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Sample records for health study protocol

  1. [Colombia 2015 National Mental Health Survey. Study Protocol].

    PubMed

    Gómez-Restrepo, Carlos; de Santacruz, Cecilia; Rodriguez, María Nelcy; Rodriguez, Viviana; Tamayo Martínez, Nathalie; Matallana, Diana; Gonzalez, Lina M

    2016-12-01

    The 2015 National Mental Health Survey (NMHS) is the fourth mental survey conducted in Colombia, and is part of the National System of Surveys and Population Studies for health. A narrative description is used to explain the background, references, the preparation, and characteristics of the 2015 NMHS. The 2015 NMHS and its protocol emerge from the requirements that support the national and international policies related to mental health. Together with the Ministry of Health and Social Protection, the objectives, the collection tools, the sample, and the operational plan are defined. The main objective was to obtain updated information about the mental health, mental problems and disorders, accessibility to health services, and an evaluation of health conditions. Participants were inhabitants from both urban and rural areas, over 7 years old, and in whom the comprehension of social determinants and equity were privileged. An observational cross-sectional design with national, regional and age group representativity, was used. The age groups selected were 7-11, 12-17, and over 18 years old. The regions considered were Central, Orient, Atlantic, Pacific, and Bogota. The calculated sample had a minimum of 12,080 and a maximum of 14,496 participants. A brief summary of the protocol of the 2015 NMHS is presented. The full document with all the collection tools can be consulted on the Health Ministry webpage. Copyright © 2016. Publicado por Elsevier España.

  2. Health Auctions: a Valuation Experiment (HAVE) study protocol

    PubMed Central

    Kularatna, Sanjeewa; Petrie, Dennis; Scuffham, Paul A; Byrnes, Joshua

    2016-01-01

    Introduction Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. Methods and analysis A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 ‘best’ health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. Ethics and dissemination Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences. PMID:27056589

  3. Health Auctions: a Valuation Experiment (HAVE) study protocol.

    PubMed

    Kularatna, Sanjeewa; Petrie, Dennis; Scuffham, Paul A; Byrnes, Joshua

    2016-04-07

    Quality-adjusted life years are derived using health state utility weights which adjust for the relative value of living in each health state compared with living in perfect health. Various techniques are used to estimate health state utility weights including time-trade-off and standard gamble. These methods have exhibited limitations in terms of complexity, validity and reliability. A new composite approach using experimental auctions to value health states is introduced in this protocol. A pilot study will test the feasibility and validity of using experimental auctions to value health states in monetary terms. A convenient sample (n=150) from a population of university staff and students will be invited to participate in 30 auction sets with a group of 5 people in each set. The 9 health states auctioned in each auction set will come from the commonly used EQ-5D-3L instrument. At most participants purchase 2 health states, and the participant who acquires the 2 'best' health states on average will keep the amount of money they do not spend in acquiring those health states. The value (highest bid and average bid) of each of the 24 health states will be compared across auctions to test for reliability across auction groups and across auctioneers. A test retest will be conducted for 10% of the sample to assess reliability of responses for health states auctions. Feasibility of conducting experimental auctions to value health states will also be examined. The validity of estimated health states values will be compared with published utility estimates from other methods. This pilot study will explore the feasibility, reliability and validity in using experimental auction for valuing health states. Ethical clearance was obtained from Griffith University ethics committee. The results will be disseminated in peer-reviewed journals and major international conferences. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  4. Study protocol for the Fukushima Health Management Survey.

    PubMed

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy and birth survey. This long

  5. Study Protocol for the Fukushima Health Management Survey

    PubMed Central

    Yasumura, Seiji; Hosoya, Mitsuaki; Yamashita, Shunichi; Kamiya, Kenji; Abe, Masafumi; Akashi, Makoto; Kodama, Kazunori; Ozasa, Kotaro

    2012-01-01

    Background The accidents that occurred at the Fukushima Daiichi Nuclear Power Plant after the Great East Japan Earthquake on 11 March 2011 have resulted in long-term, ongoing anxiety among the residents of Fukushima, Japan. Soon after the disaster, Fukushima Prefecture launched the Fukushima Health Management Survey to investigate long-term low-dose radiation exposure caused by the accident. Fukushima Medical University took the lead in planning and implementing this survey. The primary purposes of this survey are to monitor the long-term health of residents, promote their future well-being, and confirm whether long-term low-dose radiation exposure has health effects. This report describes the rationale and implementation of the Fukushima Health Management Survey. Methods This cohort study enrolled all people living in Fukushima Prefecture after the earthquake and comprises a basic survey and 4 detailed surveys. The basic survey is to estimate levels of external radiation exposure among all 2.05 million residents. It should be noted that internal radiation levels were estimated by Fukushima Prefecture using whole-body counters. The detailed surveys comprise a thyroid ultrasound examination for all Fukushima children aged 18 years or younger, a comprehensive health check for all residents from the evacuation zones, an assessment of mental health and lifestyles of all residents from the evacuation zones, and recording of all pregnancies and births among all women in the prefecture who were pregnant on 11 March. All data have been entered into a database and will be used to support the residents and analyze the health effects of radiation. Conclusions The low response rate (<30%) to the basic survey complicates the estimation of health effects. There have been no cases of malignancy to date among 38 114 children who received thyroid ultrasound examinations. The importance of mental health care was revealed by the mental health and lifestyle survey and the pregnancy

  6. Study protocol of the Center for Oral Health Research in Appalachia (COHRA) etiology study.

    PubMed

    Polk, Deborah E; Weyant, Robert J; Crout, Richard J; McNeil, Daniel W; Tarter, Ralph E; Thomas, John G; Marazita, Mary L

    2008-06-03

    People in Appalachia experience some of the worst oral health in the United States. To develop effective intervention and prevention strategies in Appalachia, we must understand the complex relationships among the contributing factors and how they affect the etiology of oral diseases. To date, no such comprehensive analysis has been conducted. This report summarizes the characteristics of the sample and describes the protocol of a study determining contributions of individual, family, and community factors to oral diseases in Appalachian children and their relatives. Families participated in a comprehensive assessment protocol involving interviews, questionnaires, a clinical oral health assessment, a microbiological assessment, and collection of DNA. The design of the study is cross-sectional. Due to its multilevel design and large, family-based sample, this study has the potential to greatly advance our understanding of factors that contribute to oral health in Appalachian children.

  7. Effectiveness of the Health Complex Model in Iranian primary health care reform: the study protocol

    PubMed Central

    Tabrizi, Jafar Sadegh; Farahbakhsh, Mostafa; Sadeghi-Bazargani, Homayoun; Hassanzadeh, Roya; Zakeri, Akram; Abedi, Leili

    2016-01-01

    Background Iranian traditional primary health care (PHC) system, although proven to be successful in some areas in rural populations, suffers major pitfalls in providing PHC services in urban areas especially the slum urban areas. The new government of Iran announced a health reform movement including the health reform in PHC system of Iran. The Health Complex Model (HCM) was chosen as the preferred health reform model for this purpose. Methods This paper aims to report a detailed research protocol for the assessment of the effectiveness of the HCM in Iran. An adaptive controlled design is being used in this research. The study is planned to measure multiple endpoints at the baseline and 2 years after the intervention. The assessments will be done both in a population covered by the HCM, as intervention area, and in control populations covered by the traditional health care system as the control area. Discussion Assessing the effectiveness of the HCM, as the Iranian PHC reform initiative, could help health system policy makers for future decisions on its continuation or modification. PMID:27784996

  8. EVA Human Health and Performance Benchmarking Study Overview and Development of a Microgravity Protocol

    NASA Technical Reports Server (NTRS)

    Norcross, Jason; Jarvis, Sarah; Bekdash, Omar; Cupples, Scott; Abercromby, Andrew

    2017-01-01

    The primary objective of this study is to develop a protocol to reliably characterize human health and performance metrics for individuals working inside various EVA suits under realistic spaceflight conditions. Expected results and methodologies developed during this study will provide the baseline benchmarking data and protocols with which future EVA suits and suit configurations (e.g., varied pressure, mass, center of gravity [CG]) and different test subject populations (e.g., deconditioned crewmembers) may be reliably assessed and compared. Results may also be used, in conjunction with subsequent testing, to inform fitness-for-duty standards, as well as design requirements and operations concepts for future EVA suits and other exploration systems.

  9. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol.

    PubMed

    Furberg, Robert D; Ortiz, Alexa M; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-06-27

    Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care-related infections were reviewed to develop the infection control protocol to support tablet maintenance. This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings.

  10. Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies.

    PubMed

    Zhou, Leming; Bao, Jie; Parmanto, Bambang

    2017-08-01

    Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as "mobile app" and "usability." Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps.

  11. Systematic Review Protocol to Assess the Effectiveness of Usability Questionnaires in mHealth App Studies

    PubMed Central

    Bao, Jie; Parmanto, Bambang

    2017-01-01

    Background Usability questionnaires have a wide use in mobile health (mHealth) app usability studies. However, no systematic review has been conducted for assessing the effectiveness of these questionnaires. Objective This paper describes a protocol for conducting a systematic review of published questionnaire-based mHealth app usability studies. Methods In this systematic review, we will select recently published (2008-2017) articles from peer-reviewed journals and conferences that describe mHealth app usability studies and implement at least one usability questionnaire. The search strategy will include terms such as “mobile app” and “usability.” Multiple databases such as PubMed, CINAHL, IEEE Xplore, ACM Digital Library, and INSPEC will be searched. There will be 2 independent reviewers in charge of screening titles and abstracts as well as determining those articles that should be included for a full-text review. The third reviewer will act as a mediator between the other 2 reviewers. Moreover, a data extraction form will be created and used during the full article data analysis. Notably, the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines will be followed in reporting this protocol. Results A preliminary search produced 1271 articles, 40 of which are duplicate records. The inclusion-exclusion criteria are being strictly followed in performing the ongoing study selection. Conclusions Usability questionnaires are an important tool in mHealth app usability studies. This review will summarize the usability questionnaires used in published research articles while assessing the efficacy of these questionnaires in determining the usability of mHealth apps. PMID:28765101

  12. Health risk behaviours amongst school adolescents: protocol for a mixed methods study.

    PubMed

    El Achhab, Youness; El Ammari, Abdelghaffar; El Kazdouh, Hicham; Najdi, Adil; Berraho, Mohamed; Tachfouti, Nabil; Lamri, Driss; El Fakir, Samira; Nejjari, Chakib

    2016-11-29

    Determining risky behaviours of adolescents provides valuable information for designing appropriate intervention programmes for advancing adolescent's health. However, these behaviours are not fully addressed by researchers in a comprehensive approach. We report the protocol of a mixed methods study designed to investigate the health risk behaviours of Moroccan adolescents with the goal of identifying suitable strategies to address their health concerns. We used a sequential two-phase explanatory mixed method study design. The approach begins with the collection of quantitative data, followed by the collection of qualitative data to explain and enrich the quantitative findings. In the first phase, the global school-based student health survey (GSHS) was administered to 800 students who were between 14 and 19 years of age. The second phase engaged adolescents, parents and teachers in focus groups and assessed education documents to explore the level of coverage of health education in the programme learnt in the middle school. To obtain opinions about strategies to reduce Moroccan adolescents' health risk behaviours, a nominal group technique will be used. The findings of this mixed methods sequential explanatory study provide insights into the risk behaviours that need to be considered if intervention programmes and preventive strategies are to be designed to promote adolescent's health in the Moroccan school.

  13. Supporting Tablet Configuration, Tracking, and Infection Control Practices in Digital Health Interventions: Study Protocol

    PubMed Central

    Furberg, Robert D; Zulkiewicz, Brittany A; Hudson, Jordan P; Taylor, Olivia M; Lewis, Megan A

    2016-01-01

    Background Tablet-based health care interventions have the potential to encourage patient care in a timelier manner, allow physicians convenient access to patient records, and provide an improved method for patient education. However, along with the continued adoption of tablet technologies, there is a concomitant need to develop protocols focusing on the configuration, management, and maintenance of these devices within the health care setting to support the conduct of clinical research. Objective Develop three protocols to support tablet configuration, tablet management, and tablet maintenance. Methods The Configurator software, Tile technology, and current infection control recommendations were employed to develop three distinct protocols for tablet-based digital health interventions. Configurator is a mobile device management software specifically for iPhone operating system (iOS) devices. The capabilities and current applications of Configurator were reviewed and used to develop the protocol to support device configuration. Tile is a tracking tag associated with a free mobile app available for iOS and Android devices. The features associated with Tile were evaluated and used to develop the Tile protocol to support tablet management. Furthermore, current recommendations on preventing health care–related infections were reviewed to develop the infection control protocol to support tablet maintenance. Results This article provides three protocols: the Configurator protocol, the Tile protocol, and the infection control protocol. Conclusions These protocols can help to ensure consistent implementation of tablet-based interventions, enhance fidelity when employing tablets for research purposes, and serve as a guide for tablet deployments within clinical settings. PMID:27350013

  14. Exploring Workarounds Related to Electronic Health Record System Usage: A Study Protocol

    PubMed Central

    Koelemeijer, Kitty; Jaspers, Monique

    2017-01-01

    Background Health care providers resort to informal temporary practices known as workarounds for handling exceptions to normal workflow that are unintentionally imposed by electronic health record (EHR) systems. Although workarounds may seem favorable at first sight, they are generally suboptimal and may jeopardize patient safety, effectiveness, and efficiency of care. Identifying workarounds and understanding their motivations, scope, and impact is pivotal to support the design of user-friendly EHRs and achieve closer alignment between EHRs and work contexts. Objective We propose a study protocol to identify EHR workarounds and subsequently determine their scope and impact on health care providers’ workflows, patient safety, effectiveness, and efficiency of care. First, knowing whether a workaround solely affects the health care provider who devised it, or whether its effects extends beyond the EHR user to the work context of other health care providers, is key to accurately assessing its degree of influence on the overall patient care workflow. Second, knowing whether the consequence of an EHR workaround is favorable or unfavorable provides insights into how to address EHR-related safety, effectiveness, and efficiency concerns. Knowledge of both perspectives can provide input on optimizing EHR designs. Methods In the study, a combination of direct observations, semistructured interviews, and qualitative coding techniques will be used to identify, analyze, and classify EHR workarounds. The research project will be conducted within three distinct pediatric care processes and settings at a large university hospital. Results Data was collected using the described approach from January 2016 to March 2017. Data analysis is underway and is expected to be completed in May 2017. We aim to report the results of this study in a follow-up publication. Conclusions This study protocol provides a grounded framework to explore EHR workarounds from a holistic and integral

  15. Exploring Workarounds Related to Electronic Health Record System Usage: A Study Protocol.

    PubMed

    Blijleven, Vincent; Koelemeijer, Kitty; Jaspers, Monique

    2017-04-28

    Health care providers resort to informal temporary practices known as workarounds for handling exceptions to normal workflow that are unintentionally imposed by electronic health record (EHR) systems. Although workarounds may seem favorable at first sight, they are generally suboptimal and may jeopardize patient safety, effectiveness, and efficiency of care. Identifying workarounds and understanding their motivations, scope, and impact is pivotal to support the design of user-friendly EHRs and achieve closer alignment between EHRs and work contexts. We propose a study protocol to identify EHR workarounds and subsequently determine their scope and impact on health care providers' workflows, patient safety, effectiveness, and efficiency of care. First, knowing whether a workaround solely affects the health care provider who devised it, or whether its effects extends beyond the EHR user to the work context of other health care providers, is key to accurately assessing its degree of influence on the overall patient care workflow. Second, knowing whether the consequence of an EHR workaround is favorable or unfavorable provides insights into how to address EHR-related safety, effectiveness, and efficiency concerns. Knowledge of both perspectives can provide input on optimizing EHR designs. In the study, a combination of direct observations, semistructured interviews, and qualitative coding techniques will be used to identify, analyze, and classify EHR workarounds. The research project will be conducted within three distinct pediatric care processes and settings at a large university hospital. Data was collected using the described approach from January 2016 to March 2017. Data analysis is underway and is expected to be completed in May 2017. We aim to report the results of this study in a follow-up publication. This study protocol provides a grounded framework to explore EHR workarounds from a holistic and integral perspective. Insights from this study can inform the

  16. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    PubMed Central

    2010-01-01

    Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1) To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2) To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1) To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1) in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2) To conduct patient focus group discussions at each of these (Phase 1) to determine care received. 3) To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2). 4) To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2). 5) To undertake document analysis to appraise

  17. Effect of Iranian Ministry of Health protocols on cesarean section rate: a quasi-experimental study.

    PubMed

    Yavangi, Mahnaz; Sohrabi, Mohammad-Reza; Alishahi Tabriz, Amir

    2013-05-29

    High Cesarean section rate is a major health problem in developing countries. This study was established to evaluate the effectiveness of Iranian Ministry of Health and Medical Education protocols on Cesarean section rate trend. Through a non-concurrent controlled quasi-experimental study, Cesarean section rate in Shohada-e-Tajrish and Taleghani hospitals in Tehran was compared during 2008-2009. Intervention group included 578 participants hospitalized because of premature rupture of membranes, prolonged pregnancy, pre-eclampsia, intra-uterine growth retardation, vaginal bleeding and premature labor in first and second trimester underwent interventions based on MOHME new protocol. On the other hand 594 cases as control group were selected during the same time before the intervention and underwent routine treatments. Descriptive statics, t-test, chi square and univariate analysis were used when appropriate. Basic characteristics in two groups had no statistically significant difference. Cesarean section applied for 360 (67.8%) women in case group and on the other hand, 270 (48.8%) Cesarean sections were done for control group (P<0.001). There was 19 % difference between intervention and control groups. Complication of pregnancies had increased by 6% in intervention group (P<0.001). Mortality rate in the study was zero in both groups. Applying clinical practice guidelines does not guarantee decreasing Cesarean section rate. Providing appropriate service may increase the ability of service providers to find more indications for Cesarean section.

  18. Design, Implementation, and Study Protocol of a Kindergarten-Based Health Promotion Intervention

    PubMed Central

    Wartha, Olivia; Dreyhaupt, Jens; Lämmle, Christine; Friedemann, Eva-Maria; Kelso, Anne; Kutzner, Claire; Hermeling, Lina

    2017-01-01

    Inactivity and an unhealthy diet amongst others have led to an increased prevalence of overweight and obesity even in young children. Since most health behaviours develop during childhood health promotion has to start early. The setting kindergarten has been shown as ideal for such interventions. “Join the Healthy Boat” is a kindergarten-based health promotion programme with a cluster-randomised study focussing on increased physical activity, reduced screen media use, and sugar-sweetened beverages, as well as a higher fruit and vegetable intake. Intervention and materials were developed using Bartholomew's Intervention Mapping approach considering Bandura's social-cognitive theory and Bronfenbrenner's ecological framework for human development. The programme is distributed using a train-the-trainer approach and currently implemented in 618 kindergartens. The effectiveness of this one-year intervention with an intervention and a control group will be examined in 62 kindergartens using standardised protocols, materials, and tools for outcome and process evaluation. A sample of 1021 children and their parents provided consent and participated in the intervention. Results of this study are awaited to give a better understanding of health behaviours in early childhood and to identify strategies for effective health promotion. The current paper describes development and design of the intervention and its implementation and planned evaluation. Trial Registration. The study is registered at the German Clinical Trials Register (DRKS), Freiburg University, Germany, ID: DRKS00010089. PMID:28303253

  19. From policy to practice: implementing frontline community health services for substance dependence--study protocol.

    PubMed

    Gill, Kathryn J; Campbell, Emily; Gauthier, Gail; Xenocostas, Spyridoula; Charney, Dara; Macaulay, Ann C

    2014-08-20

    Substance abuse is a worldwide public health concern. Extensive scientific research has shown that screening and brief interventions for substance use disorders administered in primary care provide substantial benefit at relatively low cost. Frontline health clinicians are well placed to detect and treat patients with substance use disorders. Despite effectiveness shown in research, there are many factors that impact the implementation of these practices in real-world clinical practice. Recently, the Ministry of Health and Social Services in Quebec, Canada, issued two policy documents aimed at introducing screening and early intervention for substance abuse into frontline healthcare clinics in Quebec. The current research protocol was developed in order to study the process of implementation of evidence-based addiction treatment practices at three primary care clinics in Montreal (Phase 1). In addition, the research protocol was designed to examine the efficacy of overall policy implementation, including barriers and facilitators to addictions program development throughout Quebec (Phase 2). Phase 1 will provide an in-depth case study of knowledge translation and implementation. The study protocol will utilize an integrated knowledge translation strategy to build collaborative mechanisms for knowledge exchange between researchers, addiction specialists, and frontline practitioners (guided by the principles of participatory-action research), and directly examine the process of knowledge uptake and barriers to transfer using both qualitative and quantitative methodologies. Evaluation will involve multiple measures, time points and domains; program uptake and effectiveness will be determined by changes in healthcare service delivery, sustainability and outcomes. In Phase 2, qualitative methods will be utilized to examine the contextual facilitators and barriers that frontline organizations face in implementing services for substance dependence. Phase 2 will provide

  20. Protocol for the Women And Their Children's Health (WATCH) study: a cohort of pregnancy and beyond.

    PubMed

    Hure, Alexis J; Collins, Clare E; Giles, Warwick B; Wright, Ian M R; Smith, Roger

    2012-01-01

    The developmental origins of health and disease is a conceptual framework that helps explain the links between our early life exposures and later health outcomes, and is a burgeoning field of research. In this report, we describe the study protocol used in a prospective cohort of women recruited during pregnancy, with postnatal follow-up of the mothers and offspring. The Women And Their Children's Health (WATCH) cohort (n = 180 women) is being conducted at the John Hunter Hospital, Australia (from June 2006). Women attended study visits during pregnancy at 19, 24, 30, and 36 weeks' gestation. Postnatal follow-up of the women and their offspring occurred at 3-month intervals during the first year after birth and annually thereafter, until age 4 years. Fetal ultrasound scans were performed at each pregnancy visit. Pregnancy and birth data were obtained from hospital records. Data collection has included maternal and child anthropometric, biochemical, dietary, physical activity, socioeconomic, medical, and other variables. The 2 most novel components of our prospective cohort study are (1) the regular and systematic tracking of fetal and child growth and body composition, starting in the second trimester of pregnancy and continuing to age 4 years, and (2) the detailed maternal and child dietary data collection, including biochemical parameters. Detailed cohorts that collect data on the early nutritional, physiological, and social determinants of health are valuable. Despite its relatively small sample size, many hypotheses on developmental origins can be tested or piloted using data collected from the WATCH cohort.

  1. [Study protocol on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain].

    PubMed

    Pérez, Glòria; Gotsens, Mercè; Palència, Laia; Marí-Dell'Olmo, Marc; Domínguez-Berjón, M Felicitas; Rodríguez-Sanz, Maica; Puig, Vanessa; Bartoll, Xavier; Gandarillas, Ana; Martín, Unai; Bacigalupe, Amaia; Díez, Elia; Ruiz, Miguel; Esnaola, Santiago; Calvo, Montserrat; Sánchez, Pablo; Luque Fernández, Miguel Ángel; Borrell, Carme

    The aim is to present the protocol of the two sub-studies on the effect of the economic crisis on mortality and reproductive health and health inequalities in Spain. Substudy 1: describe the evolution of mortality and reproductive health between 1990 and 2013 through a longitudinal ecological study in the Autonomous Communities. This study will identify changes caused by the economic crisis in trends or reproductive health and mortality indicators using panel data (17 Autonomous Communities per study year) and adjusting Poisson models with random effects variance. Substudy 2: analyse inequalities by socioeconomic deprivation in mortality and reproductive health in several areas of Spain. An ecological study analysing trends in the pre-crisis (1999-2003 and 2004-2008) and crisis (2009-2013) periods will be performed. Random effects models Besag York and Mollié will be adjusted to estimate mortality indicators softened in reproductive health and census tracts. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  2. How does capacity building of health managers work? A realist evaluation study protocol.

    PubMed

    Prashanth, N S; Marchal, Bruno; Hoeree, Tom; Devadasan, Narayanan; Macq, Jean; Kegels, Guy; Criel, Bart

    2012-01-01

    There has been a lot of attention on the role of human resource management interventions to improve delivery of health services in low- and middle-income countries. However, studies on this subject are few due to limited research on implementation of programmes and methodological difficulties in conducting experimental studies on human resource interventions. The authors present the protocol of an evaluation of a district-level capacity-building intervention to identify the determinants of performance of health workers in managerial positions and to understand how changes (if any) are brought about. The aim of this study is to understand how capacity building works. The authors will use realist evaluation to evaluate an intervention in Karnataka, India. The intervention is a capacity-building programme that seeks to improve management capacities of health managers at district and subdistrict levels through periodic classroom-based teaching and mentoring support at the workplace. The authors conducted interviews and reviewed literature on capacity building in health to draw out the programme theory of the intervention. Based on this, the authors formulated hypothetical pathways connecting the expected outcomes of the intervention (planning and supervision) to the inputs (contact classes and mentoring). The authors prepared a questionnaire to assess elements of the programme theory-organisational culture, self-efficacy and supervision. The authors shall conduct a survey among health managers as well as collect qualitative data through interviews with participants and non-participants selected purposively based on their planning and supervision performance. The authors will construct explanations in the form of context-mechanism-outcome configurations from the results. This will be iterative and the authors will use a realist evaluation framework to refine the explanatory theories that are based on the findings to explain and validate an improved theory on 'what works

  3. How does capacity building of health managers work? A realist evaluation study protocol

    PubMed Central

    Marchal, Bruno; Hoeree, Tom; Devadasan, Narayanan; Macq, Jean; Kegels, Guy; Criel, Bart

    2012-01-01

    Introduction There has been a lot of attention on the role of human resource management interventions to improve delivery of health services in low- and middle-income countries. However, studies on this subject are few due to limited research on implementation of programmes and methodological difficulties in conducting experimental studies on human resource interventions. The authors present the protocol of an evaluation of a district-level capacity-building intervention to identify the determinants of performance of health workers in managerial positions and to understand how changes (if any) are brought about. Methods and analysis The aim of this study is to understand how capacity building works. The authors will use realist evaluation to evaluate an intervention in Karnataka, India. The intervention is a capacity-building programme that seeks to improve management capacities of health managers at district and subdistrict levels through periodic classroom-based teaching and mentoring support at the workplace. The authors conducted interviews and reviewed literature on capacity building in health to draw out the programme theory of the intervention. Based on this, the authors formulated hypothetical pathways connecting the expected outcomes of the intervention (planning and supervision) to the inputs (contact classes and mentoring). The authors prepared a questionnaire to assess elements of the programme theory—organisational culture, self-efficacy and supervision. The authors shall conduct a survey among health managers as well as collect qualitative data through interviews with participants and non-participants selected purposively based on their planning and supervision performance. The authors will construct explanations in the form of context–mechanism–outcome configurations from the results. This will be iterative and the authors will use a realist evaluation framework to refine the explanatory theories that are based on the findings to explain and

  4. A trial of a job-specific workers' health surveillance program for construction workers: study protocol

    PubMed Central

    2011-01-01

    Background Dutch construction workers are offered periodic health examinations. This care can be improved by tailoring this workers health surveillance (WHS) to the demands of the job and adjust the preventive actions to the specific health risks of a worker in a particular job. To improve the quality of the WHS for construction workers and stimulate relevant job-specific preventive actions by the occupational physician, we have developed a job-specific WHS. The job-specific WHS consists of modules assessing both physical and psychological requirements. The selected measurement instruments chosen, are based on their appropriateness to measure the workers' capacity and health requirements. They include a questionnaire and biometrical tests, and physical performance tests that measure physical functional capabilities. Furthermore, our job-specific WHS provides occupational physicians with a protocol to increase the worker-behavioural effectiveness of their counselling and to stimulate job-specific preventive actions. The objective of this paper is to describe and clarify our study to evaluate the behavioural effects of this job-specific WHS on workers and occupational physicians. Methods/Design The ongoing study of bricklayers and supervisors is a nonrandomised trial to compare the outcome of an intervention (job-specific WHS) group (n = 206) with that of a control (WHS) group (n = 206). The study includes a three-month follow-up. The primary outcome measure is the proportion of participants who have undertaken one or more of the preventive actions advised by their occupational physician in the three months after attending the WHS. A process evaluation will be carried out to determine context, reach, dose delivered, dose received, fidelity, and satisfaction. The present study is in accordance with the TREND Statement. Discussion This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions

  5. Integrating addiction treatment into primary care using mobile health technology: protocol for an implementation research study

    PubMed Central

    2014-01-01

    Background Healthcare reform in the United States is encouraging Federally Qualified Health Centers and other primary-care practices to integrate treatment for addiction and other behavioral health conditions into their practices. The potential of mobile health technologies to manage addiction and comorbidities such as HIV in these settings is substantial but largely untested. This paper describes a protocol to evaluate the implementation of an E-Health integrated communication technology delivered via mobile phones, called Seva, into primary-care settings. Seva is an evidence-based system of addiction treatment and recovery support for patients and real-time caseload monitoring for clinicians. Methods/Design Our implementation strategy uses three models of organizational change: the Program Planning Model to promote acceptance and sustainability, the NIATx quality improvement model to create a welcoming environment for change, and Rogers’s diffusion of innovations research, which facilitates adaptations of innovations to maximize their adoption potential. We will implement Seva and conduct an intensive, mixed-methods assessment at three diverse Federally Qualified Healthcare Centers in the United States. Our non-concurrent multiple-baseline design includes three periods — pretest (ending in four months of implementation preparation), active Seva implementation, and maintenance — with implementation staggered at six-month intervals across sites. The first site will serve as a pilot clinic. We will track the timing of intervention elements and assess study outcomes within each dimension of the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, including effects on clinicians, patients, and practices. Our mixed-methods approach will include quantitative (e.g., interrupted time-series analysis of treatment attendance, with clinics as the unit of analysis) and qualitative (e.g., staff interviews regarding adaptations to implementation

  6. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol.

    PubMed

    Gamboa Delgado, Edna M; Rojas Sánchez, Lyda Z; Bermon Angarita, Anderson; Rangel Díaz, Yully Andrea; Jaraba Suárez, Silvia J; Serrano Díaz, Norma C; Vega Fernández, Evaristo

    2015-07-30

    Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution's workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population's characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. The protocol has already received funding and the enrollment phase will begin in the coming months. The results of this study will give the foundation for the design, implementation, and evaluation of a program based on

  7. Cardiovascular Risk and Its Associated Factors in Health Care Workers in Colombia: A Study Protocol

    PubMed Central

    2015-01-01

    Background Cardiovascular diseases are the leading cause of mortality worldwide, for this reason, they are a public health problem. In Colombia, cardiovascular diseases are the main cause of mortality, having a death rate of 152 deaths per 100,000 population. There are 80% of these cardiovascular events that are considered avoidable. Objective The objective of the study is to determine the prevalence of the cardiovascular risk and its associated factors among the institution’s workers in order to design and implement interventions in the work environment which may achieve a decrease in such risk. Methods An analytical cross-sectional study was designed to determine the cardiovascular risk and its associated factors among workers of a high complexity health care institution. A self-applied survey will be conducted considering sociodemographic aspects, physical activity, diet, alcohol consumption, smoking, level of perceived stress, and personal and family history. In a second appointment, a physical examination will be made, as well as anthropometric measurements and blood pressure determination. Also, blood samples for evaluating total and high density lipoprotein cholesterol, triglycerides, and fasting blood sugar will be taken. A ten-year global risk for cardiovascular disease will be determined using the Framingham score. A descriptive analysis of the population’s characteristics and a stratified analysis by sex, age, and occupation will be made. Bivariate and multivariate analysis will be made using logistic regression models to evaluate the association between cardiovascular risk and the independent variables. The research protocol was approved by the Scientific and Technical Committee and the Ethics Committee on Research of the Fundación Cardiovascular de Colombia. Results The protocol has already received funding and the enrollment phase will begin in the coming months. Conclusions The results of this study will give the foundation for the design

  8. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments

    PubMed Central

    Mokkink, LB; Terwee, CB; Knol, DL; Stratford, PW; Alonso, J; Patrick, DL; Bouter, LM; de Vet, HCW

    2006-01-01

    Background Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. Method An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field

  9. Japanese study on stratification, health, income, and neighborhood: study protocol and profiles of participants.

    PubMed

    Takada, Misato; Kondo, Naoki; Hashimoto, Hideki

    2014-01-01

    The Japanese Study on Stratification, Health, Income, and Neighborhood (J-SHINE) aims to clarify the complex associations between social factors and health from an interdisciplinary perspective and to provide a database for use in various health policy evaluations. J-SHINE is an ongoing longitudinal panel study of households of adults aged 25-50 years. The wave 1 survey was carried out in 2010 among adults randomly selected from the resident registry of four urban and suburban municipalities in the greater Tokyo metropolitan area, Japan. In 2011, surveys for the participants' spouse/partner and child were additionally conducted. The wave 2 survey was conducted in 2012 for the wave 1 participants and will be followed by the wave 2 survey for spouse/partner and child in 2013. Wave 1 sample sizes were 4357 for wave 1 participants (valid response rate: 31.3%; cooperation rate: 51.8%), 1873 for spouse/partner (response rate: 61.9%), and 1520 for child (response rate: 67.7%). Wave 2 captured 69.0% of wave 1 participants. Information gathered covered socio-demographics, household economy, self-reported health conditions and healthcare utilization, stress and psychological values, and developmental history. A subpopulation underwent physiological (n = 2468) and biomarker (n = 1205) measurements. Longitudinal survey data, including repeated measures of social factors evaluated based on theories and techniques of various disciplines, like J-SHINE, should contribute toward opening a web of causality for society and health, which may have important policy implications for recent global health promotion strategies such as the World Health Organization's Social Determinants of Health approach and the second round of Japan's Healthy Japan 21.

  10. The Study of Environment on Aboriginal Resilience and Child Health (SEARCH): study protocol

    PubMed Central

    2010-01-01

    Background Aboriginal Australians have a life expectancy more than ten years less than that of non-Aboriginal Australians, reflecting their disproportionate burden of both communicable and non-communicable disease throughout the lifespan. Little is known about the health and health trajectories of Aboriginal children and, although the majority of Aboriginal people live in urban areas, data are particularly sparse in relation to children living in urban areas. Methods/Design The Study of Environment on Aboriginal Resilience and Child Health (SEARCH) is a cohort study of Aboriginal children aged 0-17 years, from urban and large regional centers in New South Wales, Australia. SEARCH focuses on Aboriginal community identified health priorities of: injury; otitis media; vaccine-preventable conditions; mental health problems; developmental delay; obesity; and risk factors for chronic disease. Parents/caregivers and their children are invited to participate in SEARCH at the time of presentation to one of the four participating Aboriginal Community Controlled Health Organisations at Mount Druitt, Campbelltown, Wagga Wagga and Newcastle. Questionnaire data are obtained from parents/caregivers and children, along with signed permission for follow-up through repeat data collection and data linkage. All children have their height, weight, waist circumference and blood pressure measured and complete audiometry, otoscopy/pneumatic otoscopy and tympanometry. Children aged 1-7 years have speech and language assessed and their parents/caregivers complete the Parental Evaluation of Developmental Status. The Study aims to recruit 1700 children by the end of 2010 and to secure resources for long term follow up. From November 2008 to March 2010, 1010 children had joined the study. From those 446 children with complete data entry, participating children ranged in age from 2 weeks to 17 years old, with 144 aged 0-3, 147 aged 4-7, 75 aged 8-10 and 79 aged 11-17. 55% were male and 45

  11. The Study of Environment on Aboriginal Resilience and Child Health (SEARCH): study protocol.

    PubMed

    2010-05-28

    Aboriginal Australians have a life expectancy more than ten years less than that of non-Aboriginal Australians, reflecting their disproportionate burden of both communicable and non-communicable disease throughout the lifespan. Little is known about the health and health trajectories of Aboriginal children and, although the majority of Aboriginal people live in urban areas, data are particularly sparse in relation to children living in urban areas. The Study of Environment on Aboriginal Resilience and Child Health (SEARCH) is a cohort study of Aboriginal children aged 0-17 years, from urban and large regional centers in New South Wales, Australia. SEARCH focuses on Aboriginal community identified health priorities of: injury; otitis media; vaccine-preventable conditions; mental health problems; developmental delay; obesity; and risk factors for chronic disease. Parents/caregivers and their children are invited to participate in SEARCH at the time of presentation to one of the four participating Aboriginal Community Controlled Health Organisations at Mount Druitt, Campbelltown, Wagga Wagga and Newcastle. Questionnaire data are obtained from parents/caregivers and children, along with signed permission for follow-up through repeat data collection and data linkage. All children have their height, weight, waist circumference and blood pressure measured and complete audiometry, otoscopy/pneumatic otoscopy and tympanometry. Children aged 1-7 years have speech and language assessed and their parents/caregivers complete the Parental Evaluation of Developmental Status. The Study aims to recruit 1700 children by the end of 2010 and to secure resources for long term follow up. From November 2008 to March 2010, 1010 children had joined the study. From those 446 children with complete data entry, participating children ranged in age from 2 weeks to 17 years old, with 144 aged 0-3, 147 aged 4-7, 75 aged 8-10 and 79 aged 11-17. 55% were male and 45% female. SEARCH is built on

  12. Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial.

    PubMed

    Jack, Darby W; Asante, Kwaku Poku; Wylie, Blair J; Chillrud, Steve N; Whyatt, Robin M; Ae-Ngibise, Kenneth A; Quinn, Ashlinn K; Yawson, Abena Konadu; Boamah, Ellen Abrafi; Agyei, Oscar; Mujtaba, Mohammed; Kaali, Seyram; Kinney, Patrick; Owusu-Agyei, Seth

    2015-09-22

    Household air pollution exposure is a major health risk, but validated interventions remain elusive. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is a cluster-randomized trial that evaluates the efficacy of clean fuels (liquefied petroleum gas, or LPG) and efficient biomass cookstoves in the Brong-Ahafo region of central Ghana. We recruit pregnant women into LPG, efficient cookstove, and control arms and track birth weight and physician-assessed severe pneumonia incidence in the first year of life. A woman is eligible to participate if she is in the first or second trimester of pregnancy and carrying a live singleton fetus, if she is the primary cook, and if she does not smoke. We hypothesize that babies born to intervention mothers will weigh more and will have fewer cases of physician-assessed severe pneumonia in the first year of life. Additionally, an extensive personal air pollution exposure monitoring effort opens the way for exposure-response analyses, which we will present alongside intention-to-treat analyses. Major funding was provided by the National Institute of Environmental Health Sciences, The Thrasher Research Fund, and the Global Alliance for Clean Cookstoves. Household air pollution exposure is a major health risk that requires well-tested interventions. GRAPHS will provide important new evidence on the efficacy of both efficient biomass cookstoves and LPG, and will thus help inform health and energy policies in developing countries. The trial was registered with clinicaltrials.gov on 13 April 2011 with the identifier NCT01335490 .

  13. Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol.

    PubMed

    Weiner, Bryan J; Pignone, Michael P; DuBard, C Annette; Lefebvre, Ann; Suttie, Janet L; Freburger, Janet K; Cykert, Samuel

    2015-11-14

    The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capacity to incorporate other evidence-based clinical guidelines in the future. HHN is a stepped wedge, stratified, cluster randomized trial to evaluate the effect of primary care practice support on evidence-based CVD prevention, organizational change process measures, and patient outcomes. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after the start of the intervention. The intervention will be randomized to practices in one of four strata defined by region of the state (east or west) and degree of practice readiness for change. Seventy-five practices in each region with a high degree of readiness will be randomized 1:1:1 in blocks of 3 sometime prior to month 8 to receive the intervention at month 9, 11, or 12. An additional 75 practices within each region that have a low degree of readiness or are recruited later will be randomized 1:1 in blocks of 2 prior to month 13 to receive the intervention at month 14 or 16. The sites will be ordered within each strata based on time of enrollment with the blocking based on this ordering. Evaluation will examine the effect of primary care practice support on (1) practice-level delivery of evidence-based CVD prevention, (2) patient-level health outcomes, (3) practice-level implementation of clinical and organizational changes that support delivery of evidence-based CVD prevention, and (4) practice-level capacity to implement future evidence

  14. Evaluating community health centers’ adoption of a new global capitation payment (eCHANGE) study protocol

    PubMed Central

    Angier, H; O’Malley, JP; Marino, M; McConnell, KJ; Cottrell, E; Jacob, RL; Likumahuwa-Ackman, S; Heintzman, J; Huguet, N; Bailey, SR; DeVoe, JE

    2017-01-01

    Primary care patient-centered medical homes (PCMHs) are an effective healthcare delivery model. Evidence regarding the most effective payment models for increased coordination efforts is sparse. This protocol paper describes the evaluation of an Alternative Payment Methodology (APM) implemented in a subset of Oregon community health centers (CHCs), using a prospective matched observational design. The APM is a primary care payment reform intervention that changed Oregon’s Medicaid payment for several CHCs from fee-for-service reimbursement to a per-member-per-month capitated payment. We will implement a difference-in-difference analytic approach to evaluate pre-post APM changes between intervention and control groups, including: 1) clinic-level outcomes, 2) patient-level clinical outcomes, and 3) patient-level econometric outcomes. Findings from the project will be of national significance, as there is a need for evidence regarding how novel payment methods might enhance PCMH capabilities and support their capacity to produce better quality and outcomes. If this capitated payment method is proven effective, study findings will inform dissemination of similar APMs nationwide. PMID:27836506

  15. Using Ontario's "Telehealth" health telephone helpline as an early-warning system: a study protocol.

    PubMed

    Rolland, Elizabeth; Moore, Kieran M; Robinson, Victoria A; McGuinness, Don

    2006-02-15

    The science of syndromic surveillance is still very much in its infancy. While a number of syndromic surveillance systems are being evaluated in the US, very few have had success thus far in predicting an infectious disease event. Furthermore, to date, the majority of syndromic surveillance systems have been based primarily in emergency department settings, with varying levels of enhancement from other data sources. While research has been done on the value of telephone helplines on health care use and patient satisfaction, very few projects have looked at using a telephone helpline as a source of data for syndromic surveillance, and none have been attempted in Canada. The notable exception to this statement has been in the UK where research using the national NHS Direct system as a syndromic surveillance tool has been conducted. The purpose of our proposed study is to evaluate the effectiveness of Ontario's telephone nursing helpline system as a real-time syndromic surveillance system, and how its implementation, if successful, would have an impact on outbreak event detection in Ontario. Using data collected retrospectively, all "reasons for call" and assigned algorithms will be linked to a syndrome category. Using different analytic methods, normal thresholds for the different syndromes will be ascertained. This will allow for the evaluation of the system's sensitivity, specificity and positive predictive value. The next step will include the prospective monitoring of syndromic activity, both temporally and spatially. As this is a study protocol, there are currently no results to report. However, this study has been granted ethical approval, and is now being implemented. It is our hope that this syndromic surveillance system will display high sensitivity and specificity in detecting true outbreaks within Ontario, before they are detected by conventional surveillance systems. Future results will be published in peer-reviewed journals so as to contribute to the

  16. Midlife women, bone health, vegetables, herbs and fruit study. The Scarborough Fair study protocol

    PubMed Central

    2013-01-01

    Background Bone loss is accelerated in middle aged women but increased fruit/vegetable intake positively affects bone health by provision of micronutrients essential for bone formation, buffer precursors which reduce acid load and phytochemicals affecting inflammation and oxidative stress. Animal studies demonstrated bone resorption inhibiting properties of specific vegetables, fruit and herbs a decade ago. Objective: To increase fruit/vegetable intake in post menopausal women to 9 servings/day using a food specific approach to significantly reduce dietary acid load and include specific vegetables, fruit and herbs with bone resorbing inhibiting properties to assess effect on bone turnover, metabolic and inflammatory markers. Methods/Design The Scarborough Fair Study is a randomised active comparator controlled multi centre trial. It aimed to increase fruit and vegetable intake in 100 post menopausal women from ≤ 5 servings/day to ≥ 9 servings/day for 3 months. The women in the dietary intervention were randomly assigned to one of the two arms of the study. Both groups consumed ≥ 9 servings/day of fruit/vegetables and selected herbs but the diet of each group emphasised different fruit/vegetables/herbs with one group (B) selecting from a range of vegetables, fruit and culinary herbs with bone resorbing inhibiting properties. 50 women formed a negative control group (Group C usual diet). Primary outcome variables were plasma bone markers assessed at baseline, 6 weeks and 12 weeks. Secondary outcome variables were plasma inflammation and metabolic markers and urinary electrolytes (calcium, magnesium, potassium and sodium) assessed at baseline and 12 weeks. Dietary intake and urine pH change also were outcome variables. The dietary change was calculated with 3 day diet diaries and a 24 hour recall. Intervention participants kept a twice weekly record of fruit, vegetable and herb intake and urine pH. Discussion This study will provide information on midlife women

  17. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial.

    PubMed

    Heisler, Michele; Burgess, Jennifer; Cass, Jeffrey; Chardos, John F; Guirguis, Alexander B; Jeffery, Sean M; Strohecker, Lorrie A; Tremblay, Adam S; Wu, Wen-Chih; Zulman, Donna M

    2017-05-26

    Diabetes shared medical appointments (SMAs) and reciprocal peer support programs have been found in efficacy trials to help adults with diabetes improve their self-management and achieve short-term gains in clinical and patient-centered outcomes. In order to translate this evidence to system-level interventions, there is a need for large-scale, pragmatic trials that examine the effectiveness, implementation, and costs of SMAs and reciprocal peer support across diverse settings. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study is a multisite, cluster randomized trial that is evaluating the effectiveness and implementation of SMAs with and without an additional reciprocal Peer-to-Peer (P2P) support program, when compared to usual care. The P2P program comprises periodic peer support group sessions and telephone contact between SMA participant pairs to promote more effective diabetes self-management. We will examine outcomes across three different treatment groups: (1) SMAs, (2) SMAs plus P2P, and (3) usual care. We will collect and analyze data over a 2.5-year implementation period at five geographically diverse Veterans Affairs (VA) health systems. The primary outcome is the relative change in hemoglobin A1c over time. Secondary outcomes are changes in systolic blood pressure, antihypertensive medication use, statin use, and insulin initiation over the study period. The unit of analysis is the individual, adjusted by the individual's SMA group (the cluster). We will use mixed methods to rigorously evaluate processes and costs of implementing these programs in each of the clinic settings. We hypothesize that patients will experience improved outcomes immediately following participation in SMAs and that augmenting SMAs with reciprocal peer support will help to maintain these gains over time. The results of this study will be among the first to examine the effects of diabetes SMAs alone and in conjunction with P2P in a range of real

  18. A cohort study of the recovery of health and wellbeing following colorectal cancer (CREW study): protocol paper

    PubMed Central

    2012-01-01

    Background The number of people surviving colorectal cancer has doubled in recent years. While much of the literature suggests that most people return to near pre-diagnosis status following surgery for colorectal cancer, this literature has largely focused on physical side effects. Longitudinal studies in colorectal cancer have either been small scale or taken a narrow focus on recovery after surgery. There is a need for a comprehensive, long-term study exploring all aspects of health and wellbeing in colorectal cancer patients. The aim of this study is to establish the natural history of health and wellbeing in people who have been treated for colorectal cancer. People have different dispositions, supports and resources, likely resulting in individual differences in restoration of health and wellbeing. The protocol described in this paper is of a study which will identify who is most at risk of problems, assess how quickly people return to a state of subjective health and wellbeing, and will measure factors which influence the course of recovery. Methods/design This is a prospective, longitudinal cohort study following 1000 people with colorectal cancer over a period of two years, recruiting from 30 NHS cancer treatment centres across the UK. Questionnaires will be administered prior to surgery, and 3, 9, 15 and 24 months after surgery, with the potential to return to this cohort to explore on-going issues related to recovery after cancer. Discussion Outcomes will help inform health care providers about what helps or hinders rapid and effective recovery from cancer, and identify areas for intervention development to aid this process. Once established the cohort can be followed up for longer periods and be approached to participate in related projects as appropriate and subject to funding. PMID:22475242

  19. Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services

    PubMed Central

    2013-01-01

    Background Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer. Increasingly, policy-makers have recognised the need to ensure a smoother transition between children’s and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. Methods/Design Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care. We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services. In order to better understand mechanisms and aid

  20. Study protocol: longitudinal study of the transition of young people with complex health needs from child to adult health services.

    PubMed

    Colver, Allan F; Merrick, Hannah; Deverill, Mark; Le Couteur, Ann; Parr, Jeremy; Pearce, Mark S; Rapley, Tim; Vale, Luke; Watson, Rose; McConachie, Helen

    2013-07-23

    Young people with complex health needs have impairments that can limit their ability to carry out day-to-day activities. As well as coping with other developmental transitions, these young people must negotiate the transfer of their clinical care from child to adult services. The process of transition may not be smooth and both health and social outcomes may suffer.Increasingly, policy-makers have recognised the need to ensure a smoother transition between children's and adult services, with processes that are holistic, individualised, and person-centred; however, there is little outcome data to support proposed models of care. This study aims to identify the features of transitional care that are potentially effective and efficient for young people with complex health needs making their transition. Longitudinal cohort study. 450 young people aged 14 years to 18 years 11 months (with autism spectrum disorder and an additional mental health problem, cerebral palsy or diabetes) will be followed through their transition from child to adult services and will contribute data at baseline, 12, 24 and 36 months. We will collect data on: health and wellbeing outcomes (participation, quality of life, satisfaction with services, generic health status (EQ-5D-Y) and condition specific measure of disease control or management); exposure to proposed beneficial features of services (such as having a key worker, appropriate involvement of parents); socio-economic characteristics of the sample; use of condition-related health and personal social services; preferences for the characteristics of transitional care.We will us regression techniques to explore how outcomes vary by exposure to service features and by characteristics of the young people. These data will populate a decision-analytic model comparing the costs and benefits of potential alternative ways of organising transition services.In order to better understand mechanisms and aid interpretation, we will undertake

  1. The effectiveness of a health promotion with group intervention by clinical trial. Study protocol

    PubMed Central

    2012-01-01

    Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes...) are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL), incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test). Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self responsibility for his/her own

  2. A Checklist for the Conduct, Reporting, and Appraisal of Microcosting Studies in Health Care: Protocol Development

    PubMed Central

    Reiff, Marian

    2016-01-01

    Background Microcosting is a cost estimation method that requires the collection of detailed data on resources utilized, and the unit costs of those resources in order to identify actual resource use and economic costs. Microcosting findings reflect the true costs to health care systems and to society, and are able to provide transparent and consistent estimates. Many economic evaluations in health and medicine use charges, prices, or payments as a proxy for cost. However, using charges, prices, or payments rather than the true costs of resources can result in inaccurate estimates. There is currently no existing checklist or guideline for the conduct, reporting, or appraisal of microcosting studies in health care interventions. Objective The aim of this study is to create a checklist and guideline for the conduct, reporting, and appraisal of microcosting studies in health care interventions. Methods Appropriate potential domains and items will be identified through (1) a systematic review of all published microcosting studies of health and medical interventions, strategies, and programs; (2) review of published checklists and guidelines for economic evaluations of health interventions, and selection of items relevant for microcosting studies; and (3) theoretical analysis of economic concepts relevant for microcosting. Item selection, formulation, and reduction will be conducted by the research team in order to develop an initial pool of items for evaluation by an expert panel comprising individuals with expertise in microcosting and economic evaluation of health interventions. A modified Delphi process will be conducted to achieve consensus on the checklist. A pilot test will be conducted on a selection of the articles selected for the previous systematic review of published microcosting studies. Results The project is currently in progress. Conclusions Standardization of the methods used to conduct, report or appraise microcosting studies will enhance the

  3. Study protocol: national research partnership to improve primary health care performance and outcomes for Indigenous peoples

    PubMed Central

    2010-01-01

    Background Strengthening primary health care is critical to reducing health inequity between Indigenous and non-Indigenous Australians. The Audit and Best practice for Chronic Disease Extension (ABCDE) project has facilitated the implementation of modern Continuous Quality Improvement (CQI) approaches in Indigenous community health care centres across Australia. The project demonstrated improvements in health centre systems, delivery of primary care services and in patient intermediate outcomes. It has also highlighted substantial variation in quality of care. Through a partnership between academic researchers, service providers and policy makers, we are now implementing a study which aims to 1) explore the factors associated with variation in clinical performance; 2) examine specific strategies that have been effective in improving primary care clinical performance; and 3) work with health service staff, management and policy makers to enhance the effective implementation of successful strategies. Methods/Design The study will be conducted in Indigenous community health centres from at least six States/Territories (Northern Territory, Western Australia, New South Wales, South Australia, Queensland and Victoria) over a five year period. A research hub will be established in each region to support collection and reporting of quantitative and qualitative clinical and health centre system performance data, to investigate factors affecting variation in quality of care and to facilitate effective translation of research evidence into policy and practice. The project is supported by a web-based information system, providing automated analysis and reporting of clinical care performance to health centre staff and management. Discussion By linking researchers directly to users of research (service providers, managers and policy makers), the partnership is well placed to generate new knowledge on effective strategies for improving the quality of primary health care and

  4. An evaluation of two large scale demand side financing programs for maternal health in India: the MATIND study protocol.

    PubMed

    Sidney, Kristi; de Costa, Ayesha; Diwan, Vishal; Mavalankar, Dileep V; Smith, Helen

    2012-08-27

    High maternal mortality in India is a serious public health challenge. Demand side financing interventions have emerged as a strategy to promote access to emergency obstetric care. Two such state run programs, Janani Suraksha Yojana (JSY)and Chiranjeevi Yojana (CY), were designed and implemented to reduce financial access barriers that preclude women from obtaining emergency obstetric care. JSY, a conditional cash transfer, awards money directly to a woman who delivers in a public health facility. This will be studied in Madhya Pradesh province. CY, a voucher based program, empanels private obstetricians in Gujarat province, who are reimbursed by the government to perform deliveries of socioeconomically disadvantaged women. The programs have been in operation for the last seven years. The study outlined in this protocol will assess and compare the influence of the two programs on various aspects of maternal health care including trends in program uptake, institutional delivery rates, maternal and neonatal outcomes, quality of care, experiences of service providers and users, and cost effectiveness. The study will collect primary data using a combination of qualitative and quantitative methods, including facility level questionnaires, observations, a population based survey, in-depth interviews, and focus group discussions. Primary data will be collected in three districts of each province. The research will take place at three levels: the state health departments, obstetric facilities in the districts and among recently delivered mothers in the community. The protocol is a comprehensive assessment of the performance and impact of the programs and an economic analysis. It will fill existing evidence gaps in the scientific literature including access and quality to services, utilization, coverage and impact. The implementation of the protocol will also generate evidence to facilitate decision making among policy makers and program managers who currently work with or

  5. A preliminary study of youth sport concussions: Parents' health literacy and knowledge of return-to-play protocol criteria.

    PubMed

    Turner, Robert W; Lucas, Jeffery W; Margolis, Lewis H; Corwell, Brian N

    2017-01-01

    To preliminarily explore parents' health literacy and knowledge of youth sport league rules involving concussion education and training, and return-to-play protocols. This study was guided by the Knowledge, Attitude and Practice (KAP) model of health knowledge to examine parents' concussion literacy, and understanding of concussion education and training, and return-to-play protocols in youth sports. The mixed-method design involved 119 participants; that included in-person (n=8) and telephone (n=4) interviews, and web-based surveys administered through Mechanical Turk via Qualtrics (n=98). Most respondents were not familiar with concussion protocols, but trusted coaches' knowledge in return-to-play rules. More than half of the respondents report that the return-to-play concussion criteria have not been clearly explained to them. The majority of respondents were not familiar with the CDC's 'Heads Up' online concussion training programme, nor were they familiar with any other educational/training tool. About one-fifth of the parents had conversations with a coach or medical staff about youth sport concussions. Parents have a general understanding of how to identify concussion symptoms, but lack knowledge of immediate steps to take following an incident other than seeking medical help.

  6. Improving the prevention of cardiovascular disease in primary health care: the model for prevention study protocol.

    PubMed

    Volker, Nerida; Davey, Rachel C; Cochrane, Thomas; Williams, Lauren T; Clancy, Tanya

    2014-07-09

    Cardiovascular disease (CVD) is the leading cause of death globally, and accounted for nearly 31% of all deaths in Australia in 2011. The primary health care sector is at the frontline for addressing CVD, however, an evidence-to-practice gap exists in CVD risk assessment and management. General practice plays a key role in CVD risk assessment and management, but this sector cannot provide ongoing lifestyle change support in isolation. Community-based lifestyle modification services and programs provided outside the general practice setting have a key role in supporting and sustaining health behavior change. Fostering linkages between the health sector and community-based lifestyle services, and creating sustainable systems that support these sectors is important. The objective of the study Model for Prevention (MoFoP) is to take a case study approach to examine a CVD risk reduction intervention in primary health care, with the aim of identifying the key elements required for an effective and sustainable approach to coordinate CVD risk reduction across the health and community sectors. These elements will be used to consider a new systems-based model for the prevention of CVD that informs future practice. The MoFoP study will use a mixed methods approach, comprising two complementary research elements: (1) a case study, and (2) a pre/post quasi-experimental design. The case study will consider the organizations and systems involved in a CVD risk reduction intervention as a single case. The pre/post experimental design will be used for HeartLink, the intervention being tested, where a single cohort of patients between 45 and 74 years of age (or between 35 and 74 years of age if Aboriginal or Torres Strait Islander) considered to be at high risk for a CVD event will be recruited through general practice, provided with enhanced usual care and additional health behavior change support. A range of quantitative and qualitative data will be collected. This will include

  7. Influence of societal and practice contexts on health professionals’ clinical reasoning: a scoping study protocol

    PubMed Central

    Carrier, Annie; Levasseur, Mélanie; Freeman, Andrew; Mullins, Gary; Quénec'hdu, Suzanne; Lalonde, Louise; Gagnon, Michaël; Lacasse, Francis

    2013-01-01

    Introduction In a context of constrained resources, the efficacy of interventions is a pivotal aim of healthcare systems worldwide. Efficacy of healthcare interventions is highly compromised if clinical reasoning (CR), the process that practitioners use to plan, direct, perform and reflect on client care, is not optimal. The CR process of health professionals is influenced by the institutional dimension (ie, legal, regulatory, administrative and organisational aspects) of their societal and practice contexts. Although several studies have been conducted with respect to the institutional dimension influencing health professionals’ CR, no clear integration of their results is yet available. The aim of this study is to synthesise and disseminate current knowledge on the influence of the institutional dimension of contexts on health professionals’ CR. Methods and analysis A scoping study of the scientific literature from January 1980 to March 2013 will be undertaken to summarise and disseminate research findings about the influence of the institutional dimension on CR. Numerous databases (n=18) from three relevant fields (healthcare, health law and politics and management) will be searched. Extended search strategies will include the manual search of bibliographies, health-related websites, public registries and journals of interest. Data will be collected and analysed using a thematic chart and content analysis. A systematic multidisciplinary team approach will allow optimal identification of relevant studies, as well as effective and valid content analysis and dissemination of the results. Discussion This scoping study will provide a rigorous, accurate and up-to-date synthesis of existing knowledge regarding: (1) those aspects of the institutional dimension of health professionals’ societal and practice contexts that impact their CR and (2) how these aspects influence health professionals’ CR. Through the synergy of a multidisciplinary research team from a

  8. Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol

    PubMed Central

    2014-01-01

    Background There is growing evidence that health and social outcomes following motor vehicle crash injury are related to cognitive and emotional responses of the injured individual, as well as relationships between the injured individual and the compensation systems with which they interact. As most of this evidence comes from other states in Australia or overseas, investigation is therefore warranted to identify the key determinants of health and social outcomes following injury in the context of the New South Wales motor accident insurance scheme. Methods/Design In this inception cohort study, 2400 participants, aged 17 years or more, injured in a motor vehicle crash in New South Wales will be identified though hospital emergency departments, general and physiotherapy practitioners, police records and a government insurance regulator database. Participants will be initially contacted through mail. Baseline interviews will be conducted by telephone within 28 days of the injury and participants will be followed up with interviews at 6, 12 and 24 months post-injury. Health insurance and pharmaceutical prescription data will also be collected. Discussion The study results will report short and long term health and social outcomes in the study sample. Identification of factors associated with health and social outcomes following injury, including related compensation factors will provide evidence for improved service delivery, post-injury management, and inform policy development and reforms. Trial registration Australia New Zealand Clinical trial registry identification number - ACTRN12613000889752. Available at: ANZCTR Registered FISH Study. PMID:24564821

  9. The childbearing health and related service needs of newcomers (CHARSNN) study protocol

    PubMed Central

    Gagnon, Anita J; Wahoush, Olive; Dougherty, Geoffrey; Saucier, Jean-François; Dennis, Cindy-Lee; Merry, Lisa; Stanger, Elizabeth; Stewart, Donna E

    2006-01-01

    Background Refugee and asylum-seeking women in Canada may have significant harmful childbearing health outcomes and unmet health and social care needs. The most vulnerable of these women are: those who have left their countries by force (e.g., war, rape or abuse histories), are separated from their families, have limited knowledge of the host country languages, and are visible minorities. Asylum-seekers face additional stresses related to their unknown future status and are marginalized with regards to access to provincial health care systems. The prevalence and severity of health issues in this population is not known nor is the extent of response from social service and health care systems (including variation in provincial service delivery). Understanding the magnitude of health and social concerns of newcomers requires data from a representative sample of childbearing refugee and asylum-seeking women resettling in Canada to permit comparisons to be made with non-refugee immigrant and Canadian-born women. Our research questions are: (1) Do refugee or asylum-seeking women and their infants, experience a greater number or a different distribution of harmful health events during pregnancy, at birth, and during the postpartum period than non-refugee immigrant or Canadian-born women? (2) Are the harmful health events experienced postpartum by asylum-seeking women and their infants, addressed less often (compared to refugees, non-refugee immigrants, and Canadian-born women) by the Canadian health care system as delivered in each of the three major receiving cities for newcomers? Methods/design This is a four-year multi-site prospective cohort study (pregnancy to 4 months postpartum). We will seek to recruit 2400 women [200 in each of 4 groups (refugees, asylum-seekers, non-refugee immigrants, and Canadian-born) from 1 of 12 postpartum hospital units across the 3 largest receiving cities for newcomers to Canada – Montreal, Toronto, and Vancouver]. Discussion

  10. The childbearing health and related service needs of newcomers (CHARSNN) study protocol.

    PubMed

    Gagnon, Anita J; Wahoush, Olive; Dougherty, Geoffrey; Saucier, Jean-François; Dennis, Cindy-Lee; Merry, Lisa; Stanger, Elizabeth; Stewart, Donna E

    2006-12-26

    Refugee and asylum-seeking women in Canada may have significant harmful childbearing health outcomes and unmet health and social care needs. The most vulnerable of these women are: those who have left their countries by force (e.g., war, rape or abuse histories), are separated from their families, have limited knowledge of the host country languages, and are visible minorities. Asylum-seekers face additional stresses related to their unknown future status and are marginalized with regards to access to provincial health care systems. The prevalence and severity of health issues in this population is not known nor is the extent of response from social service and health care systems (including variation in provincial service delivery). Understanding the magnitude of health and social concerns of newcomers requires data from a representative sample of childbearing refugee and asylum-seeking women resettling in Canada to permit comparisons to be made with non-refugee immigrant and Canadian-born women. Our research questions are: (1) Do refugee or asylum-seeking women and their infants, experience a greater number or a different distribution of harmful health events during pregnancy, at birth, and during the postpartum period than non-refugee immigrant or Canadian-born women? (2) Are the harmful health events experienced postpartum by asylum-seeking women and their infants, addressed less often (compared to refugees, non-refugee immigrants, and Canadian-born women) by the Canadian health care system as delivered in each of the three major receiving cities for newcomers? This is a four-year multi-site prospective cohort study (pregnancy to 4 months postpartum). We will seek to recruit 2400 women [200 in each of 4 groups (refugees, asylum-seekers, non-refugee immigrants, and Canadian-born) from 1 of 12 postpartum hospital units across the 3 largest receiving cities for newcomers to Canada - Montreal, Toronto, and Vancouver]. Knowledge of the extent of harmful health

  11. Environment and Health in Children Day Care Centres (ENVIRH) - Study rationale and protocol.

    PubMed

    Araújo-Martins, J; Carreiro Martins, P; Viegas, J; Aelenei, D; Cano, M M; Teixeira, J P; Paixão, P; Papoila, A L; Leiria-Pinto, P; Pedro, C; Rosado-Pinto, J; Annesi-Maesano, I; Neuparth, N

    2014-01-01

    Indoor air quality (IAQ) is considered an important determinant of human health. The association between exposure to volatile organic compounds, particulate matter, house dust mite, molds and bacteria in day care centers (DCC) is not completely clear. The aim of this project was to study these effects. This study comprised two phases. Phase I included an evaluation of 45 DCCs (25 from Lisbon and 20 from Oporto, targeting 5161 children). In this phase, building characteristics, indoor CO2 and air temperature/relative humidity, were assessed. A children's respiratory health questionnaire derived from the ISAAC (International Study on Asthma and Allergies in Children) was also distributed. Phase II encompassed two evaluations and included 20 DCCs selected from phase I after a cluster analysis (11 from Lisbon and 9 from Oporto, targeting 2287 children). In this phase, data on ventilation, IAQ, thermal comfort parameters, respiratory and allergic health, airway inflammation biomarkers, respiratory virus infection patterns and parental and child stress were collected. In Phase I, building characteristics, occupant behavior and ventilation surrogates were collected from all DCCs. The response rate of the questionnaire was 61.7% (3186 children). Phase II included 1221 children. Association results between DCC characteristics, IAQ and health outcomes will be provided in order to support recommendations on IAQ and children's health. A building ventilation model will also be developed. This paper outlines methods that might be implemented by other investigators conducting studies on the association between respiratory health and indoor air quality at DCC. Copyright © 2013 Sociedade Portuguesa de Pneumologia. Published by Elsevier España. All rights reserved.

  12. Micro-costing studies in the health and medical literature: protocol for a systematic review.

    PubMed

    Xu, Xiao; Grossetta Nardini, Holly K; Ruger, Jennifer Prah

    2014-05-21

    Micro-costing is a cost estimation method that allows for precise assessment of the economic costs of health interventions. It has been demonstrated to be particularly useful for estimating the costs of new interventions, for interventions with large variability across providers, and for estimating the true costs to the health system and to society. However, existing guidelines for economic evaluations do not provide sufficient detail of the methods and techniques to use when conducting micro-costing analyses. Therefore, the purpose of this study is to review the current literature on micro-costing studies of health and medical interventions, strategies, and programs to assess the variation in micro-costing methodology and the quality of existing studies. This will inform current practice in conducting and reporting micro-costing studies and lead to greater standardization in methodology in the future. We will perform a systematic review of the current literature on micro-costing studies of health and medical interventions, strategies, and programs. Using rigorously designed search strategies, we will search Ovid MEDLINE, EconLit, BIOSIS Previews, Embase, Scopus, and the National Health Service Economic Evaluation Database (NHS EED) to identify relevant English-language articles. These searches will be supplemented by a review of the references of relevant articles identified. Two members of the review team will independently extract detailed information on the design and characteristics of each included article using a standardized data collection form. A third reviewer will be consulted to resolve discrepancies. We will use checklists that have been developed for critical appraisal of health economics studies to evaluate the quality and potential risk of bias of included studies. This systematic review will provide useful information to help standardize the methods and techniques for conducting and reporting micro-costing studies in research, which can improve

  13. Micro-costing studies in the health and medical literature: protocol for a systematic review

    PubMed Central

    2014-01-01

    Background Micro-costing is a cost estimation method that allows for precise assessment of the economic costs of health interventions. It has been demonstrated to be particularly useful for estimating the costs of new interventions, for interventions with large variability across providers, and for estimating the true costs to the health system and to society. However, existing guidelines for economic evaluations do not provide sufficient detail of the methods and techniques to use when conducting micro-costing analyses. Therefore, the purpose of this study is to review the current literature on micro-costing studies of health and medical interventions, strategies, and programs to assess the variation in micro-costing methodology and the quality of existing studies. This will inform current practice in conducting and reporting micro-costing studies and lead to greater standardization in methodology in the future. Methods/Design We will perform a systematic review of the current literature on micro-costing studies of health and medical interventions, strategies, and programs. Using rigorously designed search strategies, we will search Ovid MEDLINE, EconLit, BIOSIS Previews, Embase, Scopus, and the National Health Service Economic Evaluation Database (NHS EED) to identify relevant English-language articles. These searches will be supplemented by a review of the references of relevant articles identified. Two members of the review team will independently extract detailed information on the design and characteristics of each included article using a standardized data collection form. A third reviewer will be consulted to resolve discrepancies. We will use checklists that have been developed for critical appraisal of health economics studies to evaluate the quality and potential risk of bias of included studies. Discussion This systematic review will provide useful information to help standardize the methods and techniques for conducting and reporting micro

  14. System-wide analysis of health financing equity in Cambodia: a study protocol

    PubMed Central

    Wiseman, Virginia; Asante, Augustine; Ir, Por; Limwattananon, Supon; Jacobs, Bart; Liverani, Marco; Hayen, Andrew; Jan, Stephen

    2017-01-01

    Background To assess progress towards universal health coverage, countries like Cambodia require evidence on equity in the financing and distribution of healthcare benefits. This evidence must be based on a system-wide perspective that recognises the complex roles played by the public and private sectors in many contemporary healthcare systems. Objective To undertake a system-wide assessment of who pays and who benefits from healthcare in Cambodia and to understand the factors influencing this. Methods Financing and benefit incidence analysis will be used to calculate the financing burden and distribution of healthcare benefits across socioeconomic groups. Data on healthcare usage, living standards and self-assessed health status will be derived from a cross-sectional household survey designed for this study involving a random sample of 5000 households. This will be supplemented by secondary data from the Cambodian National Health Accounts 2014 and the Cambodian Socioeconomic Survey (CSES) 2014. We will also collect qualitative data through focus group discussions and in-depth interviews to inform the interpretation of the quantitative analyses. Potential impact This study will produce previously unavailable information on who pays for, and who benefits from, health services across the entire health system of Cambodia. This evidence comes at a critical juncture in healthcare reform in South-East Asia with so many countries seeking guidance on the equity impact of their current financing arrangements that include a complex mix of public and private providers. PMID:28589000

  15. Disease, activity and schoolchildren's health (DASH) in Port Elizabeth, South Africa: a study protocol.

    PubMed

    Yap, Peiling; Müller, Ivan; Walter, Cheryl; Seelig, Harald; Gerber, Markus; Steinmann, Peter; Damons, Bruce P; Smith, Danielle; Gall, Stefanie; Bänninger, Dominique; Hager, Thomas; Htun, Nan S N; Steenkamp, Liana; Gresse, Annelie; Probst-Hensch, Nicole; Utzinger, Jürg; Du Randt, Rosa; Pühse, Uwe

    2015-12-23

    An in-depth epidemiological investigation on intestinal parasite infections in an impoverished area of Port Elizabeth, South Africa provides a unique opportunity for research on its impact on children's physical fitness, cognitive performance and psychosocial health. Additionally, we will screen risk factors for the development of diabetes and hypertension in adulthood. A 2-year longitudinal cohort study will be conducted, consisting of three cross-sectional surveys (baseline and two follow-ups), in eight historically black and coloured (mixed race) primary schools located in different townships in Port Elizabeth, South Africa. Approximately 1000 Grade 4 primary schoolchildren, aged 8 to 12 years, will be enrolled and followed. At each survey, disease status, anthropometry and levels of physical fitness, cognitive performance and psychosocial health will be assessed. After each survey, individuals diagnosed with parasitic worm infections will be treated with anthelminthic drugs, while children with other infections will be referred to local clinics. Based on baseline results, interventions will be tailored to the local settings, embedded within the study and implemented in half of the schools, while the remaining schools will serve as controls. Implementation of the interventions will take place over two 8-week periods. The effect of interventions will be determined with predefined health parameters. This study will shed new light on the health burden incurred by children in deprived urban settings of South Africa and provide guidance for specific health interventions. Challenges foreseen in the conduct of this study include: (i) difficulty in obtaining written informed consent from parents/guardians; (ii) administration of questionnaires in schools where three languages are spoken (Afrikaans, Xhosa and English); (iii) challenges in grasping concepts of psychosocial health among schoolchildren using a questionnaire; and (iv) loss to follow-up due to the study

  16. [The INHES cohort study on the health status of nurses in Italy: research protocol].

    PubMed

    Calzoni, L; Filippone, A M; Mannocci, A; Germani, T; Menafra, R; Pulimeno, A; Cicolini, G; Manzoli, L; Boccia, A; La Torre, G

    2011-01-01

    Due to the intense emotional involvement and the often problematic working conditions characterizing their profession, Nurses appear to be especially susceptible to the negative effects of a complex set of stressors, with important repercussions to their health. Nevertheless, scientific literature assessing the health status of Nurses in Italy is still scarce. With INHES (Italian Nurses' HEalth Study), we propose to remedy this gap by implementing a cohort study which will start from the analysis of some local healthcare facilities and which may subsequently extend throughout the country. Study participants will be Nurses selected according to the following inclusion criteria: 1) age between 30 and 55 years; 2) having been employed in the current healthfacilityfor the last five years; 3) having performed care duties in wards or in day care services for the last five years. The objectives of this study, which will be carried out through the administration of a validated questionnaire, are the following: to measure the incidence and prevalence rates of a series of diseases in the nursing population, highlighting potential correlations with working activity, job-related stress or environmental and personal risk factors; to assess the quality of life and psychological health of the participants, evaluating the interference of psychophysical disorders with their work and social activities; to investigate the implementation of wellness promotion, prevention, case management and disability management policies by healthcare facilities. The evidence gathered will provide a valid scientific support for the development of more effective policies for protecting Nurses' health, with positive social and economic repercussions for the entire community.

  17. The OPtimising HEalth LIterAcy (Ophelia) process: study protocol for using health literacy profiling and community engagement to create and implement health reform

    PubMed Central

    2014-01-01

    Background Health literacy is a multi-dimensional concept comprising a range of cognitive, affective, social, and personal skills and attributes. This paper describes the research and development protocol for a large communities-based collaborative project in Victoria, Australia that aims to identify and respond to health literacy issues for people with chronic conditions. The project, called Ophelia (OPtimising HEalth LIterAcy) Victoria, is a partnership between two universities, eight service organisations and the Victorian Government. Based on the identified issues, it will develop and pilot health literacy interventions across eight disparate health services to inform the creation of a health literacy response framework to improve health outcomes and reduce health inequalities. Methods/Design The protocol draws on many inputs including the experience of the partners in previous co-creation and roll-out of large-scale health-promotion initiatives. Three key conceptual models/discourses inform the protocol: intervention mapping; quality improvement collaboratives, and realist synthesis. The protocol is outcomes-oriented and focuses on two key questions: ‘What are the health literacy strengths and weaknesses of clients of participating sites?’, and ‘How do sites interpret and respond to these in order to achieve positive health and equity outcomes for their clients?’. The process has six steps in three main phases. The first phase is a needs assessment that uses the Health Literacy Questionnaire (HLQ), a multi-dimensional measure of health literacy, to identify common health literacy needs among clients. The second phase involves front-line staff and management within each service organisation in co-creating intervention plans to strategically respond to the identified local needs. The third phase will trial the interventions within each site to determine if the site can improve identified limitations to service access and/or health outcomes. Discussion

  18. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Methods/Design Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m2 and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. Discussion A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. Trial registration ClinicalTrials.gov Identifier NCT01060540 PMID:22852560

  19. Examining the impact of genetic testing for type 2 diabetes on health behaviors: study protocol for a randomized controlled trial.

    PubMed

    Voils, Corrine I; Coffman, Cynthia J; Edelman, David; Maciejewski, Matthew L; Grubber, Janet M; Sadeghpour, Azita; Cho, Alex; McKenzie, Jamiyla; Blanpain, Francoise; Scheuner, Maren; Sandelowski, Margarete; Gallagher, M Patrick; Ginsburg, Geoffrey S; Yancy, William S

    2012-08-01

    We describe the study design, procedures, and development of the risk counseling protocol used in a randomized controlled trial to evaluate the impact of genetic testing for diabetes mellitus (DM) on psychological, health behavior, and clinical outcomes. Eligible patients are aged 21 to 65 years with body mass index (BMI) ≥27 kg/m(2) and no prior diagnosis of DM. At baseline, conventional DM risk factors are assessed, and blood is drawn for possible genetic testing. Participants are randomized to receive conventional risk counseling for DM with eye disease counseling or with genetic test results. The counseling protocol was pilot tested to identify an acceptable graphical format for conveying risk estimates and match the length of the eye disease to genetic counseling. Risk estimates are presented with a vertical bar graph denoting risk level with colors and descriptors. After receiving either genetic counseling regarding risk for DM or control counseling on eye disease, brief lifestyle counseling for prevention of DM is provided to all participants. A standardized risk counseling protocol is being used in a randomized trial of 600 participants. Results of this trial will inform policy about whether risk counseling should include genetic counseling. ClinicalTrials.gov Identifier NCT01060540.

  20. Same-Day Counseling: Study Protocol for the Evaluation of a New Mental Health Service

    PubMed Central

    Ewen, Victoria; Bailey, Kathleen; Haggarty, John M; Dama, Sumeet; Mushquash, Christopher J

    2016-01-01

    Background Single-session counseling is being implemented across Canada to increase the accessibility and availability of mental health services. Despite increasing use, existing research on single-session counseling is sparse and has methodological limitations. In addition, some stakeholders are skeptical that this model of care can support meaningful change for clients. Objective The aim of this study is to evaluate a new single-session counseling program (called Same-Day Counseling) offered in an outpatient community mental health clinic in Northwestern Ontario, Canada. Methods Clients who attend Same-Day Counseling services will be given the opportunity to participate in the program evaluation. Those who consent will complete measures before their session, after their session, and at 1-month follow-up. Data will provide information on who accesses Same-Day Counseling (eg, typical presenting problems, symptom severity), client satisfaction with services, and whether clients benefit from the services (eg, improved functioning and reduced symptom severity). Results Data collection is underway with 80 participants having completed baseline measures and 55 participants having completed follow-up measures. Data collection is expected to conclude in December 2015. Conclusions This study is designed to contribute to the literature regarding the integration of single-session counseling into ongoing mental health services, with additional attention to methodological rigour. Our approach will help to address ongoing concerns regarding the implementation of single-session counseling, and inform health care providers and policy makers regarding the utility of this model for addressing the mental health care need of the community. PMID:26842891

  1. Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial.

    PubMed

    Groenen, Carola J M; Faber, Marjan J; Kremer, Jan A M; Vandenbussche, Frank P H A; van Duijnhoven, Noortje T L

    2016-04-16

    A personal health record (PHR) is an online application through which individuals can access, manage, and share their health information in a private, secure, and confidential environment. Personal health records empower patients, facilitate collaboration among healthcare professionals, and improve health outcomes. Given these anticipated positive effects, we want to implement a PHR, named MyPregn@ncy, in a Dutch maternity care setting and to evaluate its effects in routine care. This paper presents the study protocol. The effects of implementing a PHR in maternity care on patients and professionals will be identified in a stepped-wedge, cluster-randomised, controlled trial. The study will be performed in the region of Nijmegen, a Dutch area with an average of 4,500 births a year and more than 230 healthcare professionals involved in maternity care. Data analyses will describe the effects of MyPregn@ncy on health outcomes in maternity care, quality of care from the patients' perspectives, and collaboration among healthcare professionals. Additionally, a process evaluation of the implementation of MyPregn@ncy will be performed. Data will be collected using data from the Dutch perinatal registry, questionnaires, interviews, and log data. The study is expected to yield new information about the effects, strengths, possibilities, and challenges to the implementation and usage of a PHR in routine maternal care settings. Results may lead to new insights and improvements in the quality of maternal and perinatal care. Netherlands Trial Register: NTR4063.

  2. WittyFit—Live Your Work Differently: Study Protocol for a Workplace-Delivered Health Promotion

    PubMed Central

    Duclos, Martine; Naughton, Geraldine; Dewavrin, Samuel; Cornet, Thomas; Huguet, Pascal; Chatard, Jean-Claude; Pereira, Bruno

    2017-01-01

    Background Morbidity before retirement has a huge cost, burdening both public health and workplace finances. Multiple factors increase morbidity such as stress at work, sedentary behavior or low physical activity, and poor nutrition practices. Nowadays, the digital world offers infinite opportunities to interact with workers. The WittyFit software was designed to understand holistic issues of workers by promoting individualized behavior changes at the workplace. Objective The shorter term feasibility objective is to demonstrate that effective use of WittyFit will increase well-being and improve health-related behaviors. The mid-term objective is to demonstrate that WittyFit improves economic data of the companies such as productivity and benefits. The ultimate objective is to increase life expectancy of workers. Methods This is an exploratory interventional cohort study in an ecological situation. Three groups of participants will be purposefully sampled: employees, middle managers, and executive managers. Four levels of engagement are planned for employees: commencing with baseline health profiling from validated questionnaires; individualized feedback based on evidence-based medicine; support for behavioral change; and formal evaluation of changes in knowledge, practices, and health outcomes over time. Middle managers will also receive anonymous feedback on problems encountered by employees, and executive top managers will have indicators by division, location, department, age, seniority, gender and occupational position. Managers will be able to introduce specific initiatives in the workplace. WittyFit is based on two databases: behavioral data (WittyFit) and medical data (WittyFit Research). Statistical analyses will incorporate morbidity and well-being data. When a worker leaves a workplace, the company documents one of three major explanations: retirement, relocation to another company, or premature death. Therefore, WittyFit will have the ability to include

  3. Policy to implementation: evidence-based practice in community mental healthstudy protocol

    PubMed Central

    2013-01-01

    Background Evidence-based treatments (EBTs) are not widely available in community mental health settings. In response to the call for implementation of evidence-based treatments in the United States, states and counties have mandated behavioral health reform through policies and other initiatives. Evaluations of the impact of these policies on implementation are rare. A systems transformation about to occur in Philadelphia, Pennsylvania, offers an important opportunity to prospectively study implementation in response to a policy mandate. Methods/design Using a prospective sequential mixed-methods design, with observations at multiple points in time, we will investigate the responses of staff from 30 community mental health clinics to a policy from the Department of Behavioral Health encouraging and incentivizing providers to implement evidence-based treatments to treat youth with mental health problems. Study participants will be 30 executive directors, 30 clinical directors, and 240 therapists. Data will be collected prior to the policy implementation, and then at two and four years following policy implementation. Quantitative data will include measures of intervention implementation and potential moderators of implementation (i.e., organizational- and leader-level variables) and will be collected from executive directors, clinical directors, and therapists. Measures include self-reported therapist fidelity to evidence-based treatment techniques as measured by the Therapist Procedures Checklist-Revised, organizational variables as measured by the Organizational Social Context Measurement System and the Implementation Climate Assessment, leader variables as measured by the Multifactor Leadership Questionnaire, attitudes towards EBTs as measured by the Evidence-Based Practice Attitude Scale, and knowledge of EBTs as measured by the Knowledge of Evidence- Based Services Questionnaire. Qualitative data will include semi-structured interviews with a subset of the

  4. Health-related quality of life among colorectal cancer patients in Malaysia: a study protocol

    PubMed Central

    2012-01-01

    Background Colorectal cancer is a major public health problem in Malaysia. However, it is also one of the most treatable cancers, resulting in significant numbers of survivors. Therefore, the impact of surviving treatment for colorectal cancer on health related quality of life is important for the patients, clinicians and policy makers, and may differ in different cultures and populations. The aim of this study was to validate the Malaysian versions of the European Organization for Research and Treatment of Cancer quality of life instruments among colorectal cancers patients. Methods/design This is a cross sectional multi centre study. Three hospitals were included, the University of Malaya Medical Centre, the Universiti Kebangsaan Malaysia Medical Centre and Hospital Tuanku Jaafar Seremban. Malaysian citizens and permanent residence were studied and demographic and clinical information obtained from hospital records. The European Organization for Research and Treatment of Cancer Quality of life Core 30, colorectal cancer CR29, and the colorectal cancer liver metastasis LMC 21 were used and an observer assessment of performance obtained with the Karnofsky Performance Scale. Questionnaires were translated into three most commonly spoken languages in Malaysia (Bahasa Malaysia, Chinese and Tamil), then administered, scored and analyzed following the developers’ guidelines. Ethical approval was obtained from the participating centres. Tests of reliability and validity were performed to examine the validity of these instruments. Conclusion The result of pilot testing shows that the use of the Malaysian versions of EORTC QLQ C30, CR29 instruments is feasible in our sample of colorectal cancer patients. Instructions for completion as well as questions were well understood except the questions on the overall quality of life, overall health status and sexual activity. Thus we anticipate obtaining good psychometric properties for the instruments at the end of the study

  5. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study.

    PubMed

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-02-16

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines.

  6. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study

    PubMed Central

    Wade, Alexandra T.; Davis, Courtney R.; Dyer, Kathryn A.; Hodgson, Jonathan M.; Woodman, Richard J.; Keage, Hannah A. D.; Murphy, Karen J.

    2017-01-01

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines. PMID:28212320

  7. Study Protocol: A randomized controlled trial of patient navigation-activation to reduce cancer health disparities

    PubMed Central

    2010-01-01

    Background Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment. Methods/Design The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge. Discussion This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs. Trials Registration clinicaltrials.gov identifier NCT00496678 PMID:20939928

  8. Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study

    PubMed Central

    Marcano-Belisario, José S; Gupta, Ajay K; O'Donoghue, John; Morrison, Cecily; Car, Josip

    2016-01-01

    Introduction Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices. Methods and analysis We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages. Ethics and dissemination This study has been approved by the National Research Ethics Service Committee South East Coast—Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers. PMID:26801468

  9. Tablet computers for implementing NICE antenatal mental health guidelines: protocol of a feasibility study.

    PubMed

    Marcano-Belisario, José S; Gupta, Ajay K; O'Donoghue, John; Morrison, Cecily; Car, Josip

    2016-01-22

    Depression is one of the most common mental health disorders that may affect women during pregnancy. The prompt identification of this disorder, and the provision of treatment, may help to reduce the likelihood of post-partum depression, prevent severe forms of the disease, and reduce its intergenerational impact. Despite women's repeated encounters with health services throughout their antenatal care, depression often goes undiagnosed. This is one area where mobile health could prove useful. We will assess the feasibility of using tablets to incorporate depression screening into antenatal pathways. We will also assess if survey layout could affect the quality of the data collected through these devices. We will test the feasibility of using iPad Airs for the administration of the Whooley questions and the Edinburgh Postnatal Depression Scale (EPDS) to pregnant women attending antenatal clinics in England. We will assess the impact of survey layout on the quality of the responses given to these screening scales using a parallel, randomised controlled study design. We will calculate the positive predictive value, the negative predictive value and the false omission rate of the Whooley questions in comparison with the EPDS. We will calculate differences in data equivalence, time needed to complete the surveys, break-off rates, data completeness and requests for help between the 2 experimental groups: using all questions in one screen and navigation by vertical scrolling, or a single question per screen and navigation by multiple pages. This study has been approved by the National Research Ethics Service Committee South East Coast--Surrey. Our findings will be disseminated through academic peer-reviewed publications, conferences and discussion with peers. 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/

  10. Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project.

    PubMed

    Quintana, José M; Gonzalez, Nerea; Anton-Ladislao, Ane; Redondo, Maximino; Bare, Marisa; Fernandez de Larrea, Nerea; Briones, Eduardo; Escobar, Antonio; Sarasqueta, Cristina; Garcia-Gutierrez, Susana; Aguirre, Urko

    2016-07-08

    Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients. a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention. In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models. The identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this

  11. The ASTUTE Health study protocol: Deliberative stakeholder engagements to inform implementation approaches to healthcare disinvestment

    PubMed Central

    2012-01-01

    Background Governments and other payers are yet to determine optimal processes by which to review the safety, effectiveness, and cost-effectiveness of technologies and procedures that are in active use within health systems, and rescind funding (partially or fully) from those that display poor profiles against these parameters. To further progress a disinvestment agenda, a model is required to support payers in implementing disinvestment in a transparent manner that may withstand challenge from vested interests and concerned citizens. Combining approaches from health technology assessment and deliberative democratic theory, this project seeks to determine if and how wide stakeholder engagement can contribute to improved decision-making processes, wherein the views of both vested and non-vested stakeholders are seen to contribute to informing policy implementation within a disinvestment context. Methods/design Systematic reviews pertaining to illustrative case studies were developed and formed the evidence base for discussion. Review findings were presented at a series of deliberative, evidence-informed stakeholder engagements, including partisan (clinicians and consumers) and non-partisan (representative community members) stakeholders. Participants were actively facilitated towards identifying shared and dissenting perspectives regarding public funding policy for each of the case studies and developing their own funding models in response to the evidence presented. Policy advisors will subsequently be invited to evaluate disinvestment options based on the scientific and colloquial evidence presented to them, and to explore the value of this information to their decision-making processes with reference to disinvestment. Discussion Analysis of the varied outputs of the deliberative engagements will contribute to the methodological development around how to best integrate scientific and colloquial evidence for consideration by policy advisors. It may contribute to

  12. Musculoskeletal health and work ability in physically demanding occupations: study protocol for a prospective field study on construction and health care workers.

    PubMed

    Lunde, Lars-Kristian; Koch, Markus; Knardahl, Stein; Wærsted, Morten; Mathiassen, Svend Erik; Forsman, Mikael; Holtermann, Andreas; Veiersted, Kaj Bo

    2014-10-16

    Musculoskeletal disorders have a profound impact on individual health, sickness absence and early retirement, particularly in physically demanding occupations. Demographics are changing in the developed countries, towards increasing proportions of senior workers. These senior workers may have particular difficulties coping with physically demanding occupations while maintaining good health. Previous studies investigating the relationship between physical work demands and musculoskeletal disorders are mainly based on self-reported exposures and lack a prospective design. The aim of this paper is to describe the background and methods and discuss challenges for a field study examining physical demands in construction and health care work and their prospective associations with musculoskeletal disorders, work ability and sickness absence. This protocol describes a prospective cohort study on 1200 construction and health care workers. Participants will answer a baseline questionnaire concerning musculoskeletal complaints, general health, psychosocial and organizational factors at work, work demands, work ability and physical activity during leisure. A shorter questionnaire will be answered every 6th months for a total of two years, together with continuous sickness absence monitoring during this period. Analysis will prospectively consider associations between self-reported physical demands and musculoskeletal disorders, work ability and sickness absence. To obtain objective data on physical exposures, technical measurements will be collected from two subgroups of N = 300 (Group A) and N = 160 (Group B) during work and leisure. Both group A and B will be given a physical health examination, be tested for physical capacity and physical activity will be measured for four days. Additionally, muscle activity, ground reaction force, body positions and physical activity will be examined during one workday for Group B. Analysis of associations between objectively measured

  13. Advancing Migrant Access to Health Services in Europe (AMASE): Protocol for a Cross-sectional Study

    PubMed Central

    Álvarez-del Arco, Débora; Monge, Susana; Copas, Andrew J; Gennotte, Anne-Francoise; Volny-Anne, Alain; Göpel, Siri; Touloumi, Giota; Prins, Maria; Barros, Henrique; Staehelin, Cornelia; del Amo, Julia; Burns, Fiona M

    2016-01-01

    Background Migrants form a substantial proportion of the population affected by the human immunodeficiency virus (HIV) epidemic in Europe, yet HIV prevention for this population is hindered by poor understanding of access to care and of postmigration transmission dynamics. Objective We present the design and methods of the advancing Migrant Access to health Services in Europe (aMASE) study, the first European cross-cultural study focused on multiple migrant populations. It aims to identify the structural, cultural, and financial barriers to HIV prevention, diagnosis, and treatment and to determine the likely country of HIV acquisition in HIV-positive migrant populations. Methods We delivered 2 cross-sectional electronic surveys across 10 countries (Belgium, France, Germany, Greece, Italy, the Netherlands, Portugal, Spain, Switzerland, and United Kingdom). A clinic survey aimed to recruit up to 2000 HIV-positive patients from 57 HIV clinics in 9 countries. A unique study number linked anonymized questionnaire data to clinical records data (viral loads, CD4 cell counts, viral clades, etc). This questionnaire was developed by expert panel consensus and cognitively tested, and a pilot study was carried out in 2 countries. A Web-based community survey (n=1000) reached those living with HIV but not currently accessing HIV clinics, as well as HIV-negative migrants. It was developed in close collaboration with a community advisory group (CAG) made up of representatives from community organizations in 9 of the participating countries. The CAG played a key role in data collection by promoting the survey to higher-risk migrant groups (sub-Saharan Africans, Latin Americans, men who have sex with men, and people who inject drugs). The questionnaires have considerable content overlap, allowing for comparison. Questions cover ethnicity, migration, immigration status, HIV testing and treatment, health-seeking behavior, sexual risk, and drug use. The electronic questionnaires

  14. A National Surveillance Survey on Noncommunicable Disease Risk Factors: Suriname Health Study Protocol

    PubMed Central

    Smits, Christel CF; Jaddoe, Vincent WV; Hofman, Albert; Toelsie, Jerry R

    2015-01-01

    Background Noncommunicable diseases (NCDs) are the leading cause of death in low- and middle-income countries. Therefore, the surveillance of risk factors has become an issue of major importance for planning and implementation of preventive measures. Unfortunately, in these countries data on NCDs and their risk factors are limited. This also prevails in Suriname, a middle-income country of the Caribbean, with a multiethnic/multicultural population living in diverse residential areas. For these reasons, “The Suriname Health Study” was designed. Objective The main objective of this study is to estimate the prevalence of NCD risk factors, including metabolic syndrome, hypertension, and diabetes in Suriname. Differences between specific age groups, sexes, ethnic groups, and geographical areas will be emphasized. In addition, risk groups will be identified and targeted actions will be designed and evaluated. Methods In this study, several methodologies were combined. A stratified multistage cluster sample was used to select the participants of 6 ethnic groups (Hindustani, Creole, Javanese, Maroon, Chinese, Amerindians, and mixed) divided into 5 age groups (between 15 and 65 years) who live in urban/rural areas or the hinterland. A standardized World Health Organization STEPwise approach to surveillance questionnaire was adapted and used to obtain information about demographic characteristics, lifestyle, and risk factors. Physical examinations were performed to measure blood pressure, height, weight, and waist circumference. Biochemical analysis of collected blood samples evaluated the levels of glucose, high-density-lipoprotein cholesterol, total cholesterol, and triglycerides. Statistical analysis will be used to identify the burden of modifiable and unmodifiable risk factors in the aforementioned subgroups. Subsequently, tailor-made interventions will be prepared and their effects will be evaluated. Results The data as collected allow for national inference and

  15. The acceptance and commitment therapy for smoking cessation in the primary health care setting: a study protocol.

    PubMed

    Mak, Yim Wah; Loke, Alice Yuen

    2015-02-07

    Access to effective smoking cessation programs is crucial to reducing smoking-related morbidity and mortality. Several studies have shown promising results for the application of Acceptance and Commitment Therapy (ACT) in managing psychological or behavioral health problems. However, to date, only one study has examined the feasibility of a telephone-based ACT for smoking cessation and it was conducted among a Western population, in the United States. This study reports a protocol for a randomized controlled trial (RCT) examining the feasibility and potential efficacy of an individual, telephone-delivered ACT for smoking cessation in primary healthcare settings among a Chinese population. A randomized, two-group design was chosen, with assessment at baseline (before intervention) and via telephone follow-ups at three and six months. Subjects will be proactively recruited from primary healthcare centers. Eligible participants will be randomized to either the intervention (ACT) or control group following the baseline assessment. Both groups will receive self-help materials on smoking cessation. Those in the ACT group will undergo an initial face-to-face session and two telephone ACT sessions at one week and one month following the first session, to be delivered by a counselor based on the treatment protocol. All of the participants will be contacted by telephone for follow-up assessments at three and six months. Treatment fidelity will be assessed by reviewing around one-fifth of audio-recorded telephone calls. To the best of our knowledge, this protocol describes the first RCT of a telephone-based ACT for smoking cessation. It is also the first RCT of ACT for smoking cessation on a Chinese population. The study will provide us with information about the feasibility of a telephone-delivered ACT within a Chinese sample. If effective, this trial will support the development of ACT treatment protocols that could be made available for use by a greater range of clinicians

  16. Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial.

    PubMed

    Levenson, Jessica C; Rollman, Bruce L; Ritterband, Lee M; Strollo, Patrick J; Smith, Kenneth J; Yabes, Jonathan G; Moore, Charity G; Harvey, Allison G; Buysse, Daniel J

    2017-06-06

    Insomnia is common in primary care medical practices. Although behavioral treatments for insomnia are safe, efficacious, and recommended in practice guidelines, they are not widely-available, and their effects on comorbid medical conditions remain uncertain. We are conducting a pragmatic clinical trial to test the efficacy of two cognitive behavioral treatments for insomnia (Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi)) versus an enhanced usual care condition (EUC). The study is a three-arm, parallel group, randomized controlled trial. Participants include 625 adults with hypertension and insomnia, recruited via electronic health records from primary care practices affiliated with a large academic medical center. After screening and baseline assessments, participants are randomized to treatment. BBTI is delivered individually with a live therapist via web-interface/telehealth sessions, while SHUTi is a self-guided, automated, interactive, web-based form of cognitive behavioral therapy for insomnia. Participants in EUC receive an individualized sleep report, educational resources, and an online educational video. Treatment outcomes are measured at 9 weeks, 6 months, and 12 months. The primary outcome is patient-reported sleep disturbances. Secondary outcomes include other self-reported sleep measures, home blood pressure, body mass index, quality of life, health functioning, healthcare utilization, and side effects. This randomized clinical trial compares two efficacious insomnia interventions to EUC, and provides a cost-effective and efficient examination of their similarities and differences. The pragmatic orientation of this trial may impact sleep treatment delivery in real world clinical settings and advance the dissemination and implementation of behavioral sleep interventions. ClinicalTrials.gov (Identifier: NCT02508129 ; Date Registered: July 21, 2015).

  17. Processes and Outcomes of the Veterans Health Administration Safe Patient Handling Program: Study Protocol

    PubMed Central

    Toyinbo, Peter; Patel, Nitin; Powell-Cope, Gail; Hahm, Bridget; Elnitsky, Christine; Besterman-Dahan, Karen; Campbell, Robert; Sutton, Bryce

    2013-01-01

    Background Health care workers, such as nurses, nursing aides, orderlies, and attendants, who manually move patients, are consistently listed in the top professions for musculoskeletal injuries (MSIs) by the Bureau of Labor Statistics. These MSIs are typically caused by high-risk patient caregiving activities. In 2008, a safe patient handling (SPH) program was implemented in all 153 Veterans Administration Medical Centers (VAMCs) throughout the United States to reduce patient handling injuries. Objective The goal of the present study is to evaluate the effects associated with the national implementation of a comprehensive SPH program. The primary objectives of the research were to determine the effectiveness of the SPH program in improving direct care nursing outcomes and to provide a context for understanding variations in program results across sites over time. Secondary objectives of the present research were to evaluate the effectiveness of the program in reducing direct and indirect costs associated with patient handling, to explore the potential mediating and moderating mechanisms, and to identify unintended consequences of implementing the program. Methods This 3-year longitudinal study used mixed methods of data collection at 6- to 9-month intervals. The analyses will include data from surveys, administrative databases, individual and focus group interviews, and nonparticipant observations. For this study, a 3-tiered measurement plan was used. For Tier 1, the unit of analysis was the facility, the data source was the facility coordinator or administrative data, and all 153 VAMCs participated. For Tier 2, frontline caregivers and program peer leaders at 17 facilities each completed different surveys. For Tier 3, six facilities completed qualitative site visits, which included individual interviews, focus groups, and nonparticipant observations. Multiple regression models were proposed to test the effects of SPH components on nursing outcomes related to

  18. Simulation modelling as a tool for knowledge mobilisation in health policy settings: a case study protocol.

    PubMed

    Freebairn, L; Atkinson, J; Kelly, P; McDonnell, G; Rychetnik, L

    2016-09-21

    Evidence-informed decision-making is essential to ensure that health programs and services are effective and offer value for money; however, barriers to the use of evidence persist. Emerging systems science approaches and advances in technology are providing new methods and tools to facilitate evidence-based decision-making. Simulation modelling offers a unique tool for synthesising and leveraging existing evidence, data and expert local knowledge to examine, in a robust, low risk and low cost way, the likely impact of alternative policy and service provision scenarios. This case study will evaluate participatory simulation modelling to inform the prevention and management of gestational diabetes mellitus (GDM). The risks associated with GDM are well recognised; however, debate remains regarding diagnostic thresholds and whether screening and treatment to reduce maternal glucose levels reduce the associated risks. A diagnosis of GDM may provide a leverage point for multidisciplinary lifestyle modification interventions. This research will apply and evaluate a simulation modelling approach to understand the complex interrelation of factors that drive GDM rates, test options for screening and interventions, and optimise the use of evidence to inform policy and program decision-making. The study design will use mixed methods to achieve the objectives. Policy, clinical practice and research experts will work collaboratively to develop, test and validate a simulation model of GDM in the Australian Capital Territory (ACT). The model will be applied to support evidence-informed policy dialogues with diverse stakeholders for the management of GDM in the ACT. Qualitative methods will be used to evaluate simulation modelling as an evidence synthesis tool to support evidence-based decision-making. Interviews and analysis of workshop recordings will focus on the participants' engagement in the modelling process; perceived value of the participatory process, perceived

  19. Protocol and methodology of Study epidemiological mental health in Andalusia: PISMA-ep.

    PubMed

    Cervilla, Jorge A; Ruiz, Isabel; Rodríguez-Barranco, Miguel; Rivera, Margarita; Ibáñez-Casas, Inmaculada; Molina, Esther; Valmisa, Eulalio; Carmona-Calvo, José; Moreno-Küstner, Berta; Muñoz-Negro, José Eduardo; Ching-López, Ana; Gutiérrez, Blanca

    This is the general methods describing paper of a cross-sectional study that aims to detect the prevalence of major mental disorders in Andalusia (Southern Spain), and their correlates or potential risk factors, using a large representative sample of community-dwelling adults. This is a cross-sectional study. We undertook a multistage sampling using different standard stratification levels and aimed to interview 4,518 randomly selected participants living in all 8 provinces of the Andalusian region utilizing a door-knocking approach. The Spanish version of the MINI International Neuropsychiatric Interview, a valid screening instrument ascertaining ICD-10/DSM-IV compatible mental disorder diagnoses was used as our main diagnostic tool. A large battery of other instruments was used to explore global functionality, medical comorbidity, personality traits, cognitive function and exposure to psychosocial potential risk factors. A saliva sample for DNA extraction was also obtained for a sub-genetic study. The interviews were administered and completed by fully trained interviewers, despite most tools used are compatible with lay interviewer use. A total of 3,892 (70.8%) of 5,496 initially attempted households had to be substituted for equivalent ones due to either no response (37.7%) or not fulfilling the required participant quota (33%). Thence, out of 5,496 eligible participants finally approached, 4,507 (83.7%) agreed to take part in the study, completed the interview and were finally included in the study (n=4,507) and 4,286 (78%) participants also agreed and consented to provide a saliva sample for DNA study. On the other hand, 989 (16.3%) approached potential participants refused to take part in the study. This is the largest mental health epidemiological study developed in the region of Spain (Andalusia). The response rates and representativeness of the sample obtained are fairly high. The method is particularly comprehensive for this sort of studies and includes

  20. Making sense of health information technology implementation: A qualitative study protocol

    PubMed Central

    2010-01-01

    Background Implementing new practices, such as health information technology (HIT), is often difficult due to the disruption of the highly coordinated, interdependent processes (e.g., information exchange, communication, relationships) of providing care in hospitals. Thus, HIT implementation may occur slowly as staff members observe and make sense of unexpected disruptions in care. As a critical organizational function, sensemaking, defined as the social process of searching for answers and meaning which drive action, leads to unified understanding, learning, and effective problem solving -- strategies that studies have linked to successful change. Project teamwork is a change strategy increasingly used by hospitals that facilitates sensemaking by providing a formal mechanism for team members to share ideas, construct the meaning of events, and take next actions. Methods In this longitudinal case study, we aim to examine project teams' sensemaking and action as the team prepares to implement new information technology in a tiertiary care hospital. Based on management and healthcare literature on HIT implementation and project teamwork, we chose sensemaking as an alternative to traditional models for understanding organizational change and teamwork. Our methods choices are derived from this conceptual framework. Data on project team interactions will be prospectively collected through direct observation and organizational document review. Through qualitative methods, we will identify sensemaking patterns and explore variation in sensemaking across teams. Participant demographics will be used to explore variation in sensemaking patterns. Discussion Outcomes of this research will be new knowledge about sensemaking patterns of project teams, such as: the antecedents and consequences of the ongoing, evolutionary, social process of implementing HIT; the internal and external factors that influence the project team, including team composition, team member interaction, and

  1. Educating for health service reform: clinical learning, governance and capability - a case study protocol.

    PubMed

    Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

    2016-01-01

    The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. A case study design will be used to investigate educational governance and capability theory in nurse practitioner education. Nurse practitioner students, their clinical mentors and university academic staff, from an Australian university that offers an accredited nurse practitioner Master's degree, will be invited to participate in the study. Semi-structured interviews will be conducted with students and their respective clinical mentors and university academic staff to investigate learning objectives related to educational governance and attributes of capability learning. Limited demographic data on age, gender, specialty, education level and nature of the clinical healthcare learning site will also be collected. Episodes of nurse practitioner student specialty clinical learning will be observed and documentation from the students' healthcare learning sites will be collected. Descriptive statistics will be used to report age groups, areas of specialty and types of facilities where clinical learning and teaching is observed. Qualitative data from interviews, observations and student documents will be coded, aggregated and explored to inform a framework of educational governance, to confirm the existing capability framework and describe any additional characteristics of capability and capability learning. This research has widespread significance and will contribute to ongoing development of the Australian health workforce. Stakeholders from industry and academic bodies will be involved in shaping the framework that

  2. A theory-based online health behavior intervention for new university students: study protocol

    PubMed Central

    2013-01-01

    Background Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Methods/design Potential participants (all undergraduates about to enter the University of Sheffield) will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni) or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions) to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking). Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy) as well as socio-demographic variables, health status, Body Mass Index (BMI), health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. Discussion The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote healthy behaviors among new

  3. A theory-based online health behavior intervention for new university students: study protocol.

    PubMed

    Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L; Ciravegna, Fabio; Brennan, Alan; Meier, Petra; Julious, Steven A; Naughton, Declan; Petroczi, Andrea; Dadzie, Aba-Sah; Kruger, Jen

    2013-02-05

    Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Potential participants (all undergraduates about to enter the University of Sheffield) will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni) or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions) to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking). Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy) as well as socio-demographic variables, health status, Body Mass Index (BMI), health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote healthy behaviors among new undergraduates. Current Controlled

  4. South Yorkshire Cohort: a 'cohort trials facility' study of health and weight - Protocol for the recruitment phase

    PubMed Central

    2011-01-01

    Background Growing levels of both obesity and chronic disease in the general population pose a major public health problem. In the UK, an innovative 'health and weight' cohort trials facility, the 'South Yorkshire Cohort', is being built in order to provide robust evidence to inform policy, commissioning and clinical decisions in this field. This protocol reports the design of the facility and outlines the recruitment phase methods. Method/Design The South Yorkshire Cohort health and weight study uses the cohort multiple randomised controlled trial design. This design recruits a large observational cohort of patients with the condition(s) of interest which then provides a facility for multiple randomised controlled trials (with large representative samples of participants, long term outcomes as standard, increased comparability between each trial conducted within the cohort and increased efficiency particularly for trials of expensive interventions) as well as ongoing information as to the natural history of the condition and treatment as usual. This study aims to recruit 20,000 participants to the population based South Yorkshire Cohort health and weight research trials facility. Participants are recruited by invitation letters from their General Practitioners. Data is collected using postal and/or online patient self completed Health Questionnaires. NHS numbers will be used to facilitate record linkage and access to routine data. Participants are eligible if they are: aged 16 - 85 years, registered with one of 40 practices in South Yorkshire, provide consent for further contact from the researchers and to have their information used to look at the benefit of health treatments. The first wave of data is being collected during 2010/12 and further waves are planned at 2 - 5 year intervals for the planned 20 year duration of the facility. Discussion The South Yorkshire Cohort combines the strengths of the standard observational, longitudinal cohort study design with

  5. How to Find Lessons from the Public Health Literature: Example of a Scoping Study Protocol on the Neighborhood Environment

    PubMed Central

    Levasseur, Mélanie; Généreux, Mélissa; Desroches, Josiane; Carrier, Annie; Lacasse, Francis; Chabot, Éric; Abecia, Ana; Gosselin, Louise; Vanasse, Alain

    2016-01-01

    Background: As key determinants of many favorable health and quality of life outcomes, it is important to identify factors associated with mobility and social participation. Although several investigations have been carried out on mobility, social participation and neighborhood environment, there is no clear integration of these results. This paper presents a scoping study protocol that aims to provide a comprehensive understanding of how the physical and social neighborhood environment is associated with or influences mobility and social participation in older adults. Methods: The rigorous methodological framework for scoping studies is used to synthesize and disseminate current knowledge on the associations or influence of the neighborhood environment on mobility and social participation in aging. Nine databases from public health and other fields are searched with 51 predetermined keywords. Using content analysis, all data are exhaustively analyzed, organized, and synthesized independently by two research assistants. Discussion: A comprehensive synthesis of empirical studies provides decision-makers, clinicians and researchers with current knowledge and best practices regarding neighborhood environments with a view to enhancing mobility and social participation. Such a synthesis represents an original contribution and can ultimately support decisions and development of innovative interventions and clear guidelines for the creation of age-supportive environments. Improvements in public health and clinical interventions might be the new innovation needed to foster health and quality of life for aging population. Finally, the aspects of the associations or influence of the neighborhood environment on mobility and social participation not covered by previous research are identified. Conclusions: Among factors that impact mobility and social participation, the neighborhood environment is important since interventions targeting it may have a greater impact on an

  6. Protocol for the Women And Their Children’s Health (WATCH) Study: A Cohort of Pregnancy and Beyond

    PubMed Central

    Hure, Alexis J; Collins, Clare E; Giles, Warwick B; Wright, Ian MR; Smith, Roger

    2012-01-01

    Background The developmental origins of health and disease is a conceptual framework that helps explain the links between our early life exposures and later health outcomes, and is a burgeoning field of research. In this report, we describe the study protocol used in a prospective cohort of women recruited during pregnancy, with postnatal follow-up of the mothers and offspring. Methods The Women And Their Children’s Health (WATCH) cohort (n = 180 women) is being conducted at the John Hunter Hospital, Australia (from June 2006). Women attended study visits during pregnancy at 19, 24, 30, and 36 weeks’ gestation. Postnatal follow-up of the women and their offspring occurred at 3-month intervals during the first year after birth and annually thereafter, until age 4 years. Fetal ultrasound scans were performed at each pregnancy visit. Pregnancy and birth data were obtained from hospital records. Data collection has included maternal and child anthropometric, biochemical, dietary, physical activity, socioeconomic, medical, and other variables. Conclusions The 2 most novel components of our prospective cohort study are (1) the regular and systematic tracking of fetal and child growth and body composition, starting in the second trimester of pregnancy and continuing to age 4 years, and (2) the detailed maternal and child dietary data collection, including biochemical parameters. Detailed cohorts that collect data on the early nutritional, physiological, and social determinants of health are valuable. Despite its relatively small sample size, many hypotheses on developmental origins can be tested or piloted using data collected from the WATCH cohort. PMID:22374367

  7. Nutrition, environment and cardiovascular health (NESCAV): protocol of an inter-regional cross-sectional study

    PubMed Central

    2010-01-01

    Background Despite the remarkable technological progress in health care and treatment, cardiovascular disease remains the leading cause of premature death, prolonged hospitalization and disability in most European countries. In the population of the Greater Region (Grand-Duchy of Luxembourg, Wallonia in Belgium, and Lorraine in France), the prevalence of cardiovascular risk factors and disease is among the highest in Europe, warranting the need for a better understanding of factors contributing to this pattern. In this context, the cross-border "Nutrition, Environment and Cardiovascular Health-NESCAV" project is initiated by an inter-regional multi-disciplinary consortium and supported by the INTERREG IV A program "Greater Region", 2007-2013, to fight synergically and harmoniously against this major public health problem. Methods/design The objectives of the three-year planned project are to assess, in a representative sample of 3000 randomly selected individuals living at the Greater Region, 1) the cardiovascular health and risk profile, 2) the association between the dietary habits and the cardiovascular risk, 3) the association of occupational and environmental pollution markers with the cardiovascular risk, 4) the knowledge, awareness and level of control of cardiovascular risk factors, 5) the potential gaps in the current primary prevention, and finally, to address evidence-based recommendations enabling the development of inter-regional guidance to help policy-makers and health care workers for the prevention of cardiovascular disease. Discussion The findings will provide tools that may enable the Greater Region's decision-makers and health professionals to implement targeted and cost-effective prevention strategies. PMID:21078172

  8. Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial.

    PubMed

    Ravenell, Joseph; Leighton-Herrmann, Ellyn; Abel-Bey, Amparo; DeSorbo, Alexandra; Teresi, Jeanne; Valdez, Lenfis; Gordillo, Madeleine; Gerin, William; Hecht, Michael; Ramirez, Mildred; Noble, James; Cohn, Elizabeth; Jean-Louis, Giardin; Spruill, Tanya; Waddy, Salina; Ogedegbe, Gbenga; Williams, Olajide

    2015-04-19

    Stroke is a leading cause of adult disability and mortality. Intravenous thrombolysis can minimize disability when patients present to the emergency department for treatment within the 3 - 4½ h of symptom onset. Blacks and Hispanics are more likely to die and suffer disability from stroke than whites, due in part to delayed hospital arrival and ineligibility for intravenous thrombolysis for acute stroke. Low stroke literacy (poor knowledge of stroke symptoms and when to call 911) among Blacks and Hispanics compared to whites may contribute to disparities in acute stroke treatment and outcomes. Improving stroke literacy may be a critical step along the pathway to reducing stroke disparities. The aim of the current study is to test a novel intervention to increase stroke literacy in minority populations in New York City. In a two-arm cluster randomized trial, we will evaluate the effectiveness of two culturally tailored stroke education films - one in English and one in Spanish - on changing behavioral intent to call 911 for suspected stroke, compared to usual care. These films will target knowledge of stroke symptoms, the range of severity of symptoms and the therapeutic benefit of calling 911, as well as address barriers to timely presentation to the hospital. Given the success of previous church-based programs targeting behavior change in minority populations, this trial will be conducted with 250 congregants across 14 churches (125 intervention; 125 control). Our proposed outcomes are (1) recognition of stroke symptoms and (2) behavioral intent to call 911 for suspected stroke, measured using the Stroke Action Test at the 6-month and 1-year follow-up. This is the first randomized trial of a church-placed narrative intervention to improve stroke outcomes in urban Black and Hispanic populations. A film intervention has the potential to make a significant public health impact, as film is a highly scalable and disseminable medium. Since there is at least one

  9. Development of quality indicators for monitoring outcomes of frail elderly hospitalised in acute care health settings: study protocol.

    PubMed

    Brand, Caroline A; Martin-Khan, Melinda; Wright, Olivia; Jones, Richard N; Morris, John N; Travers, Catherine M; Tropea, Joannne; Gray, Leonard C

    2011-10-20

    Frail older people admitted to acute care hospitals are at risk of a range of adverse outcomes, including geriatric syndromes, although targeted care strategies can improve health outcomes for these patients. It is therefore important to assess inter-hospital variation in performance in order to plan and resource improvement programs. Clinical quality outcome indicators provide a mechanism for identifying variation in performance over time and between hospitals, however to date there has been no routine use of such indicators in acute care settings. A barrier to using quality indicators is lack of access to routinely collected clinical data. The interRAI Acute Care (AC) assessment system supports comprehensive geriatric assessment of older people within routine daily practice in hospital and includes process and outcome data pertaining to geriatric syndromes. This paper reports the study protocol for the development of aged care quality indicators for acute care hospitals. The study will be conducted in three phases: 1. Development of a preliminary inclusive set of quality indicators set based on a literature review and expert panel consultation, 2. A prospective field study including recruitment of 480 patients aged 70 years or older across 9 Australian hospitals. Each patient will be assessed on admission and discharge using the interRAI AC, and will undergo daily monitoring to observe outcomes. Medical records will be independently audited, and 3. Analysis and compilation of a definitive quality indicator set, including two anonymous voting rounds for quality indicator inclusion by the expert panel. The approach to quality indicators proposed in this protocol has four distinct advantages over previous efforts: the quality indicators focus on outcomes; they can be collected as part of a routinely applied clinical information and decision support system; the clinical data will be robust and will contribute to better understanding variations in hospital care of

  10. Quantifying Queensland patients with cancer health service usage and costs: study protocol

    PubMed Central

    Callander, Emily; Topp, Stephanie M; Larkins, Sarah; Sabesan, Sabe

    2017-01-01

    Introduction The overall mortality rate for cancer has declined in Australia. However, socioeconomic inequalities exist and the out-of-pocket costs incurred by patients in Australia are high compared with some European countries. There is currently no readily available data set to provide a systematic means of measuring the out-of-pocket costs incurred by patients with cancer within Australia. The primary aim of the project is to quantify the direct out-of-pocket healthcare expenditure of individuals in the state of Queensland, who are diagnosed with cancer. Methods and analysis This project will build Australia's first model (called CancerCostMod) of out-of-pocket healthcare expenditure of patients with cancer using administrative data from Queensland Cancer Registry, for all individuals diagnosed with any cancer in Queensland between 1 July 2011 and 30 June 2012, linked to their Admitted Patient Data Collection, Emergency Department Information System, Medicare Benefits Schedule and Pharmaceutical Benefits Scheme records from 1 July 2011 to 30 June 2015. No identifiable information will be provided to the authors. The project will use a combination of linear and logistic regression modelling, Cox proportional hazards modelling and machine learning to identify differences in survival, total health system expenditure, total out-of-pocket expenditure and high out-of-pocket cost patients, adjusting for demographic and clinical confounders, and income group, Indigenous status and geographic location. Results will be analysed separately for different types of cancer. Ethics and dissemination Human Research Ethics approval has been obtained from the Townsville Hospital and Health Service Human Research Ethics Committee (HREC/16/QTHS/110) and James Cook University Human Research Ethics Committee (H6678). Permission to waive consent has been sought from Queensland Health under the Public Health Act 2005. PMID:28119391

  11. Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children’s Study

    PubMed Central

    Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

    2014-01-01

    Introduction Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. Methods and analysis This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children’s Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. Ethics and dissemination The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. Trial Registration number UMIN000010826. PMID:24958210

  12. Birth cohort study on the effects of desert dust exposure on children's health: protocol of an adjunct study of the Japan Environment & Children's Study.

    PubMed

    Kanatani, Kumiko T; Adachi, Yuichi; Sugimoto, Nobuo; Noma, Hisashi; Onishi, Kazunari; Hamazaki, Kei; Takahashi, Yoshimitsu; Ito, Isao; Egawa, Miho; Sato, Keiko; Go, Tohshin; Kurozawa, Youichi; Inadera, Hidekuni; Konishi, Ikuo; Nakayama, Takeo

    2014-06-23

    Desert dust is estimated to constitute about 35% of aerosol in the troposphere. Desertification, climatic variability and global warming all can contribute to increased dust formation. This study aims to examine possible health effects of desert dust exposure on pregnant women and their children. The purpose of this report was to present the study protocol. This 4-year birth cohort study began in 2011 as an adjunct study of the Japan Environment & Children's Study (JECS) involving three regions: Kyoto, Toyama and Tottori. The JECS participants of the three regions above who also agreed to participate in this adjunct study were enrolled prior to delivery. Light Detecting and Ranging (LIDAR) with a polarisation analyser, which can distinguish mineral dust particles from other particles, is used for exposure measurements. Outcomes are allergic symptoms for mothers and development of asthma and other allergic or respiratory diseases for their children. Data are acquired in a timely manner by connecting local LIDAR equipment to an online questionnaire system. Participants answer the online questionnaire using mobile phones or personal computers. The study protocol was approved by the ethics committees of Kyoto University, University of Toyama and Tottori University. All participants provided written informed consent. The results of this study will be published in peer-reviewed journals and disseminated to the scientific community and general public. UMIN000010826. 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.

  13. Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol.

    PubMed

    Singh, Hardeep; Ash, Joan S; Sittig, Dean F

    2013-04-12

    Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective. This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items. Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project

  14. Health and development of ART conceived young adults: a study protocol for the follow-up of a cohort.

    PubMed

    Wilson, Cate; Hammarberg, Karin; Bruinsma, Fiona; Berg, Turi; Amor, David; Sanson, Ann; Fisher, Jane R; Halliday, Jane

    2013-03-15

    Use of assisted reproductive technologies (ART) continues to increase, yet little is known of the longer term health of ART conceived offspring. There are some adverse birth outcomes associated with ART conception but the subsequent developmental trajectory is unclear. Undertaking research in this area is challenging due the sensitive nature of the topic and the time elapsed since birth of the ART conceived young adults. The aim of this report is to describe a research protocol, including design and ethical considerations, used to compare the physical and psychosocial health outcomes of ART conceived young adults aged 18-28 years, with their spontaneously conceived peers. This is a retrospective cohort study of mothers who conceived with ART in Victoria, Australia and gave birth to a singleton child between 1982 and 1992. A current address for each mother was located and a letter of invitation to participate in the study was sent by registered mail. Participation involved completing a telephone interview about her young adult offspring's health and development from birth to the present. Mothers were also asked for consent for the researcher to contact their son/daughter to invite them to complete a structured telephone interview about their physical and psychosocial health. A comparison group of women living in Victoria, Australia, who had given birth to a spontaneously conceived singleton child between 1982 and 1992 was recruited from the general population using random digit dialling. Data were collected from them and their young adult offspring in the same way. Regression analyses were used to evaluate relationships between ART exposure and health status, including birth defects, chronic health conditions, hospital admissions, growth and sexual development. Psychosocial wellbeing, parental relationships and educational achievement were also assessed. Factors associated with the age of disclosure of ART conception were explored with the ART group only. The

  15. Study protocol for the World Health Organization project to develop a Quality of Life assessment instrument (WHOQOL).

    PubMed

    1993-04-01

    The World Health Organization (WHO) has undertaken a project to develop an instrument (the WHOQOL) for measuring quality of life. Quality of life is defined as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, and their relationship to salient features of their environment. The instrument will be developed in the framework of a collaborative project involving numerous centres in different cultural settings. In addition, it will have proven psychometric properties of validity, responsiveness and reliability and will be sensitive to the cultural setting in which it is applied, whilst maintaining comparability of scores across different cultural settings. This paper outlines the characteristics of the planned instrument and the study protocol governing work on its development. To date steps 1 through 5 have been completed and work is progressing on step 6. It is anticipated that the instrument will be available for piloting in July 1993 and a final version available for use in June 1994.

  16. An oral health education video game for high caries risk children: study protocol for a randomized controlled trial.

    PubMed

    Aljafari, Ahmad; Rice, Colm; Gallagher, Jennifer Elizabeth; Hosey, Marie Therese

    2015-05-28

    Tooth decay is the most common chronic disease of childhood in the world. Many children develop caries early in their lives, and go on to develop further caries and sepsis as they grow up, indicating failure in prevention. As a result, many end up requiring general anaesthesia to undergo treatment for a disease that is completely preventable. Previous studies have suggested that the families of these children need better oral health education as well as better support in implementing healthy practices at home, as they feel impeded by broader life challenges. Parents of these children have suggested utilizing modern technologies, such as the internet, DVDs and video games as methods of delivery of education that might fit in with their busy lifestyles. The aim of this investigation is to assess the acceptability and efficiency of an oral health education video game directed at these children and their families. A two-armed phase-II randomized controlled trial will assess a children's oral health education video game in comparison with verbal oral health education in terms of: family satisfaction, effect on oral health knowledge, and effect on dietary and oral hygiene habits. Up to 110 four- to ten-year-old children, referred for tooth extraction under general anaesthesia due to caries, will be recruited. A sample of 45 participants in each group will be needed to provide 80% statistical power. The primary outcome measures for this study are: (1) parent and child satisfaction with the intervention, as indicated using a visual analogue scale; (2) improvement in the child's dietary knowledge measured by a pictorial dietary quiz; and (3) changes in the child's diet and oral hygiene habits, measured using a children's dietary questionnaire completed by the parent, and snacking and toothbrushing diaries completed by the child. Measures will be taken at baseline, directly after the intervention, and three months later. This study is a phase-II randomized controlled trial

  17. A multimethod research investigation of consumer involvement in Australian health service accreditation programmes: the ACCREDIT-SCI study protocol

    PubMed Central

    Greenfield, David; Hinchcliff, Reece; Moldovan, Max; Mumford, Virginia; Pawsey, Marjorie; Irene Westbrook, Johanna; Braithwaite, Jeffrey

    2012-01-01

    Introduction Health service accreditation programmes are a regulatory mechanism adopted to drive improvements inpatient safety and quality. Research investigating the benefits or limitations, of consumer involvement in accreditation programmes is negligible. To develop our knowledge in this area the ACCREDIT collaboration (Accreditation Collaborative for the Conduct of Research, Evaluation and Designated Investigations through Teamwork) has developed a research plan, known as the ACCREDIT-SCI (Standards of Consumer Involvement) study protocol. Two complementary studies have been designed: one, to examine the effectiveness of a standard for consumer participation and two, to explore how patient experiences vary across a range of settings with differing accreditation results. Methods and design The research setting is the Australian healthcare system, and the two studies focus on three accreditation programmes in the primary, acute and aged care domains. The studies will use multimethods: document analysis; interviews and surveys. Participants will be stakeholders across the three domains including: policy officers; frontline healthcare professionals; accreditation agency personnel, including surveyors and healthcare consumers. Drawing on previous experience, the research team has developed purpose-designed tools. Data will be analysed using thematic, narrative and statistical (descriptive and inferential) procedures. Ethics and dissemination The University of New South Wales Human Research Ethics Committee has approved the two studies (HREC 10274). Findings will be disseminated through seminars, conference presentations, academic publications and research partner websites. The findings will be formulated to facilitate uptake by policy and accreditation agency professionals, researchers and academics, and consumers, nationally and internationally. PMID:23059848

  18. Bushehr Elderly Health (BEH) programme: study protocol and design of musculoskeletal system and cognitive function (stage II)

    PubMed Central

    Shafiee, Gita; Ostovar, Afshin; Heshmat, Ramin; Darabi, Hossein; Sharifi, Farshad; Raeisi, Alireza; Mehrdad, Neda; Shadman, Zhaleh; Razi, Faride; Amini, Mohammad Reza; Arzaghi, Seyed Masoud; Meybodi, Hamidreza Aghaei; Soltani, Akbar; Nabipour, Iraj; Larijani, Bagher

    2017-01-01

    Introduction Musculoskeletal disorders and cognitive diseases are prevalent, and they are significant determinants of morbidity and mortality in older adults. The aim of this study is to investigate the prevalence of musculoskeletal and cognitive diseases and their risk factors and also to assess their associations during future follow-ups. Methods and analysis Bushehr Elderly Health (BEH) programme is a population-based prospective cohort study being conducted in Bushehr, a southern province of Iran. A total of 3000 older people aged ≥60 years participated in the first stage from which 2772 were eligible to participate in the second stage, which started after 2.5 years. Data including demographic status, lifestyle factors, general healthandmedical history, and mentalandfunctional health are collected through a questionnaire. Anthropometric measures, performance testsandmuscle strength, blood pressure and and body composition measurements are done. A total 25 cc venous blood is taken, and sera are stored at –80°C for possible future analyses. Ethics and dissemination The study protocol was approved by the ethics committee of Endocrinology and Metabolism Research Institute, affiliated to Tehran University of Medical Science as well as the Research Ethics Committee of Bushehr University of Medical Sciences. A written informed consent was signed by all the participants. The study findings will show the prevalence of musculoskeletal disease, cognitive impairment and their risk factors in an elderly population. The participants will be followed during the study to measure the occurrence outcomes. This study will also have the potential to inform the development of beneficial interventions to improve the management of musculoskeletal and cognitive impairment in Iran and other countries in the Middle East. Our findings will be disseminated via scientific publication as well as presentation to stakeholders, including the patients, clinicians, the public and

  19. Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Smoking rates, and associated negative health outcomes, are disproportionately high among people with mental illness compared to the general population. Smoke-free policies within mental health hospitals can positively impact on patients’ motivation and self-efficacy to address their smoking. However, without post-discharge support, preadmission smoking behaviours typically resume. This protocol describes a randomised controlled trial that aims to assess the efficacy of linking mental health inpatients to community-based smoking cessation supports upon discharge as a means of reducing smoking prevalence. Methods/Design Eight hundred participants with acute mental illness will be recruited into the randomised controlled trial whilst inpatients at one of four psychiatric inpatient facilities in the state of New South Wales, Australia. After completing a baseline interview, participants will be randomly allocated to receive either: ‘Supported Care’, a multimodal smoking cessation intervention; or ‘Normal Care’, consisting of existing hospital care only. The ‘Supported Care’ intervention will consist of a brief motivational interview and a package of self-help material for abstaining from smoking whilst in hospital, and, following discharge, 16 weeks of motivational telephone-based counselling, 12 weeks of free nicotine replacement therapy, and a referral to the Quitline. Data will be collected at 1, 6 and 12 months post-discharge via computer-assisted telephone interview. The primary outcomes are abstinence from smoking (7-day point prevalence and prolonged cessation), and secondary outcomes comprise daily cigarette consumption, nicotine dependence, quit attempts, and readiness to change smoking behaviour. Discussion If shown to be effective, the study will provide evidence in support of systemic changes in the provision of smoking cessation care to patients following discharge from psychiatric inpatient facilities. Trial registration

  20. A digital intake approach in specialized mental health care: study protocol of a cluster randomised controlled trial.

    PubMed

    Metz, Margot J; Elfeddali, Iman; Krol, David G H; Veerbeek, Marjolein A; de Beurs, Edwin; Beekman, Aartjan T F; van der Feltz-Cornelis, Christina M

    2017-03-07

    Enhancing patient participation is becoming increasingly important in mental health care as patients use to have a dependent, inactive role and nonadherence to treatment is a regular problem. Research shows promising results of initiatives stimulating patient participation in partnership with their clinicians. However, few initiatives targeting both patients' and clinicians' behaviour have been evaluated in randomised trials (RCT). Therefore, in GGz Breburg, a specialized mental health institution, a digital intake approach was developed aimed at exploring treatment needs, expectations and preferences of patients intended to prepare patients for the intake consultations. Subsequently, patients and clinicians discuss this information during intake consultations and make shared decisions about options in treatment. The aim of this trial is to test the efficacy of this new digital intake approach facilitated by Routine Outcome Monitoring (ROM), peer support and training of clinicians as compared to the intake as usual. The primary outcome is decisional conflict about choices in treatment. Secondary outcomes focus on patient participation, shared decision making, working alliance, adherence to treatment and clinical outcomes. This article presents the study protocol of a cluster-randomised controlled trial in four outpatient departments for adults with depression, anxiety and personality disorders, working in two different regions. Randomisation is done between two similar intake-teams within each department. In the four intervention teams the new intake approach is implemented. The four control teams apply the intake as usual and will implement the new approach after the completion of the study. In total 176 patients are projected to participate in the study. Data collection will be at baseline, and at two weeks and two months after the intake. This study will potentially demonstrate the efficacy of the new digital intake approach in mental health care in terms of the

  1. Social networks of health care providers and patients in cardiovascular risk management: a study protocol

    PubMed Central

    2014-01-01

    Background In recent years, preventive and clinical interventions for cardiovascular risk management have been implemented widely in primary care in the Netherlands. Although this has enhanced quality and outcomes of cardiovascular risk management, further improvement remains possible. In the planned observational study, we aim to examine the role of social networks of healthcare providers and patients in quality and outcomes of cardiovascular risk management. Methods/Design In a longitudinal observational study, data on social networks of approximately 300 primary care providers from 30 general practices and 900 cardiovascular patients will be collected twice, with a six month interval, using a mix of measures. Social networks are documented with specifically designed questionnaires for patients, relatives, and healthcare professionals. For each included patient, we will extract from medical records to gather data on clinical processes and cardiovascular risk predictors. Data on self-management and psychosocial outcomes of patients will be collected using questionnaires for patients. The analysis focuses on identifying network characteristics, which are associated with (changes in) cardiovascular risk management or self-management. Discussion This research will provide insight into the role of social networks of patients and providers in cardiovascular risk management in primary practice. Trial registration Nederlands Trial Register NTR4069. PMID:24942555

  2. The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial.

    PubMed

    Jimenez, Daniel E; Reynolds, Charles F; Alegría, Margarita; Harvey, Philip; Bartels, Stephen J

    2015-12-18

    Results of previous studies attest to the greater illness burden of common mental disorders (anxiety and depression) in older Latinos and the need for developing preventive interventions that are effective, acceptable, and scalable. Happy Older Latinos are Active (HOLA) is a newly developed intervention that uses a community health worker (CHW) to lead a health promotion program in order to prevent common mental disorders among at-risk older Latinos. This pilot study tests the feasibility and acceptability of delivering HOLA to older, at-risk Latinos. HOLA is a multi-component, health promotion intervention funded by the National Institute of Mental Health (NIMH). This prevention approach will be tested against a fotonovela, an enhanced psychoeducation control condition, in a sample of Latino elderly with minor or subthreshold depression or anxiety. A total of 60 older Latinos (aged 60+) will be randomized to receive HOLA or the fotonovela. The primary outcomes of interest are recruitment, adherence, retention, and acceptability. Data will also be collected on: preemption of incident and recurrent major depression, generalized anxiety, and social phobia; reduction in depression and anxiety symptom severity; physical functioning; sedentary behaviors; social engagement; and self-efficacy. The results of this study could have implications for other high-risk, highly disadvantaged populations. The development of a health promotion intervention designed to prevent common mental disorders could be a means of addressing multiple disparities (for example, mental health outcomes, mental health service use, stigma) among racial/ethnic minority elderly. CLINICALTRIALS. NCT02371954 . Date of registration: 21 January 2015.

  3. Testing Activity Monitors’ Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients

    PubMed Central

    Ottenbacher, Kenneth J; Fisher, Steve R; Jennings, Kristofer; Brown, Arleen F; Swartz, Maria C; Lyons, Elizabeth J

    2016-01-01

    Background Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users. Objective The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Methods Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders. Results The study started recruitment in October 2015 and is scheduled to be completed by October 2016. Conclusions This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level. Trial Registration ClinicalTrails.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT) PMID:27129602

  4. The respiratory health of urban indigenous children aged less than 5 years: study protocol for a prospective cohort study.

    PubMed

    Hall, Kerry K; Chang, Anne B; Sloots, Theo P; Anderson, Jennie; Kemp, Anita; Hammill, Jan; Otim, Michael; O'Grady, Kerry-Ann F

    2015-05-14

    Despite the burden of acute respiratory illnesses (ARI) among Aboriginal and Torres Strait Islander children being a substantial cause of childhood morbidity and associated costs to families, communities and the health system, data on disease burden in urban children are lacking. Consequently evidence-based decision-making, data management guidelines, health resourcing for primary health care services and prevention strategies are lacking. This study aims to comprehensively describe the epidemiology, impact and outcomes of ARI in urban Aboriginal and Torres Strait Islander children (hereafter referred to as Indigenous) in the greater Brisbane area. An ongoing prospective cohort study of Indigenous children aged less than five years registered with a primary health care service in Northern Brisbane, Queensland, Australia. Children are recruited at time of presentation to the service for any reason. Demographic, epidemiological, risk factor, microbiological, economic and clinical data are collected at enrolment. Enrolled children are followed for 12 months during which time ARI events, changes in child characteristics over time and monthly nasal swabs are collected. Children who develop an ARI with cough as a symptom during the study period are more intensely followed-up for 28 (±3) days including weekly nasal swabs and parent completed cough diary cards. Children with persistent cough at day 28 post-ARI are reviewed by a paediatrician. Our study will be one of the first to comprehensively evaluate the natural history, epidemiology, aetiology, economic impact and outcomes of ARIs in this population. The results will inform studies for the development of evidence-based guidelines to improve the early detection, prevention and management of chronic cough and setting of priorities in children during and after ARI. Australia New Zealand Clinical Trial Registry Registration Number: 12614001214628 . Registered 18 November 2014.

  5. Study protocol: cross-national comparative case study of recovery-focused mental health care planning and coordination (COCAPP).

    PubMed

    Simpson, Alan; Hannigan, Ben; Coffey, Michael; Jones, Aled; Barlow, Sally; Cohen, Rachel; Všetečková, Jitka; Faulkner, Alison; Haddad, Mark

    2015-07-03

    The collaborative care planning study (COCAPP) is a cross-national comparative study of care planning and coordination in community mental healthcare settings. The context and delivery of mental health care is diverging between the countries of England and Wales whilst retaining points of common interest, hence providing a rich geographical comparison for research. Across England the key vehicle for the provision of recovery-focused, personalised, collaborative mental health care is the care programme approach (CPA). The CPA is a form of case management introduced in England in 1991, then revised in 2008. In Wales the CPA was introduced in 2003 but has now been superseded by The Mental Health (Care Co-ordination and Care and Treatment Planning) (CTP) Regulations (Mental Health Measure), a new statutory framework. In both countries, the CPA/CTP requires providers to: comprehensively assess health/social care needs and risks; develop a written care plan (which may incorporate risk assessments, crisis and contingency plans, advanced directives, relapse prevention plans, etc.) in collaboration with the service user and carer(s); allocate a care coordinator; and regularly review care. The overarching aim of this study is to identify and describe the factors that ensure CPA/CTP care planning and coordination is personalised, recovery-focused and conducted collaboratively. COCAPP will employ a concurrent transformative mixed methods approach with embedded case studies. Phase 1 (Macro-level) will consider the national context through a meta-narrative mapping (MNM) review of national policies and the relevant research literature. Phase 2 (Meso-level and Micro-level) will include in-depth micro-level case studies of everyday 'frontline' practice and experience with detailed qualitative data from interviews and reviews of individual care plans. This will be nested within larger meso-level survey datasets, senior-level interviews and policy reviews in order to provide

  6. Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - the POIBC study.

    PubMed

    Gomez, Santiago F; Casas, Rafael; Palomo, Vanessa Taylor; Martin Pujol, Anna; Fíto, Montserrat; Schröder, Helmut

    2014-08-29

    The speeding increase and the high prevalence of childhood obesity is a serious problem for Public Health. Community Based Interventions has been developed to combat against the childhood obesity epidemic. However little is known on the efficacy of these programs. Therefore, there is an urgent need to determine the effect of community based intervention on changes in lifestyle and surrogate measures of adiposity. Parallel intervention study including two thousand 2249 children aged 8 to 10 years ( 4th and 5th grade of elementary school) from 4 Spanish towns. The THAO-Child Health Program, a community based intervention, were implemented in 2 towns. Body weight, height, and waist circumferences were measured. Children recorded their dietary intake on a computer-based 24h recall. All children also completed validated computer based questionnaires to estimate physical activity, diet quality, eating behaviors, and quality of life and sleep. Additionally, parental diet quality and physical activity were assessed by validated questionnaires. This study will provide insight in the efficacy of the THAO-Child Health Program to promote a healthy lifestyle. Additionally it will evaluate if lifestyle changes are accompanied by favorable weight management. Trial Registration Number ISRCTN68403446.

  7. Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - The POIBC study

    PubMed Central

    2014-01-01

    Background The speeding increase and the high prevalence of childhood obesity is a serious problem for Public Health. Community Based Interventions has been developed to combat against the childhood obesity epidemic. However little is known on the efficacy of these programs. Therefore, there is an urgent need to determine the effect of community based intervention on changes in lifestyle and surrogate measures of adiposity. Methods/design Parallel intervention study including two thousand 2249 children aged 8 to 10 years ( 4th and 5th grade of elementary school) from 4 Spanish towns. The THAO-Child Health Program, a community based intervention, were implemented in 2 towns. Body weight, height, and waist circumferences were measured. Children recorded their dietary intake on a computer-based 24h recall. All children also completed validated computer based questionnaires to estimate physical activity, diet quality, eating behaviors, and quality of life and sleep. Additionally, parental diet quality and physical activity were assessed by validated questionnaires. Discussion This study will provide insight in the efficacy of the THAO-Child Health Program to promote a healthy lifestyle. Additionally it will evaluate if lifestyle changes are accompanied by favorable weight management. Trial registration Trial Registration Number ISRCTN68403446 PMID:25174356

  8. Evaluating a health care provider delivered intervention to reduce intimate partner violence and mitigate associated health risks: study protocol for a randomized controlled trial in Mexico City.

    PubMed

    Falb, Kathryn L; Diaz-Olavarrieta, Claudia; Campos, Paola A; Valades, Jimena; Cardenas, Roosebelinda; Carino, Giselle; Gupta, Jhumka

    2014-07-30

    Intimate partner violence (IPV) victimization is a prevalent issue among women residing in Mexico City. Comprehensive and integrated health care provider (HCP) delivered programs in clinic-settings are needed, yet few have been evaluated in Latin America, including Mexico. In addition, there has been minimal attention to interventions among lower income women presenting at settings outside of antenatal care clinics. The current randomized controlled trial seeks to increase midlevel HCPs' capacity, specifically nurses, who are often the first point of contact in this setting, to identify women presenting at health clinics with experiences of IPV and to assist these women with health risk mitigation. Specific outcomes include changes in past-year IPV (physical and/or sexual), reproductive coercion, safety planning, use of community resources, and quality of life. Forty-two public health clinics in Mexico City were randomized to treatment or control clinics. Nurses meeting eligibility criteria in treatment groups received an intensive training on screening for IPV, providing supportive referrals, and assessing for health and safety risks. Nurses meeting eligibility criteria at control clinics received the standard of care which included a one-day training focused on sensitizing staff to IPV as a health issue and referral cards to give to women. Women were screened for eligibility (currently experiencing abuse in a heterosexual relationship, 18-44 years of age, non-pregnant or in first trimester) by research assistants in private areas of waiting rooms in health clinics. Consenting women completed a baseline survey and received the study protocol for that clinic. In treatment clinics, women received the nurse delivered session at baseline and received a follow-up counseling session after three months. Surveys are conducted at baseline, three months, and fifteen months from baseline. This study will provide important insight into whether a nurse-delivered program can

  9. Incentives and disincentives for treating of depression and anxiety in Ontario Family Health Teams: protocol for a grounded theory study

    PubMed Central

    Menear, Matthew; Silveira, Jose; Dahrouge, Simone; McKenzie, Kwame

    2016-01-01

    Introduction There is strong consensus that prevention and management of common mental disorders (CMDs) should occur in primary care and evidence suggests that treatment of CMDs in these settings can be effective. New interprofessional team-based models of primary care have emerged that are intended to address problems of quality and access to mental health services, yet many people continue to struggle to access care for CMDs in these settings. Insufficient attention directed towards the incentives and disincentives that influence care for CMDs in primary care, and especially in interprofessional team-based settings, may have resulted in missed opportunities to improve care quality and control healthcare costs. Our research is driven by the hypothesis that a stronger understanding of the full range of incentives and disincentives at play and their relationships with performance and other contextual factors will help stakeholders identify the critical levers of change needed to enhance prevention and management of CMDs in interprofessional primary care contexts. Participant recruitment began in May 2016. Methods and analysis An explanatory qualitative design, based on a constructivist grounded theory methodology, will be used. Our study will be conducted in the Canadian province of Ontario, a province that features a widely implemented interprofessional team-based model of primary care. Semistructured interviews will be conducted with a diverse range of healthcare professionals and stakeholders that can help us understand how various incentives and disincentives influence the provision of evidence-based collaborative care for CMDs. A final sample size of 100 is anticipated. The protocol was peer reviewed by experts who were nominated by the funding organisation. Ethics and dissemination The model we generate will shed light on the incentives and disincentives that are and should be in place to support high-quality CMD care and help stimulate more targeted

  10. Mapping research activity on mental health disorders in Europe: study protocol for the Mapping_NCD project.

    PubMed

    Berg Brigham, Karen; Darlington, Meryl; Wright, John S F; Lewison, Grant; Kanavos, Panos; Durand-Zaleski, Isabelle

    2016-05-26

    Mental health disorders (MHDs) constitute a large and growing disease burden in Europe, although they typically receive less attention and research funding than other non-communicable diseases (NCDs). This study protocol describes a methodology for the mapping of MHD research in Europe as part of Mapping_NCD, a 2-year project funded by the European Commission which seeks to map European research funding and impact for five NCDs in order to identify potential gaps, overlaps, synergies and opportunities, and to develop evidence-based policies for future research. The project aims to develop a multi-focal view of the MHD research landscape across the 28 European Union Member States, plus Iceland, Norway and Switzerland, through a survey of European funding entities, analysis of research initiatives undertaken in the public, voluntary/not-for-profit and commercial sectors, and expert interviews to contextualize the gathered data. The impact of MHD research will be explored using bibliometric analyses of scientific publications, clinical guidelines and newspaper stories reporting on research initiatives. Finally, these research inputs and outputs will be considered in light of various metrics that have been proposed to inform priorities for the allocation of research funds, including burden of disease, treatment gaps and cost of illness. Given the growing burden of MHDs, a clear and broad view of the current state of MHD research is needed to ensure that limited resources are directed to evidence-based priority areas. MHDs pose a particular challenge in mapping the research landscape due to their complex nature, high co-morbidity and varying diagnostic criteria. Undertaking such an effort across 31 countries is further challenged by differences in data collection, healthcare systems, reimbursement rates and clinical practices, as well as cultural and socioeconomic diversity. Using multiple methods to explore the spectrum of MHD research funding activity across Europe

  11. Psychological, social and biological determinants of ill health (pSoBid): Study Protocol of a population-based study

    PubMed Central

    Velupillai, Yoga N; Packard, Chris J; Batty, G David; Bezlyak, Vladimir; Burns, Harry; Cavanagh, Jonathan; Deans, Kevin; Ford, Ian; McGinty, Agnes; Millar, Keith; Sattar, Naveed; Shiels, Paul; Tannahill, Carol

    2008-01-01

    Background Disadvantaged communities suffer higher levels of physical and mental ill health than more advantaged communities. The purpose of the present study was to examine the psychosocial, behavioural and biological determinants of ill health within population groups in Glasgow that differed in socioeconomic status and in their propensity to develop chronic disease especially coronary heart disease and Type 2 diabetes mellitus. Methods Participants were selected at random from areas known to be at the extremes of the socioeconomic continuum in Glasgow. Within the categories of least deprived and most deprived, recruitment was stratified by sex and age to achieve an overall sample containing approximately equal numbers of males and females and an even distribution across the age categories 35–44, 45–54 and 55–64 years. Individuals were invited by letter to attend for assessment of their medical history, risk factor status, cognitive function and psychological profile, morbidity, and carotid intima-media thickness and plaque count as indices of atherosclerosis. Anonymised data on study subjects were collected from the General Practice Administration System for Scotland to analyse characteristics of participants and non-participants. Results 700 subjects were recruited. The response (active participants per 100 invitation letters) in the least deprived group was 35.1% and in the most deprived group was 20.3%. Lowest response was seen in young males (least deprived 22.4% and most deprived 14.1%). Conclusion This cross-sectional study recruited the planned sample of subjects from least deprived and most deprived areas within Glasgow. As evident in other studies response differed between the most and least deprived areas. This study brought together researchers/academics from diverse disciplines to build a more sophisticated understanding of the determinants of health inequalities than can be achieved through unidisciplinary approaches. Future analyses will

  12. A feasibility randomised controlled trial of the New Orleans intervention for infant mental health: a study protocol.

    PubMed

    Pritchett, Rachel; Fitzpatrick, Bridie; Watson, Nicholas; Cotmore, Richard; Wilson, Philip; Bryce, Graham; Donaldson, Julia; Boyd, Kathleen; Zeanah, Charles; Norrie, John; Taylor, Julie; Larrieu, Julie; Messow, Martina; Forde, Matt; Turner, Fiona; Irving, Susan; Minnis, Helen

    2013-01-01

    Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children "revolve" between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child's neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510).

  13. Protocol: a 'One health' two year follow-up, mixed methods study on antibiotic resistance, focusing children under 5 and their environment in rural India.

    PubMed

    Stålsby Lundborg, Cecilia; Diwan, Vishal; Pathak, Ashish; Purohit, Manju R; Shah, Harshada; Sharma, Megha; Mahadik, Vijay K; Tamhankar, Ashok J

    2015-12-30

    Antibiotic resistance has been referred to as 'the greatest malice of the 21st century' and a global action plan was adopted by the World Health Assembly in 2015. There is a wealth of independent studies regarding antibiotics and resistant bacteria in humans, animals and their environment, however, integrated studies are lacking, particularly ones that simultaneously also take into consideration the health related behaviour of participants and healthcare providers. Such, 'One health' studies are difficult to implement, because of the complex teamwork that they entail. This paper describes the protocol of a study that investigates 'One health' issues regarding antibiotic use and antibiotic resistance in children and their environment in Indian villages. Both quantitative and qualitative studies are planned for a cohort of children, from 6 villages, and their surrounding environment. Repeated or continues data collection is planned over 2 years for quantitative studies. Qualitative studies will be conducted once. Studies include parents' health seeking behavior for their children (1-3 years of age at the onset), prescribing pattern of formal and informal healthcare providers, analysis of phenotypic antibiotic resistance of Escherichia coli from samples of stool from children and village animals, household drinking water, village source water and waste water, and investigation on molecular mechanisms governing resistance. Analysis of interrelationship of these with each other will also be done as basis for future interventions. Ethics approval has been obtained from the Institutional Ethics Committee R.D. Gardi Medical College, Ujjain, India (No: 2013/07/17-311). The findings of the study presented in this protocol will add to our knowledge about the multi-factorial nature of causes governing antibiotic use and antibiotic resistance from a 'One health' perspective. Our study will be the first of its kind addressing antibiotic use and resistance issues related to

  14. Evaluation of Vitamin D Standardization Program protocols for standardizing serum 25-hydroxyvitamin D data: a case study of the program's potential for national nutrition and health surveys12345

    PubMed Central

    Cashman, Kevin D; Kiely, Mairead; Kinsella, Michael; Durazo-Arvizu, Ramón A; Tian, Lu; Zhang, Yue; Lucey, Alice; Flynn, Albert; Gibney, Michael J; Vesper, Hubert W; Phinney, Karen W; Coates, Paul M; Picciano, Mary F; Sempos, Christopher T

    2013-01-01

    Background: The Vitamin D Standardization Program (VDSP) has developed protocols for standardizing procedures of 25-hydroxyvitamin D [25(OH)D] measurement in National Health/Nutrition Surveys to promote 25(OH)D measurements that are accurate and comparable over time, location, and laboratory procedure to improve public health practice. Objective: We applied VDSP protocols to existing ELISA-derived serum 25(OH)D data from the Irish National Adult Nutrition Survey (NANS) as a case-study survey and evaluated their effectiveness by comparison of the protocol-projected estimates with those from a reanalysis of survey serums by using liquid chromatography–tandem mass spectrometry (LC–tandem MS). Design: The VDSP reference system and protocols were applied to ELISA-based serum 25(OH)D data from the representative NANS sample (n = 1118). A reanalysis of 99 stored serums by using standardized LC–tandem MS and resulting regression equations yielded predicted standardized serum 25(OH)D values, which were then compared with LC–tandem MS reanalyzed values for all serums. Results: Year-round prevalence rates for serum 25(OH)D concentrations <30, <40, and <50 nmol/L were 6.5%, 21.9%, and 40.0%, respectively, via original ELISA measurements and 11.4%, 25.3%, and 43.7%, respectively, when VDSP protocols were applied. Differences in estimates at <30- and <40-nmol/L thresholds, but not at the <50-nmol/L threshold, were significant (P < 0.05). A reanalysis of all serums by using LC–tandem MS confirmed prevalence estimates as 11.2%, 27.2%, and 45.0%, respectively. Prevalences of serum 25(OH)D concentrations >125 nmol/L were 1.2%, 0.3%, and 0.6% by means of ELISA, VDSP protocols, and LC–tandem MS, respectively. Conclusion: VDSP protocols hold a major potential for national nutrition and health surveys in terms of the standardization of serum 25(OH)D data. PMID:23615829

  15. Study of Health and Activity in Preschool Environments (SHAPES): Study protocol for a randomized trial evaluating a multi-component physical activity intervention in preschool children

    PubMed Central

    2013-01-01

    Background Physical inactivity is a recognized public health concern. Inadequate proportions of children in the U.S, including those of preschool age, are meeting physical activity recommendations. In response to low numbers of preschool children attaining appropriate physical activity levels, combined with the large number of young children who attend preschool, researchers have identified the need to devise interventions to increase physical activity at preschools. However, few multi-component interventions to increase physical activity in preschool children exist. The aims of this study were to observe the effects of a multi-component intervention on physical activity, sedentary behavior, and physical activity energy expenditure in 3-5 year-old children; identify factors that associate with change in those variables; and evaluate the process of implementing the multi-component intervention. The purpose of this manuscript is to describe the study design and intervention protocol. Methods/design The overall design of the Study of Health and Activity in Preschool Environments (SHAPES) was a two-year randomized trial (nested cohort design), with two conditions, two measurement occasions, and preschool serving as the unit of analysis. Sixteen schools (eight intervention and eight control) were enrolled. The intervention protocol was based on the social ecological model and included four main components: (a) indoor physical activity (“move inside”), (b) recess (“move outside”), (c) daily lessons (“move to learn”), and (d) social environment. Components were implemented using teacher and administrator trainings and workshops, site support visits, newsletters, and self-monitoring methods. Outcomes included accelerometer assessment of physical activity, sedentary behavior, and physical activity energy expenditure; weight status; and demographic factors; family/home social and physical environment; and parental characteristics. An extensive process evaluation

  16. Study protocol for a longitudinal study evaluating the impact of rape on women's health and their use of health services in South Africa.

    PubMed

    Abrahams, Naeemah; Seedat, Soraya; Lombard, Carl; Kengne, Andre P; Myers, Bronwyn; Sewnath, Alesha; Mhlongo, Shibe; Ramjee, Gita; Peer, Nasheeta; Garcia-Moreno, Claudia; Jewkes, Rachel

    2017-09-29

    South Africa is a country known for its high levels of HIV infection and sexual violence. Although the interface between gender-based violence, HIV and mental health has been described, there are substantial gaps in knowledge of the medium-term and long-term health impact. The 2010 Global Burden of Disease study excluded many health outcomes associated with rape and other forms of gender-based violence because systematic reviews revealed huge gaps in data and poor evidence of health effects. This study aims to describe the incidence and attributable burden of physical and mental health problems (including HIV acquisition) in adult women over a 2-year postrape period, through comparison with a cohort of women who have not been raped. The study will substantially advance our understanding of the impact of rape and will generate robust data to assist in the development of postrape health services and the delivery of evidence-based care. This longitudinal study seeks to recruit 1008 rape-exposed and 1008 rape non-exposed women. Women were recruited from health services, and assessments were carried out at baseline, 3, 6, 9, 12, 18 and 24 months. Outcome measures include exposure to risk factors; mental health status; cardio-metabolic risks; and biomarkers for HIV, sexually transmitted infections, pregnancy and stress. The primary analysis will be to compare HIV incidence in the two groups using log-rank tests. Appropriate models to predict health outcomes over time will also be applied. The South African Medical Research Council's Ethics Committee approved the study. As rape is a key element of the study, the safety and protection of participants guides the research process. We will adopt a research uptake strategy to ensure dissemination to policy makers, service providers and advocacy groups. Peer-reviewed journal articles will be published. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No

  17. Public health surveillance of automated external defibrillators in the USA: protocol for the dynamic automated external defibrillator registry study

    PubMed Central

    Elrod, JoAnn Broeckel; Merchant, Raina; Daya, Mohamud; Youngquist, Scott; Salcido, David; Valenzuela, Terence; Nichol, Graham

    2017-01-01

    Introduction Lay use of automated external defibrillators (AEDs) before the arrival of emergency medical services (EMS) providers on scene increases survival after out-of-hospital cardiac arrest (OHCA). AEDs have been placed in public locations may be not ready for use when needed. We describe a protocol for AED surveillance that tracks these devices through time and space to improve public health, and survival as well as facilitate research. Methods and analysis Included AEDs are installed in public locations for use by laypersons to treat patients with OHCA before the arrival of EMS providers on scene. Included cases of OHCA are patients evaluated by organised EMS personnel and treated for OHCA. Enrolment of 10 000 AEDs annually will yield precision of 0.4% in the estimate of readiness for use. Enrolment of 2500 patients annually will yield precision of 1.9% in the estimate of survival to hospital discharge. Recruitment began on 21 Mar 2014 and is ongoing. AEDs are found by using multiple methods. Each AED is then tagged with a label which is a unique two-dimensional (2D) matrix code; the 2D matrix code is recorded and the location and status of the AED tracked using a smartphone; these elements are automatically passed via the internet to a secure and confidential database in real time. Whenever the 2D matrix code is rescanned for any non-clinical or clinical use of an AED, the user is queried to answer a finite set of questions about the device status. The primary outcome of any clinical use of an AED is survival to hospital discharge. Results are summarised descriptively. Ethics and dissemination These activities are conducted under a grant of authority for public health surveillance from the Food and Drug Administration. Results are provided periodically to participating sites and sponsors to improve public health and quality of care. PMID:28360255

  18. SABE Colombia: Survey on Health, Well-Being, and Aging in Colombia—Study Design and Protocol

    PubMed Central

    Corchuelo, Jairo; Curcio, Carmen-Lucia; Calzada, Maria-Teresa; Mendez, Fabian

    2016-01-01

    Objective. To describe the design of the SABE Colombia study. The major health study of the old people in Latin America and the Caribbean (LAC) is the Survey on Health, Well-Being, and Aging in LAC, SABE (from initials in Spanish: SAlud, Bienestar & Envejecimiento). Methods. The SABE Colombia is a population-based cross-sectional study on health, aging, and well-being of elderly individuals aged at least 60 years focusing attention on social determinants of health inequities. Methods and design were similar to original LAC SABE. The total sample size of the study at the urban and rural research sites (244 municipalities) was 23.694 elderly Colombians representative of the total population. The study had three components: (1) a questionnaire covering active aging determinants including anthropometry, blood pressure measurement, physical function, and biochemical and hematological measures; (2) a subsample survey among family caregivers; (3) a qualitative study with gender and cultural perspectives of quality of life to understand different dimensions of people meanings. Conclusions. The SABE Colombia is a comprehensive, multidisciplinary study of the elderly with respect to active aging determinants. The results of this study are intended to inform public policies aimed at tackling health inequalities for the aging society in Colombia. PMID:27956896

  19. SABE Colombia: Survey on Health, Well-Being, and Aging in Colombia-Study Design and Protocol.

    PubMed

    Gomez, Fernando; Corchuelo, Jairo; Curcio, Carmen-Lucia; Calzada, Maria-Teresa; Mendez, Fabian

    2016-01-01

    Objective. To describe the design of the SABE Colombia study. The major health study of the old people in Latin America and the Caribbean (LAC) is the Survey on Health, Well-Being, and Aging in LAC, SABE (from initials in Spanish: SAlud, Bienestar & Envejecimiento). Methods. The SABE Colombia is a population-based cross-sectional study on health, aging, and well-being of elderly individuals aged at least 60 years focusing attention on social determinants of health inequities. Methods and design were similar to original LAC SABE. The total sample size of the study at the urban and rural research sites (244 municipalities) was 23.694 elderly Colombians representative of the total population. The study had three components: (1) a questionnaire covering active aging determinants including anthropometry, blood pressure measurement, physical function, and biochemical and hematological measures; (2) a subsample survey among family caregivers; (3) a qualitative study with gender and cultural perspectives of quality of life to understand different dimensions of people meanings. Conclusions. The SABE Colombia is a comprehensive, multidisciplinary study of the elderly with respect to active aging determinants. The results of this study are intended to inform public policies aimed at tackling health inequalities for the aging society in Colombia.

  20. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  1. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial.

    PubMed

    Yan, Hu; Su, Youxin; Chen, Lidian; Zheng, Guohua; Lin, Xueyi; Chen, Baojun; Zhou, Bihong; Zhang, Qing

    2013-11-04

    It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t'ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health-related quality-of-life assessments

  2. The effectiveness of introducing Group Prenatal Care (GPC) in selected health facilities in a district of Bangladesh: study protocol.

    PubMed

    Sultana, Marufa; Mahumud, Rashidul Alam; Ali, Nausad; Ahmed, Sayem; Islam, Ziaul; Khan, Jahangir A M; Sarker, Abdur Razzaque

    2017-01-31

    Despite high rates of antenatal care and relatively good access to health facilities, maternal and neonatal mortality remain high in Bangladesh. There is an immediate need for implementation of evidence-based, cost-effective interventions to improve maternal and neonatal health outcomes. The aim of the study is to assess the effect of the intervention namely Group Prenatal Care (GPC) on utilization of standard number of antenatal care, post natal care including skilled birth attendance and institutional deliveries instead of usual care. The study is quasi-experimental in design. We aim to recruit 576 pregnant women (288 interventions and 288 comparisons) less than 20 weeks of gestational age. The intervention will be delivered over around 6 months. The outcome measure is the difference in maternal service coverage including ANC and PNC coverage, skilled birth attendance and institutional deliveries between the intervention and comparison group. Findings from the research will contribute to improve maternal and newborn outcome in our existing health system. Findings of the research can be used for planning a new strategy and improving the health outcome for Bangladeshi women. Finally addressing the maternal health goal, this study is able to contribute to strengthening health system.

  3. Public health surveillance of automated external defibrillators in the USA: protocol for the dynamic automated external defibrillator registry study.

    PubMed

    Elrod, JoAnn Broeckel; Merchant, Raina; Daya, Mohamud; Youngquist, Scott; Salcido, David; Valenzuela, Terence; Nichol, Graham

    2017-03-29

    Lay use of automated external defibrillators (AEDs) before the arrival of emergency medical services (EMS) providers on scene increases survival after out-of-hospital cardiac arrest (OHCA). AEDs have been placed in public locations may be not ready for use when needed. We describe a protocol for AED surveillance that tracks these devices through time and space to improve public health, and survival as well as facilitate research. Included AEDs are installed in public locations for use by laypersons to treat patients with OHCA before the arrival of EMS providers on scene. Included cases of OHCA are patients evaluated by organised EMS personnel and treated for OHCA. Enrolment of 10 000 AEDs annually will yield precision of 0.4% in the estimate of readiness for use. Enrolment of 2500 patients annually will yield precision of 1.9% in the estimate of survival to hospital discharge. Recruitment began on 21 Mar 2014 and is ongoing. AEDs are found by using multiple methods. Each AED is then tagged with a label which is a unique two-dimensional (2D) matrix code; the 2D matrix code is recorded and the location and status of the AED tracked using a smartphone; these elements are automatically passed via the internet to a secure and confidential database in real time. Whenever the 2D matrix code is rescanned for any non-clinical or clinical use of an AED, the user is queried to answer a finite set of questions about the device status. The primary outcome of any clinical use of an AED is survival to hospital discharge. Results are summarised descriptively. These activities are conducted under a grant of authority for public health surveillance from the Food and Drug Administration. Results are provided periodically to participating sites and sponsors to improve public health and quality of care. 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/.

  4. Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial.

    PubMed

    Peckham, Emily; Arundel, Catherine; Bailey, Della; Brownings, Stuart; Fairhurst, Caroline; Heron, Paul; Li, Jinshuo; Parrott, Steve; Gilbody, Simon

    2017-01-26

    Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the 'culture' of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health. SCIMITAR+ is a multicentre, pragmatic, two-arm, parallel-group, individually randomised controlled trial. We aim to recruit 400 participants aged 18 years and above with a documented diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder who smoke. Potentially eligible participants identified in primary or secondary care will be screened, and baseline data collected. Eligible, consenting participants will be randomly allocated to one of two groups. In the intervention arm, the participant will be assigned a mental health professional trained to deliver smoking-cessation interventions who will work with the participant and participant's GP or mental health specialist to provide an individually tailored smoking-cessation service. The comparator arm will be usual care - following current NICE guidelines for smoking cessation, in line with general guidance that is offered to all smokers, with no specific adaptation or enhancement in relation to severe mental ill health. The primary outcome will be self-reported smoking cessation at 12 months verified by expired carbon monoxide (CO) measurement. Secondary outcome measures include Body Mass Index at 12 months, the Fagerström Test for Nicotine Dependence, Motivation to Quit questionnaire, SF-12, PHQ-9, GAD-7, EQ-5D-5 L, and health service utilisation at 6

  5. Preference-based disease-specific health-related quality of life instrument for glaucoma: a mixed methods study protocol

    PubMed Central

    Muratov, Sergei; Podbielski, Dominik W; Jack, Susan M; Ahmed, Iqbal Ike K; Mitchell, Levine A H; Baltaziak, Monika; Xie, Feng

    2016-01-01

    Introduction A primary objective of healthcare services is to improve patients' health and health-related quality of life (HRQoL). Glaucoma, which affects a substantial proportion of the world population, has a significant detrimental impact on HRQoL. Although there are a number of glaucoma-specific questionnaires to measure HRQoL, none is preference-based which prevent them from being used in health economic evaluation. The proposed study is aimed to develop a preference-based instrument that is capable of capturing important effects specific to glaucoma and treatments on HRQoL and is scored based on the patients' preferences. Methods A sequential, exploratory mixed methods design will be used to guide the development and evaluation of the HRQoL instrument. The study consists of several stages to be implemented sequentially: item identification, item selection, validation and valuation. The instrument items will be identified and selected through a literature review and the conduct of a qualitative study. Validation will be conducted to establish psychometric properties of the instrument followed by a valuation exercise to derive utility scores for the health states described. Ethics and dissemination This study has been approved by the Trillium Health Partners Research Ethics Board (ID number 753). All personal information will be de-identified with the identification code kept in a secured location including the rest of the study data. Only qualified and study-related personnel will be allowed to access the data. The results of the study will be distributed widely through peer-reviewed journals, conferences and internal meetings. PMID:28186941

  6. Effectiveness and efficiency of integrated mental health care programmes in Germany: study protocol of an observational controlled trial.

    PubMed

    Stierlin, Annabel Sandra; Herder, Katrin; Helmbrecht, Marina Julia; Prinz, Stefanie; Walendzik, Julia; Holzmann, Marco; Becker, Thomas; Schützwohl, Matthias; Kilian, Reinhold

    2014-06-04

    Since 2009 some German health insurance companies have implemented integrated mental health care services along the principles of assertive community treatment in collaboration with local mental health service providers across Germany. Focus of this study is the analysis of effectiveness and cost-effectiveness of this integrated care programme compared to care as usual in routine care surroundings in five regions in Germany. In this 18-month multi-centre observational trial 250 patients enrolled in an integrated mental health care programme and 250 patients who receive treatment as usual from five catchment areas will be included. In addition, in each group about 125 relatives of the participating patients will be included. The primary outcome criterion is the improvement of empowerment; secondary outcomes are subjective quality of life, functional impairment and costs of illness. Data will be collected at baseline and three follow-ups after 6, 12 and 18 months. Data will be analysed by means of mixed effects regression models. Propensity score methods are used for selection bias control. Study results are expected to provide information about how integrated care programmes in their present form contribute to the improvement of mental health care. In addition, the study will provide hints to weaknesses of the current integrated care programme and options to overcome them. The major strengths of this study are the real-world character of the study intervention with a simultaneous high level of academic rigour. However, the fact that patients are not randomised to study groups and that there is no blinding might limit the study. German Clinical Trial Register DRKS00005111.

  7. Development of a Health Empowerment Programme to improve the health of working poor families: protocol for a prospective cohort study in Hong Kong

    PubMed Central

    Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Kung, Kenny; Ho, Sin Yi; Lam, Lai Ying; Ip, Patrick; Fong, Daniel Yee Tak; Lam, David Chi Leung; Wong, William Chi Wai; Tsang, Sandra Kit Man; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

    2016-01-01

    Introduction People from working poor families are at high risk of poor health partly due to limited healthcare access. Health empowerment, a process by which people can gain greater control over the decisions affecting their lives and health through education and motivation, can be an effective way to enhance health, health-related quality of life (HRQOL), health awareness and health-seeking behaviours of these people. A new cohort study will be launched to explore the potential for a Health Empowerment Programme to enable these families by enhancing their health status and modifying their attitudes towards health-related issues. If proven effective, similar empowerment programme models could be tested and further disseminated in collaborations with healthcare providers and policymakers. Method and analysis A prospective cohort study with 200 intervention families will be launched and followed up for 5 years. The following inclusion criteria will be used at the time of recruitment: (1) Having at least one working family member; (2) Having at least one child studying in grades 1–3; and (3) Having a monthly household income that is less than 75% of the median monthly household income of Hong Kong families. The Health Empowerment Programme that will be offered to intervention families will comprise four components: health assessment, health literacy, self-care enablement and health ambassador. Their health status, HRQOL, lifestyle and health service utilisation will be assessed and compared with 200 control families with matching characteristics but will not receive the health empowerment intervention. Ethics and dissemination This project was approved by the University of Hong Kong—the Hospital Authority Hong Kong West Cluster IRB, Reference number: UW 12-517. The study findings will be disseminated through a series of peer-reviewed publications and conference presentations, as well as a yearly report to the philanthropic funding body–Kerry Group Kuok

  8. A Personal Electronic Health Record: Study Protocol of a Feasibility Study on Implementation in a Real-World Health Care Setting

    PubMed Central

    Kunz, Aline; Pohlmann, Sabrina; Hofmann, Helene; Qreini, Markus; Krisam, Johannes; Uhlmann, Lorenz; Jacke, Christian; Winkler, Eva C; Salize, Hans-Joachim; Szecsenyi, Joachim

    2017-01-01

    Background A significant potential for patient empowerment is seen in concepts aiming to give patients access to their personal health information (PHI) and to share this PHI across different care settings and health systems. Personal health records (PHRs) and the availability of information through health information exchanges are considered to be key components of effective and efficient health care. With tethered PHRs, as often used in the United States, patients’ opportunities to manage their PHI are strongly restricted. Therefore, within the INFOPAT (information technology for patient oriented care) project (2012-2016) in Germany, funded by the Federal Ministry of Education and Research (BMBF), the development of a patient-controlled “personal electronic health record” (PEPA) was based on user requirements right from the beginning. Objective The overall objective of the study is to implement and evaluate a PEPA prototype for patients with colorectal cancer who are treated at the National Center for Tumor Diseases in Heidelberg. To achieve this aim, this study has 2 parts: a pre-implementation study (phase 1) and an implementation study (phase 2). The pre-implementation study will include a usability evaluation of the PEPA approach and the consideration of organizational preconditions for the implementation. With the implementation study, we will evaluate the process of implementation (eg, barriers or facilitators), the need for organizational change (eg, processes of communication), and the impact on outcomes (eg, self-efficacy, involvement in care). Methods The pre-implementation study is based on a mixed methods approach and comprises qualitative and quantitative element according to our research aim. We will use a think-aloud method for the usability analysis. Additionally, participants will be asked to evaluate their overall satisfaction based on a standardized questionnaire, the System Usability Scale. For the analysis of preconditions, we will

  9. Oropharyngeal administration of mother's colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial.

    PubMed

    Rodriguez, Nancy A; Vento, Maximo; Claud, Erika C; Wang, Chihsiung E; Caplan, Michael S

    2015-10-12

    infants receive 0.2 mL of own mother's milk, via oropharyngeal administration, every 2 hours for 48 hours, then every 3 hours until 32 weeks corrected-gestational age. Group B infants receive a placebo (0.2 mL sterile water) following the same protocol. Milk, urine, oral mucosal swab, and stool samples are collected at various time points, before, during and after the treatment periods. Health outcome and safety data are collected throughout the infant's stay. ClinicalTrials.gov identifier: NCT02116699 on 11 April 2014. Last updated: 26 May 2015.

  10. Ascertaining dementia-related outcomes for deceased or proxy-dependent participants: an overview of the Women's Health Initiative Memory Study supplemental case ascertainment protocol.

    PubMed

    Gaussoin, Sarah A; Espeland, Mark A; Absher, John; Howard, Barbara V; Jones, Beverley M; Rapp, Stephen R

    2012-02-01

    The aim of the study was to compare a two-staged clinic-based standardized protocol with a supplemental proxy-based protocol. The Women's Health Initiative Memory Study enrolled 7479 women, aged 65-79 years and free of dementia, in a clinical trial of postmenopausal hormone therapy who were followed for up to 13 years with annual two-staged clinic-based standardized protocols to identify incidence of probable dementia. A supplemental proxy-based protocol, involving telephone administration of the dementia questionnaire, was designed to assess the cognitive status of women who could no longer attend clinic visits because they died (n = 1058) or became dependent (n = 228). Chi-squared tests were used to compare characteristics of women eligible for proxy-based versus clinic-based assessment. Risk factor relationships were described using proportional hazards regression. Women who were eligible for proxy-based assessments tended to have worse cognitive impairment risk factor profiles and had higher rates of probable dementia (15.2% vs 3.5%) than clinic-assessed participants. Augmenting the clinic-based cases with those identified from proxy interviews reduced undercounting and materially altered observed relationships that years since menopause, smoking status, diabetes, and prior use of hormone therapy had with incidence of probable dementia. Although proxy interviews were successful in reducing biases in estimated incidence rates and risk factor relationships, it is unlikely that they will fully eliminate many biases. Proxy-based assessments are necessary in longer term studies to reduce undercounting of dementia cases and to characterize risk factor relationships. Copyright © 2011 John Wiley & Sons, Ltd.

  11. Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol.

    PubMed

    Gupta, Madhu; Angeli, Federica; van Schayck, Onno C P; Bosma, Hans

    2015-01-01

    A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005-2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the broader themes across the

  12. Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol.

    PubMed

    Gupta, Madhu; Angeli, Federica; van Schayck, Onno C P; Bosma, Hans

    2015-01-01

    Background A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. Objective To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. Design A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005-2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the broader

  13. Effectiveness of a multiple-strategy community intervention to reduce maternal and child health inequalities in Haryana, North India: a mixed-methods study protocol

    PubMed Central

    Gupta, Madhu; Angeli, Federica; van Schayck, Onno C. P.; Bosma, Hans

    2015-01-01

    Background A multiple-strategy community intervention, known as National Rural Health Mission (NRHM), launched in India to improve the availability of and access to better-quality healthcare, especially for rural, poor mothers and children. The final goal of the intervention is to reduce maternal and child health inequalities across geographical areas, socioeconomic status groups, and sex of the child. Extensive, in-depth research is necessary to assess the effectiveness of NRHM, on multiple outcome dimensions. This paper presents the design of a new study, able to overcome the shortcomings of previous research. Objective To propose a comprehensive, methodologically sound protocol to assess the extent of implementation and the effectiveness of NRHM measures to improve maternal and child health outcomes and reduce maternal and child health inequalities. Design A mixed-methods approach (quantitative and qualitative) is proposed for this study in Haryana, a state in North India. NRHM's health sector plans included health system strengthening, specific maternal and child healthcare strategies, and communitization. Mission documents and reports on progress, financial monitoring, and common and joint review will be reviewed in-depth to assess the extent of the implementation of plans. Data on maternal and child health indicators will be obtained from demographic health surveys held before, during, and after the implementation of the first phase of the NRHM (2005–2012) and compared over time. Differences in maternal and child health indicators will be used to measure maternal and child health inequalities; these will be compared pre- and post-NRHM. Focus group discussions (FGDs) with service providers and in-depth interviews with program managers, community representatives, and mothers will be conducted until data saturation is achieved, in two districts of Haryana. Using Nvivo software, an inductive qualitative content analysis will be performed to search for the

  14. Shared decision-making and health for First Nations, Métis and Inuit women: a study protocol

    PubMed Central

    2012-01-01

    Background Little is known about shared decision-making (SDM) with Métis, First Nations and Inuit women (“Aboriginal women”). SDM is a collaborative process that engages health care professional(s) and the client in making health decisions and is fundamental for informed consent and patient-centred care. The objective of this study is to explore Aboriginal women’s health and social decision-making needs and to engage Aboriginal women in culturally adapting an SDM approach. Methods Using participatory research principles and guided by a postcolonial theoretical lens, the proposed mixed methods research will involve three phases. Phase I is an international systematic review of the effectiveness of interventions for Aboriginal peoples’ health decision-making. Developed following dialogue with key stakeholders, proposed methods are guided by the Cochrane handbook and include a comprehensive search, screening by two independent researchers, and synthesis of findings. Phases II and III will be conducted in collaboration with Minwaashin Lodge and engage an urban Aboriginal community of women in an interpretive descriptive qualitative study. In Phase II, 10 to 13 Aboriginal women will be interviewed to explore their health/social decision-making experiences. The interview guide is based on the Ottawa Decision Support Framework and previous decisional needs assessments, and as appropriate may be adapted to findings from the systematic review. Digitally-recorded interviews will be transcribed verbatim and analyzed inductively to identify participant decision-making approaches and needs when making health/social decisions. In Phase III, there will be cultural adaptation of an SDM facilitation tool, the Ottawa Personal Decision Guide, by two focus groups consisting of five to seven Aboriginal women. The culturally adapted guide will undergo usability testing through individual interviews with five to six women who are about to make a health/social decision. Focus

  15. Shared decision-making and health for First Nations, Métis and Inuit women: a study protocol.

    PubMed

    Jull, Janet; Stacey, Dawn; Giles, Audrey; Boyer, Yvonne

    2012-12-18

    Little is known about shared decision-making (SDM) with Métis, First Nations and Inuit women ("Aboriginal women"). SDM is a collaborative process that engages health care professional(s) and the client in making health decisions and is fundamental for informed consent and patient-centred care. The objective of this study is to explore Aboriginal women's health and social decision-making needs and to engage Aboriginal women in culturally adapting an SDM approach. Using participatory research principles and guided by a postcolonial theoretical lens, the proposed mixed methods research will involve three phases. Phase I is an international systematic review of the effectiveness of interventions for Aboriginal peoples' health decision-making. Developed following dialogue with key stakeholders, proposed methods are guided by the Cochrane handbook and include a comprehensive search, screening by two independent researchers, and synthesis of findings. Phases II and III will be conducted in collaboration with Minwaashin Lodge and engage an urban Aboriginal community of women in an interpretive descriptive qualitative study. In Phase II, 10 to 13 Aboriginal women will be interviewed to explore their health/social decision-making experiences. The interview guide is based on the Ottawa Decision Support Framework and previous decisional needs assessments, and as appropriate may be adapted to findings from the systematic review. Digitally-recorded interviews will be transcribed verbatim and analyzed inductively to identify participant decision-making approaches and needs when making health/social decisions. In Phase III, there will be cultural adaptation of an SDM facilitation tool, the Ottawa Personal Decision Guide, by two focus groups consisting of five to seven Aboriginal women. The culturally adapted guide will undergo usability testing through individual interviews with five to six women who are about to make a health/social decision. Focus groups and individual

  16. DetectaWeb Project: study protocol of a web-based detection of mental health of children and adolescents.

    PubMed

    Piqueras, Jose A; Garcia-Olcina, Mariola; Rivera-Riquelme, Maria; Rodriguez-Jimenez, Tiscar; Martinez-Gonzalez, Agustin E; Cuijpers, Pim

    2017-10-05

    Traditionally, research and practice addressing mental health has been conducted within a unidimensional model, explaining mental health as the presence/absence of psychological problems (distress or psychopathological symptoms). More recently, accumulative evidence has supported a bi-dimensional model, which conceptualises psychological problems and psychological strengths (well-being) as related-yet-distinct continua that, when considered together, yields a more comprehensive understanding of individuals. The DetectaWeb Project is a web-based early detection assessment of the mental health continuum (MHC) for children and adolescents and aims to: develop a web-based platform for screening of the MHC, including both psychological problems (anxiety, depression and suicidality) and personal strengths (emotional, cognitive/psychological and social aspects); examine the prevalence of the MHC among children and adolescents; and analyse key determinants (risk and protective factors) of the MHC. We will conduct an ongoing, multicentre observational, cross-sectional study of Spanish children and adolescents. Participants will be assessed through a web-based platform. In order to validate the web-based screening system, a clinical reappraisal will be completed among a subsample of respondents. To elucidate youth's levels of subjective distress and well-being, we will include measures of anxiety, depression, suicidality, well-being, externalising problems and socio-demographic variables. Ethical approval has been obtained at all sites. All participants will sign a free and informed consent form before the assessment. Results of the study will be communicated during national and international meetings in the field of clinical and health psychology with children and adolescents. Publications will be sought in journals usually read by psychologists or psychiatrists involved in the development of epidemiological studies and interventions for mental health promotion based on

  17. Effectiveness of a web-based health risk assessment with individually-tailored feedback on lifestyle behaviour: study protocol.

    PubMed

    Laan, Eva K; Kraaijenhagen, Roderik A; Peek, Niels; Busschers, Wim B; Deutekom, Marije; Bossuyt, Patrick M; Stronks, Karien; Essink-Bot, Marie-Louise

    2012-03-19

    Physical inactivity, unhealthy dietary habits, smoking and high alcohol consumption are recognized risk factors for cardiovascular disease and cancer. Web-based health risk assessments with tailored feedback seem promising in promoting a healthy lifestyle. This study evaluates the effectiveness of a web-based health risk assessment with individually-tailored feedback on lifestyle behaviour, conducted in a worksite setting. The web-based health risk assessment starts with a questionnaire covering socio-demographic variables, family and personal medical history, lifestyle behaviour and psychological variables. Prognostic models are used to estimate individual cardiovascular risks. In case of high risk further biometric and laboratory evaluation is advised. All participants receive individually-tailored feedback on their responses to the health risk assessment questionnaire. The study uses a quasi-experimental design with a waiting list control group. Data are collected at baseline (T0) and after six months (T1). Within each company, clusters of employees are allocated to either the intervention or the control group. Primary outcome is lifestyle behaviour, expressed as the sum of five indicators namely physical activity, nutrition, smoking behaviour, alcohol consumption, and symptoms of burnout. Multilevel regression analysis will be used to answer the main research question and to correct for clustering effects. Baseline differences between the intervention and control group in the distribution of characteristics with a potential effect on lifestyle change will be taken into account in further analyses using propensity scores. This study will increase insight into the effectiveness of health risk assessments with tailored feedback and into conditions that may modify the effectiveness. This information can be used to design effective interventions for lifestyle behaviour change among employees. Dutch Trial Register NTR8148.

  18. LInking EDCs in maternal Nutrition to Child health (LINC study) - protocol for prospective cohort to study early life exposure to environmental chemicals and child health.

    PubMed

    de Cock, Marijke; Quaak, Ilona; Sugeng, Eva J; Legler, Juliette; van de Bor, Margot

    2016-02-13

    The presence of chemicals in the environment is ubiquitous. Human biomonitoring studies have shown that various chemicals can be detected in the majority of the population, including pregnant women. These compounds may pass the placenta, and reach the fetus. This early life exposure in particular may be detrimental as some chemicals may disrupt the endocrine system, which is involved in various processes during development. The LINC study is a prospective birth cohort designed to study associations between early life environmental exposures and child health, including growth and neurodevelopment. The purpose of this paper is to give an overview of this cohort. Recruitment for this cohort has started in 2011 in three Dutch areas and is still ongoing. To date over 300 mother-child pairs have been included. Women are preferably included during the first trimester of pregnancy. Major congenital anomalies and twin births are reasons for exclusion. To assess exposure to environmental chemicals, cord blood, placenta, meconium and vernix are collected. Parents collect urine of the child shortly after birth and breast milk in the second month of life. Exposure to a broad range of environmental chemicals are determined in cord plasma and breast milk. Furthermore various hormones, including leptin and cortisone, are determined in cord plasma, and in heel prick blood spots (thyroxine). Data on anthropometry of the child is collected through midwives and youth health care centres on various time points until the child is 18 months of age. Furthermore cognitive development is monitored by means of the van Wiechen scheme, and information on behavioral development is collected by means of the infant behavior questionnaire and the child behavior checklist. When the child is 12 months of age, a house visit is scheduled to assess various housing characteristics, as well as hand-to-mouth behavior of the child. At this visit exposure of the child to flame retardants (with endocrine

  19. Brief intervention for alcohol misuse in people attending sexual health clinics: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention) or control treatment (a leaflet on healthy living). Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic intervention for excessive

  20. An audience research study to disseminate evidence about comprehensive state mental health parity legislation to US State policymakers: protocol.

    PubMed

    Purtle, Jonathan; Lê-Scherban, Félice; Shattuck, Paul; Proctor, Enola K; Brownson, Ross C

    2017-06-26

    A large proportion of the US population has limited access to mental health treatments because insurance providers limit the utilization of mental health services in ways that are more restrictive than for physical health services. Comprehensive state mental health parity legislation (C-SMHPL) is an evidence-based policy intervention that enhances mental health insurance coverage and improves access to care. Implementation of C-SMHPL, however, is limited. State policymakers have the exclusive authority to implement C-SMHPL, but sparse guidance exists to inform the design of strategies to disseminate evidence about C-SMHPL, and more broadly, evidence-based treatments and mental illness, to this audience. The aims of this exploratory audience research study are to (1) characterize US State policymakers' knowledge and attitudes about C-SMHPL and identify individual- and state-level attributes associated with support for C-SMHPL; and (2) integrate quantitative and qualitative data to develop a conceptual framework to disseminate evidence about C-SMHPL, evidence-based treatments, and mental illness to US State policymakers. The study uses a multi-level (policymaker, state), mixed method (QUAN→qual) approach and is guided by Kingdon's Multiple Streams Framework, adapted to incorporate constructs from Aarons' Model of Evidence-Based Implementation in Public Sectors. A multi-modal survey (telephone, post-mail, e-mail) of 600 US State policymakers (500 legislative, 100 administrative) will be conducted and responses will be linked to state-level variables. The survey will span domains such as support for C-SMHPL, knowledge and attitudes about C-SMHPL and evidence-based treatments, mental illness stigma, and research dissemination preferences. State-level variables will measure factors associated with C-SMHPL implementation, such as economic climate and political environment. Multi-level regression will determine the relative strength of individual- and state

  1. Impact of mobile phone-based technology to improve health, population and nutrition services in Rural Bangladesh: a study protocol.

    PubMed

    Uddin, Jasim; Biswas, Tuhin; Adhikary, Gourab; Ali, Wazed; Alam, Nurul; Palit, Rajesh; Uddin, Nizam; Uddin, Aftab; Khatun, Fatema; Bhuiya, Abbas

    2017-07-06

    Mobile phone-based technology has been used in improving the delivery of healthcare services in many countries. However, data on the effects of this technology on improving primary healthcare services in resource-poor settings are limited. The aim of this study is to develop and test a mobile phone-based system to improve health, population and nutrition services in rural Bangladesh and evaluate its impact on service delivery. The study will use a quasi-experimental pre-post design, with intervention and comparison areas. Outcome indicators will include: antenatal care (ANC), delivery care, postnatal care (PNC), neonatal care, expanded programme on immunization (EPI) coverage, and contraceptive prevalence rate (CPR). The study will be conducted over a period of 30 months, using the existing health systems of Bangladesh. The intervention will be implemented through the existing service-delivery personnel at various primary-care levels, such as community clinic, union health and family welfare centre, and upazila health complex. These healthcare providers will be given mobile phones equipped with Apps for sending text and voice messages, along with the use of Internet and device for data-capturing. Training on handling of the Smartphones, data-capturing and monitoring will be given to selected service providers. They will also be trained on inputs, editing, verifying, and monitoring the outcome variables. Mobile phone-based technology has the potential to improve primary healthcare services in low-income countries, like Bangladesh. It is expected that our study will contribute to testing and developing a mobile phone-based intervention to improve the coverage and quality of services. The learning can be used in other similar settings in the low-and middle-income countries.

  2. Monitoring air pollution effects on children for supporting public health policy: the protocol of the prospective cohort MAPEC study

    PubMed Central

    Feretti, D; Ceretti, E; De Donno, A; Moretti, M; Carducci, A; Bonetta, S; Marrese, M R; Bonetti, A; Covolo, L; Bagordo, F; Villarini, M; Verani, M; Schilirò, T; Limina, R M; Grassi, T; Monarca, S; Casini, B; Carraro, E; Zani, C; Mazzoleni, G; Levaggi, R; Gelatti, U

    2014-01-01

    Introduction Genotoxic biomarkers have been studied largely in adult population, but few studies so far have investigated them in children exposed to air pollution. Children are a high-risk group as regards the health effects of air pollution and some studies suggest that early exposure during childhood can play an important role in the development of chronic diseases in adulthood. The objective of the project is to evaluate the associations between the concentration of urban air pollutants and biomarkers of early biological effect in children, and to propose a model for estimating the global risk of early biological effects due to air pollutants and other factors in children. Methods and analysis Two biomarkers of early biological effects, DNA damage by the comet assay and the micronuclei (MN) test, will be investigated in oral mucosa cells of 6–8-year-old children. Concurrently, some toxic airborne pollutants (polycyclic aromatic hydrocarbon (PAH) and nitro-PAH) and in vitro air mutagenicity and toxicity in ultra-fine air particulates (PM0.5) will be evaluated. Furthermore, demographic and socioeconomic variables, other sources of exposures to air pollutants and lifestyle variables will be assessed by a structured questionnaire. The associations between sociodemographic, environmental and other exposure variables and biomarkers of early biological effect using univariate and multivariate models will be analysed. A tentative model for calculating the global absolute risk of having early biological effects caused by air pollution and other variables will be proposed. Ethics and dissemination The project has been approved by the Ethics Committees of the local Health Authorities. The results will be communicated to local Public Health Agencies, for supporting educational programmes and health policy strategies. LIFE+2012 Environment Policy and Governance. LIFE12 ENV/IT/000614. PMID:25227631

  3. High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial.

    PubMed

    Ramírez-Vélez, Robinson; Hernandez, Alejandra; Castro, Karem; Tordecilla-Sanders, Alejandra; González-Ruíz, Katherine; Correa-Bautista, Jorge Enrique; Izquierdo, Mikel; García-Hermoso, Antonio

    2016-06-24

    Although evidence shows the positive health effects of physical activity, most of the adult population in Colombia are sedentary. It is, therefore, important to implement strategies that generate changes in lifestyle behaviours. This protocol describes a study in which we will compare the effects of 12 weeks of high-intensity interval training (HIIT), resistance training (RT) or combined training (HIIT + RT) on the improvement of body composition, endothelial function, blood pressure, blood lipids, and cardiorespiratory fitness in a cohort of sedentary, overweight adults (aged 30-50 years). Sixty sedentary, overweight adults attending primary care in Bogotá, Colombia will be included in a factorial randomised controlled trial. Participants will be randomly assigned to the following intervention groups: (1) non-exercise group: usual care with dietary support, (2) HIIT group: 4 × 4-min intervals at 85-95 % maximum heart rate (HRmax) (with the target zone maintained for at least 2 minutes), interspersed with a 4-min recovery period, at 65 % HRmax, (3) RT group: completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject's weight until an expenditure of 500 kcal at 40-80 % of one-rep max (1RM) has been achieved, and (4) combined group: HIIT + RT. The primary end point for effectiveness is vascular function as measured by flow-mediated vasodilatation 1 week after the end of exercise training. The results of this study will provide new information about the possible effect of the programme in improving the cardiometabolic health of overweight adults, making a more efficient use of an adult's resources over time. ClinicalTrials.gov ID: NCT02715063 . Registered on 8 March 2016.

  4. Evaluating the accessibility and utility of HIV-related point-of-care diagnostics for maternal health in rural South Africa: a study protocol

    PubMed Central

    Mashamba-Thompson, T P; Drain, P K; Sartorius, B

    2016-01-01

    Introduction Poor healthcare access is a major barrier to receiving antenatal care and a cause of high maternal mortality in South Africa (SA). ‘Point-of-care’ (POC) diagnostics is a powerful emerging healthcare approach to improve healthcare access. This study focuses on evaluating the accessibility and utility of POC diagnostics for maternal health in rural SA primary healthcare (PHC) clinics in order to generate a model framework of implementation of POC diagnostics in rural South African clinics. Method and analyses We will use several research methods, including a systematic review, quasi-experiments, survey, key informant interviews and audits. We will conduct a systematic review and experimental study to determine the impact of POC diagnostics on maternal health. We will perform a cross-sectional case study of 100 randomly selected rural primary healthcare clinics in KwaZulu-Natal to measure the context and patterns of POC diagnostics access and usage by maternal health providers and patients. We will conduct interviews with relevant key stakeholders to determine the reasons for POC deficiencies regarding accessibility and utility of HIV-related POC diagnostics for maternal health. We will also conduct a vertical audit to investigate all the quality aspects of POC diagnostic services including diagnostic accuracy in a select number of clinics. On the basis of information gathered, we will propose a model framework for improved implementation of POC diagnostics in rural South African public healthcare clinics. Statistical (Stata-13) and thematic (NVIVO) data analysis will be used in this study. Ethics and dissemination The study protocol was approved by the Ethics Committee of the University of KwaZulu-Natal (BE 484/14) and the KwaZulu-Natal Department of Health based on the Helsinki Declaration (HRKM 40/15). Findings of this study will be disseminated electronically and in print. They will be presented to conferences related to HIV/AIDS, diagnostics

  5. Access 3 project protocol: young people and health system navigation in the digital age: a multifaceted, mixed methods study.

    PubMed

    Kang, Melissa; Robards, Fiona; Sanci, Lena; Steinbeck, Katharine; Jan, Stephen; Hawke, Catherine; Kong, Marlene; Usherwood, Tim

    2017-08-07

    The integration of digital technology into everyday lives of young people has become widespread. It is not known whether and how technology influences barriers and facilitators to healthcare, and whether and how young people navigate between face-to-face and virtual healthcare. To provide new knowledge essential to policy and practice, we designed a study that would explore health system access and navigation in the digital age. The study objectives are to: (1) describe experiences of young people accessing and navigating the health system in New South Wales (NSW), Australia; (2) identify barriers and facilitators to healthcare for young people and how these vary between groups; (3) describe health system inefficiencies, particularly for young people who are marginalised; (4) provide policy-relevant knowledge translation of the research data. This mixed methods study has four parts, including: (1) a cross-sectional survey of young people (12-24 years) residing in NSW, Australia; (2) a longitudinal, qualitative study of a subsample of marginalised young people (defined as young people who: identify as Aboriginal and/or Torres Strait Islander; are experiencing homelessness; identify as sexuality and/or gender diverse; are of refugee or vulnerable migrant background; and/or live in rural or remote NSW); (3) interviews with professionals; (4) a knowledge translation forum. Ethics approvals were sought and granted. Data collection commenced in March 2016 and will continue until June 2017. This study will gather practice and policy-relevant intelligence about contemporary experiences of young people and health services, with a unique focus on five different groups of marginalised young people, documenting their experiences over time. Access 3 will explore navigation around all levels of the health system, determine whether digital technology is integrated into this, and if so how, and will translate findings into policy-relevant recommendations. © Article author(s) (or

  6. Protocol for a mixed studies systematic review on the implementation of the recovery approach in adult mental health services.

    PubMed

    Piat, Myra; Sofouli, Eleni; Sabetti, Judith; Lambrou, Angella; Chodos, Howard; Briand, Catherine; Vachon, Brigitte; Curran, Janet

    2017-08-30

    Recovery is integral to mental health planning in G-8 countries including Canada. A recovery-oriented approach to care aims to promote personal empowerment, illness self-management and a life beyond services for people with serious mental illness (SMI), while reducing the financial burden associated with mental illness. Although there is a growing body of literature on recovery, no synthesis of research on the implementation of recovery into mental health services exists. The objective is to conduct a mixed studies systematic review on the operationalisation of recovery into mental health services for adults with SMI. It will inform the transformation of Canadian services to a recovery orientation, but may be applicable to other countries. Seven databases including PubMed, Ovid Medline, Ovid Embase, Ovid PsycInfo, CINAHL, the Cochrane Library and Scopus will be searched for peer-reviewed empirical studies published from 1998 to December 2016. Systematic reviews and studies using quantitative, qualitative and mixed methodologies will be included. Secondary searches will be conducted in reference lists of all selected full text articles. Handsearches will also be performed in the tables of contents of three recovery-focused journals for the last 5 years. International experts in the field will be contacted for comments and advice. Data extraction will include identification and methodological synthesis of each study; definition of recovery; information on recovery implementation; facilitators and barriers and study outcomes. A quality assessment will be conducted on each study. The data will be synthesised and a stepwise thematic analysis performed. Ethics approval is not required for this knowledge synthesis. Findings will be disseminated through knowledge translation activities including: (1) a 1-day symposium; (2) presentations in national and international conferences and to local stakeholders; (3) publications in peer-reviewed journals; (4) posts on the

  7. Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. Trial registration Current controlled trials ISRCTN62237498 Date registered: 5 September 2013 PMID:25016303

  8. Effects of community health volunteers on infectious diseases of children under five in Volta Region, Ghana: study protocol for a cluster randomized controlled trial.

    PubMed

    Ma, Yeonji; Kim, Heunghee; Cho, Yinseo; Lee, Jaeeun; Degley, Joseph Kwami; Adam, Abdul-Ghaffa; Lee, Gyuhong; Lee, Hoonsang; Cha, Seungman

    2017-01-19

    In many low- and middle-income countries, community health volunteers (CHVs) are employed as a key element of the public health system in rural areas with poor accessibility. However, few studies have assessed the effectiveness of CHVs in improving child health in sub-Saharan Africa through randomized controlled trials. The present study aims to measure the impact of health promotion and case management implemented by CHVs on the health of under-5 children in Ghana. This study presents the protocol of a cluster-randomized controlled trial assessing the impacts of CHVs, in which the community was used as the randomization unit. A phase-in design will be adopted, and the intervention arm will be implemented in the intervention arm during the first phase and in the control arm during the second phase. The key intervention is the deployment of CHVs, who provide health education, provide oral rehydration solutions and zinc tablets to children with diarrhea, and diagnose malaria using a thermometer and a rapid diagnostic test kit during home visits. The primary endpoints of the study are the prevalence of diarrhea and fever/malaria in children under 5 years of age, as well as the proportion of affected children receiving case management for diarrhea and malaria. The first and second rounds of household surveys to collect data will be conducted in the first phase, and the final round will be conducted during the second phase. With growing attention paid to the roles of CHVs as an essential part of the community health system in low-income countries, this study will contribute valuable information to the body of knowledge on the effects of CHVs. ISRCTN49236178 . (June 16th, 2015).

  9. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application.

    PubMed

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P

    2016-01-01

    -time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment.

  10. Study Protocol on Ecological Momentary Assessment of Health-Related Quality of Life Using a Smartphone Application

    PubMed Central

    Mareva, Silvana; Thomson, David; Marenco, Pietro; Estal Muñoz, Víctor; Ott, Caroline V.; Schmidt, Barbara; Wingen, Tobias; Kassianos, Angelos P.

    2016-01-01

    -time and retrospective measures in this study will provide important novel insight into the efficacy of mHealth applications for HRQoL assessment. If shown to be valid, reliable and feasible for the collection of HRQoL data, mHealth applications may have future potential for facilitating clinical assessment, patient-physician communication, and monitoring individual HRQoL over course of treatment. PMID:27486425

  11. Development of a Health Empowerment Programme to improve the health of working poor families: protocol for a prospective cohort study in Hong Kong.

    PubMed

    Fung, Colman Siu Cheung; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wong, Carlos King Ho; Kung, Kenny; Ho, Sin Yi; Lam, Lai Ying; Ip, Patrick; Fong, Daniel Yee Tak; Lam, David Chi Leung; Wong, William Chi Wai; Tsang, Sandra Kit Man; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

    2016-02-03

    People from working poor families are at high risk of poor health partly due to limited healthcare access. Health empowerment, a process by which people can gain greater control over the decisions affecting their lives and health through education and motivation, can be an effective way to enhance health, health-related quality of life (HRQOL), health awareness and health-seeking behaviours of these people. A new cohort study will be launched to explore the potential for a Health Empowerment Programme to enable these families by enhancing their health status and modifying their attitudes towards health-related issues. If proven effective, similar empowerment programme models could be tested and further disseminated in collaborations with healthcare providers and policymakers. A prospective cohort study with 200 intervention families will be launched and followed up for 5 years. The following inclusion criteria will be used at the time of recruitment: (1) Having at least one working family member; (2) Having at least one child studying in grades 1-3; and (3) Having a monthly household income that is less than 75% of the median monthly household income of Hong Kong families. The Health Empowerment Programme that will be offered to intervention families will comprise four components: health assessment, health literacy, self-care enablement and health ambassador. Their health status, HRQOL, lifestyle and health service utilisation will be assessed and compared with 200 control families with matching characteristics but will not receive the health empowerment intervention. This project was approved by the University of Hong Kong-the Hospital Authority Hong Kong West Cluster IRB, Reference number: UW 12-517. The study findings will be disseminated through a series of peer-reviewed publications and conference presentations, as well as a yearly report to the philanthropic funding body-Kerry Group Kuok Foundation (Hong Kong) Limited. Published by the BMJ Publishing Group

  12. Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial.

    PubMed

    Schmidt, Konrad; Thiel, Paul; Mueller, Friederike; Schmuecker, Katja; Worrack, Susanne; Mehlhorn, Juliane; Engel, Christoph; Brenk-Franz, Katja; Kausche, Stephan; Jakobi, Ursula; Bindara-Klippel, Anne; Schneider, Nico; Freytag, Antje; Davydow, Dimitry; Wensing, Michel; Brunkhorst, Frank Martin; Gensichen, Jochen

    2014-07-11

    Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors. In a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group. This study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare. U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011).

  13. Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Sepsis sequelae include critical illness polyneuropathy, myopathy, wasting, neurocognitive deficits, post-traumatic stress disorder, depression and chronic pain. Little is known howlong-term sequelae following hospital discharge are treated. The aim of our study is to determine the effect of a primary care-based, long-term program on health-related quality of life in sepsis survivors. Methods/Design In a two-armed randomized multicenter interventional study, patients after sepsis (n = 290) will be assessed at 6, 12 and 24 months. Patients are eligible if severe sepsis or septic shock (ICD-10), at least two criteria of systemic inflammatory response syndrome (SIRS), at least one organ dysfunction and sufficient cognitive capacity are present. The intervention comprises 1) discharge management, 2) training of general practitioners and patients in evidence-based care for sepsis sequelae and 3) telephone monitoring of patients. At six months, we expect an improved primary outcome (health-related quality of life/SF-36) and improved secondary outcomes such as costs, mortality, clinical-, psycho-social- and process-of-care measures in the intervention group compared to the control group. Discussion This study evaluates a primary care-based, long-term program for patients after severe sepsis. Study results may add evidence for improved sepsis care management. General practitioners may contribute efficiently to sepsis aftercare. Trial registration U1111-1119-6345. DRKS00000741, CCT-NAPN-20875 (25 February 2011). PMID:25015838

  14. A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients With Persistent Cancer Pain.

    PubMed

    Somers, Tamara J; Abernethy, Amy P; Edmond, Sara N; Kelleher, Sarah A; Wren, Anava A; Samsa, Greg P; Keefe, Francis J

    2015-10-01

    Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited because of a variety of barriers (e.g., travel, physical burden, cost, time). This study examined the feasibility and acceptability of a brief PCST intervention delivered to patients in their homes using mobile health (mHealth) technology. Pre-to-post intervention changes in pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing also were examined. Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain (N = 25) participated in a four-session intervention delivered using mHealth technology (videoconferencing on a tablet computer). Participants completed measures of pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing. We also assessed patient satisfaction. Participants completed an average of 3.36 (SD = 1.11) of the four intervention sessions for an overall session completion rate of 84%. Participants reported that the program was of excellent quality and met their needs. Significant preintervention to postintervention differences were found in pain, physical symptoms, psychological distress, and pain catastrophizing. The use of mHealth technology is a feasible and acceptable option for delivery of PCST for patients with cancer. This delivery mode is likely to dramatically increase intervention access for cancer patients with pain compared to traditional in-person delivery. Preliminary data also suggest that the program is likely to produce pretreatment to post-treatment decreases in pain and other important outcomes. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  15. A Pilot Study of a Mobile Health Pain Coping Skills Training Protocol for Patients with Persistent Cancer Pain

    PubMed Central

    Somers, Tamara J.; Abernethy, Amy P.; Edmond, Sara N.; Kelleher, Sarah A.; Wren, Anava A.; Samsa, Greg P.; Keefe, Francis J.

    2015-01-01

    Context Pain coping skills training (PCST) interventions have shown efficacy for reducing pain and providing other benefits in patients with cancer. However, their reach is often limited because of a variety of barriers (e.g., travel, physical burden, cost, time). Objectives This study examined the feasibility and acceptability of a brief PCST intervention delivered to patients in their homes using mobile health (mHealth) technology. Pre-to-post intervention changes in pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing also were examined. Methods Patients with a diagnosis of breast, lung, prostate, or colorectal cancer who reported persistent pain (N=25) participated in a four-session intervention delivered using mHealth technology (video-conferencing on a tablet computer). Participants completed measures of pain, physical functioning, physical symptoms, psychological distress, self-efficacy for pain management, and pain catastrophizing. We also assessed patient satisfaction. Results Participants completed an average of 3.36 (SD=1.11) of the four intervention sessions for an overall session completion rate of 84%. Participants reported that the program was of excellent quality and met their needs. Significant pre- to post-intervention differences were found in pain, physical symptoms, psychological distress, and pain catastrophizing. Conclusion The use of mHealth technology is a feasible and acceptable option for delivery of PCST for patients with cancer. This delivery mode is likely to dramatically increase intervention access for cancer patients with pain compared to traditional in-person delivery. Preliminary data also suggest that the program is likely to produce pre- to post-treatment decreases in pain and other important outcomes. PMID:26025279

  16. The effect of walking on falls in older people: the 'Easy Steps to Health' randomized controlled trial study protocol

    PubMed Central

    2011-01-01

    Background Falls in older people continue to be a major public health issue in industrialized countries. Extensive research into falls prevention has identified exercise as a proven fall prevention strategy. However, despite over a decade of promoting physical activity, hospitalisation rates due to falls injuries in older people are still increasing. This could be because efforts to increase physical activity amongst older people have been unsuccessful, or the physical activity that older people engage in is insufficient and/or inappropriate. The majority of older people choose walking as their predominant form of exercise. While walking has been shown to lower the risk of many chronic diseases its role in falls prevention remains unclear. This paper outlines the methodology of a study whose aims are to determine: if a home-based walking intervention will reduce the falls rate among healthy but inactive community-dwelling older adults (65 + years) compared to no intervention (usual activity) and; whether such an intervention can improve risk factors for falls, such as balance, strength and reaction time. Methods/Design This study uses a randomised controlled trial design. A total of 484 older people exercising less than 120 minutes per week will be recruited through the community and health care referrals throughout Sydney and neighboring regions. All participants are randomised into either the self-managed walking program group or the health-education waiting list group using a block randomization scheme. Outcome measures include prospective falls and falls injuries, quality of life, and physical activity levels. A subset of participants (n = 194) will also receive physical performance assessments comprising of tests of dynamic balance, strength, reaction time and lower limb functional status. Discussion Certain types of physical activity can reduce the risk of falls. As walking is already the most popular physical activity amongst older people, if walking is

  17. Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study.

    PubMed

    Avis, Jillian Ls; Cave, Andrew L; Donaldson, Stephanie; Ellendt, Carol; Holt, Nicholas L; Jelinski, Susan; Martz, Patricia; Maximova, Katerina; Padwal, Raj; Wild, T Cameron; Ball, Geoff Dc

    2015-03-25

    Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents' motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents' concern for, and motivation to, support children's healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children-boys and girls, 5 to 17 years old-will be recruited from a primary care pediatric clinic while they await their children's clinical appointment. Parents will be randomly assigned to one of five groups-four intervention groups and one control group-as they complete the SBIRT. The randomization function is built into the

  18. The Use of eHealth and Provider-Based Health Services by Patients with Diabetes Mellitus: Protocol for a Cross-Sectional Study.

    PubMed

    Hansen, Anne Helen; Bradway, Meghan; Broz, Jan; Claudi, Tor; Henriksen, Øystein; Wangberg, Silje C; Årsand, Eirik

    2016-10-31

    The prevalence of diabetes and the use of electronic health (eHealth) resources are increasing. People with diabetes need frequent monitoring and follow-up of health parameters, and eHealth services can be of great significance in this regard. However, little is known about the extent to which different kinds of eHealth tools are used, and how the use of eHealth is associated with the use of provider-based health care services among people with diabetes. The primary objective of this study is to investigate the use of eHealth and its association with the use of provider-based health care services. The secondary objectives include investigating which eHealth services are used (apps, search engines, video services, social media), the relationship between socioeconomic status and the use of different eHealth tools, whether the use of eHealth is discussed in the clinical encounter, and whether such tools might lead to (or prevent) doctor visits and referrals. We will conduct cross-sectional studies based on self-reported questionnaire data from the population-based seventh Tromsø Study. Participants will be diabetic patients aged 40 years and older. According to our estimates, approximately 1050 participants will be eligible for inclusion. Data will be analyzed using descriptive statistics, chi-square tests, and univariable and multivariable logistic regressions. The grant proposal for this study was approved by the Northern Norway Regional Health Authority on November 23, 2015 (HST 1306-16). Recruitment of participants for the Tromsø Study started in 2015 and will continue throughout 2016. This particular project started on July 1, 2016. This project may yield benefits for patients, health care providers, hospitals, and society as a whole. Benefits are related to improved prevention services, health, experience of care services, self-management tools and services, organizational structures, efficiency of specialist care use, allocation of resources, and

  19. Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial.

    PubMed

    Lazo-Porras, Maria; Bernabe-Ortiz, Antonio; Sacksteder, Katherine A; Gilman, Robert H; Malaga, German; Armstrong, David G; Miranda, J Jaime

    2016-04-19

    Diabetic foot neuropathy (DFN) is one of the most important complications of diabetes mellitus; its early diagnosis and intervention can prevent foot ulcers and the need for amputation. Thermometry, measuring the temperature of the feet, is a promising emerging modality for diabetic foot ulcer prevention. However, patient compliance with at-home monitoring is concerning. Delivering messages to remind patients to perform thermometry and foot care might be helpful to guarantee regular foot monitoring. This trial was designed to compare the incidence of diabetic foot ulcers (DFUs) between participants who receive thermometry alone and those who receive thermometry as well as mHealth (SMS and voice messaging) over a year-long study period. This is an evaluator-blinded, randomized, 12-month trial. Individuals with a diagnosis of type 2 diabetes mellitus, aged between 18-80 years, having a present dorsalis pedis pulse in both feet, are in risk group 2 or 3 using the diabetic foot risk classification system (as specified by the International Working Group on the Diabetic Foot), have an operating cell phone or a caregiver with an operating cell phone, and have the ability to provide informed consent will be eligible to participate in the study. Recruitment will be performed in diabetes outpatient clinics at two Ministry of Health tertiary hospitals in Lima, Peru. participants in both groups will receive education about foot care at the beginning of the study and they will be provided with a thermometry device (TempStat™). TempStat™ is a tool that captures a thermal image of the feet, which, depending on the temperature of the feet, shows different colors. In this study, if a participant notes a single yellow image or variance between one foot and the contralateral foot, they will be prompted to notify a nurse to evaluate their activity within the previous 2 weeks and make appropriate recommendations. In addition to thermometry, participants in the intervention arm

  20. Health-promoting behaviors and social support of women of reproductive age, and strategies for advancing their health: Protocol for a mixed methods study

    PubMed Central

    2011-01-01

    Background Determining the health-promoting behaviors of women during the important period of reproduction provides valuable information for designing appropriate intervention programs for advancing women's health. There is no study on the health-promoting behaviors of women of reproductive age in Iran. Thus, the aim of this study is to explore these health-promoting behaviors for the purpose of developing comprehensive and culturally sensitive health advancement strategies for Iranian women. Methods/Design This study has a sequential explanatory mixed methods design. The follow-up explanation model is used to elaborate the quantitative results by collecting qualitative data from participants who could best assist in elucidating the results. The study is conducted in two sequential phases. The first phase is a population-based cross-sectional survey in which 1350 Iranian women of reproductive age are selected by proportional random multistage cluster sampling of the 22 main municipal sectors of Tehran, Iran. Questionnaires are completed through a face-to-face interview. The second phase is a qualitative study in which participants are selected using purposive sampling in the form of extreme case sampling on the basis of health-promoting behavior scores. The qualitative phase is based on data collected from focus group discussions or individual in-depth interviews. A conventional qualitative content analysis approach is used, and the data are managed with a computer-assisted program. Women's health-promoting strategies are developed using the qualitative and quantitative results, a review of the related literature, and the nominal group technique among experts. Discussion The findings of this mixed methods sequential explanatory study, obtained using a culturally sensitive approach, provide insights into the health behavioral factors that need to be considered if preventive strategies and intervention programs are to be designed to promote women's health in the

  1. The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial.

    PubMed

    Lloyd-Evans, Brynmor; Fullarton, Kate; Lamb, Danielle; Johnston, Elaine; Onyett, Steve; Osborn, David; Ambler, Gareth; Marston, Louise; Hunter, Rachael; Mason, Oliver; Henderson, Claire; Goater, Nicky; Sullivan, Sarah A; Kelly, Kathleen; Gray, Richard; Nolan, Fiona; Pilling, Stephen; Bond, Gary; Johnson, Sonia

    2016-03-22

    As an alternative to hospital admission, crisis resolution teams (CRTs) provide intensive home treatment to people experiencing mental health crises. Trial evidence supports the effectiveness of the CRT model, but research suggests that the anticipated reductions in inpatient admissions and increased user satisfaction with acute care have been less than hoped for following the scaling up of CRTs nationally in England, as mandated by the National Health Service (NHS) Plan in 2000. The organisation and service delivery of the CRTs vary substantially. This may reflect the lack of a fully specified CRT model and the resources to enhance team model fidelity and to improve service quality. We will evaluate the impact of a CRT service improvement programme over a 1-year period on the service users' experiences of care, service use, staff well-being, and team model fidelity. Twenty-five CRTs from eight NHS Trusts across England will be recruited to this cluster-randomised trial: 15 CRTs will be randomised to receive the service improvement programme over a 1-year period, and ten CRTs will not receive the programme. Data will be collected from 15 service users and all clinical staff from each participating CRT at baseline and at the end of the intervention. Service use data will be collected from the services' electronic records systems for two 6-month periods: the period preceding and the period during months 7-12 of the intervention. The study's primary outcome is service user satisfaction with CRT care, measured using a client satisfaction questionnaire. Secondary outcomes include the following: perceived continuity of care, hospital admission rates and bed use, rates of readmission to acute care following CRT support, staff morale, job satisfaction, and general health. The adherence of the services to a model of best practice will be assessed at baseline and follow-up. Outcomes will be compared between the intervention and control teams, adjusting for baseline

  2. Public preferences for engagement in Health Technology Assessment decision-making: protocol of a mixed methods study.

    PubMed

    Wortley, Sally; Tong, Allison; Lancsar, Emily; Salkeld, Glenn; Howard, Kirsten

    2015-07-14

    Much attention in recent years has been given to the topic of public engagement in health technology assessment (HTA) decision-making. HTA organizations spend substantial resources and time on undertaking public engagement, and numerous studies have examined challenges and barriers to engagement in the decision-making process however uncertainty remains as to optimal methods to incorporate the views of the public in HTA decision-making. Little research has been done to ascertain whether current engagement processes align with public preferences and to what extent their desire for engagement is dependent on the question being asked by decision-makers or the characteristics of the decision. This study will examine public preferences for engagement in Australian HTA decision-making using an exploratory mixed methods design. The aims of this study are to: 1) identify characteristics about HTA decisions that are important to the public in determining whether public engagement should be undertaken on a particular topic, 2) determine which decision characteristics influence public preferences for the extent, or type of public engagement, and 3) describe reasons underpinning these preferences. Focus group participants from the general community, aged 18-70 years, will be purposively sampled from the Australian population to ensure a wide range of demographic groups. Each focus group will include a general discussion on public engagement as well as a ranking exercise using a modified nominal group technique (NGT). The NGT will inform the design of a discrete choice study to quantitatively assess public preferences for engagement in HTA decision-making. The proposed research seeks to investigate under what circumstances and how the public would like their views and preferences to be considered in health technology assessments. HTA organizations regularly make decisions about when and how public engagement should occur but without consideration of the public's preferences on

  3. EuroQol Protocols for Time Trade-Off Valuation of Health Outcomes.

    PubMed

    Oppe, Mark; Rand-Hendriksen, Kim; Shah, Koonal; Ramos-Goñi, Juan M; Luo, Nan

    2016-10-01

    The time trade-off (TTO) valuation technique is widely used to determine utility values of health outcomes to inform quality-adjusted life-year (QALY) calculations for use in economic evaluation. Protocols for implementing TTO vary in aspects such as the trade-off framework, iteration procedure and its administration model and method, training of respondents and interviewers, and quality control of data collection. The most widely studied and utilized TTO valuation protocols are the Measurement and Valuation of Health (MVH) protocol, the Paris protocol and the EuroQol Valuation Technology (EQ-VT) protocol, all developed by members of the EuroQol Group. The MVH protocol and its successor, the Paris protocol, were developed for valuation of EQ-5D-3L health states. Both protocols were designed for a trained interviewer to elicit preferences from a respondent using the conventional TTO framework with a fixed time horizon of 10 years and an iteration procedure combining bisection and titration. Developed for valuation of EQ-5D-5L health states, the EQ-VT protocol adopted a composite TTO framework and made use of computer technology to facilitate data collection. Training and monitoring of interviewers and respondents is a pivotal component of the EQ-VT protocol. Research is underway aiming to further improve the EuroQol protocols, which form an important basis for the current practice of health technology assessment in many countries.

  4. Accuracy and generalizability of using automated methods for identifying adverse events from electronic health record data: a validation study protocol.

    PubMed

    Rochefort, Christian M; Buckeridge, David L; Tanguay, Andréanne; Biron, Alain; D'Aragon, Frédérick; Wang, Shengrui; Gallix, Benoit; Valiquette, Louis; Audet, Li-Anne; Lee, Todd C; Jayaraman, Dev; Petrucci, Bruno; Lefebvre, Patricia

    2017-02-16

    Adverse events (AEs) in acute care hospitals are frequent and associated with significant morbidity, mortality, and costs. Measuring AEs is necessary for quality improvement and benchmarking purposes, but current detection methods lack in accuracy, efficiency, and generalizability. The growing availability of electronic health records (EHR) and the development of natural language processing techniques for encoding narrative data offer an opportunity to develop potentially better methods. The purpose of this study is to determine the accuracy and generalizability of using automated methods for detecting three high-incidence and high-impact AEs from EHR data: a) hospital-acquired pneumonia, b) ventilator-associated event and, c) central line-associated bloodstream infection. This validation study will be conducted among medical, surgical and ICU patients admitted between 2013 and 2016 to the Centre hospitalier universitaire de Sherbrooke (CHUS) and the McGill University Health Centre (MUHC), which has both French and English sites. A random 60% sample of CHUS patients will be used for model development purposes (cohort 1, development set). Using a random sample of these patients, a reference standard assessment of their medical chart will be performed. Multivariate logistic regression and the area under the curve (AUC) will be employed to iteratively develop and optimize three automated AE detection models (i.e., one per AE of interest) using EHR data from the CHUS. These models will then be validated on a random sample of the remaining 40% of CHUS patients (cohort 1, internal validation set) using chart review to assess accuracy. The most accurate models developed and validated at the CHUS will then be applied to EHR data from a random sample of patients admitted to the MUHC French site (cohort 2) and English site (cohort 3)-a critical requirement given the use of narrative data -, and accuracy will be assessed using chart review. Generalizability will be determined

  5. Understanding the impacts of care farms on health and well-being of disadvantaged populations: a protocol of the Evaluating Community Orders (ECO) pilot study

    PubMed Central

    Elsey, H; Bragg, R; Elings, M; Cade, J E; Brennan, C; Farragher, T; Tubeuf, S; Gold, R; Shickle, D; Wickramasekera, N; Richardson, Z; Murray, J

    2014-01-01

    Introduction Care farms, where all or part of the farm is used for therapeutic purposes, show much potential for improving the health and well-being of a range of disadvantaged groups. Studies to date have been qualitative or observational, with limited empirical evidence of the effectiveness of care farms in improving health and well-being. Understanding the underlying mechanisms that lead to improvements for different disadvantaged groups is a further gap in the evidence. Participants in this study are offenders serving community orders. Their low socioeconomic status and poor health outcomes relative to the general population exemplifies disadvantage. Methods and analysis This paper describes the protocol of a study to understand the impacts of care farms and to pilot the design and tools for a study to assess cost-effectiveness of care farms in improving the quality of life of offenders. As a pilot study, no power calculation has been conducted. However, 150 offenders serving community sentences on care farms and 150 on other probation locations (eg, litter picking, painting) will be recruited over a 1-year period. Changes in quality of life, measured by Clinical Outcome in Routine Evaluation–Outcome Measure, health and reconvictions of offenders at care farms compared to other probation locations will be analysed to inform the sample size calculation for the follow on study. The feasibility of recruitment, retention, collecting cost data and modelling cost-effectiveness will also be assessed. The study will use qualitative methods to explore the experiences of offenders attending care farms and perceptions of probation and care farm staff on the processes and impacts of the intervention. Ethics and dissemination Findings will be published and inform development of a natural experiment and will be disseminated to probation services, care farms and academics. University of Leeds Ethical Review Board approved: SoMREC/13/014. National Offender Management Service

  6. Cognitive behaviour therapy for older adults experiencing insomnia and depression in a community mental health setting: Study protocol for a randomised controlled trial.

    PubMed

    Sadler, Paul; McLaren, Suzanne; Klein, Britt; Jenkins, Megan; Harvey, Jack

    2015-11-27

    Cognitive behaviour therapy for insomnia (CBT-I) is a well-established treatment; however, the evidence is largely limited to homogenous samples. Although emerging research has indicated that CBT-I is also effective for comorbid insomnia, CBT-I has not been tested among a complex sample of older adults with comorbid insomnia and depression. Furthermore, no study has explored whether modifying CBT-I to target associated depressive symptoms could potentially enhance sleep and mood outcomes. Therefore, this study aims to report a protocol designed to test whether an advanced form of CBT for insomnia and depression (CBT-I-D) is more effective at reducing insomnia and depressive symptoms compared to a standard CBT-I and psychoeducation control group (PCG) for older adults in a community mental health setting. We aim to recruit 150 older adults with comorbid insomnia who have presented to community mental health services for depression. Eligible participants will be randomly allocated via block/cluster randomisation to one of three group therapy conditions: CBT-I, CBT-I-D, or PCG. Participants who receive CBT-I will only practice strategies designed to improve their sleep, whereas participants who receive CBT-I-D will practice additional strategies designed to also improve their mood. This trial will implement a mixed-methods design involving quantitative outcome measures and qualitative focus groups. The primary outcome measures are insomnia and depression severity, and secondary outcomes are anxiety, hopelessness, beliefs about sleep, comorbid sleep conditions, and health. Outcomes will be assessed at pre-intervention (week 0), post-intervention (week 8), and 3-month follow-up (week 20). This CBT study protocol has been designed to address comorbid insomnia and depression for older adults receiving community mental health services. The proposed trial will determine whether CBT-I is more effective for older adults with comorbid insomnia and depression compared to a PCG

  7. Rationale and study protocol for a multi-component Health Information Technology (HIT) screening tool for depression and post-traumatic stress disorder in the primary care setting.

    PubMed

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V; Sorkin, Dara H

    2016-09-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients' mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers' time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression and other mental health disorders in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients' primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and post-traumatic stress disorder (PTSD) among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting.

  8. A home-visiting intervention targeting determinants of infant mental health: the study protocol for the CAPEDP randomized controlled trial in France

    PubMed Central

    2012-01-01

    Background Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood. Method and design The objective of this multicentre randomized controlled parallel trial (PROBE methodology) is to assess the impact in a multi-risk French urban sample of a home-visiting program targeting child mental health and its major determinants. This paper describes the protocol of this study. In the study, pregnant women were eligible if they were: living in the intervention area; able to speak French, less than 26 years old; having their first child; less than 27 weeks of amenorrhea; and if at least one of the following criteria were true: less than twelve years of education, intending to bring up their child without the presence of the child’s father, and 3) low income. Participants were randomized into either the intervention or the control group. All had access to usual care in mother-child centres and community mental health services free of charge in every neighbourhood. Psychologists conducted all home visits, which were planned on a weekly basis from the 7th month of pregnancy and progressively decreasing in frequency until the child’s second birthday. Principle outcome measures included child mental health at 24 months and two major mediating variables for infant mental health: postnatal maternal depression and the quality of the caring environment. A total of 440 families were recruited, of which a subsample of 120 families received specific attachment and caregiver behaviour assessment. Assessment was conducted by an independent assessment team during home visits and, for the attachment study, in a specifically created Attachment Assessment laboratory. Discussion The CAPEDP study is the first large-scale randomised, controlled infant mental health promotion programme to take place in France. A major specificity of the program was that all home visits were conducted by specifically trained

  9. Study protocol and overview of the literature on long-term health and quality of life outcomes in patients treated in adolescence for scoliosis with therapeutic exercises.

    PubMed

    Plaszewski, Maciej; Kotwicki, Tomasz; Chwala, Wieslaw; Terech, Jacek; Cieśliński, Igor

    2015-01-01

    Scoliosis, the most prevalent orthopaedic condition affecting children and adolescents, may have lasting physical, psychological and social consequences. With limited evidence-base, scoliosis-specific exercise therapies are an option. An overview of the subject and description of a long-term follow-up study including adults who in adolescence were treated with a scoliosis-specific exercise programme investigating the association of the exercise regime with present physical activity, physical functioning and subjective wellbeing. To the authors' best knowledge, this is the first long-term outcome study on scoliosis-specific exercises, in opposition to a number of studies in adults who were braced or treated surgically in adolescence. Observational, registry-based case-control study. Adult subjects who in adolescence were treated with an exercise programme or were under observation are invited. Spine and trunk deformity, respiratory function, physical capacity and trunk muscles' function are measured. Health-related quality of life with generic and condition-specific instruments, general mental health, depression and anxiety symptoms, disability due to low back problems and physical activity are assessed. The report is believed to provide the readers with an overview of this controversial aspect of rehabilitation, and that the proposed protocol will assist researchers designing their studies.

  10. Examining the ethical and social issues of health technology design through the public appraisal of prospective scenarios: a study protocol describing a multimedia-based deliberative method

    PubMed Central

    2014-01-01

    Background The design of health technologies relies on assumptions that affect how they will be implemented, such as intended use, complexity, impact on user autonomy, and appropriateness. Those who design and implement technologies make several ethical and social assumptions on behalf of users and society more broadly, but there are very few tools to examine prospectively whether such assumptions are warranted and how the public define and appraise the desirability of health innovations. This study protocol describes a three-year study that relies on a multimedia-based prospective method to support public deliberations that will enable a critical examination of the social and ethical issues of health technology design. Methods The first two steps of our mixed-method study were completed: relying on a literature review and the support of our multidisciplinary expert committee, we developed scenarios depicting social and technical changes that could unfold in three thematic areas within a 25-year timeframe; and for each thematic area, we created video clips to illustrate prospective technologies and short stories to describe their associated dilemmas. Using this multimedia material, we will: conduct four face-to-face deliberative workshops with members of the public (n = 40) who will later join additional participants (n = 25) through an asynchronous online forum; and analyze and integrate three data sources: observation, group deliberations, and a self-administered participant survey. Discussion This study protocol will be of interest to those who design and assess public involvement initiatives and to those who examine the implementation of health innovations. Our premise is that using user-friendly tools in a deliberative context that foster participants’ creativity and reflexivity in pondering potential technoscientific futures will enable our team to analyze a range of normative claims, including some that may prove problematic and others that may

  11. Examining the ethical and social issues of health technology design through the public appraisal of prospective scenarios: a study protocol describing a multimedia-based deliberative method.

    PubMed

    Lehoux, Pascale; Gauthier, Philippe; Williams-Jones, Bryn; Miller, Fiona A; Fishman, Jennifer R; Hivon, Myriam; Vachon, Patrick

    2014-06-21

    The design of health technologies relies on assumptions that affect how they will be implemented, such as intended use, complexity, impact on user autonomy, and appropriateness. Those who design and implement technologies make several ethical and social assumptions on behalf of users and society more broadly, but there are very few tools to examine prospectively whether such assumptions are warranted and how the public define and appraise the desirability of health innovations. This study protocol describes a three-year study that relies on a multimedia-based prospective method to support public deliberations that will enable a critical examination of the social and ethical issues of health technology design. The first two steps of our mixed-method study were completed: relying on a literature review and the support of our multidisciplinary expert committee, we developed scenarios depicting social and technical changes that could unfold in three thematic areas within a 25-year timeframe; and for each thematic area, we created video clips to illustrate prospective technologies and short stories to describe their associated dilemmas. Using this multimedia material, we will: conduct four face-to-face deliberative workshops with members of the public (n=40) who will later join additional participants (n=25) through an asynchronous online forum; and analyze and integrate three data sources: observation, group deliberations, and a self-administered participant survey. This study protocol will be of interest to those who design and assess public involvement initiatives and to those who examine the implementation of health innovations. Our premise is that using user-friendly tools in a deliberative context that foster participants' creativity and reflexivity in pondering potential technoscientific futures will enable our team to analyze a range of normative claims, including some that may prove problematic and others that may shed light over potentially more valuable

  12. Social capital in association with health status of women in reproductive age: study protocol for a sequential explanatory mixed methods study.

    PubMed

    Baheiraei, Azam; Bakouei, Fatemeh; Mohammadi, Eesa; Hosseini, Mostafa

    2014-05-09

    Women's health is a general health priority. Preserving and improving women's health is not only a basic human right, but it is also essential for the health of all nations. Women's health in Reproductive age affects long-term health of theirs, their family members, and community. Origins of health inequalities are very complicated. Health outcomes are influenced by biological, social and political factors, so to improve women's health it is necessary to recognize all these factors. Social capital is one of the social determinants of health that might play a considerable role in health inequalities. The association between social capital and health varies according on the sample studied, the type of health outcome and the context in which it is studied. This mixed methods study was designed to determine and explore of relationship between social capital and health status of women of reproductive age in Tehran (capital city of Iran) with its specific social-cultural characteristics. This study is sequential explanatory mixed methods study, follow-up explanations variant, with two strands (phases). This design will be implemented in two distinct phases. The first phase is a population-based cross-sectional survey on 770 women of reproductive age residing in any of the 22 municipal districts across Tehran. Based on a need to further understand the quantitative results, researchers will implement a second qualitative phase that is designed to help explain the initial quantitative results. Finally, the researchers will present an interpretation about explanation of quantitative results using the qualitative data. This study promotes women's health by determining the priorities and designing evidence-based interventions founded on the basic and insightful information provided on social capital and the status of the health of women.

  13. Identifying and prioritising systematic review topics with public health stakeholders: A protocol for a modified Delphi study in Switzerland to inform future research agendas.

    PubMed

    Hoekstra, Dyon; Mütsch, Margot; Kien, Christina; Gerhardus, Ansgar; Lhachimi, Stefan K

    2017-08-04

    The Cochrane Collaboration aims to produce relevant and top priority evidence that responds to existing evidence gaps. Hence, research priority setting (RPS) is important to identify which potential research gaps are deemed most important. Moreover, RPS supports future health research to conform both health and health evidence needs. However, studies that are prioritising systematic review topics in public health are surprisingly rare. Therefore, to inform the research agenda of Cochrane Public Health Europe (CPHE), we introduce the protocol of a priority setting study on systematic review topics in several European countries, which is conceptualised as pilot. We will conduct a two-round modified Delphi study in Switzerland, incorporating an anonymous web-based questionnaire, to assess which topics should be prioritised for systematic reviews in public health. In the first Delphi round public health stakeholders will suggest relevant assessment criteria and potential priority topics. In the second Delphi round the participants indicate their (dis)agreement to the aggregated results of the first round and rate the potential review topics with the predetermined criteria on a four-point Likert scale. As we invite a wide variety of stakeholders we will compare the results between the different stakeholder groups. We have received ethical approval from the ethical board of the University of Bremen, Germany (principal investigation is conducted at the University of Bremen) and a certificate of non-objection from the Canton of Zurich, Switzerland (fieldwork will be conducted in Switzerland). The results of this study will be further disseminated through peer reviewed publication and will support systematic review author groups (i.a. CPHE) to improve the relevance of the groups´ future review work. Finally, the proposed priority setting study can be used as a framework by other systematic review groups when conducting a priority setting study in a different context.

  14. Building system capacity for the integration of mental health at the level of primary care in Tunisia: a study protocol in global mental health.

    PubMed

    Spagnolo, Jessica; Champagne, François; Leduc, Nicole; Piat, Myra; Melki, Wahid; Charfi, Fatma; Laporta, Marc

    2017-01-17

    In low- and middle-income countries (LMICs), addressing the high prevalence of mental disorders is a challenge given the limited number and unequal distribution of specialists, as well as scarce resources allocated to mental health. The Mental Health Gap Action Programme (mhGAP) and its accompanying Intervention Guide (IG), developed by the World Health Organization (WHO), aim to address this challenge by training non-specialists such as general practitioners (GPs) in mental health care. This trial aims to implement and evaluate an adapted version of the mhGAP-IG (version 1.0) offered to GPs in 2 governorates of Tunisia (i.e., Tunis and Sousse), in order to uncover important information regarding implementation process and study design before country-wide implementation and evaluation. First, a systematic review will be conducted to explore types and effectiveness of mental health training programs offered to GPs around the world, with a specific focus on programs implemented and evaluated in LMICs. Second, a cluster randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the implemented training based on the mhGAP-IG (version 1.0). Third, multiple case study design will be used to explore how contextual factors impact the successful implementation of the training and desired outcomes. In Tunisia, an important need exists to further develop proximity health services and to address the growing mental health treatment gap. One solution is to train GPs in the detection, treatment, and management of mental health problems, given their strategic role in the healthcare system. This trial thus aims to implement and evaluate an adapted version of a training based on the mhGAP-IG (version 1.0) in Tunis and Sousse before country-wide implementation and evaluation. Several contributions are envisioned: adding to the growing evidence on the mhGAP and its accompanying guide, especially in French-speaking nations; building research capacity in

  15. Rationale and Study Protocol for a Multi-component Health Information Technology (HIT) Screening Tool for Depression and Post-traumatic Stress Disorder in the Primary Care Setting

    PubMed Central

    Biegler, Kelly; Mollica, Richard; Sim, Susan Elliott; Nicholas, Elisa; Chandler, Maria; Ngo-Metzger, Quyen; Paigne, Kittya; Paigne, Sompia; Nguyen, Danh V.; Sorkin, Dara H.

    2016-01-01

    The prevalence rate of depression in primary care is high. Primary care providers serve as the initial point of contact for the majority of patients with depression, yet, approximately 50% of cases remain unrecognized. The under-diagnosis of depression may be further exacerbated in limited English-language proficient (LEP) populations. Language barriers may result in less discussion of patients’ mental health needs and fewer referrals to mental health services, particularly given competing priorities of other medical conditions and providers’ time pressures. Recent advances in Health Information Technology (HIT) may facilitate novel ways to screen for depression in LEP populations. The purpose of this paper is to describe the rationale and protocol of a clustered-randomized controlled trial that will test the effectiveness of an HIT intervention that provides a multi-component approach to delivering culturally competent, mental health care in the primary care setting. The HIT intervention has four components: 1) web-based provider training, 2) multimedia electronic screening of depression and PTSD in the patients’ primary language, 3) Computer generated risk assessment scores delivered directly to the provider, and 4) clinical decision support. The outcomes of the study include assessing the potential of the HIT intervention to improve screening rates, clinical detection, provider initiation of treatment, and patient outcomes for depression and PTSD among LEP Cambodian refugees who experienced war atrocities and trauma during the Khmer Rouge. This technology has the potential to be adapted to any LEP population in order to facilitate mental health screening and treatment in the primary care setting. PMID:27394385

  16. Health Systems Readiness to Manage the Hypertension Epidemic in Primary Health Care Facilities in the Western Cape, South Africa: A Study Protocol

    PubMed Central

    Yaya, Sanni; Labonté, Ronald

    2016-01-01

    Background Developing countries are undergoing a process of epidemiological transition from infectious to noncommunicable diseases, described by the United Nations Secretary General Ban Ki-Moon as ‘‘a public health emergency in slow motion.” One of the most prevalent in sub-Saharan Africa is hypertension, which is a complex chronic condition often referred to as a “silent killer” and key contributor to the development of cardiovascular and cerebrovascular diseases. Hypertensive patients in this setting are estimated to increase from 74.7 million in 2008 to 125.5 million in 2025, a 68% increase. However, there is an important gap between emerging high-level policies and recommendations, and the near-absence of practical guidance and experience delivering long-term medical care for noncommunicable diseases within resource-limited health systems. Objective To address this gap, our study will consist of field investigations to determine the minimum health systems requirements to ensure successful delivery of antihypertensive medications when scaling-up interventions to control the hypertension epidemic. Methods A cross-sectional analytic study will be conducted in the Western Cape using a mixed-method approach with two semistructured interview guides. The first will be for health professionals involved in the care of hypertensive patients within at least 6 community health centers (3 urban and 3 rural) to understand the challenges associated with their care. The second will be to map and assess the current supply chain management system of antihypertensive medications by interviewing key informants at different levels of the processes. Finally, modeling and simulation tools will be used to understand how to estimate minimum numbers of health workers required at each supply chain interval to ensure successful delivery of medications when scaling-up interventions. Results Funding for the study was secured through a Doctoral Research Award in October 2014 from

  17. Health Systems Readiness to Manage the Hypertension Epidemic in Primary Health Care Facilities in the Western Cape, South Africa: A Study Protocol.

    PubMed

    Deuboué Tchialeu, Rodrigue Innocent; Yaya, Sanni; Labonté, Ronald

    2016-02-29

    Developing countries are undergoing a process of epidemiological transition from infectious to noncommunicable diseases, described by the United Nations Secretary General Ban Ki-Moon as ''a public health emergency in slow motion." One of the most prevalent in sub-Saharan Africa is hypertension, which is a complex chronic condition often referred to as a "silent killer" and key contributor to the development of cardiovascular and cerebrovascular diseases. Hypertensive patients in this setting are estimated to increase from 74.7 million in 2008 to 125.5 million in 2025, a 68% increase. However, there is an important gap between emerging high-level policies and recommendations, and the near-absence of practical guidance and experience delivering long-term medical care for noncommunicable diseases within resource-limited health systems. To address this gap, our study will consist of field investigations to determine the minimum health systems requirements to ensure successful delivery of antihypertensive medications when scaling-up interventions to control the hypertension epidemic. A cross-sectional analytic study will be conducted in the Western Cape using a mixed-method approach with two semistructured interview guides. The first will be for health professionals involved in the care of hypertensive patients within at least 6 community health centers (3 urban and 3 rural) to understand the challenges associated with their care. The second will be to map and assess the current supply chain management system of antihypertensive medications by interviewing key informants at different levels of the processes. Finally, modeling and simulation tools will be used to understand how to estimate minimum numbers of health workers required at each supply chain interval to ensure successful delivery of medications when scaling-up interventions. Funding for the study was secured through a Doctoral Research Award in October 2014 from the International Development Research Centre

  18. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment. PMID:21988774

  19. A service-level action research intervention to improve identification and treatment of cannabis and related mental health issues in young Indigenous Australians: a study protocol.

    PubMed

    Bohanna, India; Bird, Katrina; Copeland, Jan; Roberts, Nicholas; Clough, Alan

    2014-07-31

    Regular cannabis use is associated with negative mental health impacts including psychosis, depression and anxiety. Rates of cannabis use have increased in Aboriginal and Torres Strait Islander communities in northern Australia within the last two decades, presenting a significant increased risk to young people's mental health in these regions. Improved screening, early detection and treatment for cannabis-related mental health issues are urgently required. This paper describes a service-level action research intervention and evaluation protocol for use in the few services where it is possible to engage young Aboriginal and Torres Strait Islander Australians. The protocol is being developed in two services where youth mental health is core business: a primary healthcare centre and a youth service in the Cairns and hinterland region, far north Queensland. The protocol calls first for baseline data to be collected using staff and client surveys; network mapping; and analysis of screening, treatment and referral rates. The protocol's intervention phase is driven by service needs identified from baseline data. Intervention strategies focus on implementing/enhancing cannabis screening instruments and processes in line with current best practice; enhancing networks with external drug and mental health services; developing culturally acceptable training and resources; developing activities aiming to reduce cannabis use in young Aboriginal and Torres Strait Islander clients using the services. The protocol requires implementation of the multilevel intervention within each service for 1 year, with follow-up data then collected and compared to baseline. Process evaluation identifies the more effective intervention strategies and documents the challenges to be overcome for full implementation. Ethics approval was provided by The James Cook University, Human Research Ethics Committee. Ethics Approval Number H5322. Peer-reviewed publications will also be used to disseminate

  20. A service-level action research intervention to improve identification and treatment of cannabis and related mental health issues in young Indigenous Australians: a study protocol

    PubMed Central

    Bohanna, India; Bird, Katrina; Copeland, Jan; Roberts, Nicholas; Clough, Alan

    2014-01-01

    Introduction Regular cannabis use is associated with negative mental health impacts including psychosis, depression and anxiety. Rates of cannabis use have increased in Aboriginal and Torres Strait Islander communities in northern Australia within the last two decades, presenting a significant increased risk to young people's mental health in these regions. Improved screening, early detection and treatment for cannabis-related mental health issues are urgently required. This paper describes a service-level action research intervention and evaluation protocol for use in the few services where it is possible to engage young Aboriginal and Torres Strait Islander Australians. Methods/Design The protocol is being developed in two services where youth mental health is core business: a primary healthcare centre and a youth service in the Cairns and hinterland region, far north Queensland. The protocol calls first for baseline data to be collected using staff and client surveys; network mapping; and analysis of screening, treatment and referral rates. The protocol's intervention phase is driven by service needs identified from baseline data. Intervention strategies focus on implementing/enhancing cannabis screening instruments and processes in line with current best practice; enhancing networks with external drug and mental health services; developing culturally acceptable training and resources; developing activities aiming to reduce cannabis use in young Aboriginal and Torres Strait Islander clients using the services. The protocol requires implementation of the multilevel intervention within each service for 1 year, with follow-up data then collected and compared to baseline. Process evaluation identifies the more effective intervention strategies and documents the challenges to be overcome for full implementation. Ethics and dissemination Ethics approval was provided by The James Cook University, Human Research Ethics Committee. Ethics Approval Number H5322. Peer

  1. BlueHealth: a study programme protocol for mapping and quantifying the potential benefits to public health and well-being from Europe's blue spaces.

    PubMed

    Grellier, James; White, Mathew P; Albin, Maria; Bell, Simon; Elliott, Lewis R; Gascón, Mireia; Gualdi, Silvio; Mancini, Laura; Nieuwenhuijsen, Mark J; Sarigiannis, Denis A; van den Bosch, Matilda; Wolf, Tanja; Wuijts, Susanne; Fleming, Lora E

    2017-06-14

    Proximity and access to water have long been central to human culture and accordingly deliver countless societal benefits. Over 200 million people live on Europe's coastline, and aquatic environments are the top recreational destination in the region. In terms of public health, interactions with 'blue space' (eg, coasts, rivers, lakes) are often considered solely in terms of risk (eg, drowning, microbial pollution). Exposure to blue space can, however, promote health and well-being and prevent disease, although underlying mechanisms are poorly understood. The BlueHealth project aims to understand the relationships between exposure to blue space and health and well-being, to map and quantify the public health impacts of changes to both natural blue spaces and associated urban infrastructure in Europe, and to provide evidence-based information to policymakers on how to maximise health benefits associated with interventions in and around aquatic environments. To achieve these aims, an evidence base will be created through systematic reviews, analyses of secondary data sets and analyses of new data collected through a bespoke international survey and a wide range of community-level interventions. We will also explore how to deliver the benefits associated with blue spaces to those without direct access through the use of virtual reality. Scenarios will be developed that allow the evaluation of health impacts in plausible future societal contexts and changing environments. BlueHealth will develop key inputs into policymaking and land/water-use planning towards more salutogenic and sustainable uses of blue space, particularly in urban areas. Throughout the BlueHealth project, ethics review and approval are obtained for all relevant aspects of the study by the local ethics committees prior to any work being initiated and an ethics expert has been appointed to the project advisory board. So far, ethical approval has been obtained for the BlueHealth International Survey and

  2. Body composition and bone health in long-term survivors of acute lymphoblastic leukaemia in childhood and adolescence: the protocol for a cross-sectional cohort study.

    PubMed

    Barr, Ronald; Nayiager, Trishana; Gordon, Christopher; Marriott, Christopher; Athale, Uma

    2015-01-20

    Success in the treatment of young people with cancer, as measured conventionally by survival rates, is mitigated by late effects of therapy that impose a burden of morbidity and limit life expectancy. Among these adverse sequelae are altered body composition, especially obesity, and compromised bone health in the form of osteoporosis and increased fragility. These outcomes are potentially reversible and even preventable. This study will examine measures of body composition and bone health in long-term survivors of acute lymphoblastic leukaemia (ALL) in childhood and adolescence. These measures will be complemented by measures of physical activity and health-related quality of life (HRQL). Survivors of ALL who are at least 10 years from diagnosis, following treatment on uniform protocols, will undergo measurements of body mass index; triceps skin fold thickness and mid-upper arm circumference; fat mass, lean body mass, skeletal muscle mass and bone mineral density by dual energy X-ray absorptiometry; trabecular and cortical bone indices and muscle density by peripheral quantitative CT; physical activity by the Habitual Activity Estimation Scale; and HRQL by Health Utilities Index instruments. Descriptive measures will be used for continuous variables and number (percent) for categorical variables. Associations between variables will be assessed using Fisher's exact t test and the χ(2) test; correlations will be tested by the Pearson correlation coefficient. The study is approved by the institutional research ethics board and is supported by a competitive funding award. Dissemination of the results will occur by presentations to scientific meetings and publications in peer-reviewed journals, and by posting summaries of the results on websites accessed by adolescent and young adult survivors of cancer. 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.

  3. Methods for evaluating the impact of vertical programs on health systems: protocol for a study on the impact of the global polio eradication initiative on strengthening routine immunization and primary health care

    PubMed Central

    2012-01-01

    Background The impact of vertical programs on health systems is a much-debated topic, and more evidence on this complex relationship is needed. This article describes a research protocol developed to assess the relationship between the Global Polio Eradication Initiative, routine immunization, and primary health care in multiple settings. Methods/Design This protocol was designed as a combination of quantitative and qualitative research methods, making use of comparative ethnographies. The study evaluates the impact of the Global Polio Eradication Initiative on routine immunization and primary health care by: (a) combining quantitative and qualitative work into one coherent study design; (b) using purposively selected qualitative case studies to systematically evaluate the impact of key contextual variables; and (c) making extensive use of the method of participant observation to create comparative ethnographies of the impact of a single vertical program administered in varied contexts. Discussion The study design has four major benefits: (1) the careful selection of a range of qualitative case studies allowed for systematic comparison; (2) the use of participant observation yielded important insights on how policy is put into practice; (3) results from our quantitative analysis could be explained by results from qualitative work; and (4) this research protocol can inform the creation of actionable recommendations. Here, recommendations for how to overcome potential challenges in carrying out such research are presented. This study illustrates the utility of mixed-methods research designs in which qualitative data are not just used to embellish quantitative results, but are an integral component of the analysis. PMID:22938708

  4. Effectiveness and cost-effectiveness of the Salut Programme: a universal health promotion intervention for parents and children—protocol of a register-based retrospective observational study

    PubMed Central

    Feldman, Inna; Eurenius, Eva; Häggström, Jenny; Sampaio, Filipa; Lindkvist, Marie; Pulkki-Brännström, Anni-Maria; Ivarsson, Anneli

    2016-01-01

    Introduction There is inadequate evidence for the effectiveness and cost-effectiveness of health promotion interventions. The Salut Programme aims to reach all parents and children in the Västerbotten County of Sweden with a combination of health promotion interventions initiated during pregnancy and continued over the childhood period. This study protocol describes an effectiveness study and an economic evaluation study, where the ongoing Salut Programme is compared to care-as-usual over the periods of pregnancy, delivery and the child's first 2 years of life. Methods A register-based retrospective observational study design will be used with existing data sources with respect to exposures and outcomes. Outcomes of interest are clustered at 3 points: around the child's birth, 1 month after the child's birth and 2 years after the child's birth. We will simulate an experiment by retrospectively identifying and comparing children and their parents in the geographical areas where the Salut Programme was implemented since 2006 and onwards, and the areas where the Programme was not implemented before 2009. Outcomes will be analysed and compared for the premeasure period, and the postmeasure period for both groups. Our analysis combines difference-in-difference estimation with matching. A complementary analysis will be carried out on the longitudinal subsample of mothers who gave birth at least once during each of the time periods. The economic evaluation aims to capture the wider societal costs and benefits of the Salut Programme for the first 2 years of the children's lives. Incremental costs will be compared with incremental health gains and the results will be presented as a cost-consequence analysis. Ethics and dissemination The Regional Ethical Review Board in Umeå has given clearance for the Salut Programme research (2010-63-31M). No individual's identity will be revealed when presenting results. This study will provide information that can guide

  5. Using an eHealth Intervention to Stimulate Health Behavior for the Prevention of Cognitive Decline in Dutch Adults: A Study Protocol for the Brain Aging Monitor

    PubMed Central

    2015-01-01

    Background Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decline or cognitive impairments. Modifiable lifestyle risk factors such as physical activity, nutrition, smoking, alcohol consumption, sleep, and stress all influence the probability of developing neurodegenerative diseases such as Alzheimer’s disease. Objective This study aims to answer two questions: (1) Is the use of a self-motivated, complex eHealth intervention effective in changing multiple health behaviors related to cognitive aging in Dutch adults in the work force, especially those aged 40 and over? and (2) Does this health behavior change result in healthier cognitive aging patterns and contribute to preventing or delaying future onset of neurodegenerative syndromes? Methods The Brain Aging Monitor study uses a quasi-experimental 2-year pre-posttest design. The Brain Aging Monitor is an online, self-motivated lifestyle intervention program. Recruitment is done both in medium to large organizations and in the Dutch general population over the age of 40. The main outcome measure is the relationship between lifestyle change and cognitive aging. The program uses different strategies and modalities such as Web content, email, online newsletters, and online games to aid its users in behavior change. To build self-regulatory skills, the Brain Aging Monitor offers its users goal-setting activities, skill-building activities, and self-monitoring. Results Study results are expected to be published in early 2016. Conclusions This study will add to the body of evidence on the effectiveness of eHealth intervention programs with the combined use of state-of-the-art applied games and established behavior change techniques. This will lead to new insights on how to use behavior change techniques and theory in multidimensional lifestyle eHealth research, and how these techniques

  6. Using an eHealth Intervention to Stimulate Health Behavior for the Prevention of Cognitive Decline in Dutch Adults: A Study Protocol for the Brain Aging Monitor.

    PubMed

    Aalbers, Teun; Baars, Maria Ae; Qin, Li; de Lange, Annet; Kessels, Roy Pc; Olde Rikkert, Marcel Gm

    2015-11-10

    Internet-delivered intervention programs are an effective way of changing health behavior in an aging population. The same population has an increasing number of people with cognitive decline or cognitive impairments. Modifiable lifestyle risk factors such as physical activity, nutrition, smoking, alcohol consumption, sleep, and stress all influence the probability of developing neurodegenerative diseases such as Alzheimer's disease. This study aims to answer two questions: (1) Is the use of a self-motivated, complex eHealth intervention effective in changing multiple health behaviors related to cognitive aging in Dutch adults in the work force, especially those aged 40 and over? and (2) Does this health behavior change result in healthier cognitive aging patterns and contribute to preventing or delaying future onset of neurodegenerative syndromes? The Brain Aging Monitor study uses a quasi-experimental 2-year pre-posttest design. The Brain Aging Monitor is an online, self-motivated lifestyle intervention program. Recruitment is done both in medium to large organizations and in the Dutch general population over the age of 40. The main outcome measure is the relationship between lifestyle change and cognitive aging. The program uses different strategies and modalities such as Web content, email, online newsletters, and online games to aid its users in behavior change. To build self-regulatory skills, the Brain Aging Monitor offers its users goal-setting activities, skill-building activities, and self-monitoring. Study results are expected to be published in early 2016. This study will add to the body of evidence on the effectiveness of eHealth intervention programs with the combined use of state-of-the-art applied games and established behavior change techniques. This will lead to new insights on how to use behavior change techniques and theory in multidimensional lifestyle eHealth research, and how these techniques and theories apply when they are used in a setting

  7. Protocol study: sexual and reproductive health knowledge, information-seeking behaviour and attitudes among Saudi women: a questionnaire survey of university students

    PubMed Central

    2014-01-01

    Background Sexual and reproductive health (SRH), a basic right for women worldwide, is infrequently researched in countries in the Middle East and North Africa (MENA). No empirical studies of SRH among Saudi women exist. This protocol describes a study to explore the SRH knowledge, information-seeking behaviour and attitudes of Saudi female university students. Methods/Design This study will administer a questionnaire survey to female students at 13 universities in Riyadh, Saudi Arabia. The questionnaire was developed following a literature search to identify relevant content, with psychometrically tested tools used when available. The content layout and the wording and order of the questions were designed to minimize the risk of bias. The questionnaire has been translated into Arabic and piloted in preparation for administration to the study sample. Ethical approval for the study has been granted (reference no. QMREC2012/54). After questionnaire administration, the data will be collated, analysed and reported anonymously. The findings will be published in compliance with reporting guidelines for survey research. Discussion This study will be the first to provide fundamental information concerning Saudi females university students SRH knowledge and information needs. PMID:24885041

  8. Protocol study: sexual and reproductive health knowledge, information-seeking behaviour and attitudes among Saudi women: a questionnaire survey of university students.

    PubMed

    Farih, Manal; Khan, Khalid; Freeth, Della; Meads, Catherine

    2014-05-06

    Sexual and reproductive health (SRH), a basic right for women worldwide, is infrequently researched in countries in the Middle East and North Africa (MENA). No empirical studies of SRH among Saudi women exist. This protocol describes a study to explore the SRH knowledge, information-seeking behaviour and attitudes of Saudi female university students. This study will administer a questionnaire survey to female students at 13 universities in Riyadh, Saudi Arabia. The questionnaire was developed following a literature search to identify relevant content, with psychometrically tested tools used when available. The content layout and the wording and order of the questions were designed to minimize the risk of bias. The questionnaire has been translated into Arabic and piloted in preparation for administration to the study sample. Ethical approval for the study has been granted (reference no. QMREC2012/54). After questionnaire administration, the data will be collated, analysed and reported anonymously. The findings will be published in compliance with reporting guidelines for survey research. This study will be the first to provide fundamental information concerning Saudi females university students SRH knowledge and information needs.

  9. African Breast Cancer—Disparities in Outcomes (ABC-DO): protocol of a multicountry mobile health prospective study of breast cancer survival in sub-Saharan Africa

    PubMed Central

    McKenzie, Fiona; Zietsman, Annelle; Galukande, Moses; Anele, Angelica; Adisa, Charles; Cubasch, Herbert; Parham, Groesbeck; Anderson, Benjamin O; Abedi-Ardekani, Behnoush; Schuz, Joachim; dos Santos Silva, Isabel; McCormack, Valerie

    2016-01-01

    Introduction Sub-Saharan African (SSA) women with breast cancer (BC) have low survival rates from this potentially treatable disease. An understanding of context-specific societal, health-systems and woman-level barriers to BC early detection, diagnosis and treatment are needed. Methods The African Breast Cancer—Disparities in Outcomes (ABC-DO) is a prospective hospital-based study of overall survival, impact on quality of life (QOL) and delays along the journey to diagnosis and treatment of BC in SSA. ABC-DO is currently recruiting in Namibia, Nigeria, South Africa, Uganda and Zambia. Women aged 18 years or older who present at participating secondary and tertiary hospitals with a new clinical or histocytological diagnosis of primary BC are invited to participate. For consented women, tumour characteristics, specimen and treatment data are obtained. Over a 2-year enrolment period, we aim to recruit 2000 women who, in the first instance, will be followed for between 1 and 3 years. A face-to-face baseline interview obtains information on socioeconomic, cultural and demographic factors, QOL, health and BC attitudes/knowledge, and timing of all prediagnostic contacts with caregivers in orthodox health, traditional and spiritual systems. Responses are immediately captured on mobile devices that are fed into a tailored mobile health (mHealth) study management system. This system implements the study protocol, by prompting study researchers to phone women on her mobile phone every 3 months and, failing to reach her, prompts contact with her next-of-kin. At follow-up calls, women provide updated information on QOL, care received and disease impacts on family and working life; date of death is asked of her next-of-kin when relevant. Ethics and dissemination The study was approved by ethics committees of all involved institutions. All participants provide written informed consent. The findings from the study will be published in peer-reviewed scientific journals

  10. Household preferences for reducing greenhouse gas emissions in four European high-income countries: Does health information matter? A mixed-methods study protocol.

    PubMed

    Herrmann, Alina; Fischer, Helen; Amelung, Dorothee; Litvine, Dorian; Aall, Carlo; Andersson, Camilla; Baltruszewicz, Marta; Barbier, Carine; Bruyère, Sébastien; Bénévise, Françoise; Dubois, Ghislain; Louis, Valérie R; Nilsson, Maria; Richardsen Moberg, Karen; Sköld, Bore; Sauerborn, Rainer

    2017-08-01

    It is now universally acknowledged that climate change constitutes a major threat to human health. At the same time, some of the measures to reduce greenhouse gas emissions, so-called climate change mitigation measures, have significant health co-benefits (e.g., walking or cycling more; eating less meat). The goal of limiting global warming to 1,5° Celsius set by the Conference of the Parties to the United Nations Framework Convention on Climate Change in Paris in 2015 can only be reached if all stakeholders, including households, take actions to mitigate climate change. Results on whether framing mitigation measures in terms of their health co-benefits increases the likelihood of their implementation are inconsistent. The present study protocol describes the transdisciplinary project HOPE (HOuseholds' Preferences for reducing greenhouse gas emissions in four European high-income countries) that investigates the role of health co-benefits in households' decision making on climate change mitigation measures in urban households in France, Germany, Norway and Sweden. HOPE employs a mixed-methods approach combining status-quo carbon footprint assessments, simulations of the reduction of households' carbon footprints, and qualitative in-depth interviews with a subgroup of households. Furthermore, a policy analysis of current household oriented climate policies is conducted. In the simulation of the reduction of households' carbon footprints, half of the households are provided with information on health co-benefits of climate change mitigation measures, the other half is not. Households' willingness to implement the measures is assessed and compared in between-group analyses of variance. This is one of the first comprehensive mixed-methods approaches to investigate which mitigation measures households are most willing to implement in order to reach the 1,5° target set by the Paris Agreement, and whether health co-benefits can serve as a motivator for households to

  11. Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial.

    PubMed

    Collings, Sunny; Mathieson, Fiona; Dowell, Anthony; Stanley, James; Hatcher, Simon; Goodyear-Smith, Felicity; Lane, Brigitte; Munsterman, Amy

    2015-06-05

    Although mild to moderate mental health problems are common and often debilitating, treatment options in primary care settings in New Zealand are often severely limited for patients with these conditions. Previously, we developed an ultra-brief intervention (UBI) to address mild to moderate psychological concerns, designed to be delivered by primary care clinicians. Recent feasibility testing, including an adaptation for Māori individuals (the indigenous people of New Zealand), showed that the brief intervention was feasible and acceptable to both clinicians and their patients. This protocol describes a large pragmatic randomized controlled trial of our UBI in primary care settings across the greater Wellington region, compared with practice as usual. We are using a two-arm cluster randomized controlled trial, with primary care practices randomized to exclusively deliver either the UBI or practice as usual to all their recruited participants. The structured, guided self-help UBI is delivered in three brief general practitioner (GP) appointments over a five week period. Participants are invited into the study based on partner primary health organization access criteria (youth, people with low income, or people with Māori or Pacific Island heritage). Improvements in mental health from baseline to post-treatment will be compared between the intervention and control groups using a mixed-models application of analysis of covariance. Data analysis will be on an intention-to-treat basis, to increase the real-world relevance of UBI and to meet the study's objective of releasing UBI to primary care clinicians nationwide. The UBI is a first-line intervention tool for GPs that models the stepped care approach advocated in New Zealand, against a background of limited access to treatments for often-overlooked patient groups. It is proposed to be accessible to clinicians and patients alike, with the potential to be relevant to primary care clinicians across New Zealand

  12. Partners for the optimal organisation of the healthcare continuum for high users of health and social services: protocol of a developmental evaluation case study design.

    PubMed

    Hudon, Catherine; Chouinard, Maud-Christine; Couture, Martine; Brousselle, Astrid; Couture, Eva Marjorie; Dubois, Marie-France; Fortin, Martin; Freund, Tobias; Loignon, Christine; Mireault, Jean; Pluye, Pierre; Roberge, Pasquale; Rodriguez, Charo

    2014-12-02

    Case management allows us to respond to the complex needs of a vulnerable clientele through a structured approach that promotes enhanced interaction between partners. Syntheses on the subject converge towards a need for a better description of the relationships between programmes and their local context, as well as the characteristics of the clienteles and programmes that contribute to positive impacts. The purpose of this project is thus to describe and evaluate the case management programmes of four health and social services centres in the Saguenay-Lac- Saint-Jean region of Québec, Canada, in order to inform their improvement while creating knowledge on case management that can be useful in other contexts. This research relies on a multiple embedded case study design based on a developmental evaluation approach. We will work with the case management programme for high users of hospital services of each centre. Three different units of analysis will be interwoven to obtain an in-depth understanding of each case, that is: (1) health and social services centre and local services network, (2) case management programme and (3) patients who are high users of services. Two strategies for programme evaluation (logic models and implementation analysis) will guide the mixed data collection based on qualitative and quantitative methods. This data collection will rely on: (1) individual interviews and focus groups; (2) participant observation; (3) document analysis; (4) clinical and administrative data and (5) questionnaires. Description and comparison of cases, and integration of qualitative and quantitative data will be used to guide the data analysis. The study protocol was approved by the Ethics Research Boards of the four health and social services centres (HSSCs) involved. Findings will be disseminated by publications in peer-reviewed journals, conferences, and policy and practice partners in local and national government. Published by the BMJ Publishing Group

  13. Managing the transition (ManTra): a resource for persons with secondary progressive multiple sclerosis and their health professionals: protocol for a mixed-methods study in Italy.

    PubMed

    Giovannetti, Ambra Mara; Giordano, Andrea; Pietrolongo, Erika; Confalonieri, Paolo; De Luca, Giovanna; Tortorella, Carla; Trojano, Maria; Messmer Uccelli, Michele; Torri Clerici, Valentina; Gitto, Lara; Köpke, Sascha; Borreani, Claudia; Heesen, Christoph; Solari, Alessandra

    2017-08-23

    15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource. Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol). The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan ; G D'Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The results will be published in peer-reviewed journals

  14. Effectiveness of an intervention in groups of family caregivers of dependent patients for their application in primary health centers. Study protocol

    PubMed Central

    2010-01-01

    Background Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers. The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and Quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres. Methods/Design This is multicentre clinical trials study, randomized in two parallel groups, carry out in two PHC, Study population: 150 caregivers will be included by consecutive sampling and they will be randomized the half to experimental group and the other half to control group. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz & Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed. Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in groups. This intervention has been initially developed for family caregivers of patients with dementia. Discussion

  15. Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial.

    PubMed

    Fehily, Caitlin; Bartlem, Kate; Wiggers, John; Wye, Paula; Clancy, Richard; Castle, David; Wutzke, Sonia; Rissel, Chris; Wilson, Andrew; McCombie, Paul; Murphy, Fionna; Bowman, Jenny

    2017-06-15

    People with a mental illness experience a greater morbidity and mortality from chronic diseases relative to the general population. A higher prevalence of modifiable health risk behaviours such as smoking, poor nutrition, physical inactivity and harmful alcohol consumption contribute substantially to this disparity. Despite clinical practice guidelines recommending that mental health services routinely provide care to address these risk behaviours, the provision of such care is consistently reported to be low internationally and in Australia. This protocol describes a randomised controlled trial that aims to assess the effectiveness of allocating a clinician within a community mental health service to the specific role of providing assessment, advice and referral for clients' chronic disease risk behaviours. Approximately 540 clients of one community mental health service will be randomised to receive either usual care for chronic disease risks provided in routine consultations or usual care plus an additional face-to-face consultation and follow-up telephone call with a 'healthy lifestyle clinician'. The clinician will assess clients' chronic disease risk behaviours, provide advice to change behaviours, and refer at-risk clients to free telephone coaching services (New South Wales (NSW) Quitline and NSW Get Healthy Information and Coaching Service) for specialist behaviour change care. The primary outcomes, regarding referral to and client uptake of the telephone services, will be obtained from the respective services. Telephone interviews of clients at baseline and at 1 and 6 months post baseline follow-ups will assess secondary outcomes: receipt of any assessment, advice and referral from the mental health service; satisfaction with the receipt of such care; satisfaction with the receipt of any care provided by the telephone services; interest and confidence in and perceived importance of changing risk behaviours; and risk behaviour status. This study will add

  16. Using Tablet Computers to Increase Patient Engagement With Electronic Personal Health Records: Protocol For a Prospective, Randomized Interventional Study

    PubMed Central

    Magan Mendoza, Yimdriuska; Rosenthal, Jaime; Jacolbia, Ronald; Rajkomar, Alvin; Lee, Herman; Auerbach, Andrew

    2016-01-01

    Background Inadequate patient engagement in care is a major barrier to successful transitions from the inpatient setting and can lead to preventable adverse events after discharge, particularly for older adults. While older adults may be less familiar with mobile devices and applications, they may benefit from focused bedside training to engage them in using their Personal Health Record (PHR). Mobile technologies such as tablet computers can be used in the hospital to help bridge this gap in experience by teaching older, hospitalized patients to actively manage their medication list through their PHR during hospitalization and continue to use their PHR for other post-discharge tasks such as scheduling follow-up appointments, viewing test results, and communicating with providers. Bridging this gap is especially important for older, hospitalized adults as they are at higher risk than younger populations for low engagement in transitions of care and poor outcomes such as readmission. Greater understanding of the advantages and limitations of mobile devices for older adults may be important for improving transitions of care. Objective To better understand the effective use of mobile technologies to improve transitions in care for hospitalized, older adults and leverage these technologies to improve inpatient and postdischarge care for older adults. Methods We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR. Results Patient enrollment is ongoing. Conclusions Through this grant, we will further develop our preliminary dataset and practical experience with these mobile technologies to catalyze patient engagement during hospitalization. ClinicalTrial ClinicalTrials.gov NCT02109601; https://clinicaltrials.gov/ct2/show/NCT02109601 (Archived by WebCite at http://www.webcitation.org/6jpXjkwM8

  17. Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services.

    PubMed

    Haines, Terry P; O'Brien, Lisa; Mitchell, Deb; Bowles, Kelly-Ann; Haas, Romi; Markham, Donna; Plumb, Samantha; Chiu, Timothy; May, Kerry; Philip, Kathleen; Lescai, David; McDermott, Fiona; Sarkies, Mitchell; Ghaly, Marcelle; Shaw, Leonie; Juj, Genevieve; Skinner, Elizabeth H

    2015-04-02

    , and patient discharge destination, satisfaction, and functional independence at discharge. This is the world's first application of the recently described non-inferiority (roll-in) stepped wedge trial design, and the largest investigation of the effectiveness of weekend allied health services on acute medical surgical wards to date. Australian New Zealand Clinical Trials Registry. ACTRN12613001231730 (first study) and ACTRN12613001361796 (second study). Was this trial prospectively registered?: Yes. Date registered: 8 November 2013 (first study), 12 December 2013 (second study). Anticipated completion: June 2015. Protocol version: 1. Role of trial sponsor: KP and DL are directly employed by one of the trial sponsors, their roles were: KP assisted with overall development of research design and assisted with overall project management; DL contributed to project management, administration and communications strategy.

  18. Can wheat germ have a beneficial effect on human health? A study protocol for a randomised crossover controlled trial to evaluate its health effects

    PubMed Central

    Moreira-Rosário, André; Pinheiro, Helder; Calhau, Conceição; Azevedo, Luís Filipe

    2016-01-01

    Introduction Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now. Previous studies do not clarify the hypothesised potential causal relationship between the consumption of wheat germ and benefits for human health. Methods and analysis We are conducting a randomised, double-blinded, crossover, placebo-controlled clinical trial designed to assess the physiological effects of daily consumption of wheat germ-enriched bread (containing 6 g of wheat germ) compared with non-enriched bread, over a 4-week period with a 15-week follow-up, in a healthy human population. A total of 55 participants (healthy volunteers, aged 18–60) have been recruited from the Porto metropolitan area in northern Portugal. Our aim is to evaluate the health effects of wheat germ on blood cholesterol and triglycerides, postprandial glycaemic response, gastrointestinal function and discomfort, and changes in intestinal microbiota and insulin resistance as secondary outcomes. The study follows the best practices for evaluating health claims in food according to the European Food Safety Authority (EFSA) scientific opinion, namely random allocation, double blinding, reporting methods to measure and maximise compliance, and validated outcomes with beneficial physiological effects as recommended by EFSA. Ethics and dissemination The study has been approved by the Health Ethics Committee of São João Hospital Centre (156-15) and the Ethics Committee of Faculty of Medicine of the University of Porto (PCEDCSS-FMUP07/2015). Results will be

  19. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    PubMed Central

    Bearsley-Smith, Cate; Browne, Mark Oakley; Sellick, Ken; Villanueva, Elmer V; Chesters, Janice; Francis, Karen; Reddy, Prasuna

    2007-01-01

    coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method. Discussion This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services. Trial Registration Australian Clinical Trials Registry ACTRNO12607000324415 PMID:17915032

  20. [Evaluation of eight Clinical Protocols and Therapeutic Guidelines under the Brazilian Ministry of Health using the AGREE II instrument: a pilot study].

    PubMed

    Ronsoni, Ricardo De March; Pereira, Claudia Cristina de Aguiar; Stein, Airton Tetelbom; Osanai, Mário Henrique; Machado, Carla Jorge

    2015-06-01

    The number of clinical guidelines is increasing worldwide, while there are concerns regarding their quality. In 2000, the Brazilian Ministry of Health began its process of creating clinical guidelines, called Clinical Protocols and Therapeutic Guidelines (PCDT). The goal of this study was to assess the quality of Brazilian guidelines approved since 2009 using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation). We identified 59 PCDT from 2009 to 2012, of which eight were randomly selected and evaluated by three independent evaluators. For the item "recommends the guidelines", two evaluators recommended the use of all eight, but with modifications, and one did not recommend any to the guidelines. Regarding the item "global quality of the guidelines" (varying from 1 to 7), the mean was 4.25 (SD = 0.46). The results showed the need for adjustments in the PCDT in relation to AGREE II domains. However, due to the instrument's limitations, further studies are needed, including the quality of evidence used in the PCDT.

  1. Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial

    PubMed Central

    2011-01-01

    Background Birth attendance by trained health workers is low in rural Nepal. Local participation in improving health services and increased interaction between health systems and communities may stimulate demand for health services. Significant increases in birth attendance by trained health workers may be affected through community mobilisation by local women's groups and health management committee strengthening. We will test the effect of community mobilisation through women's groups, and health management committee strengthening, on institutional deliveries and home deliveries attended by trained health workers in Makwanpur District. Design Cluster randomised controlled trial involving 43 village development committee clusters. 21 clusters will receive the intervention and 22 clusters will serve as control areas. In intervention areas, Female Community Health Volunteers are supported in convening monthly women's groups. The groups work through an action research cycle in which they consider barriers to institutional delivery, plan and implement strategies to address these barriers with their communities, and evaluate their progress. Health management committees participate in three-day workshops that use appreciative inquiry methods to explore and plan ways to improve maternal and newborn health services. Follow-up meetings are conducted every three months to review progress. Primary outcomes are institutional deliveries and home deliveries conducted by trained health workers. Secondary outcome measures include uptake of antenatal and postnatal care, neonatal mortality and stillbirth rates, and maternal morbidity. Trial registration number ISRCTN99834806 PMID:21595902

  2. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

    PubMed

    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way mHealth

  3. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol.

    PubMed

    Li, Sophie H; Sandler, Carolina X; Casson, Sally M; Cassar, Joanne; Bogg, Tina; Lloyd, Andrew R; Barry, Benjamin K

    2017-05-10

    Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions. A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined. The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings. ACTRN12616000296437. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  4. Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study

    PubMed Central

    Collins, Eileen G; Shim, Janet K; Whooley, Mary A

    2017-01-01

    Background Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. Objective The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). Methods We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Results Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Conclusions Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. Trial Registration

  5. Comparing Mobile Health Strategies to Improve Medication Adherence for Veterans With Coronary Heart Disease (Mobile4Meds): Protocol for a Mixed-Methods Study.

    PubMed

    Park, Linda G; Collins, Eileen G; Shim, Janet K; Whooley, Mary A

    2017-07-18

    Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence. The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT). We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports. Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018. Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence. ClinicalTrials.gov NCT03022669.

  6. Gestational Age Assessment in the Ghana Randomized Air Pollution and Health Study (GRAPHS): Ultrasound Capacity Building, Fetal Biometry Protocol Development, and Ongoing Quality Control

    PubMed Central

    Boamah, Ellen A; Asante, KP; Ae-Ngibise, KA; Kinney, Patrick L; Jack, Darby W; Manu, Grace; Azindow, Irene T; Owusu-Agyei, Seth

    2014-01-01

    Background Four million premature deaths occur yearly as a result of smoke from cooking fires. The Ghana Randomized Air Pollution and Health Study (GRAPHS) is underway in the Kintampo North municipality and South district of rural Ghana to evaluate the impact of improved cook stoves introduced during pregnancy on birth weight and childhood pneumonia. These hypotheses are being tested in a cluster-randomized intervention trial among 1415 maternal-infant pairs within 35 communities assigned to a control arm (traditional cooking) or one of two intervention arms (cooking with an improved biomass stove; cooking with liquefied petroleum gas stoves). Objective The trial is designed to ensure delivery of the stove intervention prior to the period of maximal fetal growth. To answer questions about the impact of household air pollution on pregnancy outcome, accurate gestational age assessment is critical. This manuscript describes in detail the development of the gestational dating protocol, intensive ultrasound training involved, ultrasound capacity building, and ultrasound quality control program. Methods Ultrasound training occurred in several phases over the course of 2 years. Training included a basic obstetric ultrasound course offered to all midwives performing antenatal care at the two study hospitals, followed by a more intense period of hands-on training focused on fetal biometry for a select group of providers demonstrating aptitude in the basic course. A standard operating procedure was developed describing how to obtain all fetal biometric measurements. Consensus was obtained on how biometric images are used in the trial to establish gestational age and estimate the delivery date. An ongoing ultrasound quality control program including the use of an image scorecard was also designed. Results Publication of trial results is anticipated in late 2016. Conclusions Use of ultrasound should be strongly considered in field-based trials involving pregnant women to

  7. Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal.

    PubMed

    Antunes, Ana; Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

    2017-09-03

    Economic recession periods can pose accentuated risks to population's mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users' and health professionals' perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. © 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.

  8. Perceived effects of the economic recession on population mental health, well-being and provision of care by primary care users and professionals: a qualitative study protocol in Portugal

    PubMed Central

    Frasquilho, Diana; Cardoso, Graça; Pereira, Nádia; Silva, Manuela; Caldas-de-Almeida, José Miguel; Ferrão, João

    2017-01-01

    Introduction Economic recession periods can pose accentuated risks to population’s mental health and well-being as well as additional threats to health systems. Users and health professionals are key stakeholders in care delivery; however, little attention has been given to their experiences of the crisis. This paper presents a qualitative study protocol to assess users’ and health professionals’ perceptions about the effects of the post-2008 economic recession on mental health and care delivery in the Lisbon Metropolitan Area, Portugal. Methods and analysis The methodology to assess perceived effects of the economic recession by primary care users and professionals on population mental health, well-being and provision of care is presented. Focus groups with users and semistructured interviews with health professionals will be carried out in three primary healthcare units in Lisbon areas especially affected by the crisis. Thematic analysis of full-transcribed interviews will be conducted using an iterative and reflexive approach. Ethics and dissemination The study protocol was approved by the Ethics Committee of NOVA Medical School, NOVA University of Lisbon. The findings will be useful for other researchers and policy-makers to develop and implement the assessment of prevailing experiences of users and health professionals on the effects of the economic recession on mental health and quality of care in primary health context, promoting their involvement and contribution to services responsiveness. PMID:28871022

  9. Study protocol: a mixed methods study to assess mental health recovery, shared decision-making and quality of life (Plan4Recovery).

    PubMed

    Coffey, Michael; Hannigan, Ben; Meudell, Alan; Hunt, Julian; Fitzsimmons, Deb

    2016-08-17

    Recovery in mental health care is complex, highly individual and can be facilitated by a range of professional and non-professional support. In this study we will examine how recovery from mental health problems is promoted in non-medical settings. We hypothesise a relationship between involvement in decisions about care, social support and recovery and quality of life outcomes. We will use standardised validated instruments of involvement in decision-making, social contacts, recovery and quality of life with a random sample of people accessing non-statutory mental health social care services in Wales. We will add to this important information with detailed one to one case study interviews with people, their family members and their support workers. We will use a series of these interviews to examine how people build recovery over time to help us understand more about their involvement in decisions and the social links they build. We want to see how being involved in decisions about care and the social links people have are related to recovery and quality of life for people with experience of using mental health support services. We want to understand the different perspectives of the people involved in making recovery possible. We will use this information to guide further studies of particular types of social interventions and their use in helping recovery from mental health problems.

  10. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial.

    PubMed

    Gschwind, Yves J; Kressig, Reto W; Lacroix, Andre; Muehlbauer, Thomas; Pfenninger, Barbara; Granacher, Urs

    2013-10-09

    With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale - International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with each training session lasting 30 min

  11. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background With increasing age neuromuscular deficits (e.g., sarcopenia) may result in impaired physical performance and an increased risk for falls. Prominent intrinsic fall-risk factors are age-related decreases in balance and strength / power performance as well as cognitive decline. Additional studies are needed to develop specifically tailored exercise programs for older adults that can easily be implemented into clinical practice. Thus, the objective of the present trial is to assess the effects of a fall prevention program that was developed by an interdisciplinary expert panel on measures of balance, strength / power, body composition, cognition, psychosocial well-being, and falls self-efficacy in healthy older adults. Additionally, the time-related effects of detraining are tested. Methods/Design Healthy old people (n = 54) between the age of 65 to 80 years will participate in this trial. The testing protocol comprises tests for the assessment of static / dynamic steady-state balance (i.e., Sharpened Romberg Test, instrumented gait analysis), proactive balance (i.e., Functional Reach Test; Timed Up and Go Test), reactive balance (i.e., perturbation test during bipedal stance; Push and Release Test), strength (i.e., hand grip strength test; Chair Stand Test), and power (i.e., Stair Climb Power Test; countermovement jump). Further, body composition will be analysed using a bioelectrical impedance analysis system. In addition, questionnaires for the assessment of psychosocial (i.e., World Health Organisation Quality of Life Assessment-Bref), cognitive (i.e., Mini Mental State Examination), and fall risk determinants (i.e., Fall Efficacy Scale – International) will be included in the study protocol. Participants will be randomized into two intervention groups or the control / waiting group. After baseline measures, participants in the intervention groups will conduct a 12-week balance and strength / power exercise intervention 3 times per week, with

  12. A six-step protocol to systematic process evaluation of multicomponent cluster-randomised health promoting interventions illustrated by the Boost study.

    PubMed

    Aarestrup, Anne Kristine; Jørgensen, Thea Suldrup; Due, Pernille; Krølner, Rikke

    2014-10-01

    In multicomponent interventions it is important to examine the implementation of each component to enable valid assessments of the effectiveness of each component. Many studies do not systematically document, evaluate and report the level of implementation and there is a lack of systematic approaches to conduct process evaluation studies to guide researchers and evaluators. The aim of this study was to present a systematic approach to plan process evaluation of the implementation of randomised multicomponent interventions. Building on existing process evaluation frameworks and concepts, we developed a six-step protocol: 1. Brainstorm of processes necessary for full implementation and potential barriers and facilitators to implementation; 2. Application of process evaluation concepts to ensure inclusion of important implementation processes; 3. Measurement of proximal outcomes; 4. Identification of relevant data sources; 5. Selection of methods and timing of data collection of process measures; 6. Development of instruments. The protocol was applied to the Boost study, a multicomponent school-based dietary intervention. The protocol was readily applicable for planning process evaluation of environmental and educational intervention components in a school setting. The protocol ensures systematic assessment of the implementation processes that are crucial for interpretation of intervention effects. Current Controlled Trials ISRCTN11666034. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Well-being, health and fitness of children who use wheelchairs: feasibility study protocol to develop child-centred 'keep-fit' exercise interventions.

    PubMed

    O'Brien, Thomas D; Noyes, Jane; Spencer, Llinos Haf; Kubis, Hans-Peter; Edwards, Rhiannon T; Bray, Nathan; Whitaker, Rhiannon

    2015-02-01

    To undertake the pre-clinical and modelling phases of the Medical Research Council complex intervention framework to underpin development of child-centred 'keep-fit', exercise and physical activity interventions for children and young people who use wheelchairs. Children who use wheelchairs face many barriers to participation in physical activity, which compromises fitness, obesity, well-being and health. 'Keep-fit' programmes that are child-centred and engaging are urgently required to enhance participation of disabled children and their families as part of a healthy lifestyle. Nurses will likely be important in promoting and monitoring 'keep-fit' intervention(s) when implemented in the community. Mixed-method (including economic analysis) feasibility study to capture child and family preferences and keep-fit needs and to determine outcome measures for a 'keep-fit' intervention. The study comprises three stages. Stage 1 includes a mixed-method systematic review of effectiveness, cost effectiveness and key stakeholder views and experiences of keep-fit interventions, followed by qualitative interviews with children, young people and their parents to explore preferences and motivations for physical activity. Stage 2 will identify standardized outcome measures and test their application with children who use wheelchairs to obtain baseline fitness data. Options for an exercise-based keep-fit intervention will then be designed based on Stage 1 and 2 findings. In stage 3, we will present intervention options for feedback and further refinement to children and parents/carers in focus groups. (Project funded October 2012). At completion, this study will lead to the design of the intervention and a protocol to test its efficacy. © 2014 John Wiley & Sons Ltd.

  14. Cohort study on clustering of lifestyle risk factors and understanding its association with stress on health and wellbeing among school teachers in Malaysia (CLUSTer)--a study protocol.

    PubMed

    Moy, Foong Ming; Hoe, Victor Chee Wai; Hairi, Noran Naqiah; Buckley, Brian; Wark, Petra A; Koh, David; Bueno-de-Mesquita, H Bas; Bulgiba, Awang M

    2014-06-17

    The study on Clustering of Lifestyle risk factors and Understanding its association with Stress on health and wellbeing among school Teachers in Malaysia (CLUSTer) is a prospective cohort study which aims to extensively study teachers in Malaysia with respect to clustering of lifestyle risk factors and stress, and subsequently, to follow-up the population for important health outcomes. This study is being conducted in six states within Peninsular Malaysia. From each state, schools from each district are randomly selected and invited to participate in the study. Once the schools agree to participate, all teachers who fulfilled the inclusion criteria are invited to participate. Data collection includes a questionnaire survey and health assessment. Information collected in the questionnaire includes socio-demographic characteristics, participants' medical history and family history of chronic diseases, teaching characteristics and burden, questions on smoking, alcohol consumption and physical activities (IPAQ); a food frequency questionnaire, the job content questionnaire (JCQ); depression, anxiety and stress scale (DASS21); health related quality of life (SF12-V2); Voice Handicap Index 10 on voice disorder, questions on chronic pain, sleep duration and obstetric history for female participants. Following blood drawn for predefined clinical tests, additional blood and urine specimens are collected and stored for future analysis. Active follow up of exposure and health outcomes will be carried out every two years via telephone or face to face contact. Data collection started in March 2013 and as of the end of March 2014 has been completed for four states: Kuala Lumpur, Selangor, Melaka and Penang. Approximately 6580 participants have been recruited. The first round of data collection and blood sampling is expected to be completed by the end of 2014 with an expected 10,000 participants recruited. Our study will provide a good basis for exploring the clustering of

  15. Measuring the impact of a health information exchange intervention on provider-based notifiable disease reporting using mixed methods: a study protocol.

    PubMed

    Dixon, Brian E; Grannis, Shaun J; Revere, Debra

    2013-10-30

    Health information exchange (HIE) is the electronic sharing of data and information between clinical care and public health entities. Previous research has shown that using HIE to electronically report laboratory results to public health can improve surveillance practice, yet there has been little utilization of HIE for improving provider-based disease reporting. This article describes a study protocol that uses mixed methods to evaluate an intervention to electronically pre-populate provider-based notifiable disease case reporting forms with clinical, laboratory and patient data available through an operational HIE. The evaluation seeks to: (1) identify barriers and facilitators to implementation, adoption and utilization of the intervention; (2) measure impacts on workflow, provider awareness, and end-user satisfaction; and (3) describe the contextual factors that impact the effectiveness of the intervention within heterogeneous clinical settings and the HIE. The intervention will be implemented over a staggered schedule in one of the largest and oldest HIE infrastructures in the U.S., the Indiana Network for Patient Care. Evaluation will be conducted utilizing a concurrent design mixed methods framework in which qualitative methods are embedded within the quantitative methods. Quantitative data will include reporting rates, timeliness and burden and report completeness and accuracy, analyzed using interrupted time-series and other pre-post comparisons. Qualitative data regarding pre-post provider perceptions of report completeness, accuracy, and timeliness, reporting burden, data quality, benefits, utility, adoption, utilization and impact on reporting workflow will be collected using semi-structured interviews and open-ended survey items. Data will be triangulated to find convergence or agreement by cross-validating results to produce a contextualized portrayal of the facilitators and barriers to implementation and use of the intervention. By applying mixed

  16. Prevalence, Motivations, and Social, Mental Health and Health Consequences of Cyberbullying Among School-Aged Children and Youth: Protocol of a Longitudinal and Multi-Perspective Mixed Method Study

    PubMed Central

    McInroy, Lauren B; Lacombe-Duncan, Ashley; Bhole, Payal; Van Wert, Melissa; Schwan, Kaitlin; Birze, Arija; Daciuk, Joanne; Beran, Tanya; Craig, Wendy; Pepler, Debra J; Wiener, Judith; Khoury-Kassabri, Mona; Johnston, David

    2016-01-01

    Background While the online environment may promote important developmental and social benefits, it also enables the serious and rapidly growing issue of cyberbullying. Cyberbullying constitutes an increasing public health problem – victimized children and youth experience a range of health and mental health concerns, including emotional and psychosomatic problems, maladaptive behaviors, and increased suicidality. Perpetrators demonstrate a lack of empathy, and may also struggle with health and mental health issues. Objective This paper describes the protocols applied in a longitudinal and multi-perspective mixed-methods study with five objectives: (1) to explore children/youth’s experiences, and children/youth’s, parents’, and teachers’ conceptions, definitions, and understanding of cyberbullying; (2) to explore how children/youth view the underlying motivations for cyberbullying; (3) to document the shifting prevalence rates of cyberbullying victimization, witnessing, and perpetration; (4) to identify risk and protective factors for cyberbullying involvement; and (5) to explore social, mental health, and health consequences of cyberbullying. Methods Quantitative survey data were collected over three years (2012-2014) from a stratified random baseline sample of fourth (n=160), seventh (n=243), and tenth (n=267) grade children/youth, their parents (n=246), and their teachers (n=103). Quantitative data were collected from students and teachers during in-person school visits, and from parents via mail-in surveys. Student, parent, and teacher surveys included questions regarding: student experiences with bullying/cyberbullying; student health, mental health, and social and behavioral issues; socio-demographics; and information and communication technology use. In-depth semi-structured qualitative interviews were conducted twice with a sub-sample of students (n=57), purposively selected based on socio-demographics and cyberbullying experience, twice with

  17. Oral health protocol for the dependent institutionalized elderly.

    PubMed

    Gil-Montoya, Jose Antonio; de Mello, Ana Lucia Ferreira; Cardenas, Ciro Barreto; Lopez, Inmaculada Guardia

    2006-01-01

    Establishing an oral hygiene protocol for the frail and functionally dependent elderly should be of special concern to health care providers. The previous assessment of a care center, including patients or residents and staff, allows an effective strategy to be designed. Oral health protocols are mainly based on the daily removal of bacterial plaque from teeth or prostheses (or both), cleaning of oral mucosa, and continual oral hydration. These practices are facilitated by the use of electric toothbrushes and products such as chlorhexidine, fluoride toothpastes, and rinses or gels for dry mouth. This type of protocol should include regular collaboration with dental professionals and provide a program of continuous training for nursing staff on oral health issues.

  18. Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above.

    PubMed

    Walton, Merrilyn; Jorm, Christine; Smith-Merry, Jennifer; Harrison, Reema; Manias, Elizabeth; Iedema, Rick; Kelly, Patrick

    2014-10-13

    Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia. The 45 and Up Study is a cohort of 265,000 adults aged 45 years and above in NSW. Patients who were hospitalised between 1 January and 30 June 2014 will be identified from this cohort using data linkage and a random sample of 20,000 invited to participate. A cross-sectional survey (including qualitative and quantitative components) will capture patients' experiences in hospital and specifically of adverse events. Approximately 25% of respondents are likely to report experiencing an adverse event. Quantitative components will capture the nature and type of events as well as common features of patients' experiences. Qualitative data provide contextual knowledge of their condition and care and the impact of the event on individuals. Respondents who do not report an adverse event will report their experience in hospital and be the control group. Statistical and thematic analysis will be used to present a patient perspective of their experiences in hospital; the characteristics of patients experiencing an adverse event; experiences of information sharing after an event (open disclosure) and the other avenues of redress pursued. Interviews with key policymakers and a document analysis will be used to create a map of the current practice. Dissemination via a one-day workshop, peer-reviewed publications and conference presentations will enable effective clinical responses and service provision and policy responses to adverse events to be developed. 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.

  19. The iMpact on practice, oUtcomes and costs of New roles for health pROfeSsionals: a study protocol for MUNROS.

    PubMed

    Bond, Christine; Bruhn, Hanne; de Bont, Antoinette; van Exel, Job; Busse, Reinhard; Sutton, Matthew; Elliott, Robert

    2016-04-26

    The size and composition of the European Union healthcare workforce are key drivers of expenditure and performance; it now includes new health professions and enhanced roles for established professions. This project will systematically analyse how this has contributed to health service redesign, integration and performance in 9 European countries (Scotland, England, Netherlands, Germany, Italy, Czech Republic, Poland, Norway, and Turkey(i)). This paper describes the protocol for collection of survey data in 3 distinct care pathways, and sets it in the context of the wider programme. Questionnaires will be distributed to healthcare professionals (n=14,580), managers (n=3564) and patients (n=19,440) in 3 care pathways (breast cancer; type 2 diabetes; and coronary heart disease) within 12 hospitals and associated primary care settings in each country. Questionnaire topics will include demography, the different professionals working on the care pathway, the tasks they do and the time taken, their decision-making abilities when considering skill mix, specialisation and integration of care. Patient satisfaction, healthcare utilisation and preferences will be explored. In later work, register data and data from patient records will be used to record clinical outcomes. Data will also be collected on workforce and procedure costs. Descriptive analysis will identify the different models of care and multivariate analysis will establish the most clinically and cost-effective models. This protocol was approved by ethical committees in each country. Findings will be disseminated through national/international clinical, health services research and health workforce conferences, and publications in national/international peer-reviewed journals. 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. The iMpact on practice, oUtcomes and costs of New roles for health pROfeSsionals: a study protocol for MUNROS

    PubMed Central

    Bond, Christine; Bruhn, Hanne; de Bont, Antoinette; van Exel, Job; Busse, Reinhard; Sutton, Matthew; Elliott, Robert

    2016-01-01

    Introduction The size and composition of the European Union healthcare workforce are key drivers of expenditure and performance; it now includes new health professions and enhanced roles for established professions. This project will systematically analyse how this has contributed to health service redesign, integration and performance in 9 European countries (Scotland, England, Netherlands, Germany, Italy, Czech Republic, Poland, Norway, and Turkeyi). This paper describes the protocol for collection of survey data in 3 distinct care pathways, and sets it in the context of the wider programme. Methods Questionnaires will be distributed to healthcare professionals (n=14 580), managers (n=3564) and patients (n=19 440) in 3 care pathways (breast cancer; type 2 diabetes; and coronary heart disease) within 12 hospitals and associated primary care settings in each country. Questionnaire topics will include demography, the different professionals working on the care pathway, the tasks they do and the time taken, their decision-making abilities when considering skill mix, specialisation and integration of care. Patient satisfaction, healthcare utilisation and preferences will be explored. In later work, register data and data from patient records will be used to record clinical outcomes. Data will also be collected on workforce and procedure costs. Descriptive analysis will identify the different models of care and multivariate analysis will establish the most clinically and cost-effective models. Ethics and dissemination This protocol was approved by ethical committees in each country. Findings will be disseminated through national/international clinical, health services research and health workforce conferences, and publications in national/international peer-reviewed journals. PMID:27118286

  1. Cohort study on clustering of lifestyle risk factors and understanding its association with stress on health and wellbeing among school teachers in Malaysia (CLUSTer) – a study protocol

    PubMed Central

    2014-01-01

    Background The study on Clustering of Lifestyle risk factors and Understanding its association with Stress on health and wellbeing among school Teachers in Malaysia (CLUSTer) is a prospective cohort study which aims to extensively study teachers in Malaysia with respect to clustering of lifestyle risk factors and stress, and subsequently, to follow-up the population for important health outcomes. Method/design This study is being conducted in six states within Peninsular Malaysia. From each state, schools from each district are randomly selected and invited to participate in the study. Once the schools agree to participate, all teachers who fulfilled the inclusion criteria are invited to participate. Data collection includes a questionnaire survey and health assessment. Information collected in the questionnaire includes socio-demographic characteristics, participants’ medical history and family history of chronic diseases, teaching characteristics and burden, questions on smoking, alcohol consumption and physical activities (IPAQ); a food frequency questionnaire, the job content questionnaire (JCQ); depression, anxiety and stress scale (DASS21); health related quality of life (SF12-V2); Voice Handicap Index 10 on voice disorder, questions on chronic pain, sleep duration and obstetric history for female participants. Following blood drawn for predefined clinical tests, additional blood and urine specimens are collected and stored for future analysis. Active follow up of exposure and health outcomes will be carried out every two years via telephone or face to face contact. Data collection started in March 2013 and as of the end of March 2014 has been completed for four states: Kuala Lumpur, Selangor, Melaka and Penang. Approximately 6580 participants have been recruited. The first round of data collection and blood sampling is expected to be completed by the end of 2014 with an expected 10,000 participants recruited. Discussion Our study will provide a good basis

  2. Evaluating the impact of depression, anxiety & autonomic function on health related quality of life, vocational functioning and health care utilisation in acute coronary syndrome patients: the ADVENT study protocol

    PubMed Central

    2013-01-01

    Background Depression and anxiety are highly prevalent and co-morbid in acute coronary syndrome patients. Somatic and cognitive subtypes of depression and anxiety in acute coronary syndrome have been shown to be associated with mortality although their association with patient outcomes is unknown, as are the mechanisms that underpin these associations. We are conducting a prospective cohort study which aims to examine in acute coronary syndrome patients: (1) the role of somatic subtypes of depression and anxiety as predictors of health related quality of life outcomes; (2) how somatic subtypes of depression and anxiety relate to long term vocational functioning and healthcare utilisation; and (3) the role of the autonomic nervous system assessed by heart rate variability as a moderator of these associations. Methods Patients are being screened after index admission for acute coronary syndrome at a single, high volume centre, MonashHeart, Monash Health, Victoria, Australia. The inclusion criterion is all patients aged > 21 years old and fluent in English admitted to MonashHeart, Monash Health with a diagnosis of acute coronary syndrome. The primary outcome is mean health related quality of life (Short Form-36) Physical and Mental Health Summary scores at 12 and 24 months in subtypes with somatic symptoms of depression and anxiety. Depressive domains are assessed by the Beck Depression Inventory II and the Cardiac Depression Scale. Anxiety is measured using the Speilberger State-Trait Anxiety Inventory and the Crown Crisp Phobic Anxiety questionnaire. Secondary outcomes include clinical variables, healthcare service utilisation and vocational functioning. Discussion This manuscript presents the protocol for a prospective cohort study which will investigate the role of somatic subtypes of depression and anxiety as predictors of health related quality of life, long-term vocational functioning and health service use, and the role of the autonomic nervous system in

  3. A longitudinal study of the impact of chronic psychological stress on health-related quality of life and clinical biomarkers: protocol for the Australian Healthy Aging of Women Study.

    PubMed

    Seib, Charrlotte; Whiteside, Eliza; Humphreys, Janice; Lee, Kathryn; Thomas, Patrick; Chopin, Lisa; Crisp, Gabrielle; O'Keeffe, Angela; Kimlin, Michael; Stacey, Andrew; Anderson, Debra

    2014-01-08

    Despite advancements in our understanding of the importance of stress reduction in achieving good health, we still only have limited insight into the impact of stress on cellular function. Recent studies have suggested that exposure to prolonged psychological stress may alter an individual's physiological responses, and contribute to morbidity and mortality. This paper presents an overview of the study protocol we are using to examine the impact of life stressors on lifestyle factors, health-related quality of life and novel and established biomarkers of stress in midlife and older Australian women.The primary aim of this study is to explore the links between chronic psychological stress on both subjective and objective health markers in midlife and older Australian women. The study examines the extent to which exposure frightening, upsetting or stressful events such as natural disasters, illness or death of a relative, miscarriage and relationship conflict is correlated with a variety of objective and subjective health markers. This study is embedded within the longitudinal Healthy Aging of Women's study which has collected data from midlife and older Australian women at 5 yearly intervals since 2001, and uses the Allostastic model of women's health by Groër and colleagues in 2010. The current study expands the focus of the HOW study and will assess the impact of life stressors on quality of life and clinical biomarkers in midlife and older Australian women to explain the impact of chronic psychological stress in women. The proposed study hypothesizes that women are at increased risk of exposure to multiple or repeated stressors, some being unique to women, and the frequency and chronicity of stressors increases women's risk of adverse health outcomes. This study aims to further our understanding of the relationships between stressful life experiences, perceived quality of life, stress biomarkers, chronic illness, and health status in women.

  4. A longitudinal study of the impact of chronic psychological stress on health-related quality of life and clinical biomarkers: protocol for the Australian Healthy Aging of Women Study

    PubMed Central

    2014-01-01

    Background Despite advancements in our understanding of the importance of stress reduction in achieving good health, we still only have limited insight into the impact of stress on cellular function. Recent studies have suggested that exposure to prolonged psychological stress may alter an individual’s physiological responses, and contribute to morbidity and mortality. This paper presents an overview of the study protocol we are using to examine the impact of life stressors on lifestyle factors, health-related quality of life and novel and established biomarkers of stress in midlife and older Australian women. The primary aim of this study is to explore the links between chronic psychological stress on both subjective and objective health markers in midlife and older Australian women. The study examines the extent to which exposure frightening, upsetting or stressful events such as natural disasters, illness or death of a relative, miscarriage and relationship conflict is correlated with a variety of objective and subjective health markers. Methods/Design This study is embedded within the longitudinal Healthy Aging of Women’s study which has collected data from midlife and older Australian women at 5 yearly intervals since 2001, and uses the Allostastic model of women’s health by Groër and colleagues in 2010. The current study expands the focus of the HOW study and will assess the impact of life stressors on quality of life and clinical biomarkers in midlife and older Australian women to explain the impact of chronic psychological stress in women. Discussion The proposed study hypothesizes that women are at increased risk of exposure to multiple or repeated stressors, some being unique to women, and the frequency and chronicity of stressors increases women’s risk of adverse health outcomes. This study aims to further our understanding of the relationships between stressful life experiences, perceived quality of life, stress biomarkers, chronic illness, and

  5. Study protocol for the SOFIA project: Swallowing function, Oral health, and Food Intake in old Age: a descriptive study with a cluster randomized trial.

    PubMed

    Hägglund, Patricia; Olai, Lena; Ståhlnacke, Katri; Persenius, Mona; Hägg, Mary; Andersson, Maria; Koistinen, Susanne; Carlsson, Eva

    2017-03-23

    Extensive studies have shown that older people are negatively impacted by impaired eating and nutrition. The abilities to eat, enjoy food, and participate in social activities associated with meals are important aspects of health-related quality of life (HRQoL) and recovery after illness. This project aims to (i) describe and analyze relationships between oral health and oral HRQoL, swallowing ability, eating ability, and nutritional risk among older individuals admitted to short-term care; (ii) compare the perceptions that older individuals and staff report on care quality related to oral hygiene and eating; and (iii) study the feasibility and effects of a training program for people with impaired swallowing (i.e., dysphagia). This project consists of two parts, which will be performed in five Swedish counties. It will include approximately 400 older individuals and 200 healthcare professionals. Part 1 is a cross-sectional, descriptive study of older people admitted to short-term care. Subjects will be assessed by trained professionals regarding oral health status, oral HRQoL, eating and nutritional risk, and swallowing ability. Swallowing ability will be measured with a teaspoon test and a swallowing capacity test (SCT). Furthermore, subjects and staff will complete a questionnaire regarding their perceptions of care quality. Part 2 is a cluster randomized intervention trial with controls. Older participants with dysphagia (i.e., SCT <10 ml/s, measured in part 1) will be recruited consecutively to either the intervention or control group, depending on where they were admitted for short-term care. At baseline, all subjects will be assessed for oral health status, oral HRQoL, eating and nutritional risk, swallowing ability, and swallowing-related QoL. Then, the intervention group will receive 5 weeks of training with an oral screen for neuromuscular training focused on orofacial and pharyngeal muscles. After completing the intervention, and at six months post

  6. Observational study on factors related to health-promoting community activity development in primary care (frAC Project): a study protocol

    PubMed Central

    Ripoll, Joana; Ruiz-Giménez, Juan Luís; Montaner Gomis, Isabel; Benedé Azagra, Carmen Belén; Elizalde Soto, Lázaro; Vidal, Mª Clara; Bauzà Amengual, M de Lluc; Planas Juan, Trinidad; Maria Pérez Mariano, Damiana; Llull Sarralde, Micaela; Bajo Viñas, Rosa; Jordan Martin, Matilde; Solano Villarubia, Carmen; Rodriguez Bajo, Maria; Cordoba Victoria, Manuela; Badia Capdevila, Marta; Serrano Ferrandez, Elena; Bosom Diumenjo, Maria; Zabaleta del Olmo, Nieves; Bolívar-Ribas, Bonaventura; Antoñanzas Lombarte, Angel; Bregel Cotaina, Samantha; Calvo Tocado, Ana; Olivan Blázquez, Barbara; Magallón Botaya, Rosa; Marín Palacios, Pilar; Echauri Ozcoidi, Margarita; Perez-Jarauta, Mª Jose; Ramos, Maria

    2012-01-01

    Introduction According to Spanish health regulations, primary care professionals have the responsibility to carry out health-promoting community activities (CAs). However, in practice, their implementation is not as widespread as it should be. The aims of this study were to identify factors within the team, the community and the professionals that influence the development of these activities and to describe the community interventions in progress. Methods and analysis This study is an observational analytical retrospective study. The information will be collected from five Spanish regions: Catalonia, Madrid, the Balearic Islands, Navarra and Aragón. The authors will contact primary care teams (PCTs) and identify the CAs from the previous year. The research team will conduct a peer review whether the inclusion criteria are met. In the health centres where CAs are implemented, the authors will select professionals carrying them out and randomly select an identical number of professionals not doing these activities. In the centres where no CA is implemented, three professionals will be randomly selected. The selected professionals will complete the questionnaires for individual-level variables. Information about the registered population and the PCTs will be collected through questionnaires and secondary sources. Outcomes Variables will be collected from the community, the PCTs, the individual professionals and CAs. Analysis A descriptive analysis of all the variables will be carried out, along with a bivariate and a logistic regression analysis, with CAs being the primary outcome. Ethics and dissemination This study has been approved by the Research Ethics Committee of the Jordi Gol y Gurina Foundation in Barcelona and area 11 in Madrid. The questionnaire distributed to the professionals will be anonymous. PMID:22586288

  7. Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care.

    PubMed

    Askew, Deborah A; Jackson, Claire L; Ware, Robert S; Russell, Anthony

    2010-05-24

    Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Australian New Zealand Clinical Trials Registry ACTRN12608000010392.

  8. Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care

    PubMed Central

    2010-01-01

    Background Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Methods/Design Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). Discussion This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12608000010392. PMID:20492731

  9. Design and evaluation of a park prescription program for stress reduction and health promotion in low-income families: The Stay Healthy in Nature Everyday (SHINE) study protocol.

    PubMed

    Razani, Nooshin; Kohn, Michael A; Wells, Nancy M; Thompson, Doug; Hamilton Flores, Hanna; Rutherford, George W

    2016-11-01

    Contact with nature improves human health; stress reduction is a mediating pathway. Stay Healthy in Nature Everyday (SHINE) is a stress reduction and health promotion intervention for low-income families at an urban Federally Qualified Health Center. We plan to evaluate two service-delivery models for SHINE and present here the intervention design and evaluation protocol. Behavioral change theory and environmental education literature informed the intervention. Outcomes were selected after review of the literature and field tested procedures to determine what was feasible and ethical in a busy clinic serving vulnerable populations. We designed a randomized controlled trial to examine two levels of intensity in behavioral counseling about the health benefits of nature. Dyads consisting of a caregiver and a child aged 4 to 18 who access our pediatric primary care center are eligible. All dyads receive a pediatrician's recommendation to visit parks to experience nature and written resources (a "park prescription"). The intervention group receives added case management and an invitation to three group outings into nature with transportation, meals and activities provided. Primary outcomes measured at baseline, one month and three months post-enrollment are caregiver stress measured by PSS-10 score and salivary α-amylase; secondary outcomes are park prescriptions adherence, physical activity recorded by pedometer and journaling, loneliness, family cohesion and affinity to nature as measured by a validated scales. Both groups receive incentives to participation. Our intervention represents a feasible integration of recent research findings on the health benefits of nature and primary care practice. Copyright © 2016 Elsevier Inc. All rights reserved.

  10. Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial.

    PubMed

    Robertson, Wendy; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Griffiths, Frances; Thorogood, Margaret; Simkiss, Douglas; Lang, Rebecca; Reddington, Kate; Poole, Fran; Rye, Gloria; Khan, Kamran A; Hamborg, Thomas; Kirby, Joanna

    2013-03-20

    novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. Current Controlled Trials http://ISRCTN45032201.

  11. Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program. Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. Discussion This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. Trial registration Current Controlled Trials http://ISRCTN45032201 PMID:23514100

  12. Capturing how age-friendly communities foster positive health, social participation and health equity: a study protocol of key components and processes that promote population health in aging Canadians.

    PubMed

    Levasseur, Mélanie; Dubois, Marie-France; Généreux, Mélissa; Menec, Verena; Raina, Parminder; Roy, Mathieu; Gabaude, Catherine; Couturier, Yves; St-Pierre, Catherine

    2017-05-25

    To address the challenges of the global aging population, the World Health Organization promoted age-friendly communities as a way to foster the development of active aging community initiatives. Accordingly, key components (i.e., policies, services and structures related to the communities' physical and social environments) should be designed to be age-friendly and help all aging adults to live safely, enjoy good health and stay involved in their communities. Although age-friendly communities are believed to be a promising way to help aging Canadians lead healthy and active lives, little is known about which key components best foster positive health, social participation and health equity, and their underlying mechanisms. This study aims to better understand which and how key components of age-friendly communities best foster positive health, social participation and health equity in aging Canadians. Specifically, the research objectives are to: 1) Describe and compare age-friendly key components of communities across Canada 2) Identify key components best associated with positive health, social participation and health equity of aging adults 3) Explore how these key components foster positive health, social participation and health equity METHODS: A mixed-method sequential explanatory design will be used. The quantitative part will involve a survey of Canadian communities and secondary analysis of cross-sectional data from the Canadian Longitudinal Study on Aging (CLSA). The survey will include an age-friendly questionnaire targeting key components in seven domains: physical environment, housing options, social environment, opportunities for participation, community supports and healthcare services, transportation options, communication and information. The CLSA is a large, national prospective study representative of the Canadian aging population designed to examine health transitions and trajectories of adults as they age. In the qualitative part, a multiple

  13. The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial

    PubMed Central

    2012-01-01

    Background Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Methods/Design Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas. The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during

  14. The Uganda Newborn Study (UNEST): an effectiveness study on improving newborn health and survival in rural Uganda through a community-based intervention linked to health facilities - study protocol for a cluster randomized controlled trial.

    PubMed

    Waiswa, Peter; Peterson, Stefan S; Namazzi, Gertrude; Ekirapa, Elizabeth Kiracho; Naikoba, Sarah; Byaruhanga, Romano; Kiguli, Juliet; Kallander, Karin; Tagoola, Abner; Nakakeeto, Margaret; Pariyo, George

    2012-11-15

    Reducing neonatal-related deaths is one of the major bottlenecks to achieving Millennium Development Goal 4. Studies in Asia and South America have shown that neonatal mortality can be reduced through community-based interventions, but these have not been adapted to scalable intervention packages for sub-Saharan Africa where the culture, health system and policy environment is different. In Uganda, health outcomes are poor for both mothers and newborn babies. Policy opportunities for neonatal health include the new national Health Sector Strategic Plan, which now prioritizes newborn health including use of a community model through Village Health Teams (VHT). The aim of the present study is to adapt, develop and cost an integrated maternal-newborn care package that links community and facility care, and to evaluate its effect on maternal and neonatal practices in order to inform policy and scale-up in Uganda. Through formative research around evidence-based practices, and dialogue with policy and technical advisers, we constructed a home-based neonatal care package implemented by the responsible VHT member, effectively a Community Health Worker (CHW). This CHW was trained to identify pregnant women and make five home visits - two before and three just after birth - so that linkages will be made to facility care and targeted messages for home-care and care-seeking delivered. The project is improving care in health units to provide standardized care for the mother and the newborn in both intervention and comparison areas.The study is taking place in a new Demographic Surveillance Site in two rural districts, Iganga and Mayuge, in Uganda. It is a two-arm cluster randomized controlled design with 31 intervention and 32 control areas (villages). The comparison parishes receive the standard care already being provided by the district, but to the intervention villages are added a system for CHWs to visit the mother five times in her home during pregnancy and the neonatal

  15. Community engagement to enhance trust between Gypsy/Travellers, and maternity, early years' and child dental health services: protocol for a multi-method exploratory study.

    PubMed

    McFadden, Alison; Atkin, Karl; Bell, Kerry; Innes, Nicola; Jackson, Cath; Jones, Helen; MacGillivray, Steve; Siebelt, Lindsay

    2016-11-14

    Gypsy/Travellers have poor health and experience discrimination alongside structural and cultural barriers when accessing health services and consequently may mistrust those services. Our study aims to investigate which approaches to community engagement are most likely to be effective at enhancing trust between Gypsy/Travellers and mainstream health services. This multi-method 30-month study, commenced in June 2015, and comprises four stages. 1. Three related reviews: a) systematic review of Gypsy/Travellers' access to health services; b) systematic review of reviews of how trust has been conceptualised within healthcare; c) realist synthesis of community engagement approaches to enhance trust and increase Gypsy/Travellers' participation in health services. The reviews will consider any economic literature; 2. Online consultation with health and social care practitioners, and civil society organisations on existing engagement activities, including perceptions of barriers and good practice; 3. Four in-depth case studies of different Gypsy/Traveller communities, focusing on maternity, early years and child dental health services. The case studies include the views of 32-48 mothers of pre-school children, 32-40 healthcare providers and 8-12 informants from third sector organisations. 4. Two stakeholder workshops exploring whether policy options are realistic, sustainable and replicable. Case study data will be analysed thematically informed by the evaluative framework derived from the realist synthesis in stage one. The main outputs will be: a) an evaluative framework of Gypsy/Travellers' engagement with health services; b) recommendations for policy and practice; c) evidence on which to base future implementation strategies including estimation of costs. Our novel multi-method study seeks to provide recommendations for policy and practice that have potential to improve uptake and delivery of health services, and to reduce lifetime health inequalities for Gypsy

  16. Study protocol: the Whitehall II imaging sub-study

    PubMed Central

    2014-01-01

    Background The Whitehall II (WHII) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing. This paper introduces the multi-modal magnetic resonance imaging (MRI) protocol and cognitive assessment designed to investigate brain health in a random sample of 800 members of the WHII study. Methods/design A total of 6035 civil servants participated in the WHII Phase 11 clinical examination in 2012–2013. A random sample of these participants was included in a sub-study comprising an MRI brain scan, a detailed clinical and cognitive assessment, and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures. Data collection for this sub-study started in 2012 and will be completed by 2016. The participants, for whom social and health records have been collected since 1985, were between 60–85 years of age at the time the MRI study started. Here, we describe the pre-specified clinical and cognitive assessment protocols, the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study. Discussion The integration of cutting-edge MRI techniques, clinical and cognitive tests in combination with retrospective data on social, behavioural and biological variables during the preceding 25 years from a well-established longitudinal epidemiological study (WHII cohort) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes. PMID:24885374

  17. Barriers and facilitators to patient and public engagement and recruitment to digital health interventions: protocol of a systematic review of qualitative studies.

    PubMed

    O'Connor, Siobhan; Hanlon, Peter; O'Donnell, Catherine A; Garcia, Sonia; Glanville, Julie; Mair, Frances S

    2016-09-02

    Patients and the public are beginning to use digital health tools to assist in managing chronic illness, support independent living and self-care, and remain connected to health and care providers. However, engaging with and enrolling in digital health interventions, such as telehealth systems, mobile health applications, patient portals and personal health records, in order to use them varies considerably. Many factors affect people's ability to engage with and sign up to digital health platforms. The primary aim is to identify the barriers and facilitators patients and the public experience to engagement and recruitment to digital health interventions. The secondary aim is to identify engagement and enrolment strategies, leading if possible to a taxonomy of such approaches, and a conceptual framework of digital health engagement and recruitment processes. A systematic review of qualitative studies will be conducted by searching six databases: MEDLINE, CINAHL, PubMed, EMBASE, Scopus and the ACM Digital Library for papers published between 2000 and 2015. Titles and abstracts along with full-text papers will be screened by two independent reviewers against predetermined inclusion and exclusion criteria. A data extraction form will be used to provide details of the included studies. Quality assessment will be conducted using the Consolidated Criteria for Reporting Qualitative Research checklist. Any disagreements will be resolved through discussion with an independent third reviewer. Analysis will be guided by framework synthesis and informed by normalization process theory and burden of treatment theory, to aid conceptualisation of digital health engagement and recruitment processes. This systematic review of qualitative studies will explore factors affecting engagement and enrolment in digital health interventions. It will advance our understanding of readiness for digital health by examining the complex factors that affect patients' and the public's ability to

  18. Barriers and facilitators to patient and public engagement and recruitment to digital health interventions: protocol of a systematic review of qualitative studies

    PubMed Central

    Hanlon, Peter; O'Donnell, Catherine A; Garcia, Sonia; Glanville, Julie; Mair, Frances S

    2016-01-01

    Introduction Patients and the public are beginning to use digital health tools to assist in managing chronic illness, support independent living and self-care, and remain connected to health and care providers. However, engaging with and enrolling in digital health interventions, such as telehealth systems, mobile health applications, patient portals and personal health records, in order to use them varies considerably. Many factors affect people's ability to engage with and sign up to digital health platforms. Objectives The primary aim is to identify the barriers and facilitators patients and the public experience to engagement and recruitment to digital health interventions. The secondary aim is to identify engagement and enrolment strategies, leading if possible to a taxonomy of such approaches, and a conceptual framework of digital health engagement and recruitment processes. Methods A systematic review of qualitative studies will be conducted by searching six databases: MEDLINE, CINAHL, PubMed, EMBASE, Scopus and the ACM Digital Library for papers published between 2000 and 2015. Titles and abstracts along with full-text papers will be screened by two independent reviewers against predetermined inclusion and exclusion criteria. A data extraction form will be used to provide details of the included studies. Quality assessment will be conducted using the Consolidated Criteria for Reporting Qualitative Research checklist. Any disagreements will be resolved through discussion with an independent third reviewer. Analysis will be guided by framework synthesis and informed by normalization process theory and burden of treatment theory, to aid conceptualisation of digital health engagement and recruitment processes. Discussion This systematic review of qualitative studies will explore factors affecting engagement and enrolment in digital health interventions. It will advance our understanding of readiness for digital health by examining the complex factors that

  19. Impact of an SMS advice programme on maternal and newborn health in rural China: study protocol for a quasi-randomised controlled trial

    PubMed Central

    Su, Yanfang; Yuan, Changzheng; Zhou, Zhongliang; Heitner, Jesse; Campbell, Benjamin

    2016-01-01

    Introduction Expectant mothers in low-income and middle-income countries often lack access to vital information about pregnancy, preparation for birth and best practices when caring for their newborn. Innovative solutions are needed to bridge this knowledge gap and dramatically improve maternal and neonatal health in these settings. This study aims to evaluate the impact of an innovative text messaging intervention on maternal and neonatal health outcomes. Methods and analysis This study offers expectant mothers in rural China a package of free short messages via cell phone regarding pregnancy and childbirth. These messages are tailored to each mother's gestational week. It is hypothesised that delivering these short advice messages to pregnant women can improve maternal and newborn health. The study uses factorial quasi-randomisation to compare psychological, behavioural and health outcomes between 4 groups: 2 groups receiving different sets of short message interventions (ie, good household prenatal practices and healthcare seeking), a group receiving both interventions and a control group. Treatment assignment occurs at the individual level. The primary outcome is newborn health, measured by appropriateness of weight for gestational age. Secondary outcomes include severe neonatal and maternal morbidity as well as psychological and behavioural measures. This study has enrolled pregnant women who attend county maternal and child health centres for their prenatal visits. Discussion This pilot is the first large-scale effort to build a comprehensive evidence base on the impact of prenatal text messages via cell phone on maternal and newborn health outcomes in China. The study has broad implications for public health policy in China and the implementation of mobile health interventions in low-resource settings around the world. Ethics This study was approved by the Ethics Committee of the School of Medicine at Xi'an Jiaotong University on 18 January 2013. Trial

  20. Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial.

    PubMed

    Var, Chivorn; Bazzano, Alessandra N; Srivastav, Sudesh K; Welty, James C; Ek, Navapol Iv; Oberhelman, Richard A

    2015-06-05

    Newborn health is a key issue in addressing the survival of children under five years old, particularly in low and middle income countries, and the evidence base for newborn health interventions continues to evolve. Over the last decade, maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia, but newborn health has lagged behind. Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis. While initiatives are being implemented to address some causes of newborn illness (related to pre-term birth and asphyxia), a country-level approach to reducing infections has not been formulated. The Newborn Infection Control and Care Initiative (NICCI) is a community and health facility linked intervention to improve health outcomes for newborns. The present study applies a cluster randomized trial, using a stepped wedge design, to assess the impact of a package intervention on newborn health. The intervention components include addressing infection control in the perinatal period in health facilities, promoting infection prevention and control practices in health center and home environments, and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities, by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn's life. The NICCI trial is designed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care. Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country. This trial was registered with Clinicaltrials.gov (identifier: NCT02271737) on 5 October 2014.

  1. Promoting physical activity and health literacy: study protocol for a longitudinal, mixed methods evaluation of a cross-provider workplace-related intervention in Germany (The AtRisk study).

    PubMed

    Schaller, Andrea; Dejonghe, Lea; Alayli-Goebbels, Adrienne; Biallas, Bianca; Froboese, Ingo

    2016-07-22

    Physical activity and health literacy are topics of utmost importance in the prevention of chronic diseases. The present article describes the study protocol for evaluating a cross-provider workplace-related intervention promoting physical activity and health literacy. The RE-AIM Framework will be the conceptual framework of the AtRisk study. A controlled natural experiment and a qualitative study will be conducted. The cross-provider intervention is based on the cooperation of the German Pension Fund Rhineland and cooperating German Statutory Health Insurances. It combines two components: a behavior-oriented lifestyle intervention and the assignment of a health coach. The single-provider intervention only includes the behavior-oriented lifestyle intervention. The quantitative study (natural experiment) encompasses three measuring points (T0 = start of the behavior-oriented lifestyle intervention (baseline); T1 = end of the behavior-oriented lifestyle intervention (16 weeks); T2 = 6 month follow-up) and will compare the effectiveness of the cross-provider workplace-related intervention compared with the single provider intervention. Participants are employees with health related risk factors. ANCOVA will be used to evaluate the effect of the intervention on the outcome variables leisure time physical (primary outcome) activity and health literacy (secondary outcome). The qualitative study comprises semi-structured interviews, systematic field notes of stakeholder meetings and document analyses. The AtRisk study will contribute towards the claim for cross-provider interventions and workplace-related approaches described in the new Preventive Health Care Act. The results of this study will inform providers, payers and policy makers about the effectiveness of a cross-provider workplace-related lifestyle intervention compared to a single-provider intervention. Beyond, the study will identify challenges for implementing cross-provider preventive

  2. Protocol for the process evaluation of a complex intervention designed to increase the use of research in health policy and program organisations (the SPIRIT study).

    PubMed

    Haynes, Abby; Brennan, Sue; Carter, Stacy; O'Connor, Denise; Schneider, Carmen Huckel; Turner, Tari; Gallego, Gisselle

    2014-09-27

    Process evaluation is vital for understanding how interventions function in different settings, including if and why they have different effects or do not work at all. This is particularly important in trials of complex interventions in 'real world' organisational settings where causality is difficult to determine. Complexity presents challenges for process evaluation, and process evaluations that tackle complexity are rarely reported. This paper presents the detailed protocol for a process evaluation embedded in a randomised trial of a complex intervention known as SPIRIT (Supporting Policy In health with Research: an Intervention Trial). SPIRIT aims to build capacity for using research in health policy and program agencies. We describe the flexible and pragmatic methods used for capturing, managing and analysing data across three domains: (a) the intervention as it was implemented; (b) how people participated in and responded to the intervention; and (c) the contextual characteristics that mediated this relationship and may influence outcomes. Qualitative and quantitative data collection methods include purposively sampled semi-structured interviews at two time points, direct observation and coding of intervention activities, and participant feedback forms. We provide examples of the data collection and data management tools developed. This protocol provides a worked example of how to embed process evaluation in the design and evaluation of a complex intervention trial. It tackles complexity in the intervention and its implementation settings. To our knowledge, it is the only detailed example of the methods for a process evaluation of an intervention conducted as part of a randomised trial in policy organisations. We identify strengths and weaknesses, and discuss how the methods are functioning during early implementation. Using 'insider' consultation to develop methods is enabling us to optimise data collection while minimising discomfort and burden for

  3. Can the Medical-nursing Combined Care Promote the Accessibility of Health Services for the Elderly in Nursing Home? A Study Protocol of Analysis of the Effectiveness Regarding Health Service Utilization, Health Status and Satisfaction with Care.

    PubMed

    Bao, J; Wang, X-J; Yang, Y; Dong, R-Q; Mao, Z-F

    2015-12-01

    Currently, segmentation of healthcare and daily care for the elderly living in nursing homes usually results in the elderly not getting medical treatment timely and effectively. The medical-nursing combined care, which has been put into practice in several areas in China, is developed to enhance the accessibility of healthcare for the elderly. The aim of the study is to explore the effectiveness of the new care service, based on Andersen model, regarding health service utilization, health status and service satisfaction. The effectiveness of medical-nursing combined care will be measured in a cross-sectional study in nine nursing homes in Jianghan District, Wuhan, China, with 1067 old residents expected to participate. The questionnaire containing items of demographics, health service use, service satisfaction and instrument of SF-36 V2 is developed based on the conceptual framework of Andersen behaviour model of health service utilization. Descriptive analysis, variance analysis, multiple factors analysis, and correlation analysis will be performed to compare the sociological characteristics, health service use, health status and service satisfaction of the elderly living in different modes of nursing homes, to explore the influence factors of care effectiveness, as well as to study the relationship between health behaviour and health outcomes. The study design of analysing the effects of medical-nursing combined care and performing the horizontal comparison among the nursing homes under the framework of Andersen model is blazing new trails. Recruitment and design of questionnaire are important issues. Successful data collection and quality control are also necessary. Taking these into account, this study is estimated to provide evidence for the effectiveness of medical-nursing combined care service in China.

  4. Can the Medical-nursing Combined Care Promote the Accessibility of Health Services for the Elderly in Nursing Home? A Study Protocol of Analysis of the Effectiveness Regarding Health Service Utilization, Health Status and Satisfaction with Care

    PubMed Central

    Bao, J; Wang, X-J; Yang, Y; Dong, R-Q; Mao, Z-F

    2015-01-01

    ABSTRACT Background: Currently, segmentation of healthcare and daily care for the elderly living in nursing homes usually results in the elderly not getting medical treatment timely and effectively. The medical-nursing combined care, which has been put into practice in several areas in China, is developed to enhance the accessibility of healthcare for the elderly. The aim of the study is to explore the effectiveness of the new care service, based on Andersen model, regarding health service utilization, health status and service satisfaction. Methods: The effectiveness of medical-nursing combined care will be measured in a cross-sectional study in nine nursing homes in Jianghan District, Wuhan, China, with 1067 old residents expected to participate. The questionnaire containing items of demographics, health service use, service satisfaction and instrument of SF-36 V2 is developed based on the conceptual framework of Andersen behaviour model of health service utilization. Descriptive analysis, variance analysis, multiple factors analysis, and correlation analysis will be performed to compare the sociological characteristics, health service use, health status and service satisfaction of the elderly living in different modes of nursing homes, to explore the influence factors of care effectiveness, as well as to study the relationship between health behaviour and health outcomes. Conclusion: The study design of analysing the effects of medical-nursing combined care and performing the horizontal comparison among the nursing homes under the framework of Andersen model is blazing new trails. Recruitment and design of questionnaire are important issues. Successful data collection and quality control are also necessary. Taking these into account, this study is estimated to provide evidence for the effectiveness of medical-nursing combined care service in China. PMID:27398940

  5. The effectiveness of an abuse assessment protocol in public health prenatal clinics.

    PubMed Central

    Wiist, W H; McFarlane, J

    1999-01-01

    OBJECTIVES: This study evaluated whether incorporation of an abuse assessment protocol into the routine procedures of the prenatal clinics of a large urban public health department led to increased referral for and assessment, identification, and documentation of abuse. METHODS: Evaluation was conducted at 3 matched prenatal clinics serving a total of 12,000 maternity patients per year. Two clinics used the abuse protocol and 1 did not. An audit was performed at the clinics on a randomly selected sample of 540 maternity patient charts for the 15 months before the protocol was initiated and of 540 records for the 15 months after the protocol was introduced. Ninety-six percent of the patients represented in the sample were Latina. RESULTS: At the clinics using the protocol, abuse assessment increased from 0 to 88%. Detection of abuse increased from 0.8% to 7%. There were no changes at the comparison clinic. CONCLUSIONS: Incorporation of an abuse assessment protocol into the routine procedures of public health department prenatal clinics increases the assessment, identification, and documentation of and referral for abuse among pregnant women. An abuse protocol should be a routine part of maternity care. PMID:10432909

  6. A motivational interview intervention delivered at home to improve the oral health literacy and reduce the morbidity of Chilean disadvantaged families: a study protocol for a community trial

    PubMed Central

    Araya, Carlos; Flores, Raúl; Luengo, Luis; Castillo, Francisca; Bustos, Alex

    2017-01-01

    Introduction Oral health education/promotion interventions have been identified as cost-efficient tools to improve the oral health of the population. These interventions are regularly made in contexts where the target population is captive, for example, in health centres. In Chile, there are no oral health interventions delivered at home. Methods and analysis This community trial covers two disadvantaged urban areas in the province of Concepción. Both sectors have public preschool education coverage with a traditional programme (TP) to promote oral health. The intervention will comprise four to six visits by dental hygienists trained in the delivery of a standardised oral health promotion programme using motivational interviewing (MI) at home. The experimental group will receive TP and MI, while the control group will receive only TP. If a positive and significant effect of MI is found, this will be administered to the control group. For a 50% reduction in the incidence of caries, a sample size of 120 preschoolers per group is estimated. Data will be gathered on demographic and socioeconomic variables; oral health outcomes using WHO oral health indicators (the prevalence and severity of caries, periodontal disease, dentofacial anomalies and oral hygiene); the oral health literacy of caregivers, measured by the Rapid Estimation of Adult Literacy in Dentistry and the Oral Health Literacy Instrument, both validated for the Chilean population. Assessments will take place at baseline and at 12-month follow-up. Ethics and dissemination The university bioethics committee approved this study (EI/21/2014). We will submit the trial’s results for presentation at international scientific meetings and to peer-reviewed journals. Trial registration number ACTRN12615000450516. PMID:28710202

  7. Impact assessment and cost-effectiveness of m-health application used by community health workers for maternal, newborn and child health care services in rural Uttar Pradesh, India: a study protocol.

    PubMed

    Prinja, Shankar; Nimesh, Ruby; Gupta, Aditi; Bahuguna, Pankaj; Thakur, Jarnail Singh; Gupta, Madhu; Singh, Tarundeep

    2016-01-01

    An m-health application has been developed and implemented with community health workers to improve their counseling in a rural area of India. The ultimate aim was to generate demand and improve utilization of key maternal, neonatal, and child health services. The present study aims to assess the impact and cost-effectiveness of this project. A pre-post quasi-experimental design with a control group will be used to undertake difference in differences analysis for assessing the impact of intervention. The Annual Health Survey (2011) will provide pre-intervention data, and a household survey will be carried out to provide post-intervention data.Two community development blocks where the intervention was introduced will be treated as intervention blocks while two controls blocks are selected after matching with intervention blocks on three indicators: average number of antenatal care checkups, percentage of women receiving three or more antenatal checkups, and percentage of institutional deliveries. Two categories of beneficiaries will be interviewed in both areas: women with a child between 29 days and 6 months and women with a child between 12 and 23 months. Propensity score matched samples from intervention and control areas in pre-post periods will be analyzed using the difference in differences method to estimate the impact of intervention in utilization of key services.Bottom-up costing methods will be used to assess the cost of implementing intervention. A decision model will estimate long-term effects of improved health services utilization on mortality, morbidity, and disability. Cost-effectiveness will be assessed in terms of incremental cost per disability-adjusted life year averted and cost per unit increase in composite service coverage in intervention versus control groups. The study will generate significant evidence on impact of the m-health intervention for maternal, neonatal, and child services and on the cost of scaling up m-health technology for

  8. Avian study protocols and wind energy development

    SciTech Connect

    Fisher, K.

    1995-12-01

    This paper identifies the need to develop and use standardized avian study protocols to determine avian impacts at new and existing wind energy facilities. This will allow data collected from various sites to be correlated for better understanding wind energy related avian impacts. Factors contributing to an increased interest in wind energy facilities by electric utilities include: (1) Increased demand for electricity;(2) increased constraints on traditional electrical generating facilities (i.e. hydroelectric and nuclear power plants);(3) improved wind turbine technology. During the 1980`s generous tax credits spawned the development of wind energy facilities, known as wind farms, in California. Commercial scale wind farm proposals are being actively considered in states across the country - Washington, Oregon, Wyoming, Wisconsin, Texas, and Vermont to name a few. From the wind farms in California the unexpected issue of avian impacts, especially to birds-of-prey, or raptor, surfaced and continues to plague the wind industry. However, most of the avian studies did not followed a standardized protocol or methodology and, therefore, data is unavailable to analyze and compare impacts at different sites or with differing technologies and configurations. Effective mitigation can not be designed and applied until these differences are understood. The Bonneville Power Administration is using comparable avian study protocols to collect data for two environmental impact statements being prepared for two separate wind farm proposals. Similar protocol will be required for any other avian impact analysis performed by the agency on proposed or existing wind farms. The knowledge gained from these studies should contribute to a better understanding of avian interactions with wind energy facilities and the identification of effective mitigation measures.

  9. Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial.

    PubMed

    Bennett, Sophie; Heyman, Isobel; Coughtrey, Anna; Simmonds, Jess; Varadkar, Sophia; Stephenson, Terence; DeJong, Margaret; Shafran, Roz

    2016-11-04

    Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and under-treated in clinical settings. Evidence-based guided self-help interventions are efficacious in reducing symptoms of mental health disorders in children, but their efficacy in reducing symptoms of common mental health disorders in children with neurological conditions has not been investigated. We aim to pilot a guided self-help intervention for the treatment of mental health disorders in children with neurological conditions. A pilot randomised controlled trial with 18 patients with neurological conditions and mental health disorders will be conducted. Participants attending specialist neurology clinics at a National UK Children's Hospital will be randomised to receive guided self-help for common mental health disorders or to a 12-week waiting list control. Participants in the treatment group will receive 10 sessions of guided self-help delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 12 weeks. The primary outcome measure is reduction in symptoms of mental health disorders. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than anxiety, depression or disruptive behaviour (e.g. psychosis, eating disorder, obsessive-compulsive disorder) or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Camden and Islington NHS Research Ethics Committee, registration number 14.LO.1353. Results will be disseminated to patients, the wider public, clinicians and

  10. A Study to Examine the Uses of Personal Strength in Relation to Mental Health Recovery in Adults with Serious Mental Illnesses: A Research Protocol.

    PubMed

    Xie, Huiting; Yuan, Peng; Cui, Song Song; Yen, Melissa Sng Siok

    2015-09-30

    This study will explore the relationships among strengths self-efficacy, resourcefulness, stigma experience and mental health recovery in community-dwelling adults with serious mental illnesses. Mental health practices have focued on psychopathphysiology. Stigma heavily plagued clients with mental illnesses and is one of the greatest barriers to mental health recovery. Personal strengths like strengths self-efficacy, people's confidence in using their personal strengths, and resourcefulness, the ability to carry out daily activities, have been linked to positive mental health. However, the linkage between strengths self-efficacy, resourcefulness and mental health recovery remains uncharted. A cross-sectional, descriptive, mixed methods study will be conducted. A funded study by the Sigma Theta Tau, Upsilon Eta Chapter, August 2013, involving a convenience sample of 100 participants is planned. Included are community dwelling adults between 21 to 65 years old having been diagnosed with serious mental illnesses. Clients with current co-occurring substance abuse will be excluded. Participants complete questionnaires and undergo an interview. Correlations among the study variables will be examined. Regression analysis will determine if recovery can be predicted by strengths self-efficacy, resourcefulness and stigma experience. Interview data will be transcribed and analyzed by thematic analysis. This study will look beyond clients' disability to focus on their recovery and healing capacities such as strengths self-efficacy and resourcefulness. Findings will expand our knowledge about mental health recovery. Knowledge gained from this study may pave the way for future nursing strategies to aid recovery and inform the development of positive, strengths-based interventions.

  11. A Study to Examine the Uses of Personal Strength in Relation to Mental Health Recovery in Adults with Serious Mental Illnesses: A Research Protocol

    PubMed Central

    Xie, Huiting; Yuan, Peng; Cui, Song Song; Yen, Melissa Sng Siok

    2015-01-01

    This study will explore the relationships among strengths self-efficacy, resourcefulness, stigma experience and mental health recovery in community-dwelling adults with serious mental illnesses. Mental health practices have focued on psychopathphysiology. Stigma heavily plagued clients with mental illnesses and is one of the greatest barriers to mental health recovery. Personal strengths like strengths self-efficacy, people’s confidence in using their personal strengths, and resourcefulness, the ability to carry out daily activities, have been linked to positive mental health. However, the linkage between strengths self-efficacy, resourcefulness and mental health recovery remains uncharted. A cross-sectional, descriptive, mixed methods study will be conducted. A funded study by the Sigma Theta Tau, Upsilon Eta Chapter, August 2013, involving a convenience sample of 100 participants is planned. Included are community dwelling adults between 21 to 65 years old having been diagnosed with serious mental illnesses. Clients with current co-occurring substance abuse will be excluded. Participants complete questionnaires and undergo an interview. Correlations among the study variables will be examined. Regression analysis will determine if recovery can be predicted by strengths self-efficacy, resourcefulness and stigma experience. Interview data will be transcribed and analyzed by thematic analysis. This study will look beyond clients’ disability to focus on their recovery and healing capacities such as strengths self-efficacy and resourcefulness. Findings will expand our knowledge about mental health recovery. Knowledge gained from this study may pave the way for future nursing strategies to aid recovery and inform the development of positive, strengths-based interventions. PMID:26973963

  12. Assessing the Impact and Cost of Short-Term Health Workforce in Remote Indigenous Communities in Australia: A Mixed Methods Study Protocol

    PubMed Central

    Humphreys, John; Bourke, Lisa; Dunbar, Terry; Jones, Michael; Carey, Timothy A; Guthridge, Steven; Russell, Deborah; Lyle, David; Zhao, Yuejen; Murakami-Gold, Lorna

    2016-01-01

    Background Remote Australia is a complex environment characterized by workforce shortages, isolated practice, a large resident Indigenous population, high levels of health need, and limited access to services. In recent years, there has been an increasing trend of utilizing a short-term visiting (fly-in/fly-out) health workforce in many remote areas. However, there is a dearth of evidence relating to the impact of this transitory workforce on the existing resident workforce, consumer satisfaction, and the effectiveness of current services. Objective This study aims to provide rigorous empirical data by addressing the following objectives: (1) to identify the impact of short-term health staff on the workload, professional satisfaction, and retention of resident health teams in remote areas; (2) to identify the impact of short-term health staff on the quality, safety, and continuity of patient care; and (3) to identify the impact of short-term health staff on service cost and effectiveness. Methods Mixed methods will be used. Administrative data will be extracted that relates to all 54 remote clinics managed by the Northern Territory Department of Health, covering a population of 35,800. The study period will be 2010 to 2014. All 18 Aboriginal Community-Controlled Health Services in the Northern Territory will also be invited to participate. We will use these quantitative data to describe staffing stability and turnover in these communities, and then utilize multiple regression analyses to determine associations between the key independent variables of interest (resident staff turnover, stability or median survival, and socioeconomic status, community size, and per capita funding) and dependent variables related to patient care, service cost, quality, and effectiveness. The qualitative component of the study will involve in-depth interviews and focus groups with staff and patients, respectively, in six remote communities. Three communities will be high staff turnover

  13. Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial.

    PubMed

    Atkins, Salla; Ojajärvi, Ulla; Talola, Nina; Viljamaa, Mervi; Nevalainen, Jaakko; Uitti, Jukka

    2017-07-26

    Employment protects and fosters health. Occupational health services, particularly in Finland, have a central role in protecting employee health and preventing work ability problems. However, primary care within occupational health services is currently underused in informing preventive activities. This study was designed to assess whether the recording of work ability problems and improvement of follow-up of work-related primary care visits can reduce sickness absences and work disability pensions after 1 year. A pragmatic trial will be conducted using patient electronic registers and registers of the central pensions agency in Finland. Twenty-two occupational health centres will be randomised to intervention and control groups. Intervention units will receive training to improve recording of work ability illnesses in the primary care setting and improved follow-up procedures. The intervention impact will be assessed through examining rates of sickness absence across intervention and control clinics as well as before and after the intervention. The trial will develop knowledge of the intervention potential of primary care for preventing work disability pensions and sickness absence. The use of routine patient registers and pensions registers to assess the outcomes of a randomised controlled trial will bring forward trial methodology, particularly when using register-based data. If successful, the intervention will improve the quality of occupational health care primary care and contribute to reducing work disability. ISRCTN Registry reference number ISRCTN45728263 . Registered on 18 April 2016.

  14. Positive health effects of the natural outdoor environment in typical populations in different regions in Europe (PHENOTYPE): a study programme protocol

    PubMed Central

    Nieuwenhuijsen, Mark J; Kruize, Hanneke; Gidlow, Christopher; Andrusaityte, Sandra; Antó, Josep Maria; Basagaña, Xavier; Cirach, Marta; Dadvand, Payam; Danileviciute, Asta; Donaire-Gonzalez, David; Garcia, Judith; Jerrett, Michael; Jones, Marc; Julvez, Jordi; van Kempen, Elise; van Kamp, Irene; Maas, Jolanda; Seto, Edmund; Smith, Graham; Triguero, Margarita; Wendel-Vos, Wanda; Wright, John; Zufferey, Joris; van den Hazel, Peter Jan; Lawrence, Roderick; Grazuleviciene, Regina

    2014-01-01

    Introduction Growing evidence suggests that close contact with nature brings benefits to human health and well-being, but the proposed mechanisms are still not well understood and the associations with health remain uncertain. The Positive Health Effects of the Natural Outdoor environment in Typical Populations in different regions in Europe (PHENOTYPE) project investigates the interconnections between natural outdoor environments and better human health and well-being. Aims and methods The PHENOTYPE project explores the proposed underlying mechanisms at work (stress reduction/restorative function, physical activity, social interaction, exposure to environmental hazards) and examines the associations with health outcomes for different population groups. It implements conventional and new innovative high-tech methods to characterise the natural environment in terms of quality and quantity. Preventive as well as therapeutic effects of contact with the natural environment are being covered. PHENOTYPE further addresses implications for land-use planning and green space management. The main innovative part of the study is the evaluation of possible short-term and long-term associations of green space and health and the possible underlying mechanisms in four different countries (each with quite a different type of green space and a different use), using the same methodology, in one research programme. This type of holistic approach has not been undertaken before. Furthermore there are technological innovations such as the use of remote sensing and smartphones in the assessment of green space. Conclusions The project will produce a more robust evidence base on links between exposure to natural outdoor environment and human health and well-being, in addition to a better integration of human health needs into land-use planning and green space management in rural as well as urban areas. PMID:24740979

  15. Understanding repeated non-attendance in health services: a pilot analysis of administrative data and full study protocol for a national retrospective cohort

    PubMed Central

    Williamson, Andrea E; Ellis, David A; Wilson, Philip; McQueenie, Ross; McConnachie, Alex

    2017-01-01

    Introduction Understanding the causes of low engagement in healthcare is a pre-requisite for improving health services’ contribution to tackling health inequalities. Low engagement includes missing healthcare appointments. Serially (having a pattern of) missing general practice (GP) appointments may provide a risk marker for vulnerability and poorer health outcomes. Methods and analysis A proof of concept pilot using GP appointment data and a focus group with GPs informed the development of missed appointment categories: patients can be classified based on the number of appointments missed each year. The full study, using a retrospective cohort design, will link routine health service and education data to determine the relationship between GP appointment attendance, health outcomes, healthcare usage, preventive health activity and social circumstances taking a life course approach and using data from the whole journey in the National Health Service (NHS) healthcare. 172 practices will be recruited (∼900 000 patients) across Scotland. The statistical analysis will focus on 2 key areas: factors that predict patients who serially miss appointments, and serial missed appointments as a predictor of future patient outcomes. Regression models will help understand how missed appointment patterns are associated with patient and practice characteristics. We shall identify key factors associated with serial missed appointments and potential interactions that might predict them. Ethics and dissemination The results of the project will inform debates concerning how best to reduce non-attendance and increase patient engagement within healthcare systems. Significant non-academic beneficiaries include governments, policymakers and medical practitioners. Results will be disseminated via a combination of academic outputs (papers, conferences), social media and through collaborative public health/policy fora. PMID:28196951

  16. Positive health effects of the natural outdoor environment in typical populations in different regions in Europe (PHENOTYPE): a study programme protocol.

    PubMed

    Nieuwenhuijsen, Mark J; Kruize, Hanneke; Gidlow, Christopher; Andrusaityte, Sandra; Antó, Josep Maria; Basagaña, Xavier; Cirach, Marta; Dadvand, Payam; Danileviciute, Asta; Donaire-Gonzalez, David; Garcia, Judith; Jerrett, Michael; Jones, Marc; Julvez, Jordi; van Kempen, Elise; van Kamp, Irene; Maas, Jolanda; Seto, Edmund; Smith, Graham; Triguero, Margarita; Wendel-Vos, Wanda; Wright, John; Zufferey, Joris; van den Hazel, Peter Jan; Lawrence, Roderick; Grazuleviciene, Regina

    2014-04-16

    Growing evidence suggests that close contact with nature brings benefits to human health and well-being, but the proposed mechanisms are still not well understood and the associations with health remain uncertain. The Positive Health Effects of the Natural Outdoor environment in Typical Populations in different regions in Europe (PHENOTYPE) project investigates the interconnections between natural outdoor environments and better human health and well-being. The PHENOTYPE project explores the proposed underlying mechanisms at work (stress reduction/restorative function, physical activity, social interaction, exposure to environmental hazards) and examines the associations with health outcomes for different population groups. It implements conventional and new innovative high-tech methods to characterise the natural environment in terms of quality and quantity. Preventive as well as therapeutic effects of contact with the natural environment are being covered. PHENOTYPE further addresses implications for land-use planning and green space management. The main innovative part of the study is the evaluation of possible short-term and long-term associations of green space and health and the possible underlying mechanisms in four different countries (each with quite a different type of green space and a different use), using the same methodology, in one research programme. This type of holistic approach has not been undertaken before. Furthermore there are technological innovations such as the use of remote sensing and smartphones in the assessment of green space. The project will produce a more robust evidence base on links between exposure to natural outdoor environment and human health and well-being, in addition to a better integration of human health needs into land-use planning and green space management in rural as well as urban areas.

  17. Variability in the performance of preventive services and in the degree of control of identified health problems: A primary care study protocol

    PubMed Central

    Bolíbar, Bonaventura; Pareja, Clara; Astier-Peña, M Pilar; Morán, Julio; Rodríguez-Blanco, Teresa; Rosell-Murphy, Magdalena; Iglesias, Manuel; Juncosa, Sebastián; Mascort, Juanjo; Violan, Concepció; Magallón, Rosa; Apezteguia, Javier

    2008-01-01

    Background Preventive activities carried out in primary care have important variability that makes necessary to know which factors have an impact in order to establish future strategies for improvement. The present study has three objectives: 1) To describe the variability in the implementation of 7 preventive services (screening for smoking status, alcohol abuse, hypertension, hypercholesterolemia, obesity, influenza and tetanus immunization) and to determine their related factors; 2) To describe the degree of control of 5 identified health problems (smoking, alcohol abuse, hypertension, hypercholesterolemia and obesity); 3) To calculate intraclass correlation coefficients. Design Multi-centered cross-sectional study of a randomised sample of primary health care teams from 3 regions of Spain designed to analyse variability and related factors of 7 selected preventive services in years 2006 and 2007. At the end of 2008, we will perform a cross-sectional study of a cohort of patients attended in 2006 or 2007 to asses the degree of control of 5 identified health problems. All subjects older than16 years assigned to a randomised sample of 22 computerized primary health care teams and attended during the study period are included in each region providing a sample with more than 850.000 subjects. The main outcome measures will be implementation of 7 preventive services and control of 5 identified health problems. Furthermore, there will be 3 levels of data collection: 1) Patient level (age, gender, morbidity, preventive services, attendance); 2) Health-care professional level (professional characteristics, years working at the team, workload); 3) Team level (characteristics, electronic clinical record system). Data will be transferred from electronic clinical records to a central database with prior encryption and dissociation of subject, professional and team identity. Global and regional analysis will be performed including standard analysis for primary health care

  18. Expanded Quality Management Using Information Power (EQUIP): protocol for a quasi-experimental study to improve maternal and newborn health in Tanzania and Uganda

    PubMed Central

    2014-01-01

    receive quality management and continuous surveys, and comparison districts-only continuous surveys. Discussion EQUIP is a district-scale, proof-of-concept study that evaluates a quality management approach for maternal and newborn health including communities, health facilities, and district health managers, supported by high-quality data from independent continuous household and health facility surveys. The study will generate robust evidence about the effectiveness of quality management and will inform future nationwide implementation approaches for health system strengthening in low-resource settings. Trial registration PACTR201311000681314 PMID:24690284

  19. Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Research investigating the effectiveness of universal interventions to reduce the risk of mental health problems remains limited. Schools are a promising setting within which adolescents can receive interventions aimed at promoting their mental health. The aim of this study is to assess the effectiveness of a resilience-based prevention-focused intervention in reducing the risk of mental health problems among adolescents attending secondary school in socio-economically disadvantaged areas. Methods/design A cluster randomised control trial will be conducted, with schools as the unit of randomisation. Initially, 32 secondary schools will be randomly allocated to a control or intervention group (12 control and 20 intervention). An intervention focused on improving student internal and external resilience factors will be implemented in intervention schools. A survey of students in Grade 7 in both intervention and control schools will be conducted (baseline) and repeated three years later when the students are in Grade 10. The Strengths and Difficulties Questionnaire will be used to measure the risk of mental health problems. At follow-up, the risk of mental health problems will be compared between Grade 10 students in intervention and control schools to determine intervention effectiveness. Discussion The study presents an opportunity to determine the effectiveness of a comprehensive resilience-based intervention in reducing the risk of mental health problems in adolescents attending secondary schools. The outcomes of the trial are of importance to youth, schools, mental health clinicians and policymakers. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011. PMID:25037455

  20. Impact of health beliefs, social support and self-efficacy on physical activity and dietary habits during the post-partum period after gestational diabetes mellitus: study protocol.

    PubMed

    Kaiser, Barbara; Razurel, Chantal; Jeannot, Emilien

    2013-06-21

    Gestational diabetes mellitus (GDM) is defined as a glucose intolerance of variable severity occurring or diagnosed for the first time during pregnancy. Numerous epidemiological studies show that this disorder affects between 1 and 18% of pregnancies, depending on the ethnicity of the populations studied, the diagnostic criteria, or the body mass index (BMI). Its incidence is constantly rising worldwide. Patients with GDM have a high risk of developing type 2 diabetes in the months after delivery. For this reason, GDM patients are encouraged to practice specific health behaviors (dietary habits, physical activity) during the postpartum period. It is important to identify the factors that may impact adherence to these behaviors. A targeted sample size of 200 eligible pregnant women with a diagnosis of GDM will be enrolled in this prospective, cohort study. They will be recruited from 30-36 weeks of gestation as part of their diabetes consultation in Geneva University Hospital (GUH) maternity unit. Psychosocial variables that could impact adherence to health behaviors in the postpartum period (behavioral intentions, risk perceptions, general knowledge about diabetes, health beliefs, social support, self-efficacy) will be evaluated using specific tools at the end of pregnancy, at 6 weeks postpartum and at 6 months postpartum. Multiple regression analyses will be performed on SPSS. For the first time in Europe, the objective of this research is to study in women with very recent GDM the link between dietary habits, physical activity levels, and psychosocial and cognitive factors possibly involved in the adoption of health behaviors in the postpartum period. These factors have been identified in the literature, but to date have never been combined in a single study. The study will allow a predictive theoretical model of health behavior to be established and used as a basis for reflection to optimize interventions carried out on women who have had GDM.

  1. Impact of health beliefs, social support and self-efficacy on physical activity and dietary habits during the post-partum period after gestational diabetes mellitus: study protocol

    PubMed Central

    2013-01-01

    Background Gestational diabetes mellitus (GDM) is defined as a glucose intolerance of variable severity occurring or diagnosed for the first time during pregnancy. Numerous epidemiological studies show that this disorder affects between 1 and 18% of pregnancies, depending on the ethnicity of the populations studied, the diagnostic criteria, or the body mass index (BMI). Its incidence is constantly rising worldwide. Patients with GDM have a high risk of developing type 2 diabetes in the months after delivery. For this reason, GDM patients are encouraged to practice specific health behaviors (dietary habits, physical activity) during the postpartum period. It is important to identify the factors that may impact adherence to these behaviors. Methods/Design A targeted sample size of 200 eligible pregnant women with a diagnosis of GDM will be enrolled in this prospective, cohort study. They will be recruited from 30-36 weeks of gestation as part of their diabetes consultation in Geneva University Hospital (GUH) maternity unit. Psychosocial variables that could impact adherence to health behaviors in the postpartum period (behavioral intentions, risk perceptions, general knowledge about diabetes, health beliefs, social support, self-efficacy) will be evaluated using specific tools at the end of pregnancy, at 6 weeks postpartum and at 6 months postpartum. Multiple regression analyses will be performed on SPSS. Discussion For the first time in Europe, the objective of this research is to study in women with very recent GDM the link between dietary habits, physical activity levels, and psychosocial and cognitive factors possibly involved in the adoption of health behaviors in the postpartum period. These factors have been identified in the literature, but to date have never been combined in a single study. The study will allow a predictive theoretical model of health behavior to be established and used as a basis for reflection to optimize interventions carried out on

  2. Randomized controlled trial for assessment of Internet of Things system to guide intensive glucose control in diabetes outpatients: Nagoya Health Navigator Study protocol

    PubMed Central

    Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi

    2017-01-01

    ABSTRACT The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost. PMID:28878437

  3. Randomized controlled trial for assessment of Internet of Things system to guide intensive glucose control in diabetes outpatients: Nagoya Health Navigator Study protocol.

    PubMed

    Onoue, Takeshi; Goto, Motomitsu; Kobayashi, Tomoko; Tominaga, Takashi; Ando, Masahiko; Honda, Hiroyuki; Yoshida, Yasuko; Tosaki, Takahiro; Yokoi, Hisashi; Kato, Sawako; Maruyama, Shoichi; Arima, Hiroshi

    2017-08-01

    The Internet of Things (IoT) allows collecting vast amounts of health-relevant data such as daily activity, body weight (BW), and blood pressure (BP) automatically. The use of IoT devices to monitor diabetic patients has been studied, but could not evaluate IoT-dependent effects because health data were not measured in control groups. This multicenter, open-label, randomized, parallel group study will compare the impact of intensive health guidance using IoT and conventional medical guidance on glucose control. It will be conducted in outpatients with type 2 diabetes for a period of 6 months. IoT devices to measure amount of daily activity, BW, and BP will be provided to IoT group patients. Healthcare professionals (HCPs) will provide appropriate feedback according to the data. Non-IoT control, patients will be given measurement devices that do not have a feedback function. The primary outcome is glycated hemoglobin at 6 months. The study has already enrolled 101 patients, 50 in the IoT group and 51 in the non-IoT group, at the two participating outpatient clinics. The baseline characteristics of two groups did not differ, except for triglycerides. This will be the first randomized, controlled study to evaluate IoT-dependent effects of intensive feedback from HCPs. The results will validate a new method of health-data collection and provision of feedback suitable for diabetes support with increased effectiveness and low cost.

  4. Urban upgrading and its impact on health: a "quasi-experimental" mixed-methods study protocol for the BH-Viva Project.

    PubMed

    Friche, Amélia Augusta de Lima; Dias, Maria Angélica de Salles; Reis, Priscila Brandão Dos; Dias, Cláudia Silva; Caiaffa, Waleska Teixeira

    2015-11-01

    There is little scientific evidence that urban upgrading helps improve health or reduce inequities. This article presents the design for the BH-Viva Project, a "quasi-experimental", multiphase, mixed-methods study with quantitative and qualitative components, proposing an analytical model for monitoring the effects that interventions in the urban environment can have on residents' health in slums in Belo Horizonte, Minas Gerais State, Brazil. A preliminary analysis revealed intra-urban differences in age-specific mortality when comparing areas with and without interventions; the mortality rate from 2002 to 2012 was stable in the "formal city", increased in slums without interventions, and decreased in slums with interventions. BH-Viva represents an effort at advancing methodological issues, providing learning and theoretical backing for urban health research and research methods, allowing their application and extension to other urban contexts.

  5. Linking e-health records, patient-reported symptoms and environmental exposure data to characterise and model COPD exacerbations: protocol for the COPE study

    PubMed Central

    Moore, Elizabeth; Chatzidiakou, Lia; Jones, Roderic L; Smeeth, Liam; Beevers, Sean; Kelly, Frank J; Barratt, Benjamin

    2016-01-01

    Introduction Relationships between exacerbations of chronic obstructive pulmonary disease (COPD) and environmental factors such as temperature, humidity and air pollution are not well characterised, due in part to oversimplification in the assignment of exposure estimates to individuals and populations. New developments in miniature environmental sensors mean that patients can now carry a personal air quality monitor for long periods of time as they go about their daily lives. This creates the potential for capturing a direct link between individual activities, environmental exposures and the health of patients with COPD. Direct associations then have the potential to be scaled up to population levels and tested using advanced human exposure models linked to electronic health records. Methods and analysis This study has 5 stages: (1) development and deployment of personal air monitors; (2) recruitment and monitoring of a cohort of 160 patients with COPD for up to 6 months with recruitment of participants through the Clinical Practice Research Datalink (CPRD); (3) statistical associations between personal exposure with COPD-related health outcomes; (4) validation of a time-activity exposure model and (5) development of a COPD prediction model for London. Ethics and dissemination The Research Ethics Committee for Camden and Islington has provided ethical approval for the conduct of the study. Approval has also been granted by National Health Service (NHS) Research and Development and the Independent Scientific Advisory Committee. The results of the study will be disseminated through appropriate conference presentations and peer-reviewed journals. PMID:27412104

  6. Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial.

    PubMed

    Xu, Wang Hong; Rothman, Russell L; Li, Rui; Chen, Yingyao; Xia, Qinghua; Fang, Hong; Gao, Junling; Yan, Yujie; Zhou, Peng; Jiang, Yu; Liu, Yinan; Zhou, Fangjia; Wang, Wei; Chen, Minling; Liu, Xiao Yu; Liu, Xiao Na

    2014-12-20

    Diabetes self-management often involves the interpretation and application of oral, written, or quantitative information. Numerous diabetes patients in China have limited health literacy, which likely leads to poorer clinical outcomes. This study is designed to examine the efficacy and cost-effectiveness of addressing health literacy to improve self-management skills and glycemic control in Chinese diabetes patients. This is a cluster randomized controlled trial (RCT) conducted in 20 community healthcare sites in Shanghai, China. Overall, 800 diabetes patients will be randomized into intervention and control arms and will have a baseline hemoglobin A1c (HbA1c) assay and undergo a baseline survey which includes measures of health literacy and diabetes numeracy using revised Chinese versions of the Health Literacy Management Scale and Diabetes Numeracy Test Scale. During the 1-year period of intervention, while the control group will receive usual care, the intervention group will be supplemented with a comprehensive health literacy strategy which includes i) training healthcare providers in effective health communication skills that address issues related to low literacy, and ii) use of an interactive Diabetes Education Toolkit to improve patient understanding and behaviors. Assessments will be conducted at both patient and healthcare provider levels, and will take place upon admission and after 3, 6, 12, and 24 months of intervention. The primary outcome will be the improvement in HbA1c between Intervention group and Control group patients. Secondary outcomes at the patient level will include improvement in i) clinical outcomes (blood pressure, fasting lipids, body mass index, weight, smoking status), ii) patient reported self-management behaviors, and iii) patient-reported self-efficacy. Outcomes at the provider level will include: i) provider satisfaction and ii) intensity and type of care provided. The effects of the intervention will be examined in

  7. The impact of population-based disease management services for selected chronic conditions: the Costs to Australian Private Insurance--Coaching Health (CAPICHe) study protocol.

    PubMed

    Byrnes, Joshua M; Goldstein, Stan; Venator, Benjamin; Pollicino, Christine; Ng, Shu-Kay; Veroff, David; Bennett, Christine; Scuffham, Paul A

    2012-02-10

    Recent evidence from a large scale trial conducted in the United States indicates that enhancing shared decision-making and improving knowledge, self-management, and provider communication skills to at-risk patients can reduce health costs and utilisation of healthcare resources. Although this trial has provided a significant advancement in the evidence base for disease management programs it is still left for such results to be replicated and/or generalised for populations in other countries and other healthcare environments. This trial responds to the limited analyses on the effectiveness of providing chronic disease management services through telephone health coaching in Australia. The size of this trial and it's assessment of cost utility with respect to potentially preventable hospitalisations adds significantly to the body of knowledge to support policy and investment decisions in Australia as well as to the international debate regarding the effect of disease management programs on financial outcomes. Intention to treat study applying a prospective randomised design comparing usual care with extensive outreach to encourage use of telephone health coaching for those people identified from a risk scoring algorithm as having a higher likelihood of future health costs. The trial population has been limited to people with one or more of the following selected chronic conditions: namely, low back pain, diabetes, coronary artery disease, heart failure, and chronic obstructive pulmonary disease. This trial will enrol at least 64,835 sourced from the approximately 3 million Bupa Australia private health insured members located across Australia. The primary outcome will be the total (non-maternity) cost per member as reported to the private health insurer (i.e. charged to the insurer) 12 months following entry into the trial for each person. Study recruitment will be completed in early 2012 and the results will be available in late 2013. If positive, CAPICHe will

  8. The impact of population-based disease management services for selected chronic conditions: the Costs to Australian Private Insurance - Coaching Health (CAPICHe) study protocol

    PubMed Central

    2012-01-01

    Background Recent evidence from a large scale trial conducted in the United States indicates that enhancing shared decision-making and improving knowledge, self-management, and provider communication skills to at-risk patients can reduce health costs and utilisation of healthcare resources. Although this trial has provided a significant advancement in the evidence base for disease management programs it is still left for such results to be replicated and/or generalised for populations in other countries and other healthcare environments. This trial responds to the limited analyses on the effectiveness of providing chronic disease management services through telephone health coaching in Australia. The size of this trial and it's assessment of cost utility with respect to potentially preventable hospitalisations adds significantly to the body of knowledge to support policy and investment decisions in Australia as well as to the international debate regarding the effect of disease management programs on financial outcomes. Methods Intention to treat study applying a prospective randomised design comparing usual care with extensive outreach to encourage use of telephone health coaching for those people identified from a risk scoring algorithm as having a higher likelihood of future health costs. The trial population has been limited to people with one or more of the following selected chronic conditions: namely, low back pain, diabetes, coronary artery disease, heart failure, and chronic obstructive pulmonary disease. This trial will enrol at least 64,835 sourced from the approximately 3 million Bupa Australia private health insured members located across Australia. The primary outcome will be the total (non-maternity) cost per member as reported to the private health insurer (i.e. charged to the insurer) 12 months following entry into the trial for each person. Study recruitment will be completed in early 2012 and the results will be available in late 2013. Discussion

  9. Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study

    PubMed Central

    2012-01-01

    Background Pregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP) Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC) intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth. Methods/Design The randomized controlled trial will be conducted with 220 women who have a BMI > 18.5 (American IOM cut-off for normal weight), are 18 years of age or older, English speaking, no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment. Women will be randomly allocated to either a specialized HC intervention group or an Education Alone group. Our specialized HC intervention has two components: (1) one-on-one sessions with a Health Coach, and (2) two by two hour educational group sessions led by a Health Coach. Women in the Education Alone group will receive two by two hour educational group sessions with no HC components. Body Mass Index, waist circumference, and psychological factors including motivation, readiness to change, symptoms of depression and anxiety, and body dissatisfaction will be assessed at baseline (14-16 weeks gestation), and again at follow-up: 32 weeks gestation, 6 weeks, 6 months and 12 months postpartum. Discussion Our study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention. Our pregnancy HC intervention is novel and innovative and has been designed to be easily adopted by health professionals who work with pregnant

  10. An education intervention to improve health literacy and decision making about supporting self-care among older Australians: a study protocol for a randomised controlled trial.

    PubMed

    Smith, Caroline A; Chang, Esther; Gallego, Gisselle; Balneaves, Lynda G

    2017-09-26

    Older Australians are high consumers of complementary and alternative medicines (CM). To help older people to take an active role in their health, we will develop and evaluate a novel educational intervention to support decision self-efficacy, and improve health literacy skills. The primary hypothesis is that participants receiving a web/DVD plus booklet intervention compared with a booklet-only group will demonstrate an increase in decision self-efficacy. This study is a randomised controlled trial. One hundred and sixty-eight people aged 65 years and older will be recruited from community settings comprising retirement villages and community groups, based in Sydney, Australia. Participants will be randomly allocated to either the education intervention delivered by the Internet or a DVD plus booklet versus a control group (booklet only). The primary outcome measure is CM decision self-efficacy. Secondary outcomes are health literacy, knowledge and attitudes, and change in health-seeking behaviour. Participants' views on the ease of using the resources, the length of the modules, the amount of information, and participant understanding of the modules will be assessed. Outcomes will be collected on completion of the intervention at 3 weeks, and at a 2-month follow up from trial entry. This trial has the potential to improve CM health literacy in older Australians. There are no educational resources designed to support decision self-efficacy and improve health literacy amongst older people related to CM. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12616000135415 . Registered on 5 February 2016.

  11. [Comparative study of two anti-antiretroviral protocols used for treatment of a cohort of HIV 1-positive patients followed at the Institute of Public Health and Hygiene in Dakar, Senegal].

    PubMed

    Sow, P G; Dia, A T; Diallo, P D; Traore; Gaye, A M

    2011-04-01

    In the last ten years, the discovery of several antiretroviral drugs has greatly contributed to improving the survival and quality of life of HIV-infected persons. The purpose of this retrospective study was to compare the effectiveness and tolerance of two anti-retroviral combinations, i.e., Lamivudine + Zidovudine and Efavirenz versus Lamivudine + Zidovudine and Nevirapine. The files of HIV1-infected patients treated between July 2003 and December 2004 (18 months) and followed at the Institute of public health and hygiene in Dakar were reviewed. A total of 70 patients, i.e., 35 in each protocol group, were included. The following data were collected for each patient: age, sex, locality, elements to assess tolerance, and elements to assess effectiveness (CD4 count, viral load and opportunistic infection immuno-failure). Results indicated that the immunovirologic effectiveness of the two protocols was identical with regard to mean CD4 count, i.e., 327 cells/mm3 for AZT+3TC+EFV versus 334 cells/mm3 for AZT+ 3TC+NVP (p < 0.05). Immuno effectiveness was better for Lamivudine + Zidovudine + Efavirenz than Lamivudine + Zidovudine + Nevirapine. Significant therapeutic advances in recent years have improved survival and quality of life in patients under retroviral treatment. There are currently many anti-retroviral molecules available and several relatively well codified therapeutic protocols.

  12. Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol

    PubMed Central

    Shi, Lu; Williams, Joel E; Dye, Cheryl J; Chen, Liwei; Crawford, Paul; Shry, Eric A; Griffin, Sarah F; Jones, Karyn O; Sherrill, Windsor W; Truong, Khoa; Little, Jeanette R; Edwards, Karen W; Hing, Marie; Moss, Jennie B

    2017-01-01

    Background The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. Objective We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. Methods This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome

  13. Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol.

    PubMed

    Gimbel, Ronald; Shi, Lu; Williams, Joel E; Dye, Cheryl J; Chen, Liwei; Crawford, Paul; Shry, Eric A; Griffin, Sarah F; Jones, Karyn O; Sherrill, Windsor W; Truong, Khoa; Little, Jeanette R; Edwards, Karen W; Hing, Marie; Moss, Jennie B

    2017-03-06

    The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of

  14. Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

    PubMed

    O'Reilly, Ken; Donohoe, Gary; O'Sullivan, Danny; Coyle, Ciaran; Mullaney, Ronan; O'Connell, Paul; Maddock, Catherine; Nulty, Andrea; O'Flynn, Padraic; O'Connell, Carina; Kennedy, Harry G

    2016-01-13

    Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder. An estimated sixty patients will be enrolled in the study. Participants will be randomised to one of two conditions: CRT with treatment as usual (TAU), or TAU. CRT will consist of 42 individual sessions and 14 group sessions. The primary outcome measure for this study is change in cognitive functioning using the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include change in social and occupational functioning, disorganised symptoms, negative symptoms, violence, participation in psychosocial treatment and recovery. In addition to these effectiveness measures, we will examine patient satisfaction. Cognitive difficulties experienced by schizophrenia spectrum patients are associated with general functioning, ability to benefit from psychosocial interventions and quality of life. Research into the treatment of cognitive difficulties within a forensic setting is therefore an important priority. The results of the proposed study will help answer the question whether cognitive remediation improves functional outcomes in forensic mental health patients with schizophrenia or schizoaffective disorder. Forensic mental health patients are detained for the dual purpose of receiving treatment and for public protection. There can be conflict between these two roles perhaps causing forensic services to have an increased length of stay compared to general psychiatric admissions. Ultimately a focus on emphasising cognition and general functioning over symptoms may decrease tension between the core responsibilities of

  15. Impact of family-friendly prison policies on health, justice and child protection outcomes for incarcerated mothers and their dependent children: a cohort study protocol.

    PubMed

    Myers, Helen; Segal, Leonie; Lopez, Derrick; Li, Ian W; Preen, David B

    2017-08-23

    Female imprisonment has numerous health and social sequelae for both women prisoners and their children. Examples of comprehensive family-friendly prison policies that seek to improve the health and social functioning of women prisoners and their children exist but have not been evaluated. This study will determine the impact of exposure to a family-friendly prison environment on health, child protection and justice outcomes for incarcerated mothers and their dependent children. A longitudinal retrospective cohort design will be used to compare outcomes for mothers incarcerated at Boronia Pre-release Centre, a women's prison with a dedicated family-friendly environment, and their dependent children, with outcomes for mothers incarcerated at other prisons in Western Australia (that do not offer this environment) and their dependent children. Routinely collected administrative data from 1985 to 2013 will be used to determine child and mother outcomes such as hospital admissions, emergency department presentations, custodial sentences, community service orders and placement in out-of home care. The sample consists of all children born in Western Australia between 1 January 1985 and 31 December 2011 who had a mother in a West Australian prison between 1990 and 2012 and their mothers. Children are included if they were alive and aged less than 18 years at the time of their mother's incarceration. The sample comprises an exposed group of 665 women incarcerated at Boronia and their 1714 dependent children and a non-exposed comparison sample of 2976 women incarcerated at other West Australian prisons and their 7186 dependent children, creating a total study sample of 3641 women and 8900 children. This project received ethics approval from the Western Australian Department of Health Human Research Ethics Committee, the Western Australian Aboriginal Health Ethics Committee and the University of Western Australia Human Research Ethics Committee. © Article author(s) (or their

  16. PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research

    PubMed Central

    Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

    2016-01-01

    Introduction Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. Methods and analysis This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. Ethics and Dissemination This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly

  17. Optimising reproductive and child health outcomes by building evidence-based research and practice in South East Asia (SEA-ORCHID): study protocol

    PubMed Central

    Henderson-Smart, David J; Lumbiganon, Pisake; Festin, Mario R; Ho, Jacqueline J; Mohammad, Hakimi; McDonald, Steve J; Green, Sally; Crowther, Caroline A

    2007-01-01

    Background Disorders related to pregnancy and childbirth are a major health issue in South East Asia. They represent one of the biggest health risk differentials between the developed and developing world. Our broad research question is: Can the health of mothers and babies in Thailand, Indonesia, the Philippines and Malaysia be improved by increasing the local capacity for the synthesis of research, implementation of effective interventions, and identification of gaps in knowledge needing further research? Methods/Design The project is a before-after study which planned to benefit from and extend existing regional and international networks. Over five years the project was designed to comprise five phases; pre-study, pre-intervention, intervention, outcome assessment and reporting/dissemination. The study was proposed to be conducted across seven project nodes: four in South East Asia and three in Australia. Each South East Asian study node was planned to be established within an existing department of obstetrics and gynaecology or neonatology and was intended to form the project coordinating centre and focus for evidence-based practice activities within that region. Nine hospitals in South East Asia planned to participate, representing a range of clinical settings. The three project nodes in Australia were intended to provide project support. The intervention was planned to consist of capacity-strengthening activities targeted at three groups: generators of evidence, users of evidence and teachers of evidence. The primary outcome was established as changes in adherence to recommended clinical practices from baseline to completion of the project and impact on health outcomes. Discussion The SEA-ORCHID project was intended to improve care during pregnancy and the perinatal period of mothers and their babies in South East Asia. The possible benefits extend beyond this however, as at the end of this project there is hoped to be an existing network of South East Asian

  18. The effectiveness of an intervention in increasing community health clinician provision of preventive care: a study protocol of a non-randomised, multiple-baseline trial

    PubMed Central

    2011-01-01

    Background The primary behavioural risks for the most common causes of mortality and morbidity in developed countries are tobacco smoking, poor nutrition, risky alcohol use, and physical inactivity. Evidence, guidelines and policies support routine clinician delivery of care to prevent these risks within primary care settings. Despite the potential afforded by community health services for the delivery of such preventive care, the limited evidence available suggests it is provided at suboptimal levels. This study aims to assess the effectiveness of a multi-strategic practice change intervention in increasing clinician's routine provision of preventive care across a network of community health services. Methods/Design A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being 'at risk'. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity) will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken prior to and following the

  19. The effectiveness of an intervention in increasing community health clinician provision of preventive care: a study protocol of a non-randomised, multiple-baseline trial.

    PubMed

    McElwaine, Kathleen M; Freund, Megan; Campbell, Elizabeth M; Knight, Jenny; Slattery, Carolyn; Doherty, Emma L; McElduff, Patrick; Wolfenden, Luke; Bowman, Jennifer A; Wye, Paula M; Gillham, Karen E; Wiggers, John H

    2011-12-30

    The primary behavioural risks for the most common causes of mortality and morbidity in developed countries are tobacco smoking, poor nutrition, risky alcohol use, and physical inactivity. Evidence, guidelines and policies support routine clinician delivery of care to prevent these risks within primary care settings. Despite the potential afforded by community health services for the delivery of such preventive care, the limited evidence available suggests it is provided at suboptimal levels. This study aims to assess the effectiveness of a multi-strategic practice change intervention in increasing clinician's routine provision of preventive care across a network of community health services. A multiple baseline study will be conducted involving all 56 community health facilities in a single health district in New South Wales, Australia. The facilities will be allocated to one of three administratively-defined groups. A 12 month practice change intervention will be implemented in all facilities in each group to facilitate clinician risk assessment of eligible clients, and clinician provision of brief advice and referral to those identified as being 'at risk'. The intervention will be implemented in a non-random sequence across the three facility groups. Repeated, cross-sectional measurement of clinician provision of preventive care for four individual risks (smoking, poor nutrition, risky alcohol use, and physical inactivity) will occur continuously for all three facility groups for 54 months via telephone interviews. The interviews will be conducted with randomly selected clients who have visited a community health facility in the last two weeks. Data collection will commence 12 months prior to the implementation of the intervention in the first group, and continue for six months following the completion of the intervention in the last group. As a secondary source of data, telephone interviews will be undertaken prior to and following the intervention with randomly

  20. Tecla: a telephone- and text-message based telemedical concept for patients with severe mental health disorders--study protocol for a controlled, randomized, study.

    PubMed

    Stentzel, Ulrike; Grabe, Hans-Jörgen; Strobel, Lara; Penndorf, Peter; Langosch, Jens; Freyberger, Harald J; Hoffmann, Wolfgang; van den Berg, Neeltje

    2015-11-04

    Severe mental disorders like psychotic disorders including schizophrenia and schizoaffective disorders have a 12-month-prevalence of 2.6, bipolar disorders of 1.5% in Germany. The relapse risk is high; so many patients need intensive monitoring and lifelong treatment. A high medication adherence is essential for a successful treatment. But in practice, medication adherence is low and decreases over time. Telemedical care concepts might improve treatment and bridge gaps between in- and outpatient treatment. A telemedical care concept based on regular telephone calls and short text messages was developed. The primary objective is to assess whether regular telephone calls and text messages can improve the medication adherence of patients. Secondary objectives are the reduction of rehospitalization rates, the improvement of quality of life and of the severity of symptoms. The Tecla study (Post stationary telemedical care of patients with severe psychiatric disorders) is a two-armed prospective randomized controlled trial. The participants in the intervention group receive in addition to usual care regular telephone calls every 2 weeks and weekly text messages on patient-individual topics during a 6 months period. Patients in the control group receive only regular care. Inclusion criteria are a physician-diagnosed bipolar disorder, schizoaffective disorder or schizophrenia and a signed informed consent. Exclusion criteria are planned inpatient treatments within the next 6 months and being non-reachable by phone. After 3 and 6 months both groups receive follow up assessments. The primary objective of this study is the medication adherence that is measured with the Medication Adherence Report Scale, German version (MARS-D). The MARS-D is a self-report with five items. Adherent behaviour is mostly overestimated using self-reports. The strength of the MARS-D is to detect non-adherent behaviour. The original Medication Adherence Report Scale in English language (MARS-5) was

  1. Maternal lifestyle and nutritional status in relation to pregnancy and infant health outcomes in Western China: protocol for a prospective cohort study.

    PubMed

    Tang, Li; Pan, Xiong-Fei; Lee, Andy H; Binns, Colin W; Yang, Chun-Xia; Sun, Xin

    2017-06-19

    Improving the health and nutrition of women and children is a priority for Western China, where the economy is less developed. Due to the dynamic nature of lifestyle, modern food habits and nutrition, there is a need to update our limited knowledge and understanding of maternal lifestyle and nutritional status and their impact on pregnancy and infant health outcomes. While breast milk is the preferred feeding option, infant formula use is widespread in China. It is thus necessary to examine the effects of formula consumption on growth and morbidity. This is an ongoing prospective cohort study started in 2015 in Chengdu, Sichuan Province. A sample of 1901 pregnant women at 15-20 weeks of gestation were recruited from four maternal and child health hospitals and are followed prospectively to 12 months post partum. Detailed information on maternal lifestyle and nutritional status, obstetric complications, pregnancy outcomes, infant feeding practices, illnesses of the mother and infant and growth trajectory is collected through personal interviews, anthropometric measures and medical records and local health management system records retrieval. Multilevel mixed regression models, adjusted for clustering, will be applied to investigate the association between various exposure variables of interest and the longitudinal outcomes, taking into account the correlated data structure and the nesting of observations. Kaplan-Meier test and Cox regression analysis will be used to analyse the time-to-event data. Ethical approval has been obtained from the ethics committee of West China School of Public Health, Sichuan University and the Human Research Ethics Committee of Curtin University. Results will be presented at national and international conferences and published in peer-reviewed journals. © 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.

  2. Maternal lifestyle and nutritional status in relation to pregnancy and infant health outcomes in Western China: protocol for a prospective cohort study

    PubMed Central

    Tang, Li; Pan, Xiong-Fei; Lee, Andy H; Binns, Colin W; Yang, Chun-Xia; Sun, Xin

    2017-01-01

    Introduction Improving the health and nutrition of women and children is a priority for Western China, where the economy is less developed. Due to the dynamic nature of lifestyle, modern food habits and nutrition, there is a need to update our limited knowledge and understanding of maternal lifestyle and nutritional status and their impact on pregnancy and infant health outcomes. While breast milk is the preferred feeding option, infant formula use is widespread in China. It is thus necessary to examine the effects of formula consumption on growth and morbidity. Methods and analysis This is an ongoing prospective cohort study started in 2015 in Chengdu, Sichuan Province. A sample of 1901 pregnant women at 15–20 weeks of gestation were recruited from four maternal and child health hospitals and are followed prospectively to 12 months post partum. Detailed information on maternal lifestyle and nutritional status, obstetric complications, pregnancy outcomes, infant feeding practices, illnesses of the mother and infant and growth trajectory is collected through personal interviews, anthropometric measures and medical records and local health management system records retrieval. Multilevel mixed regression models, adjusted for clustering, will be applied to investigate the association between various exposure variables of interest and the longitudinal outcomes, taking into account the correlated data structure and the nesting of observations. Kaplan-Meier test and Cox regression analysis will be used to analyse the time-to-event data. Ethics and dissemination Ethical approval has been obtained from the ethics committee of West China School of Public Health, Sichuan University and the Human Research Ethics Committee of Curtin University. Results will be presented at national and international conferences and published in peer-reviewed journals. PMID:28630084

  3. Engaging teenagers in improving their health behaviours and increasing their interest in science (Evaluation of LifeLab Southampton): study protocol for a cluster randomized controlled trial.

    PubMed

    Woods-Townsend, Kathryn; Bagust, Lisa; Barker, Mary; Christodoulou, Andri; Davey, Hannah; Godfrey, Keith; Grace, Marcus; Griffiths, Janice; Hanson, Mark; Inskip, Hazel

    2015-08-21

    Lifestyle and health behaviours are strongly linked to non-communicable disease risk, but modifying them is challenging. There is an increasing recognition that adolescence is an important time for lifestyle and health behaviours to become embedded. Improving these behaviours in adolescents is important not only for their own health but also for that of their future children. LifeLab Southampton has been developed as a purpose-built classroom and laboratory in University Hospital Southampton. Secondary school students visit LifeLab to learn how childhood, adolescent and parental nutrition influences health, understand the impact of their lifestyle on their cardiovascular and metabolic health, and to inspire them with the excitement of research and future career possibilities in science. The LifeLab visit is part of a programme of work linked to the English National Curriculum. Pilot work has indicated that attitudes towards health can be changed by such LifeLab sessions. A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the LifeLab intervention, the primary outcome being a measurement of the change in nutrition, health and lifestyle literacy from before to after the LifeLab intervention. The LifeLab intervention comprises professional development for the teachers involved; preparatory lessons for the school students, delivered in school; a hands-on practical day at LifeLab, including a 'Meet the Scientist' session; post-visit lessons delivered in school; and the opportunity to participate in the annual LifeLab Schools' Conference. This study aims to recruit approximately 2,500 secondary school students aged 13 to 14 years from 32 schools (the clusters) from Southampton and neighbouring areas. Participating schools will be randomised to control or intervention groups. The intervention will be run over two academic school years, with baseline questionnaire data collected from students at participating schools at the start of

  4. Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial.

    PubMed

    Källander, Karin; Strachan, Daniel; Soremekun, Seyi; Hill, Zelee; Lingam, Raghu; Tibenderana, James; Kasteng, Frida; Vassall, Anna; Meek, Sylvia; Kirkwood, Betty

    2015-04-12

    If trained, equipped and utilised, community health workers (CHWs) delivering integrated community case management for sick children can potentially reduce child deaths by 60%. However, it is essential to maintain CHW motivation and performance. The inSCALE project aims to evaluate, using a cluster randomised controlled trial, the effect of interventions to increase CHW supervision and performance on the coverage of appropriate treatment for children with diarrhoea, pneumonia and malaria. Participatory methods were used to identify best practices and innovative solutions. Quantitative community based baseline surveys were conducted to allow restricted randomisation of clusters into intervention and control arms. Individual informed consent was obtained from all respondents. Following formative research and stakeholder consultations, two intervention packages were developed in Uganda and one in Mozambique. In Uganda, approximately 3,500 CHWs in 39 clusters were randomised into a mobile health (mHealth) arm, a participatory community engagement arm and a control arm. In Mozambique, 275 CHWs in 12 clusters were randomised into a mHealth arm and a control arm. The mHealth interventions encompass three components: 1) free phone communication between users; 2) data submission using phones with automated feedback, messages to supervisors for targeted supervision, and online data access for district statisticians; and 3) motivational messages. The community engagement arm in Uganda established village health clubs seeking to 1) improve the status and standing of CHWs, 2) increase demand for health services and 3) communicate that CHWs' work is important. Process evaluation was conducted after 10 months and end-line surveys will establish impact after 12 months in Uganda and 18 months in Mozambique. Main outcomes include proportion of sick children appropriately treated, CHW performance and motivation, and cost effectiveness of interventions. Study strengths include a user

  5. Complementary school garden, nutrition, water, sanitation and hygiene interventions to improve children's nutrition and health status in Burkina Faso and Nepal: a study protocol.

    PubMed

    Erismann, Séverine; Shrestha, Akina; Diagbouga, Serge; Knoblauch, Astrid; Gerold, Jana; Herz, Ramona; Sharma, Subodh; Schindler, Christian; Odermatt, Peter; Drescher, Axel; Yang, Ray-Yu; Utzinger, Jürg; Cissé, Guéladio

    2016-03-09

    Malnutrition and intestinal parasitic infections are common among children in Burkina Faso and Nepal. However, specific health-related data in school-aged children in these two countries are scarce. In the frame of a larger multi-stakeholder project entitled "Vegetables go to School: Improving Nutrition through Agricultural Diversification" (VgtS), a study has been designed with the objectives to: (i) describe schoolchildren's health status in Burkina Faso and Nepal; and to (ii) provide an evidence-base for programme decisions on the relevance of complementary school garden, nutrition, water, sanitation and hygiene (WASH) interventions. The studies will be conducted in the Centre Ouest and the Plateau Central regions of Burkina Faso and the Dolakha and Ramechhap districts of Nepal. Data will be collected and combined at the level of schools, children and their households. A range of indicators will be used to examine nutritional status, intestinal parasitic infections and WASH conditions in 24 schools among 1144 children aged 8-14 years at baseline and a 1-year follow-up. The studies are designed as cluster randomised trials and the schools will be assigned to two core study arms: (i) the 'complementary school garden, nutrition and WASH intervention' arm; and the (ii) 'control' arm with no interventions. Children will be subjected to parasitological examinations using stool and urine samples and to quality-controlled anthropometric and haemoglobin measurements. Drinking water will be assessed for contamination with coliform bacteria and faecal streptococci. A questionnaire survey on nutritional and health knowledge, attitudes and practices (KAP) will be administered to children and their caregivers, also assessing socioeconomic, food-security and WASH conditions at household level. Focus group and key-informant interviews on children's nutrition and hygiene perceptions and behaviours will be conducted with their caregivers and school personnel. The studies will

  6. Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.

    PubMed

    Walsh, Fiona J; Bärnighausen, Till; Delva, Wim; Fleming, Yvette; Khumalo, Gavin; Lejeune, Charlotte L; Mazibuko, Sikhathele; Mlambo, Charmaine Khudzie; Reis, Ria; Spiegelman, Donna; Zwane, Mandisa; Okello, Velephi

    2017-08-18

    There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system. This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling. A

  7. Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol.

    PubMed

    Reinwand, Dominique; Kuhlmann, Tim; Wienert, Julian; de Vries, Hein; Lippke, Sonia

    2013-11-19

    Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events. Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work. This includes physical activity as well as fruit and vegetable consumption. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation. The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation. The study will consist of one intervention group which will be compared to a waiting list control group. During the eight week duration of the intervention, participants will be invited to participate in the online after-care program once per week. The intervention encourages participants to define individual health behavior goals as well as action, and coping plans to reach these self-determined goals. The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change, antecedents of behavior change (e.g., self-efficacy), ability to return to work and increased well-being. Further, subgroup-differences will be assessed including differences between the two countries, socioeconomic inequalities and across age groups. The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle. Implications can include how such an online program could enrich cardiac rehabilitation aftercare further. NTR 3706, NCT01909349.

  8. Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol

    PubMed Central

    2013-01-01

    Background Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events. Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work. This includes physical activity as well as fruit and vegetable consumption. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation. Methods The study will have a randomized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation. The study will consist of one intervention group which will be compared to a waiting list control group. During the eight week duration of the intervention, participants will be invited to participate in the online after-care program once per week. The intervention encourages participants to define individual health behavior goals as well as action, and coping plans to reach these self-determined goals. The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change, antecedents of behavior change (e.g., self-efficacy), ability to return to work and increased well-being. Further, subgroup-differences will be assessed including differences between the two countries, socioeconomic inequalities and across age groups. Discussion The present study will make a contribution to understanding how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle. Implications can include how such an online program could enrich cardiac rehabilitation aftercare further. Trial registration NTR 3706, NCT01909349 PMID:24245493

  9. PRISMA-Children (C) and PRISMA-Protocol for Children (P-C) Extensions: a study protocol for the development of guidelines for the conduct and reporting of systematic reviews and meta-analyses of newborn and child health research.

    PubMed

    Kapadia, Mufiza Z; Askie, Lisa; Hartling, Lisa; Contopoulos-Ioannidis, Despina; Bhutta, Zulfiqar A; Soll, Roger; Moher, David; Offringa, Martin

    2016-04-18

    Paediatric systematic reviews differ from adult systematic reviews in several key aspects such as considerations of child tailored interventions, justifiable comparators, valid outcomes and child sensitive search strategies. Available guidelines, including PRISMA-P (2015) and PRISMA (2009), do not cover all the complexities associated with reporting systematic reviews in the paediatric population. Using a collaborative, multidisciplinary structure, we aim to develop evidence-based and consensus-based PRISMA-P-C (Protocol for Children) and PRISMA-C (Children) Extensions to guide paediatric systematic review protocol and completed review reporting. This project's methodology follows published recommendations for developing reporting guidelines and involves the following six phases; (1) establishment of a steering committee representing key stakeholder groups; (2) a scoping review to identify potential Extension items; (3) three types of consensus activities including meetings of the steering committee to achieve high-level decisions on the content and methodology of the Extensions, a survey of key stakeholders to generate a list of possible items to include in the Extensions and a formal consensus meeting to select the reporting items to add to, or modify for, the Extension; (4) the preliminary checklist items generated in phase III will be evaluated against the existing evidence and reporting practices in paediatric systematic reviews; (5) extension statements and explanation and elaboration documents will provide detailed advice for each item and examples of good reporting; (6) development and implementation of effective knowledge translation of the extension checklist, and an evaluation of the Extensions by key stakeholders. This protocol was considered a quality improvement project by the Hospital for Sick Children's Ethics Committee and did not require ethical review. The resultant checklists, jointly developed with all relevant stakeholders, will be

  10. Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Discussion Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care

  11. Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial.

    PubMed

    Ahmed, Sara; Bartlett, Susan J; Ernst, Pierre; Paré, Guy; Kanter, Maria; Perreault, Robert; Grad, Roland; Taylor, Laurel; Tamblyn, Robyn

    2011-12-14

    Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to

  12. Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.

    PubMed

    van der Meij, Eva; Huirne, Judith Af; Bouwsma, Esther Va; van Dongen, Johanna M; Terwee, Caroline B; van de Ven, Peter M; den Bakker, Chantal M; van der Meij, Suzan; van Baal, W Marchien; Leclercq, Wouter Kg; Geomini, Peggy Maj; Consten, Esther Cj; Schraffordt Koops, Steven E; van Kesteren, Paul Jm; Stockmann, Hein Bac; Ten Cate, A Dorien; Davids, Paul Hp; Scholten, Petrus C; van den Heuvel, Baukje; Schaafsma, Frederieke G; Meijerink, Wilhelmus Jhj; Bonjer, H Jaap; Anema, Johannes R

    2016-12-21

    Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health

  13. Early identification in primary health care of people at risk for sick leave due to work-related stress - study protocol of a randomized controlled trial (RCT).

    PubMed

    Holmgren, Kristina; Sandheimer, Christine; Mårdby, Ann-Charlotte; Larsson, Maria E H; Bültmann, Ute; Hange, Dominique; Hensing, Gunnel

    2016-11-25

    Early identification of persons at risk of sickness absence due to work-related stress is a crucial problem for society in general, and primary health care in particular. Tho date, no established method to do this exists. This project's aim is to evaluate whether systematic early identification of work-related stress can prevent sickness absence. This paper presents the study design, procedure and outcome measurements, as well as allocation and baseline characteristics of the study population. The study is a two-armed randomized controlled trial with follow-up at 3, 6 and 12 months. Non-sick-listed employed women and men, aged 18 to 64 years, who had mental and physical health complaints and sought care at primary health care centers (PHCC) were eligible to participate. At baseline work-related stress was measured by the Work Stress Questionnaire (WSQ), combined with feedback at consultation, at PHCC. The preventive intervention included early identification of work-related stress by the WSQ, GP training in the use of WSQ, GP feedback at consultation and finding suitable preventive measures. A process evaluation was used to explore how to facilitate future implementation and structural use of the WSQ at the PHCC. The primary outcome to compare the preventive sick leave intervention by the general practitioner (GP) versus treatment as usual is sick leave data obtained from the Swedish Social Insurance Agency register. Early screening for sick leave due to work-related stress makes it possible not only to identify those at risk for sick leave, but also to put focus on the patient's specific work-related stress problems, which can be helpful in finding suitable preventive measures. This study investigates if use of the WSQ by GPs at PHCCs, combined with feedback at consultation, prevents future sickness absence. ClinicalTrials.gov. Identifier: NCT02480855 . Registered 20 May 2015.

  14. An exploratory trial of a health education programme to promote healthy lifestyles through social and emotional competence in young children: Study protocol.

    PubMed

    Bermejo-Martins, Elena; López-Dicastillo, Olga; Mujika, Agurtzane

    2017-07-26

    To implement and evaluate a health education programme based on the development of social and emotional competence in young children. Children's social and emotional skills play a key role in the adoption and maintenance of their lifestyles. Currently, a more comprehensive perspective dealing with these aspects is needed to promote healthy habits in children and develop effective health education programmes. An exploratory randomized controlled trial. A convenience sample of 30 children (5 and 6 years old) will be recruited from a public school in Spain, with 15 participants in the experimental group and 15 in the control group. Participants in the experimental group will receive the first unit of the programme, consisting of developing emotional knowledge skills around daily health habits (eating, hygiene, sleep and physical exercise) using different game-based dynamics and an emotional diary, while those in the control group will continue with their usual school routine. Outcome measures include emotional knowledge ability, basic social skills and children's health profile. The perceived impact of the intervention by parents, acceptability (by parents and children) and feasibility of the programme will be also assessed. Data will be collected at baseline, postintervention and at 7-month follow-up. This study offers an innovative intervention aimed at improving children's healthy lifestyles from a holistic perspective by addressing social and emotional competence as one of the most influential aspects of children's development. This exploratory trial is an essential step to explore crucial aspects of the full-scale clinical trial. © 2017 John Wiley & Sons Ltd.

  15. A health economic model for the development and evaluation of innovations in aged care: an application to consumer-directed care-study protocol.

    PubMed

    Ratcliffe, Julie; Lancsar, Emily; Luszcz, Mary; Crotty, Maria; Gray, Len; Paterson, Jan; Cameron, Ian D

    2014-06-25

    Consumer-directed care is currently being embraced within Australia and internationally as a means of promoting autonomy and choice in the delivery of health and aged care services. Despite its wide proliferation little research has been conducted to date to assess the views and preferences of older people for consumer-directed care or to assess the costs and benefits of such an approach relative to existing models of service delivery. A comprehensive health economic model will be developed and applied to the evolution, implementation and evaluation of consumer-directed care in an Australian community aged care setting. A mixed methods approach comprising qualitative interviews and a discrete choice experiment will determine the attitudes and preferences of older people and their informal carers for consumer-directed care. The results of the qualitative interviews and the discrete choice experiment will inform the introduction of a new consumer-directed care innovation in service delivery. The cost-effectiveness of consumer-directed care will be evaluated by comparing incremental changes in resource use, costs and health and quality of life outcomes relative to traditional services. The discrete choice experiment will be repeated at the end of the implementation period to determine the extent to which attitudes and preferences change as a consequence of experience of consumer-directed care. The proposed framework will have wide applicability in the future development and economic evaluation of new innovations across the health and aged care sectors. The study is approved by Flinders University Social and Behavioural Research Ethics Committee (Project No. 6114/SBREC). Findings from the qualitative interviews, discrete choice experiments and the economic evaluation will be reported at a workshop of stakeholders to be held in 2015 and will be documented in reports and in peer reviewed journal articles. Published by the BMJ Publishing Group Limited. For permission to

  16. The effect of an affordable daycare program on health and economic well-being in Rajasthan, India: protocol for a cluster-randomized impact evaluation study.

    PubMed

    Nandi, Arijit; Maloney, Shannon; Agarwal, Parul; Chandrashekar, Anoushaka; Harper, Sam

    2016-06-09

    The provision of affordable and reliable daycare services is a potentially important policy lever for empowering Indian women. Access to daycare might reduce barriers to labor force entry and generate economic opportunities for women, improve education for girls caring for younger siblings, and promote nutrition and learning among children. However, empirical evidence concerning the effects of daycare programs in low-and-middle-income countries is scarce. This cluster-randomized trial will estimate the effect of a community-based daycare program on health and economic well-being over the life-course among women and children living in rural Rajasthan, India. This three-year study takes place in rural communities from five blocks in the Udaipur District of rural Rajasthan. The intervention is the introduction of a full-time, affordable, community-based daycare program. At baseline, 3177 mothers with age eligible children living in 160 village hamlets were surveyed. After the baseline, these hamlets were randomized to the intervention or control groups and respondents will be interviewed on two more occasions. Primary social and economic outcomes include women's economic status and economic opportunity, women's empowerment, and children's educational attainment. Primary health outcomes include women's mental health, as well as children's nutritional status. This interdisciplinary research initiative will provide rigorous evidence concerning the effects of daycare in lower-income settings. In doing so it will address an important research gap and has the potential to inform policies for improving the daycare system in India in ways that promote health and economic well-being. (1) The ISRCTN clinical trial registry (ISRCTN45369145), http://www.isrctn.com/ISRCTN45369145 , registered on May 16, 2016 and (2) The American Economic Association's registry for randomized controlled trials (AEARCTR-0000774), http://www.socialscienceregistry.org/trials/774 , registered on July

  17. Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial.

    PubMed

    Singer, Susanne; Danker, Helge; Briest, Susanne; Dietrich, Arne; Dietz, Andreas; Einenkel, Jens; Papsdorf, Kirsten; Lordick, Florian; Meixensberger, Jürgen; Mössner, Joachim; Niederwieser, Dietger; Prietzel, Torsten; Schiefke, Franziska; Stolzenburg, Jens-Uwe; Wirtz, Hubert; Kersting, Anette

    2014-12-10

    High levels of emotional distress in cancer patients often goes unnoticed in daily clinical routine, resulting in severe undertreatment of mental health problems in this patient group. Screening tools can be used to increase case identification, however, screening alone does not necessarily translate into better mental health for the patient. Doctors play a key role in providing basic emotional support and transferring the patients in need of such specific support to mental health professionals. This study investigates whether a stepped care model, combining screening, doctor consultation and professional psycho-oncological service in a structured way, improves the emotional wellbeing of cancer patients. This study is a cluster randomized trial with two parallel groups (intervention vs. care as usual), set in an academic hospital. Participants are cancer patients, a total of 1,000 at baseline. The intervention consists of stepped psychosocial care. Step one: screening for distress, step two: feedback of screening results to the doctor in charge of the patient and consultation with the patient, and step three: based on a shared patient-doctor decision, either transferal to the consultation liaison (CL) service or not. The outcome will be emotional well-being half a year after baseline, ascertained with the Hospital Anxiety and Depression Scale. Randomization will be done by the cluster randomization of wards. Mental health problems not only cause emotional suffering but also direct and indirect costs. This calls for timely and adequate psychosocial support, especially as we know that such support is effective. However, not every cancer patient can and must be treated by a mental health professional. Allocating limited resources most sensibly and economically is of crucial importance for our healthcare system to ensure the best quality of care to as many patients as possible. It is the hope of the STEPPED CARE trial that this model is both effective and efficient

  18. Health protocol for translocation of free-ranging elk.

    PubMed

    Corn, J L; Nettles, V F

    2001-07-01

    When considering an elk (Cervus elaphus) restoration program, wildlife managers must evaluate the positive and negative elements of translocation. We prepared this protocol to give an overview of health considerations associated with translocation of elk, with an emphasis on movement of free-ranging elk from western North America to the southeastern USA. We evaluated infectious agents and ectoparasites reported in elk from two perspectives. First, we made a qualitative estimate of the ability of the agent to be introduced and to become established. This was done using a selected set of epidemiologic factors. Second, if there was a good possibility that the organism could become established in the release area, the potential pathological consequences for elk and other wildlife, domestic animals, and humans were assessed via examination of the literature and consultation with other animal health specialists. The results of these evaluations were used to classify infectious agents and ectoparasites as low risk (n = 174), unknown risk (n = 10), and high risk (n = 9). We classified Anaplasma marginale, Anaplasma ovis, Mycobacterium paratuberculosis, Pasteurella multocida serotype 3, Elaphostrongylus cervi, Dicrocoelium dendriticum, Fascioloides magna, Echinococcus granulosus, Dermacentor albipictus, and Otobius megnini as unknown risks. High risk infectious agents and ectoparasites were the agent of chronic wasting disease, Brucella abortus, Mycobacterium bovis, Dermacentor andersoni, Ixodes pacificus, and Psoroptes sp. Parelaphostrongylus tennis, Elaeophora schneideri, and a Babesia sp. are parasites endemic in the southeastern USA that may present a "reverse risk" and adversely affect elk if released in some parts of the region. We developed a five-component protocol to reduce the risk of introduction of high risk infectious agents and ectoparasites that included: (1) evaluation of the health status of source populations, (2) quarantines, (3) physical examination and

  19. Expectations, experiences and attitudes of patients and primary care health professionals regarding online psychotherapeutic interventions for depression: protocol for a qualitative study

    PubMed Central

    2013-01-01

    Background In the year 2020, depression will cause the second highest amount of disability worldwide. One quarter of the population will suffer from depression symptoms at some point in their lives. Mental health services in Western countries are overburdened. Therefore, cost-effective interventions that do not involve mental health services, such as online psychotherapy programs, have been proposed. These programs demonstrate satisfactory outcomes, but the completion rate for patients is low. Health professionals’ attitudes towards this type of psychotherapy are more negative than the attitudes of depressed patients themselves. The aim of this study is to describe the profile of depressed patients who would benefit most from online psychotherapy and to identify expectations, experiences, and attitudes about online psychotherapy among both patients and health professionals that can facilitate or hinder its effects. Methods A parallel qualitative design will be used in a randomised controlled trial on the efficiency of online psychotherapeutic treatment for depression. Through interviews and focus groups, the experiences of treated patients, their reasons for abandoning the program, the expectations of untreated patients, and the attitudes of health professionals will be examined. Questions will be asked about training in new technologies, opinions of online psychotherapy, adjustment to therapy within the daily routine, the virtual and anonymous relationship with the therapist, the process of online communication, information necessary to make progress in therapy, process of working with the program, motivations and attitudes about treatment, expected consequences, normalisation of this type of therapy in primary care, changes in the physician-patient relationship, and resources and risks. A thematic content analysis from the grounded theory for interviews and an analysis of the discursive positions of participants based on the sociological model for focus groups

  20. Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Healthy, active ageing is strongly associated with good mental wellbeing which in turn helps to prevent mental illness. However, more investment has been made into research into interventions to prevent mental illness than into those designed to improve mental wellbeing. This applied research programme will provide high quality evidence for an intervention designed to improve and sustain mental wellbeing in older adults. Methods/Design This study was a multi-centre, pragmatic, two-arm, parallel group, individually randomised controlled trial to determine the population benefit of an occupational therapy based intervention for community living people aged 65 years or older. Participants (n = 268) will be identified in one city in the North of England and in North Wales through GP mail-outs, signposting by local authority, primary care staff and voluntary sector organisations and through community engagement. Participants will be randomised to one of two treatment arms: an intervention (Lifestyle Matters programme); or control (routine access to health and social care). All participants will be assessed at baseline, 6 and 24 months post-randomisation. The primary outcome, which is a person reported outcome, is the SF-36 Mental Health dimension at six months post randomisation. Secondary outcome measures have been selected to measure psychosocial, physical and mental health outcomes. They include other dimensions of the SF36, EQ-5D-3L, Brief Resilience Scale, General Perceived Self Efficacy Scale, PHQ-9, de Jong Gierveld Loneliness Scale, Health and Social Care Resource Use and the wellbeing question of the Integrated Household Survey 2011. A cost effectiveness analysis will investigate the incremental cost per Quality Adjusted Life Years (QALYs) of the Lifestyle Matters intervention compared with treatment as usual. Discussion The questions being posed through this research are important given the increasing numbers of older people, pressure on the public

  1. e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

    PubMed Central

    Mandellos, George J.; Koukias, Michael N.; Styliadis, Ioannis St.; Lymberopoulos, Dimitrios K.

    2010-01-01

    Standard Communication Protocol for Computer-assisted Electrocardiography (SCP-ECG) provides standardized communication among different ECG devices and medical information systems. This paper extends the use of this protocol in order to be included in health monitoring systems. It introduces new sections into SCP-ECG structure for transferring data for positioning, allergies, and five additional biosignals: noninvasive blood pressure (NiBP), body temperature (Temp), Carbon dioxide (CO2), blood oxygen saturation (SPO2), and pulse rate. It also introduces new tags in existing sections for transferring comprehensive demographic data. The proposed enhanced version is referred to as e-SCP-ECG+ protocol. This paper also considers the pilot implementation of the new protocol as a software component in a Health Telemonitoring System. PMID:20628537

  2. Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial.

    PubMed

    Huang, Keng-Yen; Nakigudde, Janet; Calzada, Esther; Boivin, Michael J; Ogedegbe, Gbenga; Brotman, Laurie Miller

    2014-12-01

    Children in Sub-Saharan Africa (SSA) are burdened by significant unmet mental health needs, but this region has limited access to mental health workers and resources to address these needs. Despite the successes of numerous school-based interventions for promoting child mental health, most evidence-based interventions are not available in SSA. This study will investigate the transportability of an evidence-based program from a developed country (United States) to a SSA country (Uganda). The approach includes task-shifting to early childhood teachers and consists of professional development (five days) to introduce strategies for effective behavior management and positive teacher-student interactions, and group-based consultation (14 sessions) to support adoption of effective practices and tailoring to meet the needs of individual students. The design of this study is guided by two implementation frameworks, the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model, that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes. Using a cluster randomized design, 10 schools in Uganda will be randomized to either the intervention group (five schools) or the waitlist control group (five schools). A total of 80 to 100 early childhood teachers will be enrolled in the study. Teacher utilization of evidence-based strategies and practices will be assessed at baseline, immediate post-intervention (six months after baseline), and at seven months post-intervention (during a new academic year). Fidelity measures will be assessed throughout the program implementation period (during professional development and consultation sessions). Individual teacher and contextual factors will be assessed at baseline. Data will be collected from multiple sources. Linear mixed-effect modeling, adjusting for school nesting, will be applied to address study questions. The

  3. Protocol for a mixed methods study investigating the impact of investment in housing, regeneration and neighbourhood renewal on the health and wellbeing of residents: the GoWell programme

    PubMed Central

    2010-01-01

    Background There is little robust evidence to test the policy assumption that housing-led area regeneration strategies will contribute to health improvement and reduce social inequalities in health. The GoWell Programme has been designed to measure effects on health and wellbeing of multi-faceted regeneration interventions on residents of disadvantaged neighbourhoods in the city of Glasgow, Scotland. Methods/Design This mixed methods study focused (initially) on 14 disadvantaged neighbourhoods experiencing regeneration. These were grouped by intervention into 5 categories for comparison. GoWell includes a pre-intervention householder survey (n = 6008) and three follow-up repeat-cross sectional surveys held at two or three year intervals (the main focus of this protocol) conducted alongside a nested longitudinal study of residents from 6 of those areas. Self-reported responses from face-to-face questionnaires are analysed along with various routinely produced ecological data and documentary sources to build a picture of the changes taking place, their cost and impacts on residents and communities. Qualitative methods include interviews and focus groups of residents, housing managers and other stakeholders exploring issues such as the neighbourhood context, potential pathways from regeneration to health, community engagement and empowerment. Discussion Urban regeneration programmes are 'natural experiments.' They are complex interventions that may impact upon social determinants of population health and wellbeing. Measuring the effects of such interventions is notoriously challenging. GoWell compares the health and wellbeing effects of different approaches to regeneration, generates theory on pathways from regeneration to health and explores the attitudes and responses of residents and other stakeholders to neighbourhood change. PMID:20459767

  4. Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

    PubMed

    Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

    2017-05-26

    A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

  5. A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

    PubMed

    Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

    2015-02-03

    Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

  6. Study protocol for "MOVEdiabetes": a trial to promote physical activity for adults with type 2 diabetes in primary health care in Oman.

    PubMed

    Alghafri, Thamra S; Alharthi, Saud M; Al-Farsi, Yahya M; Craigie, Angela M; Mcleod, Maureen; Anderson, Annie S

    2017-01-06

    Benefits of physical activity in the management of diabetes are well documented. However, evidence on the effectiveness of interventions integrating physical activity in diabetes care is sparse especially in the countries of the Gulf Cooperation Council. The results from this study will increase our understanding of the use of multi-component interventions aimed at increasing physical activity levels in inactive adults with type 2 diabetes in primary health care in Oman. The study is a one year 1:1 cluster randomized controlled trial of the MOVEdiabetes programme (intervention) versus usual care in eight primary health care centres in Oman. The MOVEdiabetes programme utilizes face to face physical activity consultations promoting 150 min of moderate to vigorous physical activity per week (≥600MET-mins/week), pedometers to self-monitor step counts and monthly telephone WhatsApp messages for follow up support. Inactive adults with type 2 diabetes and no contraindication to physical activity will be recruited over a two months period, and followed up for 12 months. To demonstrate a 50% between group difference in physical activity levels (MET-mins/week) over 12 months, (at a power of 80%, and significance level of 5%), 128 participants would be required to complete the study (64 in each arm). Based on a drop-out rate of 20%, 154 participants would require to be recruited (77 in each arm). Assuming a recruitment rate of 70%, 220 potential eligible participants would need to be approached. The primary outcome is change in levels of physical activity measured by the Global Physical Activity Questionnaire. In addition, accelerometers will be used in a sub group to objectively assess physical activity. Secondary outcomes include changes in metabolic and cardiovascular biomarkers, change in self-reported health, social support, self-efficacy for physical activity, and perceived acceptability of the program. All intervention delivery and support costs will be monitored

  7. Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of ‘forced abstinence’ for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). Methods/Design The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at

  8. A behavioural change package to prevent hand dermatitis in nurses working in the national health service (the SCIN trial): study protocol for a cluster randomised controlled trial.

    PubMed

    Madan, Ira; Parsons, Vaughan; Cookson, Barry; English, John; Lavender, Tina; McCrone, Paul; Murphy, Caroline; Ntani, Georgia; Rushton, Lesley; Smedley, Julia; Williams, Hywel; Wright, Alison; Coggon, David

    2016-03-17

    Hand dermatitis can be a serious health problem in healthcare workers. While a range of skin care strategies and policy directives have been developed in recent years to minimise the risk, their effectiveness and cost-effectiveness remain unclear. Evidence now suggests that psychological theory can facilitate behaviour change with respect to improved hand care practices. Therefore, we will test the hypothesis that a behavioural change intervention to improve hand care, based on the Theory of Planned Behaviour and implementation intentions, coupled with provision of hand moisturisers, can produce a clinically useful reduction in the occurrence of hand dermatitis, when compared to standard care, among nurses working in the UK National Health Service (NHS) who are particularly at risk. Secondary aims will be to assess impacts on participants' beliefs and behaviour regarding hand care. In addition, we will assess the cost-effectiveness of the intervention in comparison with normal care. We will conduct a cluster randomised controlled trial at 35 NHS hospital trusts/health boards/universities, focussing on student nurses with a previous history of atopic disease or hand eczema and on nurses in intensive care units. Nurses at 'intervention-light' sites will be managed according to what would currently be regarded as best practice, with provision of an advice leaflet about optimal hand care to prevent hand dermatitis and encouragement to contact their occupational health (OH) department early if hand dermatitis occurs. Nurses at 'intervention-plus' sites will additionally receive a behavioural change programme (BCP) with on-going active reinforcement of its messages, and enhanced provision of moisturising cream. The impact of the interventions will be compared using information collected by questionnaires and through standardised photographs of the hands and wrists, collected at baseline and after 12 months follow-up. In addition, we will assemble relevant economic data

  9. Physical activity and the rejuvenation of Connswater (PARC study): protocol for a natural experiment investigating the impact of urban regeneration on public health

    PubMed Central

    2013-01-01

    potential, individually and interactively, to affect the behaviour of a diverse population. The development and implementation of our comprehensive evaluation framework reflects this complexity and illuminates an approach to the empirical, rigorous evaluation of urban regeneration. More specifically, this study will add to the much needed evidence-base about the impact of urban regeneration on public health as well as having important implications for the development of natural experiment methodology. PMID:24103381

  10. Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial

    PubMed Central

    Huirne, Judith AF; Bouwsma, Esther VA; van Dongen, Johanna M; Terwee, Caroline B; van de Ven, Peter M; den Bakker, Chantal M; van der Meij, Suzan; van Baal, W Marchien; Leclercq, Wouter KG; Geomini, Peggy MAJ; Consten, Esther CJ; Schraffordt Koops, Steven E; van Kesteren, Paul JM; Stockmann, Hein BAC; ten Cate, A Dorien; Davids, Paul HP; Scholten, Petrus C; van den Heuvel, Baukje; Schaafsma, Frederieke G; Meijerink, Wilhelmus JHJ; Bonjer, H Jaap; Anema, Johannes R

    2016-01-01

    Background Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social

  11. Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial.

    PubMed

    Katsuki, Fujika; Takeuchi, Hiroshi; Watanabe, Norio; Shiraishi, Nao; Maeda, Tohru; Kubota, Yosuke; Suzuki, Masako; Yamada, Atsurou; Akechi, Tatsuo

    2014-08-12

    Major depressive disorder (MDD) is a long-lasting disorder with frequent relapses that have significant effects on the patient's family. Family psychoeducation is recognized as part of the optimal treatment for patients with psychotic disorder. A previous randomized controlled trial has found that family psychoeducation is effective in enhancing the treatment of MDD. Although MDD can easily become a chronic illness, there has been no intervention study on the families of patients with chronic depression. In the present study, we design a randomized controlled trial to examine the effectiveness of family psychoeducation in improving the mental health of relatives of patients with MDD lasting more than one year. Participants are patients with MDD lasting more than one year and their relatives. Individually randomized, parallel-group trial design will be employed. Participants will be allocated to one of two treatment conditions: relatives will receive (a) family psychoeducation (four, two-hour biweekly multifamily psychoeducation sessions) plus treatment-as-usual for the patient (consultation by physicians), or (b) counseling for the family (one counseling session from a nurse) plus treatment-as-usual for the patient. The primary outcome measure will be relatives' mental health as measured by K6 that was developed to screen for DSM-IV depressive and anxiety disorder. Additionally, the severity of depressive symptoms in patients measured by the Beck Depression Inventory-II (BDI-II) scale will be assessed. Data from the intention-to-treat sample will be analyzed 16 weeks after randomization. This is the first study to evaluate the effectiveness of family psychoeducation for relatives of patients with MDD lasting more than one year. If this type of intervention is effective, it could be a new method of rehabilitation for patients with MDD lasting more than one year. Clinical Trials.gov NCT01734291 (registration date: 18 October 2012).

  12. A Secure Protocol to Distribute Unlinkable Health Data

    PubMed Central

    Malin, Bradley; Sweeney, Latanya

    2005-01-01

    Health data that appears anonymous, such as DNA records, can be re-identified to named patients via location visit patterns, or trails. This is a realistic privacy concern which continues to exist because data holders do not collaborate prior to making disclosures. In this paper, we present STRANON, a novel computational protocol that enables data holders to work together to determine records that can be disclosed and satisfy a formal privacy protection model. STRANON incorporates a secure encrypted environment, so no data holder reveals information until the trails of disclosed records are provably unlinkable. We evaluate STRANON on real-world datasets with known susceptibilities and demonstrate data holders can release significant quantities of data with zero trail re-identifiability. PMID:16779087

  13. A secure protocol to distribute unlinkable health data.

    PubMed

    Malin, Bradley A; Sweeney, Latanya

    2005-01-01

    Health data that appears anonymous, such as DNA records, can be re-identified to named patients via location visit patterns, or trails. This is a realistic privacy concern which continues to exist because data holders do not collaborate prior to making disclosures. In this paper, we present STRANON, a novel computational protocol that enables data holders to work together to determine records that can be disclosed and satisfy a formal privacy protection model. STRANON incorporates a secure encrypted environment, so no data holder reveals information until the trails of disclosed records are provably unlinkable. We evaluate STRANON on real-world datasets with known susceptibilities and demonstrate data holders can release significant quantities of data with zero trail re-identifiability.

  14. Study Protocol--Alcohol Management Plans (AMPs) in remote indigenous communities in Queensland: their impacts on injury, violence, health and social indicators and their cost-effectiveness.

    PubMed

    Clough, Alan R; Fitts, Michelle S; Robertson, Jan A; Shakeshaft, Anthony; Miller, Adrian; Doran, Christopher M; Muller, Reinhold; Ypinazar, Valmae; Martin, David; McDermott, Robyn; Sanson-Fisher, Rob; Towle, Simon; Margolis, Stephen A; West, Caryn

    2014-01-09

    In 2002/03 the Queensland Government responded to high rates of alcohol-related harm in discrete Indigenous communities by implementing alcohol management plans (AMPs), designed to include supply and harm reduction and treatment measures. Tighter alcohol supply and carriage restrictions followed in 2008 following indications of reductions in violence and injury. Despite the plans being in place for over a decade, no comprehensive independent review has assessed to what level the designed aims were achieved and what effect the plans have had on Indigenous community residents and service providers. This study will describe the long-term impacts on important health, economic and social outcomes of Queensland's AMPs. The project has two main studies, 1) outcome evaluation using de-identified epidemiological data on injury, violence and other health and social indicators for across Queensland, including de-identified databases compiled from relevant routinely-available administrative data sets, and 2) a process evaluation to map the nature, timing and content of intervention components targeting alcohol. Process evaluation will also be used to assess the fidelity with which the designed intervention components have been implemented, their uptake and community responses to them and their perceived impacts on alcohol supply and consumption, injury, violence and community health. Interviews and focus groups with Indigenous residents and service providers will be used. The study will be conducted in all 24 of Queensland's Indigenous communities affected by alcohol management plans. This evaluation will report on the impacts of the original aims for AMPs, what impact they have had on Indigenous residents and service providers. A central outcome will be the establishment of relevant databases describing the parameters of the changes seen. This will permit comprehensive and rigorous surveillance systems to be put in place and provided to communities empowering them with the

  15. Effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care: study protocol of a three-arm parallel-group randomized controlled trial

    PubMed Central

    2014-01-01

    Background Routine Outcome Monitoring refers to regular measurements of clients’ progress in clinical practice, aiming to evaluate and, if necessary, adapt treatment. Clients fill out questionnaires and clinicians receive feedback about the results. Studies concerning feedback in youth mental health care are rare. The effects of feedback, the importance of specific aspects of feedback, and the mechanisms underlying the effects of feedback are unknown. In the present study, several potentially effective components of feedback from Routine Outcome Monitoring in youth mental health care in the Netherlands are investigated. Methods/Design We will examine three different forms of feedback through a three-arm parallel-group randomized controlled trial. 432 children and adolescents (aged 4 to 17 years) and their parents, who have been referred to mental health care institution Pro Persona, will be randomly assigned to one of three feedback conditions (144 participants per condition). Randomization will be stratified by age of the child or adolescent and by department. All participants fill out questionnaires at the start of treatment, one and a half months after the start of treatment, every three months during treatment, and at the end of treatment. Participants in the second and third feedback conditions fill out an additional questionnaire. In condition 1, clinicians receive basic feedback regarding clients’ symptoms and quality of life. In condition 2, the feedback of condition 1 is extended with feedback regarding possible obstacles to a good outcome and with practical suggestions. In condition 3, the feedback of condition 2 is discussed with a colleague while following a standardized format for case consultation. The primary outcome measure is symptom severity and secondary outcome measures are quality of life, satisfaction with treatment, number of sessions, length of treatment, and rates of dropout. We will also examine the role of being not on track (not

  16. Evaluation of an Australian health literacy training program for socially disadvantaged adults attending basic education classes: study protocol for a cluster randomised controlled trial.

    PubMed

    McCaffery, Kirsten J; Morony, Suzanne; Muscat, Danielle M; Smith, Sian K; Shepherd, Heather L; Dhillon, Haryana M; Hayen, Andrew; Luxford, Karen; Meshreky, Wedyan; Comings, John; Nutbeam, Don

    2016-05-27

    People with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes. This is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education colleges across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content). The primary outcome is functional health literacy skills - knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, more advanced health literacy skills; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention. A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program to better understand implementation issues and to strengthen the potential for scaling up the program. Outcomes will provide evidence regarding real-world implementation of a health literacy training program with health worker involvement in an Australian adult education setting. The evaluation trial will provide insight into translating and scaling up health literacy education for vulnerable populations with low literacy. Australian New Zealand Clinical Trials

  17. The CORE study protocol: a stepped wedge cluster randomised controlled trial to test a co-design technique to optimise psychosocial recovery outcomes for people affected by mental illness in the community mental health setting

    PubMed Central

    Palmer, Victoria J; Chondros, Patty; Piper, Donella; Callander, Rosemary; Weavell, Wayne; Godbee, Kali; Potiriadis, Maria; Richard, Lauralie; Densely, Konstancja; Herrman, Helen; Furler, John; Pierce, David; Schuster, Tibor; Iedema, Rick; Gunn, Jane

    2015-01-01

    Introduction User engagement in mental health service design is heralded as integral to health systems quality and performance, but does engagement improve health outcomes? This article describes the CORE study protocol, a novel stepped wedge cluster randomised controlled trial (SWCRCT) to improve psychosocial recovery outcomes for people with severe mental illness. Methods An SWCRCT with a nested process evaluation will be conducted over nearly 4 years in Victoria, Australia. 11 teams from four mental health service providers will be randomly allocated to one of three dates 9 months apart to start the intervention. The intervention, a modified version of Mental Health Experience Co-Design (MH ECO), will be delivered to 30 service users, 30 carers and 10 staff in each cluster. Outcome data will be collected at baseline (6 months) and at completion of each intervention wave. The primary outcome is improvement in recovery score using the 24-item Revised Recovery Assessment Scale for service users. Secondary outcomes are improvements to user and carer mental health and well-being using the shortened 8-item version of the WHOQOL Quality of Life scale (EUROHIS), changes to staff attitudes using the 19-item Staff Attitudes to Recovery Scale and recovery orientation of services using the 36-item Recovery Self Assessment Scale (provider version). Intervention and usual care periods will be compared using a linear mixed effects model for continuous outcomes and a generalised linear mixed effects model for binary outcomes. Participants will be analysed in the group that the cluster was assigned to at each time point. Ethics and dissemination The University of Melbourne, Human Research Ethics Committee (1340299.3) and the Federal and State Departments of Health Committees (Project 20/2014) granted ethics approval. Baseline data results will be reported in 2015 and outcomes data in 2017. Trial registration number Australian and New Zealand Clinical Trials Registry ACTRN

  18. A novel dynamic exercise initiative for older people to improve health and well-being: study protocol for a randomised controlled trial.

    PubMed

    Sales, Myrla Patricia Reis; Polman, Remco; Hill, Keith D; Karaharju-Huisman, Tuire; Levinger, Pazit

    2015-06-24

    Exercise is an important and effective approach to preventing falls in older people, but adherence to exercise participation remains a persistent problem. A unique purpose-built exercise park was designed to provide a fun but physically challenging environment to support exercise in a community setting. This project is a randomised controlled trial designed to evaluate the effectiveness of an exercise intervention using an exercise park specifically designed for older people in reducing the risk of falls. This study will be a parallel randomised control trial with pre and post intervention design. One hundred and twenty people aged between 60 and 90 years old will be recruited from Melbourne suburbs and will be randomly allocated to either an exercise park intervention group (EPIG) or a control group (CG). The CG will receive social activities and an educational booklet on falls prevention. The BOOMER balance test will be used as the primary outcome measure. Secondary outcome measures will include hand grip strength, two minute walk test, lower limb strength test, spatio-temporal walking parameters, health related quality of life, feasibility, adherence, safety, and a number of other psychosocial measures. Outcome assessment will be conducted at baseline and at 18 and 26 weeks after intervention commencement. Participants will inform their falls and physical activity history for a 12-month period via monthly calendars. Mixed linear modelling incorporating intervention and control groups at the baseline and two follow up time points (18 weeks and 26 weeks after intervention commencement) will be used to assess outcomes. This planned trial will be the first to provide evidence if the exercise park can improve functional and physiological health, psychological and well-being. In addition, this study will provide empirical evidence for effectiveness and explore the barriers to participation and the acceptability of the senior exercise park in the Australian older

  19. Improving awareness, knowledge and heart-related lifestyle of coronary heart disease among working population through a mHealth programme: study protocol.

    PubMed

    Wang, Wenru; Zhang, Hui; Lopez, Violeta; Wu, Vivien Xi; Poo, Danny Chiang Choon; Kowitlawakul, Yanika

    2015-09-01

    To develop a mHealth programme, entitled 'Care4Heart' for the working population in Singapore and thereafter examine its feasibility and effectiveness in increasing the awareness and knowledge of coronary heart disease and improving their heart-related lifestyle. Teaching and encouraging the working population to adopt a healthier lifestyle could result in preventing and/or decreasing the incidence of coronary heart disease among this population. The use of mobile application (app) is the next logical wave of healthcare support tools to prevent and manage chronic diseases like coronary heart disease. A quasi-experimental longitudinal study design. The study will be conducted in a tertiary university in Singapore. A non-probability, quota sampling of 200 participants will be recruited including 100 academic and research staff, 50 administrative staff and 50 support staff and business owners. Once consent is obtained, the newly developed mobile app will be installed onto the participants' smartphones and a well-trained research assistant will brief the participant on the use of the app. The main outcomes will be measured using the survey questionnaires: Awareness of coronary heart disease, Heart Disease Fact Questionnaire-2, Behavioural Risk Factor Surveillance System and Perceived Stress Scale. Data will be collected at baseline and at the 4th week and 6th month thereafter. If this project is successful, Care4Heart - a mHealth and novel prevention educational programme for the working population in Singapore - can be used to promote knowledge and positive heart-related lifestyle changes to prevent coronary heart disease. © 2015 John Wiley & Sons Ltd.

  20. Protocol for a cluster randomised controlled trial of an intervention to improve the mental health support and training available to secondary school teachers - the WISE (Wellbeing in Secondary Education) study.

    PubMed

    Kidger, Judi; Evans, Rhiannon; Tilling, Kate; Hollingworth, William; Campbell, Rona; Ford, Tamsin; Murphy, Simon; Araya, Ricardo; Morris, Richard; Kadir, Bryar; Moure Fernandez, Aida; Bell, Sarah; Harding, Sarah; Brockman, Rowan; Grey, Jill; Gunnell, David

    2016-10-18

    Teachers are reported to be at increased risk of common mental health disorders compared to other occupations. Failure to support teachers adequately may lead to serious long-term mental disorders, poor performance at work (presenteeism), sickness absence and health-related exit from the profession. It also jeopardises student mental health, as distressed staff struggle to develop supportive relationships with students, and such relationships are protective against student depression. A number of school-based trials have attempted to improve student mental health, but these have mostly focused on classroom based approaches and have failed to establish effectiveness. Only a few studies have introduced training for teachers in supporting students, and none to date have included a focus on improving teacher mental health. This paper sets out the protocol (version 4.4 20/07/16) for a study aiming to address this gap. Cluster randomised controlled trial with secondary schools as the unit of randomisation. Intervention schools will receive: i) Mental Health First Aid (MHFA) training for a group of staff nominated by their colleagues, after which they will set up a confidential peer support service for colleagues ii) training in MHFA for schools and colleges for a further group of teachers, which will equip them to more effectively support student mental health iii) a short mental health awareness raising session and promotion of the peer support service for all teachers. Comparison schools will continue with usual practice. The primary outcome is teacher wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcomes are teacher depression, absence and presenteeism, and student wellbeing, mental health difficulties, attendance and attainment. Measures will be taken at baseline, one year follow up (teachers only) and two year follow up. Economic and process evaluations will be embedded within the study. This study will establish the

  1. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial.

    PubMed

    Lupiáñez-Pérez, Inmaculada; Morilla-Herrera, Juan Carlos; Ginel-Mendoza, Leovigildo; Martín-Santos, Francisco Javier; Navarro-Moya, Francisco Javier; Sepúlveda-Guerra, Rafaela Pilar; Vázquez-Cerdeiros, Rosa; Cuevas-Fernández-Gallego, Magdalena; Benítez-Serrano, Isabel María; Lupiáñez-Pérez, Yolanda; Morales-Asencio, José Miguel

    2013-10-23

    Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. The regular use of olive-oil-based formulas

  2. Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment. Methods/design The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student’s t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis. Discussion The

  3. Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness

    PubMed Central

    Parati, Gianfranco; Avolio, Alberto; Rogoza, Anatoly N; Kotovskaya, Yulia V; Mulè, Giuseppe; Muiesan, Maria Lorenza; Orlova, Iana A; Grigoricheva, Elena A; Cardona Muñoz, Ernesto; Zelveian, Parounak H; Pereira, Telmo; Peixoto Maldonado, João Manuel

    2016-01-01

    Background Hypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulse wave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances in technology have enabled devices to combine non-invasive estimation of these parameters over the 24-hour ABP monitoring. However, currently there is limited evidence on the usefulness of such an approach for routine hypertension management. Objective We recently launched an investigator-initiated, international, multicenter, observational, prospective study, the Vascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hour ABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatory blood pressure monitoring (ABPM) for clinical reasons; (2) assessing the changes in estimates following treatment; (3) weighing the impact of 24-hour PWA on target organ damage and cardiovascular prognosis; (4) assessing the relationship between arterial stiffness, BP absolute mean level and variability, and prognosis; and (5) validating the use of a 24-hour PWA electronic health (e-health) solution for hypertension screening. Methods Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowing simultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascular outcomes). As recommended by current guidelines, each patient will be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year depending on disease severity). A Web-based telemedicine platform (THOLOMEUS) will be used for data collection. The use of the telemedicine system will allow

  4. Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial.

    PubMed

    Leiva-Fernández, José; Vázquez-Alarcón, Rubén L; Aguiar-Leiva, Virginia; Lobnig-Becerra, Mireya; Leiva-Fernández, Francisca; Barnestein-Fonseca, Pilar

    2016-03-17

    Chronic obstructive pulmonary disease (COPD) accounts for 10-12 % of primary care consultations, 7 % of hospital admissions and 35 % of chronic incapacity related to productivity. The misuse of inhalers is a significant problem in COPD because it is associated with reduced therapeutic drug effects leading to lack of control of both symptoms and disease. Despite all advice, health care professionals' practice management of inhalation treatments is usually deficient. Interventions to improve inhaler technique by health care professionals are limited, especially among primary care professionals, who provide the most care to patients with COPD. The aim of this study is to evaluate the efficacy of an educational intervention to train general practitioners (GPs) in the right inhalation technique for the most commonly used inhalers. We are conducting a pragmatic cluster randomised controlled trial. The sample population is composed of 267 patients diagnosed with COPD using inhalation therapy selected from among those in 20 general practices, divided into two groups (control and intervention) by block randomisation at 8 primary care centres. The sample has two levels. The first level is patients with COPD who agree to participate in the trial and receive the educational intervention from their GPs. The second level is GPs who are primary health care professionals and receive the educational intervention. The intervention is one session of the educational intervention with a monitor given to GPs for training in the right inhalation technique. The primary outcome is correct inhalation technique in patients. Secondary outcomes are functional status (spirometry) and quality of life. The follow-up period will be 1 year. GPs will have two visits (baseline and at the 1-year follow-up visit. Patients will have four visits (at baseline and 3, 6 and 12 months). Analysis will be done on an intention-to-treat basis. We carried out three previous clinical trials in patients with COPD

  5. Effect of including fitness testing in preventive health checks on cardiorespiratory fitness and motivation: study protocol of a randomized controlled trial.

    PubMed

    Høj, Kirsten; Skriver, Mette Vinther; Hansen, Anne-Louise Smidt; Christensen, Bo; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2014-10-10

    Preventive health checks may identify individuals with an unhealthy lifestyle and motivate them to change behaviour. However, knowledge about the impact of the different components included in preventive health checks is deficient. The aim of this trial is to evaluate whether including cardiorespiratory fitness testing in preventive health checks 1) increases cardiorespiratory fitness level and motivation to change physical activity behaviour and 2) reduces physical inactivity prevalence and improves self-rated health compared with preventive health checks without fitness testing. An open-label, household-cluster, randomized controlled trial with a two-group parallel design is used. The trial is embedded in a population-based health promotion program, "Check your Health Preventive Program", in which all 30-49 year-old citizens in a Danish municipality are offered a preventive health check. In each arm of the trial, 750 citizens will be recruited (1,500 in total). The primary outcome is cardiorespiratory fitness level assessed by submaximal cycle ergometer testing after one year. An intermediate outcome is the percentage of participants increasing motivation for physical activity behaviour change between baseline and two-weeks follow-up assessed using the Transtheoretical Model's stages of change. Secondary outcomes include changes from baseline to one-year follow-up in physical inactivity prevalence measured by a modified version of the questions developed by Saltin and Grimby, and in self-rated health measures using the Short-Form 12, Health Survey, version 2. This trial will contribute to a critical appraisal of the value of fitness testing as part of preventive health checks. The conduction in real-life community and general practice structures makes the trial findings applicable and transferable to other municipalities providing support to decision-makers in the development of approaches to increase levels of physical activity and improve health. Clinical

  6. Leveraging Electronic Health Care Record Information to Measure Pressure Ulcer Risk in Veterans With Spinal Cord Injury: A Longitudinal Study Protocol

    PubMed Central

    Thomason, Susan S; Sabharwal, Sunil; Finch, Dezon K; McCart, James; Toyinbo, Peter; Bouayad, Lina; Matheny, Michael E; Gobbel, Glenn T; Powell-Cope, Gail

    2017-01-01

    Background Pressure ulcers (PrUs) are a frequent, serious, and costly complication for veterans with spinal cord injury (SCI). The health care team should periodically identify PrU risk, although there is no tool in the literature that has been found to be reliable, valid, and sensitive enough to assess risk in this vulnerable population. Objective The immediate goal is to develop a risk assessment model that validly estimates the probability of developing a PrU. The long-term goal is to assist veterans with SCI and their providers in preventing PrUs through an automated system of risk assessment integrated into the veteran’s electronic health record (EHR). Methods This 5-year longitudinal, retrospective, cohort study targets 12,344 veterans with SCI who were cared for in the Veterans Health Administration (VHA) in fiscal year (FY) 2009 and had no record of a PrU in the prior 12 months. Potential risk factors identified in the literature were reviewed by an expert panel that prioritized factors and determined if these were found in structured data or unstructured form in narrative clinical notes for FY 2009-2013. These data are from the VHA enterprise Corporate Data Warehouse that is derived from the EHR structured (ie, coded in database/table) or narrative (ie, text in clinical notes) data for FY 2009-2013. Results This study is ongoing and final results are expected in 2017. Thus far, the expert panel reviewed the initial list of risk factors extracted from the literature; the panel recommended additions and omissions and provided insights about the format in which the documentation of the risk factors might exist in the EHR. This list was then iteratively refined through review and discussed with individual experts in the field. The cohort for the study was then identified, and all structured, unstructured, and semistructured data were extracted. Annotation schemas were developed, samples of documents were extracted, and annotations are ongoing. Operational

  7. Prayer Healing: A Case Study Research Protocol.

    PubMed

    Kruijthoff, Dirk J; van der Kooi, Cornelis; Glas, Gerrit; Abma, Tineke A

    2017-01-01

    Context • Prayer healing is a common practice in many religious communities around the world. Even in the highly secularized Dutch society, cases of prayer healing are occasionally reported in the media, often generating public attention. There is an ongoing debate regarding whether such miraculous cures do actually occur and how to interpret them. Objective • The aim of the article was to present a research protocol for the investigation of reported cases of remarkable and/or unexplained healing after prayer. Design • The research team developed a method to perform a retrospective, case-based study of prayer healing. Reported prayer healings can be investigated systematically in accordance with a step-by-step methodology. The focus is on understanding the healing by studying it from multiple perspectives, using both medical judgment and patients' narratives collected by qualitative methods Setting • The study occurred at Vrije Universiteit (VU) and VU Medical Center (Amsterdam, Netherlands) as well as the general medical practice of the first author. Participants • Potential participants could be any individuals in the Netherlands or neighboring countries who claim to have been healed through prayer. The reports of healing came from multiple sources, including the research team's medical practices and their direct vicinities, newspaper articles, prayer healers, and medical colleagues. Outcome Measures • Medical data were obtained before and after prayer. Subsequently, a member of a research team and of a medical assessment committee made a standardized judgment that evaluated whether a cure was clinically remarkable or scientifically unexplained. The participants' experiences and insider perspectives were studied, using in-depth interviews in accordance with a qualitative research methodology, to gain insight into the perceptions and explanations of the cures that were offered by participants and by the members of the medical assessment committee. The

  8. [The research protocol III. Study population].

    PubMed

    Arias-Gómez, Jesús; Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The study population is defined as a set of cases, determined, limited, and accessible, that will constitute the subjects for the selection of the sample, and must fulfill several characteristics and distinct criteria. The objectives of this manuscript are focused on specifying each one of the elements required to make the selection of the participants of a research project, during the elaboration of the protocol, including the concepts of study population, sample, selection criteria and sampling methods. After delineating the study population, the researcher must specify the criteria that each participant has to comply. The criteria that include the specific characteristics are denominated selection or eligibility criteria. These criteria are inclusion, exclusion and elimination, and will delineate the eligible population. The sampling methods are divided in two large groups: 1) probabilistic or random sampling and 2) non-probabilistic sampling. The difference lies in the employment of statistical methods to select the subjects. In every research, it is necessary to establish at the beginning the specific number of participants to be included to achieve the objectives of the study. This number is the sample size, and can be calculated or estimated with mathematical formulas and statistic software.

  9. Is health coaching effective in changing the health status and behaviour of prisoners?-a systematic review protocol.

    PubMed

    Almondes, Nadja; Downie, Denise; Cinar, Ayse B; Richards, Derek; Freeman, Ruth

    2017-07-03

    This is a protocol for a systematic review of the impact of health coaching on changing the health behaviour of offenders. Prisoners are more likely to suffer from health-related issues when compared to the general population. Health coaching has been shown to influence health outcomes of patients with chronic conditions. This review, therefore, aims to assess the effectiveness of health coaching interventions on the health of adolescent and adult offenders in custodial institutions. We plan to conduct a systematic review of the current literature on health coaching interventions delivered in the prison setting. We will include randomised controlled trials and observational studies that compare health coaching to the usual care or other alternative interventions. The ideal interventions will be delivered either by health professionals or peer coaches, and the outcomes extracted in the data collection will be disease-specific, clients' life and self-management skills, behavioural and psychosocial outcomes. If appropriate, a meta-analysis of the data collected will be carried out on the last stage of the review. This systematic review will identify and gather evidence on the impact of health coaching interventions delivered in the prison setting and can function as a supporting material for health professionals, prison staff, the healthcare system, and public health departments when considering delivering health coaching. PROSPERO CRD42016053237 .

  10. Impact of a Telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized trial study protocol

    PubMed Central

    2014-01-01

    Background Pediatric rheumatic diseases have a significant impact on children’s quality of life and family functioning. Disease control and management of the symptoms are important to minimize disability and pain. Specialist clinical nurses play a key role in supporting medical teams, recognizing poor disease control and the need for treatment changes, providing a resource to patients on treatment options and access to additional support and advice, and identifying best practices to achieve optimal outcomes for patients and their families. This highlights the importance of investigating follow-up telenursing (TN) consultations with experienced, specialist clinical nurses in rheumatology to provide this support to children and their families. Methods/Design This randomized crossover, experimental longitudinal study will compare the effects of standard care against a novel telenursing consultation on children’s and family outcomes. It will examine children below 16 years old, recently diagnosed with inflammatory rheumatic diseases, who attend the pediatric rheumatology outpatient clinic of a tertiary referral hospital in western Switzerland, and one of their parents. The telenursing consultation, at least once a month, by a qualified, experienced, specialist nurse in pediatric rheumatology will consist of providing affective support, health information, and aid to decision-making. Cox’s Interaction Model of Client Health Behavior serves as the theoretical framework for this study. The primary outcome measure is satisfaction and this will be assessed using mixed methods (quantitative and qualitative data). Secondary outcome measures include disease activity, quality of life, adherence to treatment, use of the telenursing service, and cost. We plan to enroll 56 children. Discussion The telenursing consultation is designed to support parents and children/adolescents during the course of the disease with regular follow-up. This project is novel because it is based

  11. INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.

    PubMed

    Bogaerts, Annick; Ameye, Lieveke; Bijlholt, Margriet; Amuli, Kelly; Heynickx, Dorine; Devlieger, Roland

    2017-05-26

    Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large

  12. [The research protocol IV: study variables].

    PubMed

    Villasís-Keever, Miguel Ángel; Miranda-Novales, María Guadalupe

    2016-01-01

    The variables in a research study are all that is measured, the information collected, or the data that is collected in order to answer the research questions, which are specified in the objectives. Their selection is essential to the research protocol. This article aims to point out the elements to be considered in the section of the variables. To avoid ambiguity, it is necessary to select only those that will help achieve the study objectives. It should subsequently be defined how they will be measured to ensure that the findings can be replicated; it is therefore desirable to include conceptual and operational definitions. From the methodological point of view, the classification of variables helps us understand how the relationship between them is conceptualized. Depending on the study design, the independent, dependent, universal, and confounding variables should be noted. Another indispensable element for planning statistical analyses is the scale of variable measurement. Therefore, one must specify whether the variables correspond to one of the following four: qualitative nominal, qualitative ordinal, quantitative range, or quantitative ratio. Finally, we should detail the measurement units of each variable.

  13. Policies and protocols for preventing transmission of HIV infection in oral health care in South Africa.

    PubMed

    Ogunbodede, E O; Rudolph, M J

    2002-12-01

    Human immunodeficiency virus (HIV) infection constitutes an unparalleled public health challenge. The unique nature of most oral health procedures, instrumentation and patient-care settings requires specific strategies and protocols aimed at preventing the transmission of HIV/AIDS between oral health care providers and patients, as well as between patients themselves. The present study investigated the level of information and training about protocols and policies for preventing the transmission of HIV/AIDS in oral health care settings in South Africa. The data collection techniques utilised available information, in-depth interviews and an open-ended questionnaire. The respondents were 20 purposively selected key informants who were senior officers for HIV/AIDS programmes and/or oral health organisations. Sixteen (80%) of the respondents reported that there were no existing oral health policies on HIV/AIDS in their health care institutions or organisations. None of the interviewees knew of any specific protocols on HIV/AIDS in the oral health care setting that emanated from South Africa. In addition, none of the dental professional associations had established an infection control committee or a support system for members who might become infected with HIV and develop AIDS. Territorial boundaries existed between sectors within the medical disciplines, as well as between the medical and oral health disciplines. Numerous general impediments were identified, such as prejudice, denial and fear, inadequate training and/or information about the infection, lack of representation and resources for policy planning, a lack of interest from the business sector, and approaching HIV/AIDS in the workplace as a 'one-time issue' Other obstacles identified included unemployment, poverty, illiteracy, disempowerment of women and inadequate communication of policies to service providers. Additional issues raised included the migrant labour systeM, complexities of language and culture

  14. Influence of the day care, home and neighbourhood environment on young children's physical activity and health: protocol for the PLAYCE observational study

    PubMed Central

    Christian, Hayley; Maitland, Clover; Enkel, Stephanie; Trapp, Georgina; Trost, Stewart G; Schipperijn, Jasper; Boruff, Bryan; Lester, Leanne; Rosenberg, Michael; Zubrick, Stephen R

    2016-01-01

    Introduction The early years are a critical period in a child's health and development, yet most preschool children fail to meet physical activity guidelines. Outside of the home and neighbourhood, children spend a large proportion of time within early childhood education and care (ECEC) services such as long day care. Research is required to determine how the design of day care outdoor (and indoor) spaces provides opportunities or constraints for physical activity. A significant evidence gap surrounds what objectively measured attributes of the home and neighbourhood environment influence preschoolers’ physical activity. The PLAY Spaces & Environments for Children's Physical Activity (PLAYCE) study will empirically investigate the relative and cumulative influence of the day care, home and neighbourhood environment on preschoolers’ physical activity. Methods and analysis The PLAYCE study is a cross-sectional observational study (April 2015 to April 2018) of 2400 children aged 2–5 years attending long day care in metropolitan Perth, Western Australia. Accelerometers will measure physical activity with indoor physical activity measured using radio frequency identification. Global positioning systems will be used to determine outdoor location of physical activity around the home and neighbourhood for a subsample (n=310). The day care environment will be objectively measured using a validated audit tool. Other potential individual, social and physical environmental influences on preschoolers’ physical activity will be collected by geographic information systems measures, parent and day care educator surveys. Ethics and dissemination Ethical approval has been granted by The University of Western Australia Human Ethics Research Committee, approval number RA/4/1/7417. Findings will be published in international peer-reviewed journals and presented at international conferences. Key findings will be disseminated to stakeholders, collaborators, policymakers and

  15. Influence of the day care, home and neighbourhood environment on young children's physical activity and health: protocol for the PLAYCE observational study.

    PubMed

    Christian, Hayley; Maitland, Clover; Enkel, Stephanie; Trapp, Georgina; Trost, Stewart G; Schipperijn, Jasper; Boruff, Bryan; Lester, Leanne; Rosenberg, Michael; Zubrick, Stephen R

    2016-12-08

    The early years are a critical period in a child's health and development, yet most preschool children fail to meet physical activity guidelines. Outside of the home and neighbourhood, children spend a large proportion of time within early childhood education and care (ECEC) services such as long day care. Research is required to determine how the design of day care outdoor (and indoor) spaces provides opportunities or constraints for physical activity. A significant evidence gap surrounds what objectively measured attributes of the home and neighbourhood environment influence preschoolers' physical activity. The PLAY Spaces & Environments for Children's Physical Activity (PLAYCE) study will empirically investigate the relative and cumulative influence of the day care, home and neighbourhood environment on preschoolers' physical activity. The PLAYCE study is a cross-sectional observational study (April 2015 to April 2018) of 2400 children aged 2-5 years attending long day care in metropolitan Perth, Western Australia. Accelerometers will measure physical activity with indoor physical activity measured using radio frequency identification. Global positioning systems will be used to determine outdoor location of physical activity around the home and neighbourhood for a subsample (n=310). The day care environment will be objectively measured using a validated audit tool. Other potential individual, social and physical environmental influences on preschoolers' physical activity will be collected by geographic information systems measures, parent and day care educator surveys. Ethical approval has been granted by The University of Western Australia Human Ethics Research Committee, approval number RA/4/1/7417. Findings will be published in international peer-reviewed journals and presented at international conferences. Key findings will be disseminated to stakeholders, collaborators, policymakers and practitioners working in the ECEC sector. Day care centre directors

  16. The role of academic health centres in building equitable health systems: a systematic review protocol.

    PubMed

    Edelman, Alexandra; Taylor, Judy; Ovseiko, Pavel V; Topp, Stephanie M

    2017-05-29

    Academic health centres (AHCs) are complex organisations often defined by their 'tripartite' mission: to achieve high standards of clinical care, undertake clinical and laboratory research and educate health professionals. In the last decade, AHCs have moved away from what was a dominant focus on high impact (clinical) interventions for individuals, towards a more population-oriented paradigm requiring networked institutions and responsiveness to a range of issues including distribution of health outcomes and health determinants. Reflective of this paradigm shift is a growing interest in the role of AHCs in addressing health disparities and improving health system equity. This protocol outlines a systematic review that seeks to synthesise and critically appraise the current state of evidence on the role of AHCs in contributing to equitable health systems locally and globally. Electronic searches will be conducted on a pilot list of bibliographic databases, including Google Scholar, Scopus, MEDLINE, PsycInfo, CINAHL, ERIC, ProQuest Dissertations & Theses, Cochrane Library, Evidence Based Medicine Reviews, Campbell Library and A+ Education, from 1 January 2000 to 31 December 2016. Apart from studies reporting clinical interventions or trials, all types of published peer-reviewed and grey literature will be included in the review. The single screening method will be employed in selecting studies, with two additional reviewers consulted where allocation is unclear. Quality and relevance appraisal utilising Joanna Briggs Institute critical appraisal tools will follow data extraction to a preprepared template. Thematic synthesis will be undertaken to develop descriptive themes and inform analysis. As the review is focused on the analysis of secondary data, it does not require ethics approval. The results of the study will be disseminated through articles in peer-reviewed journals and trade publications as well as presentations at relevant national and international

  17. Improving the management of behaviour that challenges associated with dementia in care homes: protocol for pharmacy-health psychology intervention feasibility study.

    PubMed

    Maidment, Ian D; Shaw, Rachel L; Killick, Kirsty; Damery, Sarah; Hilton, Andrea; Wilcock, Jane; Barnes, Nigel; Brown, Graeme; Gillespie, Sarah; Fox, Chris; Barton, Garry; Iliffe, Steve; Seare, Nichola

    2016-03-23

    The inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to other equally dangerous psychotropics. Little is known about the role of pharmacists in the management of psychotropics used to treat behaviours that challenge. This research aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy-health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in care home residents with dementia. 6 care homes within the West Midlands will be recruited. People with dementia receiving medication for behaviour that challenges, or their personal consultee, will be approached regarding participation. Medication used to treat behaviour that challenges will be reviewed by the pharmacist, in collaboration with the general practitioner (GP), person with dementia and carer. The behavioural intervention consists of a training package for care home staff and GPs promoting person-centred care and treating behaviours that challenge as an expression of unmet need. The primary outcome measure is the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Other outcomes include quality of life (EQ-5D and DEMQoL), cognition (sMMSE), health economic (CSRI) and prescribed medication including whether recommendations were implemented. Outcome data will be collected at 6 weeks, and 3 and 6 months. Pretraining and post-training interviews will explore stakeholders' expectations and experiences of the intervention. Data will be used to estimate the sample size for a definitive study. The project has received a favourable opinion from the East Midlands REC (15/EM/3014). If potential participants lack capacity, a personal consultee will be consulted regarding participation in line

  18. Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial.

    PubMed

    Morjaria, Priya; Bastawrous, Andrew; Murthy, Gudlavalleti Venkata Satyanarayana; Evans, Jennifer; Gilbert, Clare

    2017-04-08

    Uncorrected refractive errors are the commonest cause of visual loss in children despite spectacle correction being highly cost-effective. Many affected children do not benefit from correction as a high proportion do not wear their spectacles. Reasons for non-wear include parental attitudes, overprescribing and children being teased/bullied. Most school programmes do not provide health education for affected children, their peers, teachers or parents. The Portable Eye Examination Kit (Peek) will be used in this study. Peek has applications for measuring visual acuity with software for data entry and sending automated messages to inform providers and parents. Peek also has an application which simulates the visual blur of uncorrected refractive error (SightSim). The hypothesis is that higher proportion of children with uncorrected refractive errors in schools allocated to the Peek educational package will wear their spectacles 3-4 months after they are dispensed, and a higher proportion of children identified with other eye conditions will access services, compared with schools receiving standard school screening. Cluster randomized, double-masked trial of children with and without uncorrected refractive errors or other eye conditions. Government schools in Hyderabad, India will be allocated to intervention (Peek) or comparator (standard programme) arms before vision screening. In the intervention arm Peek will be used for vision screening, SightSim images will be used in classroom teaching and will be taken home by children, and voice messages will be sent to parents of children requiring spectacles or referral. In both arms the same criteria for recruitment, prescribing and dispensing spectacles will be used. After 3-4 months children dispensed spectacles will be followed up to assess spectacle wear, and uptake of referrals will be ascertained. The cost of developing and delivering the Peek package will be assessed. The cost per child wearing their spectacles or

  19. Beyond communication: the role of standardized protocols in a changing health care environment.

    PubMed

    Vardaman, James M; Cornell, Paul; Gondo, Maria B; Amis, John M; Townsend-Gervis, Mary; Thetford, Carol

    2012-01-01

    Communication errors have grave consequences in health care settings. The situation-background-assessment-recommendation (SBAR) protocol has been theorized to improve communication by creating a common language between nurses and physicians in acute care situations. This practice is gaining acceptance across the health care field. However, as yet, there has been little investigation of the ways in which SBAR may have an impact on how health care professionals operate beyond the creation of a common language. The purposes of the study were to explore the implementation of the SBAR protocol and investigate the potential impact of SBAR on the day-to-day experiences of nurses. We performed a qualitative case study of 2 hospitals that were implementing the SBAR protocol. We collected data from 80 semistructured interviews with nurses, nurse manager, and physicians; observation of nursing and other hospital activities; and documents that pertained to the implementation of the SBAR protocol. Data were analyzed using a thematic approach. Our analysis revealed 4 dimensions of impact that SBAR has beyond its use as a communication tool: schema formation, development of legitimacy, development of social capital, and reinforcement of dominant logics. The results indicate that SBAR may function as more than a tool to standardize communication among nurses and physicians. Rather, the findings indicate that SBAR may aid in schema development that allows rapid decision making by nurses, provide social capital and legitimacy for less-tenured nurses, and reinforce a move toward standardization in the nursing profession. Our findings further suggest that standardized protocols such as SBAR may be a cost-effective method for hospital managers and administrators to accelerate the socialization of nurses, particularly new hires.

  20. Mindfulness-based cognitive therapy (MBCT) versus the health-enhancement program (HEP) for adults with treatment-resistant depression: a randomized control trial study protocol.

    PubMed

    Eisendrath, Stuart J; Gillung, Erin P; Delucchi, Kevin L; Chartier, Maggie; Mathalon, Daniel H; Sullivan, Jude C; Segal, Zindel V; Feldman, Mitchell D

    2014-03-11

    Major depressive disorder (MDD) is the leading cause of disability in the developed world, yet broadly effective treatments remain elusive. Up to 40% of patients with depression are unresponsive to at least two trials of antidepressant medication and thus have "treatment-resistant depression" (TRD). There is an urgent need for cost-effective, non-pharmacologic, evidence-based treatments for TRD. Mindfulness-Based Cognitive Therapy (MBCT) is an effective treatment for relapse prevention and residual depression in major depression, but has not been previously studied in patients with TRD in a large randomized trial. The purpose of this study was to evaluate whether MBCT is an effective augmentation of antidepressants for adults with MDD who failed to respond to standard pharmacotherapy. MBCT was compared to an active control condition, the Health-Enhancement Program (HEP), which incorporates physical activity, functional movement, music therapy and nutritional advice. HEP was designed as a comparator condition for mindfulness-based interventions to control for non-specific effects. Originally investigated in a non-clinical sample to promote stress reduction, HEP was adapted for a depressed population for this study. Individuals age 18 and older with moderate to severe TRD, who failed to respond to at least two trials of antidepressants in the current episode, were recruited to participate. All participants were taking antidepressants (Treatment as usual; TAU) at the time of enrollment. After signing an informed consent, participants were randomly assigned to either MBCT or HEP condition. Participants were followed for 1 year and assessed at weeks 1-7, 8, 24, 36, and 52. Change in depression severity, rate of treatment response and remission after 8 weeks were the primary outcomes measured by the clinician-rated Hamilton Depression Severity Rating (HAM-D) 17-item scale. The participant-rated Quick Inventory of Depression Symptomology (QIDS-SR) 16-item scale was the

  1. Impact of peer-led quality improvement networks on quality of inpatient mental health care: study protocol for a cluster randomized controlled trial.

    PubMed

    Aimola, Lina; Jasim, Sarah; Tripathi, Neeraj; Tucker, Sarah; Worrall, Adrian; Quirk, Alan; Crawford, Mike J

    2016-09-21

    Quality improvement networks are peer-led programmes in which members of the network assess the quality of care colleagues provide according to agreed standards of practice. These networks aim to help members identify areas of service provision that could be improved and share good practice. Despite the widespread use of peer-led quality improvement networks, there is very little information about their impact. We are conducting a cluster randomized controlled trial of a quality improvement network for low-secure mental health wards to examine the impact of membership on the process and outcomes of care over a 12 month period. Standalone low secure units in England and Wales that expressed an interest in joining the quality improvement network were recruited for the study from 2012 to 2014. Thirty-eight units were randomly allocated to either the active intervention (participation in the network n = 18) or a control arm (delayed participation in the network n = 20). Using a 5 % significance level and 90 % power, it was calculated that a sample size of 60 wards was required taking into account a 10 % drop out. A total of 75 wards were assessed at baseline and 8 wards dropped out the study before the data collection at follow up. Researchers masked to the allocation status of the units assessed all study outcomes at baseline and follow-up 12 months later. The primary outcome is the quality of the physical environment and facilities on the wards. The secondary outcomes are: safety of the ward, patient-rated satisfaction with care and mental well-being, staff burnout, training and supervision. Relative to control wards, it is hypothesized that the quality of the physical environment and facilities will be higher on wards in the active arm of the trial 12 months after randomization. To our knowledge, this is the first randomized evaluation of a peer-led quality improvement network that has examined the impact of participation on both patient-level and

  2. Effect of a program of short bouts of exercise on bone health in adolescents involved in different sports: the PRO-BONE study protocol.

    PubMed

    Vlachopoulos, Dimitris; Barker, Alan R; Williams, Craig A; Knapp, Karen M; Metcalf, Brad S; Gracia-Marco, Luis

    2015-04-11

    Osteoporosis is a skeletal disease associated with high morbidity, mortality and increased economic costs. Early prevention during adolescence appears to be one of the most beneficial practices. Exercise is an effective approach for developing bone mass during puberty, but some sports may have a positive or negative impact on bone mass accrual. Plyometric jump training has been suggested as a type of exercise that can augment bone, but its effects on adolescent bone mass have not been rigorously assessed. The aims of the PRO-BONE study are to: 1) longitudinally assess bone health and its metabolism in adolescents engaged in osteogenic (football), non-osteogenic (cycling and swimming) sports and in a control group, and 2) examine the effect of a 9 month plyometric jump training programme on bone related outcomes in the sport groups. This study will recruit 105 males aged 12-14 years who have participated in sport specific training for at least 3 hours per week during the last 3 years in the following sports groups: football (n = 30), cycling (n = 30) and swimming (n = 30). An age-matched control group (n = 15) that does not engage in these sports more than 3 hours per week will also be recruited. Participants will be measured on 5 occasions: 1) at baseline; 2) after 12 months of sport specific training where each sport group will be randomly allocated into two sub-groups: intervention group (sport + plyometric jump training) and sport group (sport only); 3) exactly after the 9 months of intervention; 4) 6 months following the intervention; 5) 12 months following the intervention. Body composition (dual energy X-ray absorptiometry, air displacement plethysmography and bioelectrical impedance), bone stiffness index (ultrasounds), physical activity (accelerometers), diet (24 h recall questionnaire), pubertal maturation (Tanner stage), physical fitness (cardiorespiratory and muscular), bone turnover markers and vitamin D will be measured at each visit. The PRO

  3. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Downing Jr, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

    2016-01-01

    Background Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. Objective To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Methods Sex Positive![+] is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Results Participant recruitment began in June 2015 and ended in December 2015. Conclusions This protocol

  4. Developing a Video-Based eHealth Intervention for HIV-Positive Gay, Bisexual, and Other Men Who Have Sex with Men: Study Protocol for a Randomized Controlled Trial.

    PubMed

    Hirshfield, Sabina; Downing, Martin J; Parsons, Jeffrey T; Grov, Christian; Gordon, Rachel J; Houang, Steven T; Scheinmann, Roberta; Sullivan, Patrick S; Yoon, Irene S; Anderson, Ian; Chiasson, Mary Ann

    2016-06-17

    Gay, bisexual, and other men who have sex with men (GBMSM) accounted for 67% of new US human immunodeficiency virus (HIV) infections in 2012; however, less than 40% of HIV-positive GBMSM are virally suppressed. Preventing transmission from virally unsuppressed men who have condomless anal sex (CAS) with serodiscordant partners is a public health imperative. New HIV infections in GBMSM are attributed in part to online access to sex partners; therefore, low-cost eHealth interventions are a unique opportunity to reach men where they meet partners. To describe the protocol of a randomized controlled trial evaluating whether video-based messaging delivered online may lead to reductions in serodiscordant CAS and increased HIV disclosure. Sex Positive!([+]) is a two-arm, phase III, video-based randomized controlled trial delivered online to GBMSM living with HIV. Participants in the intervention arm receive 10 video vignettes grounded in social learning and social cognitive theories that are designed to elicit critical thinking around issues of HIV transmission and disclosure. Participants in the attention control arm receive 10 video vignettes that focus on healthy living. All videos are optimized for mobile viewing. The study protocol includes five online assessments conducted over a 1-year period among 1500 US white, black, or Hispanic/Latino GBMSM living with HIV who report suboptimal antiretroviral therapy (ART) adherence or a detectable viral load in the past 12 months and recent CAS (past 6 months) with HIV-negative or unknown status male partners. Compared to the control arm, we hypothesize that men who watch the intervention videos will report at 12-month follow-up significantly fewer serodiscordant CAS partners, increased HIV disclosure, and improved social cognition (eg, condom use self-efficacy, perceived responsibility). Participant recruitment began in June 2015 and ended in December 2015. This protocol describes the underlying theoretical framework and

  5. Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) Study: formative protocol for mHealth platform development and piloting.

    PubMed

    Gonsalves, Lianne; L'Engle, Kelly L; Tamrat, Tigest; Plourde, Kate F; Mangone, Emily R; Agarwal, Smisha; Say, Lale; Hindin, Michelle J

    2015-08-07

    There is a high unmet need for sexual and reproductive health (SRH) information and services among youth (ages 15-24) worldwide (MacQuarrie KLD. Unmet Need for Family Planning among Young Women: Levels and Trends 2014). With the proliferation of mobile technology, and its popularity with this age group, mobile phones offer a novel and accessible platform for a discreet, on-demand service providing SRH information. The Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) formative study will inform the development of an intervention, which will use the popular channel of SMS (text messages) to deliver SRH information on-demand to youth. Following the development of potential SMS message content in partnership with SRH technical experts and youth, formative research activities will take place over two phases. Phase 1 will use focus group discussions (FGDs) with youth and parents/caregivers to develop and test the appropriateness and acceptability of the SMS messages. Phase 2 will consist of 'peer piloting', where youth participants will complete an SRH outcome-focused pretest, be introduced to the system and then have three weeks to interact with the system and share it with friends. Participants will then return to complete the SRH post-test and participate in an in-depth interview about their own and their peers' opinions and experiences using ARMADILLO. The ARMADILLO formative stage will culminate in the finalization of country-specific ARMADILLO messaging. Reach and impact of ARMADILLO will be measured at later stages. We anticipate that the complete ARMADILLO platform will be scalable, with the potential for national-level adoption.

  6. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    PubMed

    Saeki, Keigo; Obayashi, Kenji; Nishi, Tomo; Miyata, Kimie; Maruoka, Shinji; Ueda, Tetsuo; Okamoto, Masahiro; Hasegawa, Taiji; Matsuura, Toyoaki; Tone, Nobuhiro; Ogata, Nahoko; Kurumatani, Norio

    2014-12-29

    Light information is the most important cue of circadian rhythm which synchronizes biological rhythm with external environment. Circadian misalignment of biological rhythm and external environment is associated with increased risk of depression, insomnia, obesity, diabetes, cardiovascular disease, and cancer. Increased light transmission by cataract surgery may improve circadian misalignment and related health outcomes. Although some observational studies have shown improvement of depression and insomnia after cataract surgery, randomized controlled trials are lacking. We will conduct a parallel-group, assessor-blinded, simple randomized controlled study comparing a cataract surgery group at three months after surgery with a control group to determine whether cataract surgery improves depressive symptoms, sleep quality, body mass regulation, and glucose and lipid metabolism. We will recruit patients who are aged 60 years and over, scheduled to receive their first cataract surgery, and have grade 2 or higher nuclear opacification as defined by the lens opacities classification system III. Exclusion criteria will be patients with major depression, severe corneal opacity, severe glaucoma, vitreous haemorrhage, proliferative diabetic retinopathy, macular oedema, age-related macular degeneration, and patients needing immediate or combined cataract surgery. After baseline participants will be randomized to two groups. Outcomes will be measured at three months after surgery among the intervention group, and three months after baseline among the control group. We will assess depressive symptoms as a primary outcome, using the short version geriatric depression scale (GDS-15). Secondary outcomes will be subjective and actigraph-measured sleep quality, sleepiness, glycated haemoglobin, fasting plasma glucose and triglyceride, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, body mass index, abdominal circumference, circadian rhythms of physical

  7. How do community health committees contribute to capacity building for maternal and child health? A realist evaluation protocol

    PubMed Central

    McAuliffe, Eilish; Larkan, Fiona; Conteh, Magnus; Dunne, Nicola; Gaudrault, Michele; Mollel, Henry; Tumwesigye, Nazarius Mbona; Vallières, Frédérique

    2016-01-01

    Introduction The proposed research is part of ongoing operations research within World Vision's Access: Infant and Maternal Health Programme. This study aims to identify key context features and underlying mechanisms through which community health committees build community capacity within the field of maternal and child health. This may help to improve programme implementation by providing contextually informed and explanatory findings for how community health committees work, what works best and for whom do they work for best for. Though frequently used within health programmes, little research is carried out on such committees’ contribution to capacity building—a frequent goal or proposed outcome of these groups. Methods and analysis The scarce information that does exist often fails to explain ‘how, why, and for whom’ these committees work best. Since such groups typically operate within or as components of complex health interventions, they require a systems thinking approach and design, and thus so too does their evaluation. Using a mixed methods realist evaluation with intraprogramme case studies, this protocol details a proposed study on community health committees in rural Tanzania and Uganda to better understand underlying mechanisms through which these groups work (or do not) to build community capacity for maternal and child health. This research protocol follows the realist evaluation methodology of eliciting initial programme theories, to inform the field study design, which are detailed within. Thus far, the methodology of a realist evaluation has been well suited to the study of community health committees within these contexts. Implications for its use within these contexts are discussed within. Ethics and dissemination Institutional Review Boards and the appropriate research clearance bodies within Ireland, Uganda and Tanzania have approved this study. Planned dissemination activities include via academic and programme channels, as well as

  8. Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial.

    PubMed

    Newton, Amanda S; Wozney, Lori; Bagnell, Alexa; Fitzpatrick, Eleanor; Curtis, Sarah; Jabbour, Mona; Johnson, David; Rosychuk, Rhonda J; Young, Michael; Ohinmaa, Arto; Joyce, Anthony; McGrath, Patrick

    2016-01-29

    There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected

  9. HEALTH-SCREENING PROTOCOLS FOR VINACEOUS AMAZONS (AMAZONA VINACEA) IN A REINTRODUCTION PROJECT.

    PubMed

    Saidenberg, André B S; Zuniga, Eveline; Melville, Priscilla A; Salaberry, Sandra; Benites, Nilson R

    2015-12-01

    Reintroduction is a growing field in the conservation of endangered species. The vinaceous Amazon parrot (Amazona vinacea) is extinct in several areas, and a project to release confiscated individuals to their former range is currently underway. The objective of this study was to evaluate and improve the selection and treatment of individual release candidates by detecting possible pathogen carriers using samples taken before and during release. As part of prerelease health protocols, samples were obtained from 29 parrots on three different occasions while in captivity and once after their release. Samples were screened for paramyxovirus type 1, avian influenza, poxvirus, coronavirus, psittacine herpesvirus 1, Chlamydia psittaci , enteropathogenic Escherichia coli (EPEC), Salmonella spp., and endoparasites. The majority of samples returned negative results, with the exception of two individuals that tested positive for C. psittaci in the first sampling and for Ascaridia spp. in the second pooled sampling. Treatments for C. psittaci and endoparasites were administered prior to release, and negative results were obtained in subsequent exams. The number of positive results for E. coli (non-EPEC) decreased during the rehabilitation period. Adequate quarantine procedures and health examinations greatly minimize disease risks. The protocols employed in this study resulted in acceptable health status in accordance with current environmental legislation in Brazil. Additionally, protocols allowed informed decisions to release candidates, minimized risks, and favored the selection of healthy individuals, thereby contributing to the recovery of this species. It is important to determine appropriate minimum health-screening protocols when advanced diagnostics may not be available or high costs make the tests prohibitive in countries where confiscations occur. We hypothesize that a minimum panel of tests of pooled samples can serve as an alternative approach that minimizes