outside the health sector. Weighting the selected criteria might also be assessed.

  3. 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.

  4. 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.

  5. Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

    PubMed Central

    Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

    2014-01-01

    The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

  6. iPhone ECG screening by practice nurses and receptionists for atrial fibrillation in general practice: the GP-SEARCH qualitative pilot study.

    PubMed

    Orchard, Jessica; Freedman, Saul Benedict; Lowres, Nicole; Peiris, David; Neubeck, Lis

    2014-05-01

    Atrial fibrillation (AF) is often asymptomatic and substantially increases stroke risk. A single-lead iPhone electrocardiograph (iECG) with a validated AF algorithm could make systematic AF screening feasible in general practice. A qualitative screening pilot study was conducted in three practices. Receptionists and practice nurses screened patients aged ≥65 years using an iECG (transmitted to a secure website) and general practitioner (GP) review was then provided during the patient's consultation. Fourteen semi-structured interviews with GPs, nurses, receptionists and patients were audio-recorded, transcribed and analysed thematically. Eighty-eight patients (51% male; mean age 74.8 ± 8.8 years) were screened: 17 patients (19%) were in AF (all previously diagnosed). The iECG was well accepted by GPs, nurses and patients. Receptionists were reluctant, whereas nurses were confident in using the device, explaining and providing screening. AF screening in general practice is feasible. A promising model is likely to be one delivered by a practice nurse, but depends on relevant contextual factors for each practice.

  7. Effectiveness of a Psychoeducational Parenting Group on Child, Parent and Family Behavior: A Pilot Study in a Family Practice Clinic with an Underserved Population

    PubMed Central

    Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain

    2013-01-01

    Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627

  8. 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.

  9. A heel-strike real-time auditory feedback device to promote motor learning in children who have cerebral palsy: a pilot study to test device accuracy and feasibility to use a music and dance-based learning paradigm.

    PubMed

    Pitale, Jaswandi Tushar; Bolte, John H

    2018-01-01

    Cerebral palsy (CP) is a developmental disorder of movement and posture that occurs due to damage to the developing nervous system. As part of therapy, wearable sensors that trigger interactive feedback may provide multi-sensory guidance and motivation. A prototype of a heel-strike real-time feedback system has been developed which records the number of heel strikes during gait and indicates successful heel contact through real-time auditory feedback. The first aim of this feasibility study was to test the prototype accuracy.Since the end user for this device is a child, the device should be esthetically appealing and sufficiently motivating for children to perform repetitive challenging therapeutic movements. The second aim of this study was to collect feedback from the subjects with regard to the device usability and understand if the bell sound used as feedback used was motivating enough for children to continue using the prototype. This would help us in developing the next generation of the device. The prototype was tested with typically developing children and children who have CP. The accuracy in detecting heel strikes was calculated. As part of the study, the subjects were also asked questions to test the device compliance and acceptability of the musical beats with the pediatric population. The device accuracy in identifying heel strikes is 97.44% (95% CI 96.31, 98.88%). The subjects did not show any hesitation to put on the device and the sound feedback motivated them to move. Based on this pilot study, a minimum age limit of 5 years is appropriate and the intervention study should be conducted for no more than 30 min per week. The pilot study showed that a main study can be conducted to test auditory feedback as an intervention to promote motor learning in children who have cerebral palsy. No adverse event or safety issues were reported in the feasibility study.

  10. An investigation into pilot and system response to critical in-flight events. Volume 2: Appendix

    NASA Technical Reports Server (NTRS)

    Rockwell, T. H.; Griffin, W. C.

    1981-01-01

    Materials relating to the study of pilot and system response to critical in-flight events (CIFE) are given. An annotated bibliography and a trip summary outline are presented, as are knowledge surveys with accompanying answer keys. Performance profiles of pilots and performance data from the simulations of CIFE's are given. The paper and pencil testing materials are reproduced. Conditions for the use of the additive model are discussed. A master summary of data for the destination diversion scenario is given. An interview with an aircraft mechanic demonstrates the feasibility of system problem diagnosis from a verbal description of symptoms and shows the information seeking and problem solving logic used by an expert to narrow the list of probable causes of aircraft failure.

  11. Family Model of Diabetes Education With a Pacific Islander Community.

    PubMed

    McElfish, Pearl Anna; Bridges, Melissa D; Hudson, Jonell S; Purvis, Rachel S; Bursac, Zoran; Kohler, Peter O; Goulden, Peter A

    2015-12-01

    The purpose of the study was to use a community-based participatory research approach to pilot-test a family model of diabetes education conducted in participants' homes with extended family members. The pilot test included 6 families (27 participants) who took part in a family model of diabetes self-management education (DSME) using an intervention-driven pre- and posttest design with the aim of improving glycemic control as measured by A1C. Questionnaires and additional biometric data were also collected. Researchers systematically documented elements of feasibility using participant observations and research field reports. More than three-fourths (78%) of participants were retained in the study. Posttest results indicated a 5% reduction in A1C across all participants and a 7% reduction among those with type 2 diabetes. Feasibility of an in-home model with extended family members was documented, along with observations and recommendations for further DSME adaptations related to blood glucose monitoring, physical activity, nutrition, and medication adherence. The information gained from this pilot helps to bridge the gap between knowledge of an evidence-based intervention and its actual implementation within a unique minority population with especially high rates of type 2 diabetes and significant health disparities. Building on the emerging literature of family models of DSME, this study shows that the family model delivered in the home had high acceptance and that the intervention was more accessible for this hard-to-reach population. © 2015 The Author(s).

  12. Asian Women's Action for Resilience and Empowerment Intervention: Stage I Pilot Study.

    PubMed

    Hahm, Hyeouk Chris; Chang, Stephanie Tzu-Han; Lee, Gloria Yoonseung; Tagerman, Michelle D; Lee, Christina S; Trentadue, Mia Pamela; Hien, Denise A

    2017-01-01

    This study describes the development and pilot test of Asian Women's Action for Resilience and Empowerment (AWARE), a culturally informed group psychotherapy intervention designed to reduce depressive symptoms, suicidality, substance use, and HIV and sexual risk behaviors among 1.5 and second generation Asian American (AA) women. To participate, AA women had to meet the criteria for posttraumatic stress disorder (PTSD) or have a history of exposure to interpersonal violence (IPV) as determined using the Clinician-Administered PTSD Scale (CAPS) and Traumatic Life Events Questionnaire (TLEQ). This article also presents the preliminary feasibility and acceptability of AWARE from its Stage I pilot study of nine Chinese, Korean, and Vietnamese American women. To foster holistic treatment, AWARE was developed based on original research findings from Stage 0 and integrated theoretical models including fractured identity theory, empowerment theory, cognitive behavioral therapy (CBT), mindfulness-based techniques, and the AIDS Risk Reduction Model (ARRM). The development of AWARE was an iterative process informed by participant feedback, which led to frequent intervention modifications for a future randomized controlled trial (RCT) in Stage II. A qualitative analysis of participant feedback informed the following modifications: further exploration of feelings, improvements in technology delivery, learning and practicing coping skills, more specific cultural tailoring related to sexual health, decreased number of sessions and increased time per session. Findings provide support for the acceptability and feasibility of AWARE as "culturally informed" for AA young women with IPV histories, high-risk behaviors, and mental health issues.

  13. Pilot validation of an individualised pharmacokinetic algorithm for protamine dosing after systemic heparinisation for cardiopulmonary bypass.

    PubMed

    Miles, Lachlan F; Marchiori, Paolo; Falter, Florian

    2017-09-01

    This manuscript represents a pilot study assessing the feasibility of a single-compartment, individualised, pharmacokinetic algorithm for protamine dosing after cardiopulmonary bypass. A pilot cohort study in a specialist NHS cardiothoracic hospital targeting patients undergoing elective cardiac surgery using cardiopulmonary bypass. Patients received protamine doses according to a pharmacokinetic algorithm (n = 30) or using an empirical, fixed-dose model (n = 30). Categorical differences between the groups were evaluated using the Chi-squared test or Fisher's exact test. Continuous data was analysed using a paired Student's t-test for parametric data and the paired samples Wilcoxon test for non-parametric data. Patients who had protamine dosing according to the algorithm demonstrated a lower protamine requirement post-bypass relative to empirical management as measured by absolute dose (243 ± 49mg vs. 305 ± 34.7mg; p<0.001) and the heparin to protamine ratio (0.79 ± 0.12 vs. 1.1 ± 0.15; p<0.001). There was no difference in the pre- to post-bypass activated clotting time (ACT) ratio (1.05 ± 0.12 vs. 1.02 ± 0.15; p=0.9). Patients who received protamine according to the algorithm had no significant difference in transfusion requirement (13.3% vs. 30.0%; p=0.21). This study showed that an individualized pharmacokinetic algorithm for the reversal of heparin after cardiopulmonary bypass is feasible in comparison with a fixed dosing strategy and may reduce the protamine requirement following on-pump cardiac surgery.

  14. 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.

  15. Pilot study of a smartphone application designed to socially motivate cardiovascular disease patients to improve medication adherence

    PubMed Central

    Fujita, Saki; Pitaktong, Isaree; Steller, Graeme Vosit; Dadfar, Victor; Huang, Qinwen; Banerjee, Sindhu; Guo, Richard; Nguyen, Hien Tan; Allen, Robert Harry

    2018-01-01

    Background Social support received by patients from family and community has been identified as a key factor for success in improving medication adherence in those patients. This pilot study aimed to investigate the usability and feasibility of PillPal, a smartphone application that uses video-chatting as a social motivation medium to encourage medication adherence in cardiovascular disease (CVD) patients. We additionally gathered feedback on the Physician Calendar, an accompanying web platform that allows clinicians to view patient adherence data generated from the app. Methods Thirty patients were recruited from the Johns Hopkins Hospital (JHH) Lipid Clinic (n=14) and Inpatient Cardiology Service (n=16) to pilot test the app. Data were obtained through in-person interviews in which patients tested out the app and answered standardized questions regarding the app’s feasibility as a means to enhance social support, as well as its usability measured in terms of ease of use and patient comfort level with the video-chat technology. Cardiologists (n=10) from JHH were interviewed to gain feedback on the Physician Calendar. Results We recorded 43.4% participants who stated that PillPal would increase their motivation to take their medications; 96.7% stated the app was easy to use; and 70% stated they were comfortable with video-chatting while taking their medications. Patient factors such as current adherence level, disease severity, and personality were more predictive of positive app reviews than the perceived level of social support. Clinicians generally approved of the Physician Calendar, as they would be able to quickly screen for non-adherence and begin conversations with patients to address the root cause of their non-adherence. Conclusions Based on pilot testing and interviews, using a smartphone app for video-chatting as a social support medium to improve patient medication adherence is feasible and has potential to increase medication adherence depending on certain patient characteristics. The Physician Calendar was deemed a useful tool by clinicians to quickly identify and understand reasons for medication non-adherence. PMID:29445730

  16. A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

    PubMed

    Matthews, James; Hall, Amanda M; Hernon, Marian; Murray, Aileen; Jackson, Ben; Taylor, Ian; Toner, John; Guerin, Suzanne; Lonsdale, Chris; Hurley, Deirdre A

    2015-07-05

    Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

  17. 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.

  18. 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

  19. "Merging Yoga and Occupational Therapy (MY-OT): A feasibility and pilot study".

    PubMed

    Schmid, Arlene A; Puymbroeck, Marieke Van; Portz, Jennifer D; Atler, Karen E; Fruhauf, Christine A

    2016-10-01

    To examine the feasibility and benefits of the Merging Yoga and Occupational Therapy (MY-OT) intervention. This is the primary analysis of a non-controlled pretest-posttest pilot study to understand the feasibility and impact of MY-OT on balance, balance self-efficacy, and fall risk factor management in people with chronic stroke. University research laboratory. People with chronic stroke were included in the study if they: had sustained a fall or had fear of falling, were able to stand, and hand impaired balance and were at risk for falls (≤46 on the Berg Balance Scale (BBS)). Individuals completed an 8 week intervention that included 16 sessions of both yoga and group occupational therapy (OT). Yoga included physical postures, breathing exercises, and meditation. OT focused on post-stroke fall risk factor management. The BBS was used to assess balance, the Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. Five fall risk factor management scales were used. Overall, the intervention was considered feasible, as individuals were able to safely complete the intervention with little attrition and high attendance. Balance improved by 30% (p=0.002). Balance self-efficacy improved by 15% (p=0.034). Each of the five fall risk factor management scales improved, but only two significantly improved (Fall Prevention and Management Questionnaire, 29%, p=0.004 and Fall Prevention Strategy Survey, 42%, p=0.032). The results demonstrate that MY-OT is a potential intervention to improve multiple fall related outcomes for people with stroke. Therapists may consider these interventions for people with stroke, but additional research is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

  20. Using a virtual reality game to assess goal-directed hand movements in children: A pilot feasibility study.

    PubMed

    Gabyzon, M Elboim; Engel-Yeger, B; Tresser, S; Springer, S

    2016-01-01

    Virtual reality gaming environments may be used as a supplement to the motor performance assessment tool box by providing clinicians with quantitative information regarding motor performance in terms of movement accuracy and speed, as well as sensory motor integration under different levels of dual tasking. To examine the feasibility of using the virtual reality game `Timocco' as an assessment tool for evaluating goal-directed hand movements among typically developing children. In this pilot study, 47 typically-developing children were divided into two age groups, 4-6 years old and 6-8 years old. Performance was measured using two different virtual environment games (Bubble Bath and Falling Fruit), each with two levels of difficulty. Discriminative validity (age effect) was examined by comparing the performance of the two groups, and by comparing the performance between levels of the games for each group (level effect). Test-retest reliability was examined by reassessing the older children 3-7 days after the first session. The older children performed significantly better in terms of response time, action time, game duration, and efficiency in both games compared to the younger children. Both age groups demonstrated poorer performance at the higher game level in the Bubble Bath game compared to the lower level. A similar level effect was found in the Falling Fruit game for both age groups in response time and efficiency, but not in action time. The performance of the older children was not significantly different between the two sessions at both game levels. The discriminative validity and test-retest reliability indicate the feasibility of using the Timocco virtual reality game as a tool for assessing goal-directed hand movements in children. Further studies should examine its feasibility for use in children with disabilities.

  1. 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.

  2. Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

    PubMed

    Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

    2018-01-01

    Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mhGAP), clinical competency (ENhancing Assessment of Common Therapeutic factors, ENACT), and implicit attitudes (Implicit Association Test, IAT), and patient outcomes including stigma-related barriers to care, daily functioning, and symptoms. The pilot and feasibility study will contribute to refining recommendations for implementation of mhGAP and other mental health services in primary healthcare settings in low-resource health systems. The pilot c-RCT findings will inform an effectiveness trial of RESHAPE to advance the evidence-base for optimal approaches to training and supervision for non-specialist providers. ClinicalTrials.gov identifier, NCT02793271.

  3. Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya.

    PubMed

    Papas, Rebecca K; Sidle, John E; Martino, Steve; Baliddawa, Joyce B; Songole, Rogers; Omolo, Otieno E; Gakinya, Benson N; Mwaniki, Michael M; Adina, Japheth O; Nafula, Tobista; Owino-Ong'or, Willis D; Bryant, Kendall J; Carroll, Kathleen M; Goulet, Joseph L; Justice, Amy C; Maisto, Stephen A

    2010-06-01

    Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n = 27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52-100% (women) and 21-36% (men), and by session 6 was 96-100% (women) and 89-100% (men). PDA effect sizes (Cohen's d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya.

  4. 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.

  5. Aiding Vertical Guidance Understanding

    NASA Technical Reports Server (NTRS)

    Feary, Michael; McCrobie, Daniel; Alkin, Martin; Sherry, Lance; Polson, Peter; Palmer, Everett; McQuinn, Noreen

    1998-01-01

    A two-part study was conducted to evaluate modern flight deck automation and interfaces. In the first part, a survey was performed to validate the existence of automation surprises with current pilots. Results indicated that pilots were often surprised by the behavior of the automation. There were several surprises that were reported more frequently than others. An experimental study was then performed to evaluate (1) the reduction of automation surprises through training specifically for the vertical guidance logic, and (2) a new display that describes the flight guidance in terms of aircraft behaviors instead of control modes. The study was performed in a simulator that was used to run a complete flight with actual airline pilots. Three groups were used to evaluate the guidance display and training. In the training, condition, participants went through a training program for vertical guidance before flying the simulation. In the display condition, participants ran through the same training program and then flew the experimental scenario with the new Guidance-Flight Mode Annunciator (G-FMA). Results showed improved pilot performance when given training specifically for the vertical guidance logic and greater improvements when given the training and the new G-FMA. Using actual behavior of the avionics to design pilot training and FMA is feasible, and when the automated vertical guidance mode of the Flight Management System is engaged, the display of the guidance mode and targets yields improved pilot performance.

  6. Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

    PubMed

    Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

    2017-09-01

    Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

  7. Using an iPad for Basic Communication Between Spanish-Speaking Families and Nurses in Pediatric Acute Care: A Feasibility Pilot Study.

    PubMed

    Jackson, Kylie H; Mixer, Sandra J

    2017-08-01

    The growing number of Spanish speakers in the United States poses communication challenges for healthcare providers. Language barriers in pediatric acute care have been associated with an increased risk for adverse events, longer hospital stays, and decreased quality of care. In addition, clinicians' usage of interpreter services is inconsistent. In fact, nurses often lack interpreter support during daily bedside care. Nursing staff at a pediatric children's hospital in the southeastern United States identified bedside communication with Spanish-speaking patients and families as a clinical challenge. To address this challenge, a basic communication interface, UTalk version 1.0 (the author is the owner and proprietor), supported by an Apple iPad, was developed by the researcher with input from nursing staff, a certified medical interpreter, and Spanish-speaking community members. A feasibility pilot study of the interface's usability and engagement was conducted on the hospital's pediatric medical-surgical unit through qualitative interviews with nurse-family dyads. Three themes emerged from the data: UTalk-facilitated communication, UTalk needs improvement, and interpreter miscommunication. These findings indicate that a mobile digital device interface is a feasible method for augmenting bedside communication with Spanish-speaking patients and families. These results also may serve as a reference for the development of similar mobile device interfaces. Further research with a larger sample size is needed.

  8. 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.

  9. Two Pilot Randomized Trials To Examine Feasibility and Impact of Treated Parents as Peer Interventionists in Family-Based Pediatric Weight Management.

    PubMed

    Saelens, Brian E; Scholz, Kelley; Walters, Kelly; Simoni, Jane M; Wright, Davene R

    2017-08-01

    To examine feasibility and initial efficacy of having previously treated parents serve as peer interventionists in family-based behavioral weight management treatment (FBT). Children aged 7-11 years with overweight/obesity and parents (n = 59 families) were enrolled in one of two pilot trials, the EPICH (Engaging Parents in Child Health) randomized trial comparing professional versus peer FBT delivery or the Parent Partnership trial, which provided professionally delivered FBT to families (first generation) and then randomly assigned first generation parents to either be or not be peer interventionists for subsequent families (second generation). Efficacy (child zBMI change), feasibility, and costs for delivering FBT, and impacts of being a peer interventionist were examined. In EPICH, families receiving professional versus peer intervention had similar decreases in child zBMI and parent BMI, with markedly lower costs for peer versus professional delivery. In Parent Partnership, families receiving peer intervention significantly decreased weight status, with very preliminary evidence suggesting better maintenance of child zBMI changes if parents served as peer interventionists. Previously treated parents were willing, highly confident, and able to serve as peer interventionists in FBT. Two pilot randomized clinical trials suggest parents-as-peer interventionists in FBT may be feasible, efficacious, and delivered at lower costs, with perhaps some additional benefits to serving as a peer interventionist. More robust investigation is warranted of peer treatment delivery models for pediatric weight management.

  10. 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…

  11. Autism Treatment in the First Year of Life: A Pilot Study of Infant Start, a Parent-Implemented Intervention for Symptomatic Infants

    PubMed Central

    Vismara, L.; Wagner, A. L.; McCormick, C.; Young, G.; Ozonoff, S.

    2016-01-01

    The goal of early autism screening is earlier treatment. We pilot-tested a 12-week, low-intensity treatment with seven symptomatic infants ages 7–15 months. Parents mastered the intervention and maintained skills after treatment ended. Four comparison groups were matched from a study of infant siblings. The treated group of infants was significantly more symptomatic than most of the comparison groups at 9 months of age but was significantly less symptomatic than the two most affected groups between 18 and 36 months. At 36 months, the treated group had much lower rates of both ASD and DQs under 70 than a similarly symptomatic group who did not enroll in the treatment study. It appears feasible to identify and enroll symptomatic infants in parent-implemented intervention before 12 months, and the pilot study outcomes are promising, but testing the treatment’s efficacy awaits a randomized trial. PMID:25212413

  12. Feasibility and Usability of a Mobile Application to Assess Symptoms and Affect in Patients with Atrial Fibrillation: A Pilot Study.

    PubMed

    Ghanbari, Hamid; Ansari, Sardar; Ghannam, Michael; Lathkar-Pradhan, Sangeeta; Kratz, Anna; Oral, Hakan; Najarian, Kayvan; Clauw, Daniel; Nallamothu, Brahmajee

    2017-01-01

    Atrial fibrillation (AF) is the most prevalent arrhythmia leading to hospital admissions. The majority of patients with AF report symptoms that are believed to be associated with the arrhythmia. The symptoms related to AF traditionally are collected during a clinic visit that is influenced by biases associated with recalling the experience over a limited period of time. We designed this pilot study to assess the usability and feasibility of a mobile application to assess symptoms in patients with AF. We designed a mobile application (miAfib) to assess symptoms (chest pain, palpitation, shortness of breath, fatigue, dizziness/lightheadedness), positive affect (happy, excited, content) and negative affect (worried, angry, sad) on multiple occasions throughout the day based on iOS platform. We performed a four-week feasibility trial to examine user adherence, acceptance and experiences with the mobile application. We administered questionnaires to assess factors affecting usage and self-reported acceptance of the application based on a five-point Likert scale with zero representing strongly disagree and 5 representing strongly disagree with. We included ten patients with paroxysmal and persistent AF. The mean number of completed assessments each day was 2.81 ± 1.59 with 94.7% of days with at least one assessment. The users found the application easy to use (4.75±0.46), intended to use it in the future (4.37±1.06) and found it easy to integrate into daily routine (4.5±1.07). In this pilot study, we found participants in this four-week trial reliably used the application and were able to use the app to report their daily symptoms and affect regularly. Participants reported that they found the application easy to use and would consider using the application in the future.

  13. Parenting in 2 Worlds: Pilot Results from a Culturally Adapted Parenting Program for Urban American Indians

    PubMed Central

    Kulis, Stephen; Ayers, Stephanie L.; Baker, Tahnee

    2014-01-01

    This study reports the implementation and feasibility of a culturally adapted parenting curriculum, Parenting in 2 Worlds (P2W), which we designed specifically for urban American Indian families by means of community-based participatory research and then pilot tested in three Arizona cities. Data come from matched pre- and post-test surveys completed in 2012 by 75 American Indian parents of adolescents aged 10–17 who participated in the pilot version of P2W. P2W is a 10-workshop program administered twice a week for five weeks by trained American Indian community facilitators. Parents completed pretest surveys during Workshop 1 and post-test surveys five weeks later during Workshop 10. Paired t tests assessed changes in parenting outcomes, cultural identity, and child anti-social behavior. Changes from pre- to post-test demonstrated statistically significant improvements in several parenting outcomes (discipline, involvement, self-agency, and supervision), a strengthened sense of ethnic and cultural identity and Native spirituality, and a decrease in the child’s anti-social behavior. These results, which show significant if preliminary improvements in parenting skills and family functioning, suggest the feasibility of implementing a culturally grounded parenting intervention for urban American Indian parents. PMID:25367804

  14. Anaerobic Digestion of Laminaria japonica Waste from Industrial Production Residues in Laboratory- and Pilot-Scale

    PubMed Central

    Barbot, Yann Nicolas; Thomsen, Claudia; Thomsen, Laurenz; Benz, Roland

    2015-01-01

    The cultivation of macroalgae to supply the biofuel, pharmaceutical or food industries generates a considerable amount of organic residue, which represents a potential substrate for biomethanation. Its use optimizes the total resource exploitation by the simultaneous disposal of waste biomaterials. In this study, we explored the biochemical methane potential (BMP) and biomethane recovery of industrial Laminaria japonica waste (LJW) in batch, continuous laboratory and pilot-scale trials. Thermo-acidic pretreatment with industry-grade HCl or industrial flue gas condensate (FGC), as well as a co-digestion approach with maize silage (MS) did not improve the biomethane recovery. BMPs between 172 mL and 214 mL g−1 volatile solids (VS) were recorded. We proved the feasibility of long-term continuous anaerobic digestion with LJW as sole feedstock showing a steady biomethane production rate of 173 mL g−1 VS. The quality of fermentation residue was sufficient to serve as biofertilizer, with enriched amounts of potassium, sulfur and iron. We further demonstrated the upscaling feasibility of the process in a pilot-scale system where a CH4 recovery of 189 L kg−1 VS was achieved and a biogas composition of 55% CH4 and 38% CO2 was recorded. PMID:26393620

  15. Flight assessment of a data-link-based navigation-guidance concept

    NASA Technical Reports Server (NTRS)

    Abbott, T. S.

    1983-01-01

    With the proposed introduction of a data-link provision into the Air-Traffic-control (ATC) system, the capability will exist to supplement the ground-air, voice (radio) link with digital, data-link information. Additionally, ATC computers could provide, via the data link guidance and navigation information to the pilot which could then be presented in much the same manner as conventional navigation information. The primary objective of this study was to assess the feasibility and acceptability of using 4-sec and 12-sec information updating to drive conventional cockpit-navigation-instrument formats for path-tracking guidance. A flight test, consisting of 19 tracking tasks, was conducted and, through the use of pilot questionnaires and performance data, the following results were obtained. From a performance standpoint, the 4-sec and 12-sec updating led to a slight degradation in path-tracking performance, relative to continuous updating. From the pilot's viewpoint, the 12-sec data interval was suitable for long path segments (greater than 2 min of flight time), but it was difficult to use on shorter segments because of higher work load and insufficient stabilization time. Overall, it was determined that the utilization of noncontinuous data for navigation was both feasible and acceptable for the prescribed task.

  16. Care Planning for Prostate Cancer Patients on Active Surveillance

    DTIC Science & Technology

    2016-10-01

    intervention (PCPEP) for prostate cancer patients on active surveillance ( Study Specific Aim 1). As part of the adoption process, we will: (Aim 1a...evaluate the acceptability and feasibility of the program with prostate cancer patients on active surveillance in a small pilot study ( Study Specific...to a poster depicting the study finding on “Treatment 4 Decision-making and Adherence to Active Surveillance in Prostate Cancer Patients” presented

  17. Depression training in nursing homes: lessons learned from a pilot study.

    PubMed

    Smith, Marianne; Stolder, Mary Ellen; Jaggers, Benjamin; Liu, Megan Fang; Haedtke, Chris

    2013-02-01

    Late-life depression is common among nursing home residents, but often is not addressed by nurses. Using a self-directed CD-based depression training program, this pilot study used mixed methods to assess feasibility issues, determine nurse perceptions of training, and evaluate depression-related outcomes among residents in usual care and training conditions. Of 58 nurses enrolled, 24 completed the training and gave it high ratings. Outcomes for 50 residents include statistically significant reductions in depression severity over time (p < 0.001) among all groups. Depression training is an important vehicle to improve depression recognition and daily nursing care, but diverse factors must be addressed to assure optimal outcomes.

  18. Depression Training in Nursing Homes: Lessons Learned from a Pilot Study

    PubMed Central

    Smith, Marianne; Stolder, Mary Ellen; Jaggers, Benjamin; Liu, Megan; Haedke, Chris

    2014-01-01

    Late-life depression is common among nursing home residents, but often is not addressed by nurses. Using a self-directed, CD-based depression training program, this pilot study used mixed methods to assess feasibility issues, determine nurse perceptions of training, and evaluate depression-related outcomes among residents in usual care and training conditions. Of 58 nurses enrolled, 24 completed the training and gave it high ratings. Outcomes for 50 residents include statistically significant reductions in depression severity over time (p<0.001) among all groups. Depression training is an important vehicle to improve depression recognition and daily nursing care, but diverse factors must be addressed to assure optimal outcomes. PMID:23369120

  19. Pacing, Conventional Physical Activity and Active Video Games to Increase Physical Activity for Adults with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Protocol for a Pilot Randomized Controlled Trial

    PubMed Central

    Smith, Ashleigh E; Davison, Kade

    2017-01-01

    Background Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a serious illness of biological origin characterized by profound physical and cognitive exhaustion and postexertion malaise. Pacing is a common strategy used to manage available energy and complete activities of daily living; yet little research has investigated this as a strategy to increase physical activity levels. Typically, people living with ME/CFS are faced by unique barriers to physical activity participation and are less physically active than healthy peers. As such they are at increased risk of physical inactivity–related health consequences. Active video games may be a feasible and acceptable avenue to deliver physical activity intervention by overcoming many of the reported barriers to participation. Objective The primary objective of this pilot study is to determine the feasibility and acceptability of active video games to increase physical activity levels of people with ME/CFS. The secondary aims are to explore the preliminary effectiveness of pacing and active video gaming to pacing alone and pacing plus conventional physical activity to increase the physical activity levels of adults with ME/CFS and explore the relationship between physical activity and cumulative inflammatory load (allostatic load). Methods This study will use a mixed method design, with a 3-arm pilot randomized controlled trial, exit interviews, and collection of feasibility and process data. A total of 30 adults with ME/CFS will be randomized to receive either (1) pacing, (2) pacing and conventional physical activity, or (3) pacing and active video gaming. The intervention duration will be 6 months, and participants will be followed up for 6 months postintervention completion. The intervention will be conducted in the participant’s home, and activity intensity will be determined by continuously monitored heart rate and ratings of perceived exertion. Feasibility and acceptability and process data will be collected during and at the end of the intervention. Health-related outcomes (eg, physical activity, blood samples, quality of life, and functioning) will be collected at baseline, end of intervention, and 6 months after intervention completion. Results This protocol was developed after 6 months of extensive stakeholder and community consultation. Enrollment began in January 2017; as of publication, 12 participants were enrolled. Baseline testing is scheduled to commence in mid-2017. Conclusions This pilot study will provide essential feasibility and acceptability data which will guide the use of active video games for people with ME/CFS to increase their physical activity levels. Physical activity promotion in this clinical population has been poorly and under-researched, and any exploration of alternative physical activity options for this population is much needed. Trial Registration Australia New Zealand Clinical Trials Registry: ACTRN12616000285459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370224 (Archived by WebCite at http://www.webcitation.org/6qgOLhWWf) PMID:28765100

  20. Novel use of a flowable collagen-glycosaminoglycan matrix (Integra™ Flowable Wound Matrix) combined with percutaneous cannula scar tissue release in treatment of post-burn malfunction of the hand--A preliminary 6 month follow-up.

    PubMed

    Hirche, C; Senghaas, A; Fischer, S; Hollenbeck, S T; Kremer, T; Kneser, U

    2016-02-01

    Long-term function following severe burns to the hand may be poor secondary to scar adhesions to the underlying tendons, webspaces, and joints. In this pilot study, we report the feasibility of applying a pasty dermal matrix combined with percutaneous cannula teno- and adhesiolysis. In this 6 month follow-up pilot study, we included eight hands in five patients with hand burns undergoing minimal-invasive, percutaneous cannula adhesiolysis and injection of INTEGRA™ Flowable Wound Matrix for a pilot study of this new concept. The flowable collagen-glycosaminoglycan wound matrix (FCGWM) was applied with a buttoned 2mm cannula to induce formation of a neo-gliding plane. Post treatment follow-up was performed to assess active range of motion (AROM), grip strength, Disabilities of the Arm, Shoulder and Hand (DASH) score, Vancouver Scar Scale (VSS) and quality of life Short-Form (SF)-36 questionnaire. No complications were detected associated with the treatment of FCGWM injection. The mean improvement (AROM) at 6 months was 30.6° for digits 2-5. The improvement in the DASH score was a mean of 9 points out of 100. The VSS improved by a mean of 2 points out of 14. The study demonstrates the feasibility and safety of percutaneous FCGWM for dermal augmentation after burn. Results from this pilot study show improvements in AROM for digits 2-5, functional scores from the patient's perspective (DASH) and scar quality (VSS). The flowable form of established INTEGRA™ wound matrix offers the advantage of minimal-invasive injection after scar release in the post-burned hand with a reduction in the risk of postsurgical re-scarring. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  1. The Women's Recovery Group Study: a Stage I trial of women-focused group therapy for substance use disorders versus mixed-gender group drug counseling.

    PubMed

    Greenfield, Shelly F; Trucco, Elisa M; McHugh, R Kathryn; Lincoln, Melissa; Gallop, Robert J

    2007-09-06

    The aim of this Stage I Behavioral Development Trial was to develop a manual-based 12-session Women's Recovery Group (WRG) and to pilot test this new treatment in a randomized controlled trial against a mixed-gender Group Drug Counseling (GDC), an effective manual-based treatment for substance use disorders. After initial manual development, two pre-pilot groups of WRG were conducted to determine feasibility and initial acceptability of the treatment among subjects and therapists. In the pilot stage, women were randomized to either WRG or GDC. No significant differences in substance use outcomes were found between WRG and GDC during the 12-week group treatment. However, during the 6-month post-treatment follow-up, WRG members demonstrated a pattern of continued reductions in substance use while GDC women did not. In addition, pilot WRG women with alcohol dependence had significantly greater reductions in average drinks/drinking day than GDC women 6 months post-treatment (p<.03, effect size=0.81). While satisfaction with both groups was high, women were significantly more satisfied with WRG than GDC (p<.009, effect size=1.11). In this study, the newly developed 12-session women-focused WRG was feasible with high satisfaction among participants. It was equally effective as mixed-gender GDC in reducing substance use during the 12-week in-treatment phase, but demonstrated significantly greater improvement in reductions in drug and alcohol use over the post-treatment follow-up phase compared with GDC. A women-focused single-gender group treatment may enhance longer-term clinical outcomes among women with substance use disorders.

  2. A Pilot Test of the Additive Benefits of Physical Exercise to CBT for OCD.

    PubMed

    Rector, Neil A; Richter, Margaret A; Lerman, Bethany; Regev, Rotem

    2015-01-01

    The majority of "responders" to first-line cognitive-behavioural therapy (CBT) and pharmacological treatments for obsessive-compulsive disorder (OCD) are left with residual symptoms that are clinically relevant and disabling. Therefore, there is pressing need for widely accessible efficacious alternative and/or adjunctive treatments for OCD. Accumulating evidence suggests that physical exercise may be one such intervention in the mood and anxiety disorders broadly, although we are aware of only two positive small-scale pilot studies that have tested its clinical benefits in OCD. This pilot study aimed to test the feasibility and preliminary efficacy of adding a structured physical exercise programme to CBT for OCD. A standard CBT group was delivered concurrently with a 12-week customized exercise programme to 11 participants. The exercise regimen was individualized for each participant based on peak heart rate measured using an incremental maximal exercise test. Reports of exercise adherence across the 12-week regimen exceeded 80%. A paired-samples t-test indicated very large treatment effects in Yale-Brown Obsessive-Compulsive Scale scores from pre- to post-treatment in CBT group cohorts led by expert CBT OCD specialists (d = 2.55) and junior CBT clinician non-OCD specialists (d = 2.12). These treatment effects are very large and exceed effects typically observed with individual and group-based CBT for OCD based on leading meta-analytic reviews, as well as previously obtained treatment effects for CBT using the same recruitment protocol without exercise. As such, this pilot work demonstrates the feasibility and significant potential clinical utility of a 12-week aerobic exercise programme delivered in conjunction with CBT for OCD.

  3. Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial

    PubMed Central

    2014-01-01

    Background Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction. These difficulties can lead to anxiety, depression and reduced quality of life. Many partners also experience psychological distress. An additional impact can be on the couple relationship, with changes to intimacy, and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation. The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention. Methods/Design The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners. Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles. Sixty-eight couples will be randomised to receive either the intervention or standard care (comprising usual follow-up hospital appointments). A pre-test, post-test design will be used to test the feasibility of the intervention (baseline, end of intervention and six-month follow-up) and its acceptability to couples and healthcare professionals (qualitative interviews). Both individual and relational outcome measures will assess sexual functioning, anxiety and depression, couple relationship, use of health services and erectile dysfunction medication/technologies. An economic analysis will estimate population costs of the intervention, compared to usual care, using simple modelling to evaluate the affordability of the intervention. Discussion Given the increasing incidence and survival of post-operative men with prostate cancer, it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples. The study will provide evidence about the components of a couple-based intervention, its acceptability to patients and healthcare professionals, and its influence on sexual and relational functioning. Data from this study will be used to calculate sample sizes required for any definitive trial. Trial registration ClinicalTrials.gov Identifier: NCT01842438. Registration date: 24 April 2013; Randomisation of first patient: 13 May 2013 PMID:24886676

  4. 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

  5. A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

    PubMed Central

    2012-01-01

    Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

  6. The value of a pilot study in breast-feeding research.

    PubMed

    Carfoot, Sue; Williamson, Paula R; Dickson, Rumona

    2004-06-01

    To test the integrity of a protocol for a randomised controlled trial (RCT) to examine the effectiveness of skin-to-skin care compared to routine care on the initiation and duration of breast feeding and to provide data to be used in the power calculation for a proposed trial. Randomised pilot study. Warrington Hospital, Cheshire, UK. Women at 36 weeks' gestation with healthy singleton pregnancies, who intended to breast feed, who had 'booked' for care at Warrington Hospital and had given informed consent to participate. Twenty-eight women were randomised in the pilot study. Women were randomly allocated to receive either routine or skin-to-skin care following birth. The first breast feed was assessed using the Breast-feeding Assessment Tool (BAT). Mothers were followed up at discharge from hospital and again at four months to provide details of duration of breast feeding. 66 women were approached to participate in the trial and 44 consented (67% consent rate). Twenty-eight women were randomised in the study and 26 breast feeds were observed (93%). The pilot study identified procedural changes that were required in the design of the main study, provided an estimate of recruitment rates and confirmed the previously calculated sample size. The pilot study demonstrated that a large RCT of skin-to-skin versus routine care was feasible. This is an example of how a pilot study has the ability to identify unforeseen challenges in the conduct of the trial as well as allowing necessary changes to be made to the design that will increase the quality of the subsequent research.

  7. Feasibility, Acceptability, and Impact of a Web-based Gratitude Exercise among Individuals in Outpatient Treatment for Alcohol Use Disorder

    PubMed Central

    Krentzman, Amy R.; Mannella, Kristin A.; Hassett, Afton L.; Barnett, Nancy P.; Cranford, James A.; Brower, Kirk J.; Higgins, Margaret M.; Meyer, Piper S.

    2015-01-01

    This mixed-methods pilot study examined the feasibility, acceptability, and impact of a web-based gratitude exercise (the ‘Three Good Things’ exercise (TGT)) among 23 adults in outpatient treatment for alcohol use disorder (AUD). Participants were randomized to TGT or a placebo condition. The intervention was feasible with high rates of completion. Participants found TGT acceptable and welcomed the structure of daily emails; however, they found it difficult at times and discontinued TGT when the study ended. Participants associated TGT with gratitude, although there were no observed changes in grateful disposition over time. TGT had a significant effect on decreasing negative affect and increasing unactivated (e.g., feeling calm, at ease) positive affect, although there were no differences between groups at the 8 week follow up. Qualitative results converged on quantitative findings that TGT was convenient, feasible, and acceptable, and additionally suggested that TGT was beneficial for engendering positive cognitions and reinforcing recovery. PMID:27076837

  8. 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

  9. Increasing fruit and vegetable consumption and offerings to Somali children: the FAV-S pilot study.

    PubMed

    Hearst, Mary O; Kehm, Rebecca; Sherman, Shelley; Lechner, Kate E

    2014-04-01

    To determine the feasibility, acceptability, and impact of a parent-centered intervention to increase fruit and vegetable servings and consumption among Somali children living in the United States. Pilot intervention that included Somali community health workers who organized groups of 3 or 4 women to participate in 2 initial educational sessions, including topics of health and nutrition, serving size, and label reading. A third session taught interactive cooking to increase skills in preparing fruits and vegetables and increasing the numbers of vegetables included in traditional Somali dishes. The final session was a trip to the grocery store to identify fruits and vegetables, determine ripeness, and explore frozen and canned fruits and vegetables for halal, low-sodium, and low-sugar products. Surveys were completed pre- and post-intervention. Study participants were recruited from a large housing complex in Minneapolis, Minnesota, with a high population of Somali immigrants. Somali women (N = 25) with children aged 3 to 10 years. The intervention was feasible and well accepted. In comparing pre- and post-intervention surveys, mothers reported providing their children significantly more frequent servings of fruits and vegetables at dinner, lunch, snack, and breakfast (vegetable only). There was a statistically significant increase in parent-reported intake of fruits and vegetables for themselves and their children. The FAV-S study was feasible and acceptable, and it demonstrated potential for increasing fruit and vegetable servings and consumption among Somali children. A larger-scale randomized trial is needed to assess the impact of this intervention.

  10. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents

    PubMed Central

    Bluth, Karen; Gaylord, Susan A.; Campo, Rebecca A.; Mullarkey, Michael C.; Hobbs, Lorraine

    2015-01-01

    The aims of this mixed-method pilot study were to determine the feasibility, acceptability, and preliminary psychosocial outcomes of “Making Friends with Yourself: A Mindful Self-Compassion Program for Teens” (MFY), an adaptation of the adult Mindful Self-Compassion program. Thirty-four students age 14–17 enrolled in this waitlist controlled crossover study. Participants were randomized to either the waitlist or intervention group and administered online surveys at baseline, after the first cohort participated in the intervention, and after the waitlist crossovers participated in the intervention. Attendance and retention data were collected to determine feasibility, and audiorecordings of the 6-week class were analyzed to determine acceptability of the program. Findings indicated that MFY is a feasible and acceptable program for adolescents. Compared to the waitlist control, the intervention group had significantly greater self-compassion and life satisfaction and significantly lower depression than the waitlist control, with trends for greater mindfulness, greater social connectedness and lower anxiety. When waitlist crossovers results were combined with that of the first intervention group, findings indicated significantly greater mindfulness and self-compassion, and significantly less anxiety, depression, perceived stress and negative affect post-intervention. Additionally, regression results demonstrated that self-compassion and mindfulness predicted decreases in anxiety, depression, perceived stress, and increases in life satisfaction post-intervention. MFY shows promise as a program to increase psychosocial wellbeing in adolescents through increasing mindfulness and self-compassion. Further testing is needed to substantiate the findings. PMID:27110301

  11. Computerized cognitive training in survivors of childhood cancer: a pilot study.

    PubMed

    Hardy, Kristina K; Willard, Victoria W; Bonner, Melanie J

    2011-01-01

    The objective of the current study was to pilot a computerized cognitive training program, Captain's Log, in a small sample of survivors of childhood cancer. A total of 9 survivors of acute lymphoblastic leukemia and brain tumors with attention and working memory deficits were enrolled in a home-based 12-week cognitive training program. Survivors returned for follow-up assessments postintervention and 3 months later. The intervention was associated with good feasibility and acceptability. Participants exhibited significant increases in working memory and decreases in parent-rated attention problems following the intervention. Findings indicate that home-based, computerized cognitive intervention is a promising intervention for survivors with cognitive late effects; however, further study is warranted with a larger sample.

  12. Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials.

    PubMed

    Cooper, Cindy L; Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

    2018-04-01

    External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland-Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was -4.4% with limits of agreement of -37.1% to 28.2%. Limits of agreement for randomisation rates were -47.8% to 77.5%. Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate.

  13. Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

    PubMed Central

    Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

    2018-01-01

    Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

  14. Task rotation in an underground coal mine: A pilot study.

    PubMed

    Jones, Olivia F; James, Carole L

    2018-01-01

    Task rotation is used to decrease the risk of workplace injuries and improve work satisfaction. To investigate the feasibility, benefits and challenges of implementing a task rotation schedule within an underground coalmine in NSW, Australia. A mixed method case control pilot study with the development and implementation of a task rotation schedule for 6 months with two work crews. A questionnaire including The Nordic Musculoskeletal Questionnaire, The Need for Recovery after Work Scale, and The Australian WHOQOL- BREF Australian Edition was used to survey workers at baseline, 3 and 6 months. A focus group was completed with the intervention crew and management at the completion of the study. In total, twenty-seven participants completed the survey. Significant improvements in the psychological and environmental domains of the WHOQOL-BREF questionnaire were found in the intervention crew. Musculoskeletal pain was highest in the elbow, lower back and knee, and fatigue scores improved, across both groups. The intervention crew felt 'mentally fresher', 'didn't do the same task twice in a row', and 'had more task variety which made the shift go quickly'. Task rotation was positively regarded, with psychological benefits identified. Three rotations during a 9-hour shift were feasible and practical in this environment.

  15. Feasibility and tolerability of whole‐body, low‐intensity vibration and its effects on muscle function and bone in patients with dystrophinopathies: a pilot study

    PubMed Central

    Polgreen, Lynda E.; Grames, Molly; Lowe, Dawn A.; Hodges, James S.; Karachunski, Peter

    2017-01-01

    ABSTRACT Introduction Dystrophinopathies are X‐linked muscle degenerative disorders that result in progressive muscle weakness complicated by bone loss. This study's goal was to evaluate feasibility and tolerability of whole‐body, low‐intensity vibration (WBLIV) and its potential effects on muscle and bone in patients with Duchenne or Becker muscular dystrophy. Methods This 12‐month pilot study included 5 patients (age 5.9–21.7 years) who used a low‐intensity Marodyne LivMD plate vibrating at 30–90 Hz for 10 min/day for the first 6 months. Timed motor function tests, myometry, and peripheral quantitative computed tomography were performed at baseline and at 6 and 12 months. Results Motor function and lower extremity muscle strength remained either unchanged or improved during the intervention phase, followed by deterioration after WBLIV discontinuation. Indices of bone density and geometry remained stable in the tibia. Conclusions WBLIV was well tolerated and appeared to have a stabilizing effect on lower extremity muscle function and bone measures. Muscle Nerve 55: 875–883, 2017 PMID:27718512

  16. A feasibility study on the bioconversion of CO2 and H2 to biomethane by gas sparging through polymeric membranes.

    PubMed

    Díaz, I; Pérez, C; Alfaro, N; Fdz-Polanco, F

    2015-06-01

    In this study, the potential of a pilot hollow-fiber membrane bioreactor for the conversion of H2 and CO2 to CH4 was evaluated. The system transformed 95% of H2 and CO2 fed at a maximum loading rate of 40.2 [Formula: see text] and produced 0.22m(3) of CH4 per m(3) of H2 fed at thermophilic conditions. H2 mass transfer to the liquid phase was identified as the limiting step for the conversion, and kLa values of 430h(-1) were reached in the bioreactor by sparging gas through the membrane module. A simulation showed that the bioreactor could upgrade biogas at a rate of 25m(3)/mR(3)d, increasing the CH4 concentration from 60 to 95%v. This proof-of-concept study verified that gas sparging through a membrane module can efficiently transfer H2 from gas to liquid phase and that the conversion of H2 and CO2 to biomethane is feasible on a pilot scale at noteworthy load rates. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Solar photocatalytic degradation of some hazardous water-soluble pesticides at pilot-plant scale.

    PubMed

    Oller, I; Gernjak, W; Maldonado, M I; Pérez-Estrada, L A; Sánchez-Pérez, J A; Malato, S

    2006-12-01

    The technical feasibility and performance of photocatalytic degradation of six water-soluble pesticides (cymoxanil, methomyl, oxamyl, dimethoate, pyrimethanil and telone) have been studied at pilot-plant scale in two well-defined systems which are of special interest because natural solar UV light can be used: heterogeneous photocatalysis with titanium dioxide and homogeneous photocatalysis by photo-Fenton. TiO(2) photocatalysis tests were performed in a 35L solar pilot plant with three Compound Parabolic Collectors (CPCs) under natural illumination and a 75L solar pilot plant with four CPC units was used for homogeneous photocatalysis tests. The initial pesticide concentration studied was 50 mg L(-1) and the catalyst concentrations employed were 200 mg L(-1) of TiO(2) and 20 mg L(-1) of iron. Both toxicity (Vibrio fischeri, Biofix) and biodegradability (Zahn-Wellens test) of the initial pesticide solutions were also measured. Total disappearance of the parent compounds and nearly complete mineralization were attained with all pesticides tested. Treatment time, hydrogen peroxide consumption and release of heteroatoms are discussed.

  18. Investigating the Feasibility and Utility of Bedside Balance Technology Acutely After Pediatric Concussion: A Pilot Study.

    PubMed

    Rhine, Tara D; Byczkowski, Terri L; Clark, Ross A; Babcock, Lynn

    2016-05-01

    To examine postural instability in children acutely after concussion, using the Wii Balance Board (WBB). We hypothesized that children with traumatic brain injury would have significantly worse balance relative to children without brain injury. Prospective case-control pilot study. Emergency department of a tertiary urban pediatric hospital. Cases were a convenience sample 11-16 years old who presented within 6 hours of sustaining concussion. Two controls, matched on gender, height, and age, were enrolled for each case that completed study procedures. Controls were children who presented for a minor complaint that was unlikely to affect balance. Not applicable. The participant's postural sway expressed as the displacement in centimeters of the center of pressure during a timed balance task. Balance testing was performed using 4 stances (single or double limb, eyes open or closed). Three of the 17 (17.6%) cases were too dizzy to complete testing. One stance, double limbs eyes open, was significantly higher in cases versus controls (85.6 vs 64.3 cm, P = 0.04). A simple test on the WBB consisting of a 2-legged standing balance task with eyes open discriminated children with concussion from non-head-injured controls. The low cost and feasibility of this device make it a potentially viable tool for assessing postural stability in children with concussion for both longitudinal research studies and clinical care. These pilot data suggest that the WBB is an inexpensive tool that can be used on the sideline or in the outpatient setting to objectively identify and quantify postural instability.

  19. A pilot study using children's books to understand caregiver perceptions of parenting practices.

    PubMed

    Bauer, Nerissa S; Hus, Anna M; Sullivan, Paula D; Szczepaniak, Dorota; Carroll, Aaron E; Downs, Stephen M

    2012-06-01

    To conduct a pilot study to test the feasibility and acceptability of using children's books to understand caregiver perceptions of parenting practices around common behavior challenges. A prospective 1-month pilot study was conducted in 3 community-based pediatric clinics serving lower income families living in central Indianapolis. One hundred caregivers of 4- to 7-year-old children presenting for a well-child visit chose 1 of 3 available children's books that dealt with a behavioral concern the caregiver reported having with the child. The book was read aloud to the child in the caregiver's presence by a trained research assistant and given to the families to take home. Outcomes measured were caregiver intent to change their interaction with their child after the book reading, as well as caregiver reports of changes in caregiver-child interactions at 1 month. Reading the book took an average of 3 minutes. Most (71%) caregivers reported intent to change after the book reading; two-thirds (47/71) were able to identify a specific technique or example illustrated in the story. One month later, all caregivers remembered receiving the book, and 91% reported reading the book to their child and/or sharing it with someone else. Three-fourths of caregivers (60/80) reported a change in caregiver-child interactions. The distribution of children's books with positive parenting content is a feasible and promising tool, and further study is warranted to see whether these books can serve as an effective brief intervention in pediatric primary care practice.

  20. Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

    PubMed

    Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

    2016-04-01

    The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

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