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Sample records for health study protocol

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

    Science.gov (United States)

    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. Study protocol for the Fukushima health management survey

    International Nuclear Information System (INIS)

    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

  3. Study protocol

    DEFF Research Database (Denmark)

    Smith, Benjamin E; Hendrick, Paul; Bateman, Marcus

    2017-01-01

    avoidance behaviours, catastrophising, self-efficacy, sport and leisure activity participation, and general quality of life. Follow-up will be 3 and 6 months. The analysis will focus on descriptive statistics and confidence intervals. The qualitative components will follow a thematic analysis approach....... DISCUSSION: This study will evaluate the feasibility of running a definitive large-scale trial on patients with patellofemoral pain, within the NHS in the UK. We will identify strengths and weaknesses of the proposed protocol and the utility and characteristics of the outcome measures. The results from...... this study will inform the design of a multicentre trial. TRIAL REGISTRATION: ISRCTN35272486....

  4. Health effects of smoke from planned burns: a study protocol

    Directory of Open Access Journals (Sweden)

    David O’Keeffe

    2016-02-01

    Full Text Available Abstract Background Large populations are exposed to smoke from bushfires and planned burns. Studies investigating the association between bushfire smoke and health have typically used hospital or ambulance data and been done retrospectively on large populations. The present study is designed to prospectively assess the association between individual level health outcomes and exposure to smoke from planned burns. Methods/design A prospective cohort study will be conducted during a planned burn season in three locations in Victoria (Australia involving 50 adult participants who undergo three rounds of cardiorespiratory medical tests, including measurements for lung inflammation, endothelial function, heart rate variability and markers of inflammation. In addition daily symptoms and twice daily lung function are recorded. Outdoor particulate air pollution is continuously measured during the study period in these locations. The data will be analysed using mixed effect models adjusting for confounders. Discussion Planned burns depend on weather conditions and dryness of ‘fuels’ (i.e. forest. It is potentially possible that no favourable conditions occur during the study period. To reduce the risk of this occurring, three separate locations have been identified as having a high likelihood of planned burn smoke exposure during the study period, with the full study being rolled out in two of these three locations. A limitation of this study is exposure misclassification as outdoor measurements will be conducted as a measure for personal exposures. However this misclassification will be reduced as participants are only eligible if they live in close proximity to the monitors.

  5. Regional South Australia Health (RESONATE) survey: study protocol

    Science.gov (United States)

    Jones, Martin; Gillam, Marianne; May, Esther

    2018-01-01

    Introduction Access to quality healthcare services is considered a moral right. However, for people living in regional locations, timely access to the services that they need may not always be possible because of structural and attitudinal barriers. This suggests that people living in regional areas may have unmet healthcare needs. The aim of this research will be to examine the healthcare needs, expectations and experiences of regional South Australians. Methods and analysis The Regional South Australia Health (RESONATE) survey is a cross-sectional study of adult health consumers living in any private or non-private dwelling, in any regional, rural, remote or very remote area of South Australia and with an understanding of written English. Data will be collected using a 45-item, multidimensional, self-administered instrument, designed to measure healthcare need, barriers to healthcare access and health service utilisation, attitudes, experiences and satisfaction. The instrument has demonstrated acceptable psychometric properties, including good content validity and internal reliability, good test–retest reliability and a high level of acceptability. The survey will be administered online and in hard-copy, with at least 1832 survey participants to be recruited over a 12-month period, using a comprehensive, multimodal recruitment campaign. Ethics and dissemination The study has been reviewed and approved by the Human Research Ethics Committee of the University of South Australia. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media, broadcast media, print media, the internet and various community/stakeholder engagement activities. PMID:29654014

  6. Study protocol: Evaluating the impact of a rural Australian primary health care service on rural health

    Directory of Open Access Journals (Sweden)

    Buykx Penny

    2011-03-01

    Full Text Available Abstract Background Rural communities throughout Australia are experiencing demographic ageing, increasing burden of chronic diseases, and de-population. Many are struggling to maintain viable health care services due to lack of infrastructure and workforce shortages. Hence, they face significant health disadvantages compared with urban regions. Primary health care yields the best health outcomes in situations characterised by limited resources. However, few rigorous longitudinal evaluations have been conducted to systematise them; assess their transferability; or assess sustainability amidst dynamic health policy environments. This paper describes the study protocol of a comprehensive longitudinal evaluation of a successful primary health care service in a small rural Australian community to assess its performance, sustainability, and responsiveness to changing community needs and health system requirements. Methods/Design The evaluation framework aims to examine the health service over a six-year period in terms of: (a Structural domains (health service performance; sustainability; and quality of care; (b Process domains (health service utilisation and satisfaction; and (c Outcome domains (health behaviours, health outcomes and community viability. Significant international research guided the development of unambiguous reliable indicators for each domain that can be routinely and unobtrusively collected. Data are to be collected and analysed for trends from a range of sources: audits, community surveys, interviews and focus group discussions. Discussion This iterative evaluation framework and methodology aims to ensure the ongoing monitoring of service activity and health outcomes that allows researchers, providers and administrators to assess the extent to which health service objectives are met; the factors that helped or hindered achievements; what worked or did not work well and why; what aspects of the service could be improved and how

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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. ©Leming Zhou, Jie Bao, Bambang Parmanto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 01.08.2017.

  9. Study protocol

    DEFF Research Database (Denmark)

    Thorsteinsson, Troels; Helms, Anne Sofie; Adamsen, Lis

    2013-01-01

    , and problems related to interaction with peers. Methods/design The RESPECT study is a nationwide population-based prospective, controlled, mixed-methods intervention study looking at children aged 6-18 years newly diagnosed with cancer in eastern Denmark (n = 120) and a matched control group in western Denmark......, and one year after the cessation of treatment. The study is powered to quantify the impact of the combined educational, physical, and social intervention programs. Discussion RESPECT is the first population-based study to examine the effect of early rehabilitation for children with cancer, and to use...

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    Youness El Achhab

    2016-11-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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.

  12. The world health organization multicountry survey on maternal and newborn health: study protocol

    Directory of Open Access Journals (Sweden)

    Souza João

    2011-10-01

    Full Text Available Abstract Background Effective interventions to reduce mortality and morbidity in maternal and newborn health already exist. Information about quality and performance of care and the use of critical interventions are useful for shaping improvements in health care and strengthening the contribution of health systems towards the Millennium Development Goals 4 and 5. The near-miss concept and the criterion-based clinical audit are proposed as useful approaches for obtaining such information in maternal and newborn health care. This paper presents the methods of the World Health Organization Multicountry Study in Maternal and Newborn Health. The main objectives of this study are to determine the prevalence of maternal near-miss cases in a worldwide network of health facilities, evaluate the quality of care using the maternal near-miss concept and the criterion-based clinical audit, and develop the near-miss concept in neonatal health. Methods/Design This is a large cross-sectional study being implemented in a worldwide network of health facilities. A total of 370 health facilities from 29 countries will take part in this study and produce nearly 275,000 observations. All women giving birth, all maternal near-miss cases regardless of the gestational age and delivery status and all maternal deaths during the study period comprise the study population. In each health facility, medical records of all eligible women will be reviewed during a data collection period that ranges from two to three months according to the annual number of deliveries. Discussion Implementing the systematic identification of near-miss cases, mapping the use of critical evidence-based interventions and analysing the corresponding indicators are just the initial steps for using the maternal near-miss concept as a tool to improve maternal and newborn health. The findings of projects using approaches similar to those described in this manuscript will be a good starter for a more

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

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract 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

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

    Directory of Open Access Journals (Sweden)

    Susanne Kobel

    2017-01-01

    Full Text Available 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.

  15. Health care access for rural youth on equal terms? A mixed methods study protocol in northern Sweden.

    Science.gov (United States)

    Goicolea, Isabel; Carson, Dean; San Sebastian, Miguel; Christianson, Monica; Wiklund, Maria; Hurtig, Anna-Karin

    2018-01-11

    The purpose of this paper is to propose a protocol for researching the impact of rural youth health service strategies on health care access. There has been no published comprehensive assessment of the effectiveness of youth health strategies in rural areas, and there is no clearly articulated model of how such assessments might be conducted. The protocol described here aims to gather information to; i) Assess rural youth access to health care according to their needs, ii) Identify and understand the strategies developed in rural areas to promote youth access to health care, and iii) Propose actions for further improvement. The protocol is described with particular reference to research being undertaken in the four northernmost counties of Sweden, which contain a widely dispersed and diverse youth population. The protocol proposes qualitative and quantitative methodologies sequentially in four phases. First, to map youth access to health care according to their health care needs, including assessing horizontal equity (equal use of health care for equivalent health needs,) and vertical equity (people with greater health needs should receive more health care than those with lesser needs). Second, a multiple case study design investigates strategies developed across the region (youth clinics, internet applications, public health programs) to improve youth access to health care. Third, qualitative comparative analysis of the 24 rural municipalities in the region identifies the best combination of conditions leading to high youth access to health care. Fourth, a concept mapping study involving rural stakeholders, care providers and youth provides recommended actions to improve rural youth access to health care. The implementation of this research protocol will contribute to 1) generating knowledge that could contribute to strengthening rural youth access to health care, as well as to 2) advancing the application of mixed methods to explore access to health care.

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

    Science.gov (United States)

    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.

  17. An mHealth Framework to Improve Birth Outcomes in Benue State, Nigeria: A Study Protocol.

    Science.gov (United States)

    Ezeanolue, Echezona Edozie; Gbadamosi, Semiu Olatunde; Olawepo, John Olajide; Iwelunmor, Juliet; Sarpong, Daniel; Eze, Chuka; Ogidi, Amaka; Patel, Dina; Onoka, Chima

    2017-05-26

    The unprecedented coverage of mobile technology across the globe has led to an increase in the use of mobile health apps and related strategies to make health information available at the point of care. These strategies have the potential to improve birth outcomes, but are limited by the availability of Internet services, especially in resource-limited settings such as Nigeria. Our primary objective is to determine the feasibility of developing an integrated mobile health platform that is able to collect data from community-based programs, embed collected data into a smart card, and read the smart card using a mobile phone-based app without the need for Internet access. Our secondary objectives are to determine (1) the acceptability of the smart card among pregnant women and (2) the usability of the smart card by pregnant women and health facilities in rural Nigeria. We will leverage existing technology to develop a platform that integrates a database, smart card technology, and a mobile phone-based app to read the smart cards. We will recruit 300 pregnant women with one of the three conditions-HIV, hepatitis B virus infection, and sickle cell trait or disease-and four health facilities in their community. We will use Glasgow's Reach, Effectiveness, Adoption, Implementation, and Maintenance framework as a guide to assess the implementation, acceptability, and usability of the mHealth platform. We have recruited four health facilities and 300 pregnant women with at least one of the eligible conditions. Over the course of 3 months, we will complete the development of the mobile health platform and each participant will be offered a smart card; staff in each health facility will receive training on the use of the mobile health platform. Findings from this study could offer a new approach to making health data from pregnant women available at the point of delivery without the need for an Internet connection. This would allow clinicians to implement evidence

  18. Multi-level analysis of electronic health record adoption by health care professionals: A study protocol

    Directory of Open Access Journals (Sweden)

    Labrecque Michel

    2010-04-01

    Full Text Available Abstract Background The electronic health record (EHR is an important application of information and communication technologies to the healthcare sector. EHR implementation is expected to produce benefits for patients, professionals, organisations, and the population as a whole. These benefits cannot be achieved without the adoption of EHR by healthcare professionals. Nevertheless, the influence of individual and organisational factors in determining EHR adoption is still unclear. This study aims to assess the unique contribution of individual and organisational factors on EHR adoption in healthcare settings, as well as possible interrelations between these factors. Methods A prospective study will be conducted. A stratified random sampling method will be used to select 50 healthcare organisations in the Quebec City Health Region (Canada. At the individual level, a sample of 15 to 30 health professionals will be chosen within each organisation depending on its size. A semi-structured questionnaire will be administered to two key informants in each organisation to collect organisational data. A composite adoption score of EHR adoption will be developed based on a Delphi process and will be used as the outcome variable. Twelve to eighteen months after the first contact, depending on the pace of EHR implementation, key informants and clinicians will be contacted once again to monitor the evolution of EHR adoption. A multilevel regression model will be applied to identify the organisational and individual determinants of EHR adoption in clinical settings. Alternative analytical models would be applied if necessary. Results The study will assess the contribution of organisational and individual factors, as well as their interactions, to the implementation of EHR in clinical settings. Conclusions These results will be very relevant for decision makers and managers who are facing the challenge of implementing EHR in the healthcare system. In addition

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

    Science.gov (United States)

    Boschman, Julitta S; van der Molen, Henk F; van Duivenbooden, Cor; Sluiter, Judith K; Frings-Dresen, Monique H W

    2011-09-29

    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. 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. This study will allow an evaluation of the behaviour of both the workers and occupational physician regarding the preventive actions undertaken by them within the scope of a job

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

    Directory of Open Access Journals (Sweden)

    Sluiter Judith K

    2011-09-01

    Full Text Available Abstract 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

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

    Science.gov (United States)

    Quanbeck, Andrew R; Gustafson, David H; Marsch, Lisa A; McTavish, Fiona; Brown, Randall T; Mares, Marie-Louise; Johnson, Roberta; Glass, Joseph E; Atwood, Amy K; McDowell, Helene

    2014-05-29

    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. 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 protocol) methods, and assessment of

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

    OpenAIRE

    Furberg, Robert D; Ortiz, Alexa M; 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. Obj...

  3. Transitions of Care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study: A study of protocols in Greater London

    Directory of Open Access Journals (Sweden)

    Ford Tamsin

    2008-06-01

    Full Text Available Abstract Background Although young people's transition from Child and Adolescent Mental Health Services (CAMHS to Adult Mental Health Services (AMHS in England is a significant health issue for service users, commissioners and providers, there is little evidence available to guide service development. The TRACK study aims to identify factors which facilitate or impede effective transition from CAHMS to AMHS. This paper presents findings from a survey of transition protocols in Greater London. Methods A questionnaire survey (Jan-April 2005 of Greater London CAMHS to identify transition protocols and collect data on team size, structure, transition protocols, population served and referral rates to AMHS. Identified transition protocols were subjected to content analysis. Results Forty two of the 65 teams contacted (65% responded to the survey. Teams varied in type (generic/targeted/in-patient, catchment area (locality-based, wider or national and transition boundaries with AMHS. Estimated annual average number of cases considered suitable for transfer to AMHS, per CAMHS team (mean 12.3, range 0–70, SD 14.5, n = 37 was greater than the annual average number of cases actually accepted by AMHS (mean 8.3, range 0–50, SD 9.5, n = 33. In April 2005, there were 13 active and 2 draft protocols in Greater London. Protocols were largely similar in stated aims and policies, but differed in key procedural details, such as joint working between CAHMS and AMHS and whether protocols were shared at Trust or locality level. While the centrality of service users' involvement in the transition process was identified, no protocol specified how users should be prepared for transition. A major omission from protocols was procedures to ensure continuity of care for patients not accepted by AMHS. Conclusion At least 13 transition protocols were in operation in Greater London in April 2005. Not all protocols meet all requirements set by government policy. Variation in

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

    Directory of Open Access Journals (Sweden)

    Patrick DL

    2006-01-01

    Full Text Available Abstract 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

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

    Science.gov (United States)

    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.

  6. Social media for health promotion in diabetes: study protocol for a participatory public health intervention design.

    Science.gov (United States)

    Gabarron, E; Bradway, M; Fernandez-Luque, L; Chomutare, T; Hansen, A H; Wynn, R; Årsand, E

    2018-06-05

    Participatory health approaches are increasingly drawing attention among the scientific community, and could be used for health promotion programmes on diabetes through social media. The main aim of this project is to research how to best use social media to promote healthy lifestyles with and within the Norwegian population. The design of the health promotion intervention (HPI) will be participatory, and will involve both a panel of healthcare experts and social media users following the Norwegian Diabetes Association. The panel of experts will agree on the contents by following the Delphi method, and social media users will participate in the definition of the HPI by expressing their opinions through an adhoc online questionnaire. The agreed contents between both parties to be used in the HPI will be posted on three social media channels (Facebook, Twitter and Instagram) along 24 months. The 3 months before starting the HPI, and the 3 months after the HPI will be used as control data. The effect of the HPI will be assessed by comparing formats, frequency, and reactions to the published HPI messages, as well as comparing potential changes in five support-intended communication behaviours expressed on social media, and variations in sentiment analysis before vs during and after the HPI. The HPI's effect on social media users' health-related lifestyles, online health behaviours, and satisfaction with the intervention will be assessed every 6 months through online questionnaires. A separate questionnaire will be used to assess the panel of experts' satisfaction and perceptions of the benefits for health professionals of a HPI as this one. The time constraints of today's medical practice combined with the piling demand of chronic conditions such as diabetes make any additional request of extra time used by health care professionals a challenge. Social media channels provide efficient, ubiquitous and user-friendly platforms that can encourage participation

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

    Directory of Open Access Journals (Sweden)

    2010-05-01

    Full Text Available Abstract 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

  8. Defining antimicrobial stewardship competencies for undergraduate health professional education in the United Kingdom: A study protocol.

    Science.gov (United States)

    Courtenay, Molly; Castro-Sánchez, Enrique; Deslandes, Rhian; Hodson, Karen; Lim, Rosemary; Morris, Gary; Reeves, Scott; Weiss, Marjorie

    2018-04-16

    Multi-drug resistant infections have been identified as one of the greatest threats to human health. Healthcare professionals are involved in an array of patient care activities for which an understanding of antimicrobial stewardship is important. Although antimicrobial prescribing and stewardship competencies have been developed for healthcare professionals who adopt the role of a prescriber, competencies do not exist for other medicine-related stewardship activities. Undergraduate education provides an ideal opportunity to prepare healthcare professionals for these roles and activities. This report presents a protocol for a study designed to provide national consensus on antimicrobial stewardship competencies appropriate for undergraduate healthcare professional education. A modified Delphi process will be used in which a panel of Experts, comprising members from across the United Kingdom, with expertise in prescribing and medicines management with regard to the education and practice of healthcare professionals, and antimicrobial prescribing and stewardship, will be invited to take part in two survey rounds. The competencies developed will be applicable to all undergraduate healthcare professional education programmes. They will help to standardise curricula content and enhance the impact of antimicrobial stewardship education.

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

    Science.gov (United States)

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

    2017-04-13

    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. 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. 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 mortality as an outcome

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

    Directory of Open Access Journals (Sweden)

    Gunn Caroline A

    2013-01-01

    Full Text Available Abstract 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

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

    Directory of Open Access Journals (Sweden)

    Fenlon Deborah

    2012-04-01

    Full Text Available Abstract 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.

  12. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    OpenAIRE

    Mustila, Taina; Keskinen, Päivi; Luoto, Riitta

    2012-01-01

    Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The con...

  13. Study Protocol - an exploratory trial on health promoting schools at Dutch secondary schools

    Directory of Open Access Journals (Sweden)

    Vincent Busch

    2012-07-01

    Full Text Available Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural domains simultaneously via a combination of education, creating a healthy environment and introducing healthy behavioural policies. Additionally, extensive partnerships are formed between schools, parents, neighbourhoods and youth health authorities to coordinate health promotion efforts.Study design and data collection methods: The intervention will be implemented at two secondary schools. Results will be compared with two control schools (n≈1500. The intervention's effectiveness in changing student behaviours as well as physical and psychosocial health status along with qualitative lessons learned on the integration of youth health care services and school health education practices are the main aimed outcomes of this study. Data are collected via a mixed methods design combining an annual youth health (behaviour monitor with a qualitative process evaluation via interviews with key stakeholders.Data analysis: A multilevel analysis is performed combined with a systematic analysis of qualitative interview data.Conclusions: This study will produce an evaluation of a comprehensive health promoting school intervention that combines an integrated approach of schools, neighbourhoods, families and youth health services to improve adolescent health.

  14. Study Protocol- An exploratory trial on health promoting schools at Dutch secondary schools

    NARCIS (Netherlands)

    Busch, Vincent; Leeuw, Rob J. de; Schrijvers, A.J.P.

    2012-01-01

    Background: Recent studies show adolescent health-related behaviours to co-occur synergistically. This paper describes the study design for an exploratory trial on the effects of a comprehensive, whole-school health promoting school intervention. This intervention tackles seven different behavioural

  15. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    LENUS (Irish Health Repository)

    Moorhead, Anne

    2011-03-31

    Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices\\/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups\\' ability to identify body weight status in both adults and children. The health professional groups are: (a) community related public health nurses; (b) school public health nurses; (c) GPs and practice nurses (primary care); and (d) occupational health nurses (workplace) from both Northern Ireland and the Republic of Ireland. Methods\\/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based) - to determine the attitudes, current practices\\/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals\\' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices\\/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

  16. Weight Care Project: Health professionals' attitudes and ability to assess body weight status - Study protocol

    Directory of Open Access Journals (Sweden)

    Murphy Kathy

    2011-03-01

    Full Text Available Abstract Background Health professionals working in primary care and public health have opportunities to address body weight status issues with their patients through face-to-face contact. The objectives of this all-Ireland project are: 1. to assess the attitudes, current practices/behaviours and knowledge of key health professional groups on body weight status; 2. to assess the health professional groups' ability to identify body weight status in both adults and children. The health professional groups are: (a community related public health nurses; (b school public health nurses; (c GPs and practice nurses (primary care; and (d occupational health nurses (workplace from both Northern Ireland and the Republic of Ireland. Methods/Design This all-Ireland multi-disciplinary project follows a mixed methods approach using both quantitative and qualitative methodologies, and consists of four components: 1. Literature review - to explore the role of health professionals in managing obesity through spontaneous intervention in a variety of health promotion settings. 2. Telephone interviews and focus groups - to gain an in-depth insight into the views of health professionals in assessing body weight status. 3. Survey (primarily online but also paper-based - to determine the attitudes, current practices/behaviours and knowledge of health professionals in assessing body weight status. 4. Online evaluation study - an online interactive programme will be developed to assess health professionals' ability to identify the body weight status of adults and children. Discussion This project will assess and report the attitudes, current practices/behaviours and knowledge of key health professional groups within Northern Ireland and the Republic of Ireland on body weight status, and their ability to identify body weight status in both adults and children. The results of this project will generate recommendations for clinical practice in managing obesity, which may

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

    Directory of Open Access Journals (Sweden)

    Campo Osaba Maria-Antonia

    2012-03-01

    Full Text Available Abstract 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

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

    Directory of Open Access Journals (Sweden)

    Sidney Kristi

    2012-08-01

    Full Text Available Abstract Background 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 (JSYand 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. Methods/designs 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. Discussion 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

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    McDermott Robyn

    2010-05-01

    Full Text Available Abstract 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

  1. Promoting Self-Regulation in Health Among Vulnerable Brazilian Children: Protocol Study

    Directory of Open Access Journals (Sweden)

    Luciana B. Mattos

    2018-05-01

    Full Text Available The Health and Education Ministries of Brazil launched the Health in School Program (Programa Saúde na Escola - PSE in 2007. The purpose of the PSE is two-fold: articulate the actions of the education and health systems to identify risk factors and prevent them; and promote health education in the public elementary school system. In the health field, the self-regulation (SR construct can contribute to the understanding of life habits which can affect the improvement of individuals' health. This research aims to present a program that promotes SR in health (SRH. This program (PSRH includes topics on healthy eating and oral health from the PSE; it is grounded on the social cognitive framework and uses story tools to train 5th grade Brazilian students in SRH. The study consists of two phases. In Phase 1, teachers and health professionals participated in a training program on SRH, and in Phase 2, they will be expected to conduct an intervention in class to promote SRH. The participants were randomly assigned into three groups: the Condition I group followed the PSE program, the Condition II group followed the PSRH (i.e., PSE plus the SRH program, and the control group (CG did not enroll in either of the health promotion programs. For the baseline of the study, the following measures and instruments were applied: Body Mass Index (BMI, Simplified Oral Hygiene Index (OHI-S, Previous Day Food Questionnaire (PFDQ, and Declarative Knowledge for Health Instrument. Data indicated that the majority are eutrophic children, but preliminary outcomes showed high percentages of children that are overweight, obese and severely obese. Moreover, participants in all groups reported high consumption of ultraprocessed foods (e.g., soft drinks, artificial juices, and candies. Oral health data from the CI and CII groups showed a prevalence of regular oral hygiene, while the CG presented good oral hygiene. The implementation of both PSE and PSRH are expected to help

  2. Publication trends of study protocols in rehabilitation.

    Science.gov (United States)

    Jesus, Tiago S; Colquhoun, Heather L

    2017-09-04

    Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved

  3. Measurement of health system performance at district level: A study protocol

    Directory of Open Access Journals (Sweden)

    Atul Sharma

    2018-01-01

    Full Text Available Background: Limited efforts have been observed in low and middle income countries to undertake health system performance assessment at district level. Absence of a comprehensive data collection tool and lack of a standardised single summary measure defining overall performance are some of the main problems. Present study has been undertaken to develop a summary composite health system performance index at district level. Methods: A broad range of indicators covering all six domains as per building block framework were finalized by an expert panel. The domains were classified into twenty sub-domains, with 70 input and process indicators to measure performance. Seven sub-domains for assessing health system outputs and outcomes were identified, with a total of 28 indicators. Districts in Haryana state from north India were selected for the study. Primary and secondary data will be collected from 378 health facilities, district and state health directorate headquarters. Indicators will be normalized, aggregated to generate composite performance index at district level. Domain specific scores will present the quality of individual building block domains in the public health system. Robustness of the results will be checked using sensitivity analysis. Expected impact for public health: The study presents a methodology for comprehensive assessment of all health system domains on basis of input, process, output and outcome indicators which has never been reported from India. Generation of this index will help identify policy and implementation areas of concern and point towards potential solutions. Results may also help understand relationships between individual building blocks and their sub-components.

  4. Built to last? The sustainability of health system improvements, interventions and change strategies: a study protocol for a systematic review.

    Science.gov (United States)

    Braithwaite, Jeffrey; Testa, Luke; Lamprell, Gina; Herkes, Jessica; Ludlow, Kristiana; McPherson, Elise; Campbell, Margie; Holt, Joanna

    2017-11-12

    The sustainability of healthcare interventions and change programmes is of increasing importance to researchers and healthcare stakeholders interested in creating sustainable health systems to cope with mounting stressors. The aim of this protocol is to extend earlier work and describe a systematic review to identify, synthesise and draw meaning from studies published within the last 5 years that measure the sustainability of interventions, improvement efforts and change strategies in the health system. The protocol outlines a method by which to execute a rigorous systematic review. The design includes applying primary and secondary data collection techniques, consisting of a comprehensive database search complemented by contact with experts, and searching secondary databases and reference lists, using snowballing techniques. The review and analysis process will occur via an abstract review followed by a full-text screening process. The inclusion criteria include English-language, peer-reviewed, primary, empirical research articles published after 2011 in scholarly journals, for which the full text is available. No restrictions on location will be applied. The review that results from this protocol will synthesise and compare characteristics of the included studies. Ultimately, it is intended that this will help make it easier to identify and design sustainable interventions, improvement efforts and change strategies. As no primary data were collected, ethical approval was not required. Results will be disseminated in conference presentations, peer-reviewed publications and among policymaker bodies interested in creating sustainable health systems. © 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.

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

    Science.gov (United States)

    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.

  6. Development of a Behavior Change Intervention to Improve Sexual Health Service Use Among University Undergraduate Students: Mixed Methods Study Protocol.

    Science.gov (United States)

    Cassidy, Christine; Steenbeek, Audrey; Langille, Donald; Martin-Misener, Ruth; Curran, Janet

    2017-11-02

    University students are at risk for acquiring sexually transmitted infections and suffering other negative health outcomes. Sexual health services offer preventive and treatment interventions that aim to reduce these infections and associated health consequences. However, university students often delay or avoid seeking sexual health services. An in-depth understanding of the factors that influence student use of sexual health services is needed to underpin effective sexual health interventions. In this study, we aim to design a behavior change intervention to address university undergraduate students' use of sexual health services at two universities in Nova Scotia, Canada. This mixed methods study consists of three phases that follow a systematic approach to intervention design outlined in the Behaviour Change Wheel. In Phase 1, we examine patterns of sexual health service use among university students in Nova Scotia, Canada, using an existing dataset. In Phase 2, we identify the perceived barriers and enablers to students' use of sexual health services. This will include focus groups with university undergraduate students, health care providers, and university administrators using a semistructured guide, informed by the Capability, Opportunity, Motivation-Behaviour Model and Theoretical Domains Framework. In Phase 3, we identify behavior change techniques and intervention components to develop a theory-based intervention to improve students' use of sexual health services. This study will be completed in March 2018. Results from each phase and the finalized intervention design will be reported in 2018. Previous intervention research to improve university students' use of sexual health services lacks a theoretical assessment of barriers. This study will employ a mixed methods research design to examine university students' use of sexual health service and apply behavior change theory to design a theory- and evidence-based sexual health service intervention. Our

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

    Directory of Open Access Journals (Sweden)

    Voils Corrine I

    2012-08-01

    Full Text Available Abstract 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

  8. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  9. A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol.

    Science.gov (United States)

    Hargraves, J Lee; Bonollo, Debra; Person, Sharina D; Ferguson, Warren J

    2018-04-12

    Uncontrolled hypertension is a significant public health problem in the U.S. with about one half of people able to keep blood pressure (BP) under control. Uncontrolled hypertension leads to increased risk of stroke, heart attack, and death. Furthermore, the social and economic costs of poor hypertension control are staggering. People living with hypertension can benefit from additional educational outreach and support. This randomized trial conducted at two Community Health Centers (CHCs) in Massachusetts assessed the effect of community health workers (CHWs) assisting patients with hypertension. In addition to the support provided by CHWs, the study uses video narratives from patients who have worked to control their BP through diet, exercise, and better medication adherence. Participants enrolled in the study were randomly assigned to immediate intervention (I) by CHWs or a delayed intervention (DI) (4 to 6 months later). Each participant was asked to meet with the CHW 5 times (twice in person and three times telephonically). Study outcomes include systolic and diastolic BP, diet, exercise, and body mass index. CHWs working directly with patients, using multiple approaches to support patient self-management, can be effective agents to support change in chronic illness management. Moreover, having culturally appropriate tools, such as narratives available through videos, can be an important, cost effective aid to CHWs. Recruitment and intervention delivery within a busy CHC environment required adaptation of the study design and protocols for staff supervision, data collection and intervention delivery and lessons learned are presented. Clinical Trials.gov registration submitted 8/17/16: Protocol ID# 5P60MD006912-02 and Clinical trials.gov ID# NCT02874547 Community Health Workers Using Patient Stories to Support Hypertension Management. Copyright © 2018. Published by Elsevier Inc.

  10. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol.

    Science.gov (United States)

    Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max

    2012-03-22

    With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a

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

    OpenAIRE

    Gamboa Delgado, Edna M; Rojas S?nchez, Lyda Z; Bermon Angarita, Anderson; Rangel D?az, Yully Andrea; Jaraba Su?rez, Silvia J; Serrano D?az, Norma C; Vega Fern?ndez, Evaristo

    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 orde...

  12. Factors influencing psychological, social and health outcomes after major burn injuries in adults: cohort study protocol.

    Science.gov (United States)

    Druery, Martha; Newcombe, Peter A; Cameron, Cate M; Lipman, Jeffrey

    2017-06-17

    The goal of burn care is that 'the quality of the outcome must be worth the pain of survival'. More research is needed to understand how best to deliver care for patients with burns to achieve this aim. Loss of independence, function as well as loss of income for patients with burns and carers cause a significant burden at both individual and societal levels. Much is being done to advance knowledge in the clinical care field; however, there has been a paucity of research exploring psychosocial outcomes. This paper describes the study background and methods, as implemented in an Australian cohort study of psychosocial outcomes after major burn injuries. In this inception cohort study, a target sample of 230 participants, aged 18 years or over, admitted to a single statewide burns centre with a burn injury are identified by hospital staff for inclusion. Baseline survey data are collected either in person or by telephone within 28 days of the injury and participants then followed up with telephone interviews at 3, 6 and 12 months postburn. Injury and burns treatment information is collected from medical records. Social support is measured as a predictor variable using the Multidimensional Scale of Perceived Social Support. Outcome data are collected via standardised measures in the domains of Quality of Life (SF-12, EQ-5D, BSHS-B), depression (PHQ-9), post-traumatic stress disorder (PCL-C, PAS), community integration (CIQ-R) and Quality-Adjusted Life Years (EQ-5D). Additional survey questions measure life satisfaction, return to work and public services utilisation at 12 months postinjury. Data analysis methods will include analysis of variance, Pearson correlation and hierarchical multiple regression analyses. Hospital-based and University of Queensland Human Research Ethics Committees have approved the protocol. Results from the study will be disseminated at national and international conferences, in peer-reviewed journals and in a doctoral thesis. Australia New

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

    Directory of Open Access Journals (Sweden)

    Magaji Bello

    2012-09-01

    Full Text Available Abstract 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

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

    Science.gov (United States)

    Magaji, Bello Arkilla; Moy, Foong Ming; Roslani, April Camilla; Sagap, Ismail; Zakaria, Jasiah; Blazeby, Jane M; Law, Chee Wei

    2012-09-03

    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. 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. 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.

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

    Science.gov (United States)

    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.

  16. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol

    Directory of Open Access Journals (Sweden)

    Chisholm Katharine

    2012-03-01

    Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors

  17. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK

    Directory of Open Access Journals (Sweden)

    Wedderkopp Niels

    2012-08-01

    Full Text Available Abstract Background An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the ‘normal’ schools of the region using the design of a “natural experiment”. Methods Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. Discussion This project is embedded in a local community, which set up the intervention (The Sport Schools and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the ‘normal’ schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese could be relatively small. Therefore, results specific to minority groups may be

  18. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK).

    Science.gov (United States)

    Wedderkopp, Niels; Jespersen, Eva; Franz, Claudia; Klakk, Heidi; Heidemann, Malene; Christiansen, Christina; Møller, Niels Christian; Leboeuf-Yde, Charlotte

    2012-08-20

    An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the 'normal' schools of the region using the design of a "natural experiment". Children from the age of 6 till the age of 10, who accepted to be included in the monitoring process, were surveyed at baseline with questionnaires, physical examinations and physical and biological testing, including DXA scans. The physical examination and testing was repeated during the early stage of the study. Every week over the whole study period, the children will be followed with an automated mobile phone text message (SMS-Track) asking questions on their leisure time sports activities and the presence of any musculoskeletal problems. Children who report any such problems are monitored individually by health care personnel. Data are collected on demography, health habits and attitudes, physical characteristics, physical activity using accelerometers, motor performance, fitness, bone health, life-style disorders, injuries and musculoskeletal problems. Data collection will continue at least once a year until the children reach grade 9. This project is embedded in a local community, which set up the intervention (The Sport Schools) and thereafter invited researchers to provide documentation and evaluation. Sport schools are well matched with the 'normal' schools, making comparisons between these suitable. However, subgroups that would be specifically targeted in lifestyle intervention studies (such as the definitely obese) could be relatively small. Therefore, results specific to minority groups may be diluted. Nonetheless, the many rigorously collected data will make

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

    NARCIS (Netherlands)

    Boschman, J.S.; van der Molen, H.F.; van Duivenbooden, C.; Sluiter, J.K.; Frings-Dresen, M.H.W.

    2011-01-01

    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

  20. The ASTUTE Health study protocol: deliberative stakeholder engagements to inform implementation approaches to healthcare disinvestment.

    Science.gov (United States)

    Watt, Amber M; Hiller, Janet E; Braunack-Mayer, Annette J; Moss, John R; Buchan, Heather; Wale, Janet; Riitano, Dagmara E; Hodgetts, Katherine; Street, Jackie M; Elshaug, Adam G

    2012-10-22

    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. 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. 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 the legitimization of broad and

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    Fakoya, Ibidun; 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

    2016-05-16

    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. 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. 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, which were available in 15

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

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

    NARCIS (Netherlands)

    Blijleven, Vincent; Koelemeijer, Kitty; Jaspers, Monique

    2017-01-01

    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

  7. Study protocol. The Childhood Health, Activity, and Motor Performance School Study Denmark (The CHAMPS-study DK)

    DEFF Research Database (Denmark)

    Wedderkopp, Niels; Jespersen, Eva; Franz, Claudia

    2012-01-01

    An increasingly passive life-style in the Western World has led to a rise in life-style related disorders. This is a major concern for all segments of society. The county council of the municipality of Svendborg in Denmark, created six Sport Schools with increased levels of suitable physical...... activities, which made it possible to study the health outcomes in these children whilst comparing them to children who attended the 'normal' schools of the region using the design of a "natural experiment"....

  8. Improving health-related fitness in children: the fit-4-Fun randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Eather Narelle

    2011-12-01

    Full Text Available Abstract Background Declining levels of physical fitness in children are linked to an increased risk of developing poor physical and mental health. Physical activity programs for children that involve regular high intensity physical activity, along with muscle and bone strengthening activities, have been identified by the World Health Organisation as a key strategy to reduce the escalating burden of ill health caused by non-communicable diseases. This paper reports the rationale and methods for a school-based intervention designed to improve physical fitness and physical activity levels of Grades 5 and 6 primary school children. Methods/Design Fit-4-Fun is an 8-week multi-component school-based health-related fitness education intervention and will be evaluated using a group randomized controlled trial. Primary schools from the Hunter Region in NSW, Australia, will be invited to participate in the program in 2011 with a target sample size of 128 primary schools children (age 10-13. The Fit-4-Fun program is theoretically grounded and will be implemented applying the Health Promoting Schools framework. Students will participate in weekly curriculum-based health and physical education lessons, daily break-time physical activities during recess and lunch, and will complete an 8-week (3 × per week home activity program with their parents and/or family members. A battery of six health-related fitness assessments, four days of pedometery-assessed physical activity and a questionnaire, will be administered at baseline, immediate post-intervention (2-months and at 6-months (from baseline to determine intervention effects. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention program, assessments, process evaluation and statistical analyses are described. Discussion The Fit-4-Fun program is an innovative school-based intervention targeting fitness improvements in primary school children. The program will

  9. Improving health-related fitness in children: the Fit-4-Fun randomized controlled trial study protocol.

    Science.gov (United States)

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

    2011-12-05

    Declining levels of physical fitness in children are linked to an increased risk of developing poor physical and mental health. Physical activity programs for children that involve regular high intensity physical activity, along with muscle and bone strengthening activities, have been identified by the World Health Organisation as a key strategy to reduce the escalating burden of ill health caused by non-communicable diseases. This paper reports the rationale and methods for a school-based intervention designed to improve physical fitness and physical activity levels of Grades 5 and 6 primary school children. Fit-4-Fun is an 8-week multi-component school-based health-related fitness education intervention and will be evaluated using a group randomized controlled trial. Primary schools from the Hunter Region in NSW, Australia, will be invited to participate in the program in 2011 with a target sample size of 128 primary schools children (age 10-13). The Fit-4-Fun program is theoretically grounded and will be implemented applying the Health Promoting Schools framework. Students will participate in weekly curriculum-based health and physical education lessons, daily break-time physical activities during recess and lunch, and will complete an 8-week (3 × per week) home activity program with their parents and/or family members. A battery of six health-related fitness assessments, four days of pedometery-assessed physical activity and a questionnaire, will be administered at baseline, immediate post-intervention (2-months) and at 6-months (from baseline) to determine intervention effects. Details of the methodological aspects of recruitment, inclusion criteria, randomization, intervention program, assessments, process evaluation and statistical analyses are described. The Fit-4-Fun program is an innovative school-based intervention targeting fitness improvements in primary school children. The program will involve a range of evidence-based behaviour change strategies to

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

    Science.gov (United States)

    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

  11. Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study

    OpenAIRE

    García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

    2018-01-01

    Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to...

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

    Science.gov (United States)

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

    2017-01-24

    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. 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. 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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

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

    Science.gov (United States)

    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

  14. Iran′s Multiple Indicator Demographic and Health Survey - 2010: Study Protocol

    Directory of Open Access Journals (Sweden)

    Arash Rashidian

    2014-01-01

    Conclusions: IrMIDHS will provide valuable data for policymakers in Iran. Designing and implementation of the study involve contributions from academics as well as program managers and policy makers. The collaborative nature of the study may facilitate better usage of its results.

  15. Behavioral counseling to prevent childhood obesity – study protocol of a pragmatic trial in maternity and child health care

    Directory of Open Access Journals (Sweden)

    Mustila Taina

    2012-07-01

    Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710

  16. Study protocol of a Dutch smoking cessation e-health program

    Directory of Open Access Journals (Sweden)

    Bolman Catherine

    2011-11-01

    Full Text Available Abstract Background The study aims to test the differential effects of a web-based text and a web-based video-driven computer-tailored approach for lower socio-economic status (LSES and higher socio-economic status (HSES smokers which incorporate multiple computer-tailored feedback moments. The two programs differ only in the mode of delivery (video- versus text-based messages. The paper aims to describe the development and design of the two computer-tailored programs. Methods/design Respondents who smoked at the time of the study inclusion, who were motivated to quit within the following six months and who were aged 18 or older were included in the program. The study is a randomized control trial with a 2 (video/text * 2(LSES/HSES design. Respondents were assigned either to one of the intervention groups (text versus video tailored feedback or to the control group (non-tailored generic advice. In all three conditions participants were asked to fill in the baseline questionnaire based on the I-Change model. The questionnaire assessed socio-demographics, attitude towards smoking, knowledge, self-efficacy, social influence, depression, level of addiction, action planning, goal actions, intention to quit smoking, seven-day point prevalence and continued abstinence. Follow-up measurements were conducted at six and twelve months after baseline. Discussion The present paper describes the development of the two computer-tailored smoking cessation programs, their components and the design of the study. The study results reveal different working mechanisms of multiple tailored smoking cessation interventions and will help us to gain more insight into effective strategies to target different subgroups, especially smokers with a lower socio-economic status. Trial registration Dutch Trial Register NTR3102

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

    Science.gov (United States)

    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.

  18. A Peer-Led Electronic Mental Health Recovery App in an Adult Mental Health Service: Study Protocol for a Pilot Trial.

    Science.gov (United States)

    Gulliver, Amelia; Banfield, Michelle; Reynolds, Julia; Miller, Sarah; Galati, Connie; Morse, Alyssa R

    2017-12-07

    There is growing demand for peer workers (people who use their own lived experience to support others in their recovery) to work alongside consumers to improve outcomes and recovery. Augmenting the workforce with peer workers has strong capacity to enhance mental health and recovery outcomes and make a positive contribution to the workforce within mental health systems and to the peer workers themselves. Technology-based applications are highly engaging and desirable methods of service delivery. This project is an exploratory proof-of-concept study, which aims to determine if a peer worker-led electronic mental (e-mental) health recovery program is a feasible, acceptable, and effective adjunct to usual treatment for people with moderate to severe mental illness. The study design comprises a recovery app intervention delivered by a peer worker to individual consumers at an adult mental health service. Evaluation measures will be conducted at post-intervention. To further inform the acceptability and feasibility of the model, consumers will be invited to participate in a focus group to discuss the program. The peer worker, peer supervisor, and key staff at the mental health service will also be individually interviewed to further evaluate the feasibility of the program within the health service and further inform its future development. The program will be delivered over a period of approximately 4 months, commencing June 2017. If the peer worker-led recovery app is found to be feasible, acceptable, and effective, it could be used to improve recovery in mental health service consumers. ©Amelia Gulliver, Michelle Banfield, Julia Reynolds, Sarah Miller, Connie Galati, Alyssa R Morse. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.12.2017.

  19. Occupational radiation exposure and its health effects on interventional medical workers: study protocol for a prospective cohort study.

    Science.gov (United States)

    Ko, Seulki; Chung, Hwan Hoon; Cho, Sung Bum; Jin, Young Woo; Kim, Kwang Pyo; Ha, Mina; Bang, Ye Jin; Ha, Yae Won; Lee, Won Jin

    2017-12-15

    Although fluoroscopically guided procedures involve a considerably high dose of radiation, few studies have investigated the effects of radiation on medical workers involved in interventional fluoroscopy procedures. Previous research remains in the early stages and has not reached a level comparable with other occupational studies thus far. Furthermore, the study of radiation workers provides an opportunity to estimate health risks at low doses and dose rates of ionising radiation. Therefore, the objectives of this study are (1) to initiate a prospective cohort study by conducting a baseline survey among medical radiation workers who involve interventional fluoroscopy procedures and (2) to assess the effect of occupational radiation exposure and on the overall health status through an in-depth cross-sectional study. Intervention medical workers in Korea will be enrolled by using a self-administered questionnaire survey, and the survey data will be linked with radiation dosimetry data, National Health Insurance claims data, cancer registry and mortality data. After merging these data, the radiation organ dose, lifetime attributable risk due to cancer and the risk per unit dose will be estimated. For the cross-sectional study, approximately 100 intervention radiology department workers will be investigated for blood tests, clinical examinations such as ultrasonography (thyroid and carotid artery scan) and lens opacity, the validation of badge dose and biodosimetry. This study was reviewed and approved by the institutional review board of Korea University (KU-IRB-12-12-A-1). All participants will provide written informed consent prior to enrolment. The findings of the study will be disseminated through peer-reviewed scientific journals, conference presentations, and a report will be submitted to the relevant public health authorities in the Korea Centers for Disease Control and Prevention to help with the development of appropriate research and management policies.

  20. World Health Organization "School Mental Health Manual"-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Imran, Nazish; Rahman, Atif; Chaudhry, Nakhshab; Asif, Aftab

    2018-05-24

    The teacher's role in school mental health initiatives cannot be overemphasized. Despite global evidence of educational interventions in improving teachers' knowledge and attitudes regarding mental health, this area remains under researched in Pakistan. This paper presents a study protocol of a pilot randomized controlled trial to examine the effectiveness of a teacher training intervention for improving mental health literacy and self-efficacy among school teachers in urban Lahore, Pakistan. The randomized controlled trial will follow the CONSORT guidelines. Participants will be allocated to the Intervention group (receiving the World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School Mental Health Manual-based intervention in three 6-h, face-to-face sessions) or a waitlist control group (not receiving training during the study period). Participants will be teachers of private schools with similar broad demographic characteristics in an inner city area of Lahore. The primary outcome measures for the trial is teachers' mental health literacy. It will be assessed by using the previously applied (during WHO training of Master Trainers) self-administered questionnaire in both groups pre and post training and at 3 months' follow-up. Secondary outcomes include: for teachers: Teachers' self-efficacy (assessed by the Teachers' Sense of Self Efficacy Scale (TSES) short form.); for students (11-16 years): socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire (assessed at baseline and 3 months post intervention); for schools: the WHO School Psychosocial Profile Questionnaire (baseline and 3 months post intervention). Given the high prevalence of child mental health problems, stigma and lack of services, it is important to consider alternate avenues for promoting positive mental health among youth. This pilot study should establish the effectiveness of the WHO-EMRO School Mental Health Manual

  1. What are the physical and psychological health effects of suicide bereavement on family members? Protocol for an observational and interview mixed-methods study in Ireland.

    LENUS (Irish Health Repository)

    Spillane, Ailbhe

    2017-03-30

    Research indicates that experiencing the suicide of a relative can have a significant impact on family members\\' emotional health. However, research incorporating the impact of suicide bereavement on family members\\' physical health is sparse. This paper details the protocol for a mixed-methods study of suicide-bereaved family members. The study will primarily examine the physical and mental health needs of those bereaved by suicide. A secondary objective of the study is to describe the support service needs of family members bereaved by suicide.

  2. Comparison of Nutrigenomics Technology Interface Tools for Consumers and Health Professionals: Protocol for a Mixed-Methods Study.

    Science.gov (United States)

    Littlejohn, Paula; Cop, Irene; Brown, Erin; Afroze, Rimi; Davison, Karen M

    2018-06-11

    because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the quantitative data have not been analyzed yet, the overwhelming interest in the study and the extremely high retention rate show that there is a great degree of interest in this field. Given this interest and the fact that nutrigenomics is an evolving science, a need for continued research exists to further the understanding of the role of genetic variation and its role and applications in nutrition practice. Clinicaltrials.gov NCT03310814; http://clinicaltrials.gov/ct2/show/NCT03310814 (Archived by WebCite at http://www.webcitation.org/6yGnU5deB). RR1-10.2196/9846. ©Paula Littlejohn, Irene Cop, Erin Brown, Rimi Afroze, Karen M Davison. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.06.2018.

  3. Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

    Science.gov (United States)

    García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

    2018-01-08

    Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for

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

    Science.gov (United States)

    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

  5. The German MultiCare-study: Patterns of multimorbidity in primary health care – protocol of a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Schäfer Ingmar

    2009-08-01

    Full Text Available Abstract Background Multimorbidity is a highly frequent condition in older people, but well designed longitudinal studies on the impact of multimorbidity on patients and the health care system have been remarkably scarce in numbers until today. Little is known about the long term impact of multimorbidity on the patients' life expectancy, functional status and quality of life as well as health care utilization over time. As a consequence, there is little help for GPs in adjusting care for these patients, even though studies suggest that adhering to present clinical practice guidelines in the care of patients with multimorbidity may have adverse effects. Methods/Design The study is designed as a multicentre prospective, observational cohort study of 3.050 patients aged 65 to 85 at baseline with at least three different diagnoses out of a list of 29 illnesses and syndromes. The patients will be recruited in approx. 120 to 150 GP surgeries in 8 study centres distributed across Germany. Information about the patients' morbidity will be collected mainly in GP interviews and from chart reviews. Functional status, resources/risk factors, health care utilization and additional morbidity data will be assessed in patient interviews, in which a multitude of well established standardized questionnaires and tests will be performed. Discussion The main aim of the cohort study is to monitor the course of the illness process and to analyse for which reasons medical conditions are stable, deteriorating or only temporarily present. First, clusters of combinations of diseases/disorders (multimorbidity patterns with a comparable impact (e.g. on quality of life and/or functional status will be identified. Then the development of these clusters over time will be analysed, especially with regard to prognostic variables and the somatic, psychological and social consequences as well as the utilization of health care resources. The results will allow the development of an

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

    Science.gov (United States)

    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

  7. Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Templeman, Iain; Thompson, Dylan; Gonzalez, Javier; Walhin, Jean-Philippe; Reeves, Sue; Rogers, Peter J; Brunstrom, Jeffrey M; Karagounis, Leonidas G; Tsintzas, Kostas; Betts, James A

    2018-02-02

    Prior studies have shown that intermittent fasting is capable of producing improvements in body weight and fasted health markers. However, the extent to which intermittent fasting incurs compensatory changes in the components of energy balance and its impact on postprandial metabolism are yet to be ascertained. A total of 30-36 lean participants and 30-36 overweight/obese participants will be recruited to provide two separate study groups who will undergo the same protocol. Following an initial assessment of basic anthropometry and key health markers, measurements of habitual energy intake (weighed food and fluid intake) and physical activity energy expenditure (combined heart rate and accelerometry) will be obtained over 4 weeks under conditions of energy balance. Participants will then be randomly allocated to one of three experimental conditions for 20 days, namely (1) daily calorie restriction (reduce habitual daily energy intake by 25%), (2) intermittent fasting with calorie restriction (alternate between 24-hour periods of fasting and feeding to 150% of habitual daily energy intake), (3) intermittent fasting without calorie restriction (alternate between 24-hour periods of fasting and feeding to 200% of habitual daily energy intake). In addition to continued monitoring of energy intake and physical activity during the intervention, participants will report for laboratory-based assessments of various metabolic parameters both before and after the intervention. Specifically, fasting and postprandial measurements of resting metabolic rate, substrate oxidation, appetite, food preference, and plasma concentrations of key metabolites and hormones will be made, in addition to subcutaneous abdominal adipose tissue biopsies in the fasted state and an assessment of body composition via dual-energy x-ray absorptiometry. Comparing observed changes in these measures across the three intervention arms in each group will establish the impact of intermittent fasting on

  8. [Protocols for the health surveillance of fisherman].

    Science.gov (United States)

    Soleo, Leonardo; Cannizzaro, Emanuele; Lovreglio, Piero; Basso, Antonella; D'Errico, Maria Nicolà; Pira, Enrico

    2013-01-01

    To define protocols for health surveillance of workers in the marine fishing sector for specific occupational risk factors, considering the latest and most advanced scientific knowledge. The specific literature was analyzed to identify the occupational risk factors to which fishermen are exposed. Then, for each risk factor a protocol for the relative health checkups and their time schedule was defined. The risk factors to which fishermen are exposed are essentially noise, vibrations, solar and ultraviolet radiation, climatic agents (heat, cold, wind, rain, damp), chemical agents, shifts, work rate, night work, physical strain, stress, manual handling of loads, upper limb repetitive tasks, incongruous postures. The health protocols stipulate the health screening investigations to be carried out in all workers of a homogeneous group, and in-depth diagnostic investigations to be carried out in symptomatic workers. Complementary health investigations must be focused on a functional exploration of the organs specifically exposed to the risk factor. For hearing impairments due to noise exposure, the medico-legal measures with which the occupational health physician must comply, in cases of occupational disease, are indicated.

  9. The DOMUS study protocol

    DEFF Research Database (Denmark)

    Nordly, Mie; Benthien, Kirstine Skov; Von Der Maase, Hans

    2014-01-01

    be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges. TRIAL REGISTRATION: Clinicaltrials......BACKGROUND: The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate...... psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options. DISCUSSION: Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can...

  10. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available 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.

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

    Science.gov (United States)

    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

  12. An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Berglind, Daniel; Nyberg, Gisela; Willmer, Mikaela; Persson, Margareta; Wells, Michael; Forsell, Yvonne

    2018-04-27

    Young adults with mobility disability (MD) are less likely to engage in regular physical activity (PA) compared with their able-bodied peers and inactive adults with a MD are more likely to report one or more chronic diseases compared to those who are physically active. Despite the vast amount of research published in the field of PA interventions over the past decades, little attention has been focused on interventions aiming to increase PA among individuals with MD. Thus, we propose to compare the effects of an eHealth program compared to a usual care supervised health program on levels of PA and other health behaviors. The current intervention will use a randomized controlled trial (RCT) design with two treatment groups (an eHealth program and a usual care supervised health program) in young adults with newly acquired MD. In total, 110 young adults (aged 18-40 years) with a MD, acquired within the past 3 years, will be recruited to participate in a 12-week intervention. The primary study outcome is accelerometer-measured time spent in moderate to vigorous PA. Secondary outcomes includes health-related quality of life, depression, stress, fitness, body composition, diet, musculoskeletal pain, motivation to exercise and work ability. There is a lack of RCTs investigating effective ways to increase levels of PA in young adults with MD. Increased levels of PA among this physically inactive population have the potential to substantially improve health-related outcomes, possibly more so than in the general population. The trial will put strong emphasis on optimizing exercise adherence and investigating feasibility in the two treatment programs. The Ethical Review Board (EPN) at Karolinska Institutet has approved the study (2017/1206-31/1). International Standard Randomised Controlled Trial Number (ISRCTN), reference number ISRCTN22387524 . Prospectively registered February 4, 2018.

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

    OpenAIRE

    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

    2016-01-01

    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 Healt...

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

    Science.gov (United States)

    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

  15. Longitudinal measurement of cortisol in association with mental health and experience of domestic violence and abuse: study protocol

    OpenAIRE

    Lokhmatkina, Natalia V; Feder, Gene; Blake, Sarah; Morris, Richard; Powers, Victoria; Lightman, Stafford

    2013-01-01

    Background Domestic violence and abuse is threatening behavior, violence/abuse used by one person to control the other within an intimate or family-type relationship. Women experience more severe physical and sexual domestic violence and abuse and more mental health consequences than men. The current study aims at exploring of the role of hypothalamic-pituitary-adrenocortical axis activity in abuse impact on women's mental health. Study objectives: 1) To evaluate diurnal cortisol slope, corti...

  16. Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ørts, Lene Maria; Løkke, Anders; Bjerregaard, Anne-Louise; Maindal, Helle Terkildsen; Sandbæk, Annelli

    2016-12-01

    Early detection of lung diseases can help to reduce their severity. Lung diseases are among the most frequently occurring and serious diseases worldwide; nonetheless, many patients remain undiagnosed. Preventive health checks including spirometry can detect lung diseases at early stages; however, recruitment for health checks remains a challenge, and little is known about what motivates the attendance. The aim of the study is to examine whether focused information on spirometry in the invitation compared to general information will impact the attendance rate in preventive health checks. This randomized, controlled trial tests the effect of information on spirometry embedded in the Check your Health Preventive Program (CHPP). The CHPP is an open-label, household cluster-randomized, controlled trial offering a preventive health check to 30- to -49-year-olds in a Danish municipality from 2012 to 2017 (n = 26,216). During 2015-2016, 4356 citizens aged 30-49 years will be randomized into two groups. The intervention group receives an invitation which highlights the value and contents of spirometry as part of a health check and information about lung diseases. The comparison group receives a standard invitation containing practical information and specifies the contents of the general health check. Outcomes are (1) differences in attendance rates measured by the proportion of citizens attending each of the two study groups and (2) proportion of persons at risk defined by smoking status and self-reported lung symptoms in the study groups. The proportion of participants with abnormal spirometry assessed at the preventive health check will be compared between the two study groups. The results from the present study will inform future recruitment strategies to health checks. The developed material on content, value, and information about lung disease is feasible and transferable to other populations, making it easy to implement if effective. ClinicalTrials.gov: NCT

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

  19. Protocol for implementing the concept of citizen scientists for HealthWise Wales: a national population study

    Directory of Open Access Journals (Sweden)

    Julia Townson

    2017-04-01

    The concept of HealthWise Champion is agreeable to members of the public but appropriate training and support will need to be provided. Materials will be developed in conjunction with the advisory group members to ensure that HealthWise Wales Champions are able to clearly and confidently disseminate the more difficult elements of the study to others e.g data linkage. An evaluation will be available by July.

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

    Science.gov (United States)

    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.

  1. A prospective cohort study to investigate parental stress and child health in low-income Chinese families: protocol paper.

    Science.gov (United States)

    Wong, Rosa Sze Man; Yu, Esther Yee Tak; Guo, Vivian Yawei; Wan, Eric Yuk-Fai; Chin, Weng-Yee; Wong, Carlos King Ho; Fung, Colman Siu Cheung; Tung, Keith Tsz Suen; Wong, Wilfred Hing-Sang; Ip, Patrick; Tiwari, Agnes Fung Yee; Lam, Cindy Lo Kuen

    2018-02-22

    Chronic stress has adverse effects on health. Adults and children from low-income families are subject to multiple sources of stress. Existing literature about economic hardship mostly focuses on either adults or children but not both. Moreover, there is limited knowledge on the relationship between parental generalised stress and child health problems. This study aims to explore the bidirectional relationship between parental stress and child health in Chinese low-income families and to identify other modifiable factors influencing this relationship. This prospective cohort study will sample 254 low-income parent-child pairs and follow them up for 24 months with assessments at three time points (baseline, 12 and 24 months) on parental stress, health-related quality of life (HRQOL) and child health and behaviour using both subjective measures and objective physiological parameters. This study will collect data using standardised measures on HRQOL and behaviours of children as well as on HRQOL, mental health and stress levels of parents along with physiological tests of allostatic load and telomere length. The mediating or moderating effect of family harmony, parenting style and neighbourhood conditions will also be assessed. Data will be analysed using latent growth modelling and cross-lagged path analysis modelling to examine the bidirectional effect of parental stress and child health over time. Mediation and moderation analysis will also be conducted to examine the mechanism by which the variables relate. This study was approved by the institutional review board of the University of Hong Kong-the Hospital Authority Hong Kong West Cluster, reference no: UW 16-415. The study findings will be disseminated through peer-reviewed publications and international conferences. NCT03185273; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise

  2. Survey of patient and public perceptions of electronic health records for healthcare, policy and research: Study protocol

    Directory of Open Access Journals (Sweden)

    Luchenski Serena

    2012-05-01

    Full Text Available Abstract Background Immediate access to patients’ complete health records via electronic databases could improve healthcare and facilitate health research. However, the possible benefits of a national electronic health records (EHR system must be balanced against public concerns about data security and personal privacy. Successful development of EHR requires better understanding of the views of the public and those most affected by EHR: users of the National Health Service. This study aims to explore the correlation between personal healthcare experience (including number of healthcare contacts and number and type of longer term conditions and views relating to development of EHR for healthcare, health services planning and policy and health research. Methods/design A multi-site cross-sectional self-complete questionnaire designed and piloted for use in waiting rooms was administered to patients from randomly selected outpatients’ clinics at a university teaching hospital (431 beds and general practice surgeries from the four primary care trusts within the catchment area of the hospital. All patients entering the selected outpatients clinics and general practice surgeries were invited to take part in the survey during August-September 2011. Statistical analyses will be conducted using descriptive techniques to present respondents’ overall views about electronic health records and logistic regression to explore associations between these views and participants’ personal circumstances, experiences, sociodemographics and more specific views about electronic health records. Discussion The study design and implementation were successful, resulting in unusually high response rates and overall recruitment (85.5%, 5336 responses. Rates for face-to-face recruitment in previous work are variable, but typically lower (mean 76.7%, SD 20. We discuss details of how we collected the data to provide insight into how we obtained this unusually high

  3. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

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

    Science.gov (United States)

    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

  5. Protocol for investigating genetic determinants of posttraumatic stress disorder in women from the Nurses' Health Study II

    OpenAIRE

    Koenen, Karestan C; DeVivo, Immaculata; Rich-Edwards, Janet; Smoller, Jordan W; Wright, Rosalind J; Purcell, Shaun M

    2009-01-01

    Abstract Background One in nine American women will meet criteria for the diagnosis of posttraumatic stress disorder (PTSD) in their lifetime. Although twin studies suggest genetic influences account for substantial variance in PTSD risk, little progress has been made in identifying variants in specific genes that influence liability to this common, debilitating disorder. Methods and design We are using the unique resource of the Nurses Health Study II, a prospective epidemiologic cohort of 6...

  6. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

    2018-05-11

    Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of

  7. What are the physical and psychological health effects of suicide bereavement on family members? Protocol for an observational and interview mixed-methods study in Ireland.

    Science.gov (United States)

    Spillane, Ailbhe; Larkin, Celine; Corcoran, Paul; Matvienko-Sikar, Karen; Arensman, Ella

    2017-03-30

    Research indicates that experiencing the suicide of a relative can have a significant impact on family members' emotional health. However, research incorporating the impact of suicide bereavement on family members' physical health is sparse. This paper details the protocol for a mixed-methods study of suicide-bereaved family members. The study will primarily examine the physical and mental health needs of those bereaved by suicide. A secondary objective of the study is to describe the support service needs of family members bereaved by suicide. A mixed-methods approach, using semistructured interviews and self-report questionnaires, will be used. Interviews will be conducted with a group of 15-20 relatives who experienced suicide bereavement. This protocol will follow the COREQ checklist criteria for the reporting of qualitative research interviews. Thematic analysis will be used to examine experiences and impact of bereavement on psychological and physical health. Self-report quantitative data on well-being will be analysed using descriptive statistics. Ethical approval to conduct this study has been granted from the Clinical Research Ethics Committee of the Cork Teaching Hospitals. Pseudonyms will be given to participants to protect anonymity. It will be explained to participants that participation in the study is voluntary and they have to right to withdraw at any time. The findings of this research will be disseminated to regional, national and international audiences through publication in peer-reviewed international journals and presentations at scientific conferences. This research also forms part of a PhD thesis. 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/.

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

    Directory of Open Access Journals (Sweden)

    Jull Janet

    2012-12-01

    Full Text Available Abstract 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

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

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    Laan Eva K

    2012-03-01

    Full Text Available Abstract Background 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. Methods/Design 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. Discussion 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. Trial

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

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    Madhu Gupta

    2015-02-01

    Full Text Available 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

  11. 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.

    Science.gov (United States)

    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.

  12. Longitudinal measurement of cortisol in association with mental health and experience of domestic violence and abuse: study protocol.

    Science.gov (United States)

    Lokhmatkina, Natalia V; Feder, Gene; Blake, Sarah; Morris, Richard; Powers, Victoria; Lightman, Stafford

    2013-07-13

    Domestic violence and abuse is threatening behavior, violence/abuse used by one person to control the other within an intimate or family-type relationship. Women experience more severe physical and sexual domestic violence and abuse and more mental health consequences than men. The current study aims at exploring of the role of hypothalamic-pituitary-adrenocortical axis activity in abuse impact on women's mental health. 1) To evaluate diurnal cortisol slope, cortisol awakening response, and the mean cortisol concentration in women with a current or recent experience of abuse; 2) To estimate whether cortisol secretion is associated with type, severity, duration and cessation of abuse; 3) To investigate whether cortisol acts as mediator between abuse and mental health condition; 4) To examine whether there is any distinction in cortisol levels between those women exposed to both childhood abuse and domestic violence and abuse and those experienced only the latter. 4) To explore whether cortisol secretion differs between women living in refuge and those still living in the community. To meet study objectives 128 women will be recruited in a domestic violence agency and local communities. Baseline and 3-month follow-up measures will be taken over 6 months after recruitment. Each assessment will include: (1) standardized self-administered questionnaires to evaluate socio-demographics, experience of violence and abuse, mental and physical health; (2) weight and height measurement; (3) self-completion of wakening, post-wakening and evening saliva samples. Saliva will be analysed for cortisol and cortisone using Ultra performance liquid chromatography-tandem mass spectrometry. We will compare diurnal cortisol parameters between non-abused controls and abuse survivors with and without mental health conditions. First following descriptive statistics for all the cortisol and mental health outcomes, relationships between them will be investigated using appropriate regression

  13. Toward optimal implementation of cancer prevention and control programs in public health: a study protocol on mis-implementation.

    Science.gov (United States)

    Padek, Margaret; Allen, Peg; Erwin, Paul C; Franco, Melissa; Hammond, Ross A; Heuberger, Benjamin; Kasman, Matt; Luke, Doug A; Mazzucca, Stephanie; Moreland-Russell, Sarah; Brownson, Ross C

    2018-03-23

    Much of the cancer burden in the USA is preventable, through application of existing knowledge. State-level funders and public health practitioners are in ideal positions to affect programs and policies related to cancer control. Mis-implementation refers to ending effective programs and policies prematurely or continuing ineffective ones. Greater attention to mis-implementation should lead to use of effective interventions and more efficient expenditure of resources, which in the long term, will lead to more positive cancer outcomes. This is a three-phase study that takes a comprehensive approach, leading to the elucidation of tactics for addressing mis-implementation. Phase 1: We assess the extent to which mis-implementation is occurring among state cancer control programs in public health. This initial phase will involve a survey of 800 practitioners representing all states. The programs represented will span the full continuum of cancer control, from primary prevention to survivorship. Phase 2: Using data from phase 1 to identify organizations in which mis-implementation is particularly high or low, the team will conduct eight comparative case studies to get a richer understanding of mis-implementation and to understand contextual differences. These case studies will highlight lessons learned about mis-implementation and identify hypothesized drivers. Phase 3: Agent-based modeling will be used to identify dynamic interactions between individual capacity, organizational capacity, use of evidence, funding, and external factors driving mis-implementation. The team will then translate and disseminate findings from phases 1 to 3 to practitioners and practice-related stakeholders to support the reduction of mis-implementation. This study is innovative and significant because it will (1) be the first to refine and further develop reliable and valid measures of mis-implementation of public health programs; (2) bring together a strong, transdisciplinary team with

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

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    Sanatinia Rahil

    2012-08-01

    Full Text Available Abstract 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

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

    Science.gov (United States)

    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.

  17. Effectiveness of an Internet-based learning program on venous leg ulcer nursing care in home health care--study protocol.

    Science.gov (United States)

    Ylönen, Minna; Viljamaa, Jaakko; Isoaho, Hannu; Junttila, Kristiina; Leino-Kilpi, Helena; Suhonen, Riitta

    2015-10-01

    To describe the study protocol for a study of the effectiveness of an internet-based learning program on venous leg ulcer nursing care (eVLU) in home health care. The prevalence of venous leg ulcers is increasing as population age. The majority of these patients are treated in a municipal home healthcare setting. However, studies show nurses' lack of knowledge of ulcer nursing care. Quasi-experimental study with pre- and postmeasurements and non-equivalent intervention and comparison groups. During the study, nurses taking care of patients with a chronic leg ulcer in home health care in one Finnish municipality will use the eVLU. Nurses working in home health care in another Finnish municipality will not use it providing standard care. Nurses will complete three questionnaires during the study and they will also be observed three times at patients' homes. Nurses' perceived and theoretical knowledge is the primary outcome of the study. Funding for this study was received from the Finnish Foundation for Nursing Education in 2014. Data from this study will provide information about the effectiveness of an internet-based educational program. After completing the program nurses will be accustomed to using internet-based resources that can aid them in the nursing care of patients with a VLU. Nurses will also have better knowledge of VLU nursing care. This study is registered with the International Clinical Trials Registry, identifier NCT02224300. © 2015 John Wiley & Sons Ltd.

  18. Study protocol for a controlled trial of Strengths Model Case Management in mental health services in Hong Kong.

    Science.gov (United States)

    Tsoi, Wing-See Emily; Tse, Samson; Fukui, Sadaaki; Jones, Steven

    2015-10-06

    Although strengths-based models are popular within recovery-oriented approaches, there is still a lack of conclusive research to guide how they should be implemented. A recent meta-analysis confirmed the lack of clarity in how this perspective is operationalised and that fidelity monitoring during the implementation process is lacking. Hence, there is a clear need to evaluate the feasibility of delivering and evaluating a clearly operationalised strengths-based intervention that incorporates fidelity checks to inform more definitive research. This protocol therefore describes a controlled trial of Strengths Model Case Management (SMCM), a complex intervention, for people with severe mental illnesses in Hong Kong. This trial follows the guidelines of the Medical Research Council as a phase 2 trial. Hence, it is a pilot study that tests the feasibility and effectiveness of the model. This is a 9-month controlled trial that uses the Kansas Model. Participants and a matched control group are recruited on a voluntary basis, after screening for eligibility. Effectiveness of the SMCM will be measured through outcome measures taken at baseline, the mid-point and at the end of the trial. Outcomes for service users include personal recovery, hope, subjective well-being, psychiatric symptoms, perceived level of recovery features within the organisation, therapeutic alliance and achievement of recovery goals. Outcomes for care workers will include job burnout, organisational features of recovery and perceived supervisory support. With a 2×3 analysis of variance design and a moderate intervention effect (Cohen's d=0.50), a total of 86 participants will be needed for a statistical power of 0.80. Ethical approval has been obtained from the Human Research Ethics Committee for Non-Clinical Faculties at The University of Hong Kong (HRECNCF: EA140913). Australian New Zealand Clinical Trial Registry (ACTRN)12613001120763. Published by the BMJ Publishing Group Limited. For permission

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

    Science.gov (United States)

    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

    2014-09-16

    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. 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. 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. 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.

  20. A community-based oral health promotion model for HIV patients in Nairobi, East District in Kenya: a study protocol

    Directory of Open Access Journals (Sweden)

    Lucina N. Koyio

    2013-06-01

    Full Text Available Background: General HIV-related orofacial lesions, most commonly oropharyngeal candidiasis, have a typical clinical appearance and can be recognised by members of the community. Although affected patients often experience pain leading to compromised eating and swallowing, barriers such as social stigma and lack of knowledge regarding available services may prevent them from seeking early care. Educating the community about these lesions through community health workers (CHWs who are democratically elected community members may encourage individuals affected to seek early oral health-care in the health facilities. A health facility (HF is a health centre mainly run by clinical officers (CO, i.e. personnel with a 3-year medical training, and nurses. This study aims to evaluate the effect of a CHW training programme on: i their knowledge and recognition of HIV-related oral-facial lesions at a community level; and ii referral of affected patients from the community to the HFs. Design and Methods: All 800 CHWs in 2 administrative divisions of Nairobi East District (test group n=400; control group n=400 will be selected. The test group will receive training. CHWs in both groups will be assessed at 4 time points: −3, 0, +3 and +6 months with reference to the training on: i their knowledge of HIV-related orofacial lesions (using a written questionnaire; and ii their performance in referring affected patients to the HFs (using clinical data. Expected Impact: Early recognition of HIV-related orofacial lesions at a community level will prompt community members to seek early oral care, leading to early HIV testing and counselling regarding failure of antiretroviral therapy, while treatment outcomes are still favourable.

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

    Science.gov (United States)

    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

  2. Effectiveness of the 'Home-but not Alone' mobile health application educational programme on parental outcomes: a randomized controlled trial, study protocol.

    Science.gov (United States)

    Shorey, Shefaly; Ng, Yvonne Peng Mei; Danbjørg, Dorthe Boe; Dennis, Cindy-Lee; Morelius, Evalotte

    2017-01-01

    The aim of this study was to describe a study protocol that evaluates the effectiveness of the 'Home-but not Alone' educational programme delivered via a mobile health application in improving parenting outcomes. The development in mobile-based technology gives us the opportunity to develop an accessible educational programme that can be potentially beneficial to new parents. However, there is a scarcity of theory-based educational programmes that have incorporated technology such as a mobile health application in the early postpartum period. A randomized controlled trial with a two-group pre-test and post-test design. The data will be collected from 118 couples. Eligible parents will be randomly allocated to either a control group (receiving routine care) or an intervention group (routine care plus access to the 'Home-but not Alone' mobile health application. Outcome measures comprise of parenting self-efficacy, social support, parenting satisfaction and postnatal depression. Data will be collected at the baseline (on the day of discharge) and at four weeks postpartum. This will be an empirical study that evaluates a theory-based educational programme delivered via an innovative mobile health application on parental outcomes. Results from this study will enhance parenting self-efficacy, social support and parenting satisfaction, which may then reduce parental risks of postnatal depression. © 2016 John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    Silvana Mareva

    2016-07-01

    routine HRQoL assessment. The direct comparison of real-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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

  7. Assessing the consequences of gestational diabetes mellitus on offspring's cardiovascular health: MySweetHeart Cohort study protocol, Switzerland.

    Science.gov (United States)

    Di Bernardo, Stefano; Mivelaz, Yvan; Epure, Adina Mihaela; Vial, Yvan; Simeoni, Umberto; Bovet, Pascal; Estoppey Younes, Sandrine; Chiolero, Arnaud; Sekarski, Nicole

    2017-11-14

    Gestational diabetes mellitus (GDM) is a state of glucose intolerance with onset during pregnancy. GDM carries prenatal and perinatal risks as well as long-term risks for the mother and her child. GDM may be involved in the foetal programming of long-term cardiovascular health. However, evidence is sparse and the effect of GDM on cardiovascular health is unknown. To address these issues, we will conduct MySweetHeart Cohort study. The objectives are to assess the effect of GDM on offspring's cardiovascular health early in life by using surrogate markers of cardiovascular disease and atherosclerosis. This is a cohort study of 100 offspring of women with GDM and 100 offspring of women without GDM. At inclusion, a baseline assessment of the mothers will be conducted through means of self-report questionnaires, a researcher-administrated interview, blood pressure and anthropometric measurements, and a maternal blood sampling. Between the 30th and 34th weeks of gestation, a foetal echography will be performed to assess the foetal cardiac structure and function, the fetomaternal circulation and the hepatic volume. At birth, maternal and neonatal characteristics will be assessed. An echocardiography will be performed to assess cardiac structure and function 2-7 days after birth; carotid intima-media thickness will be also measured to assess vascular structure. MySweetHeart Cohort is linked to MySweetHeart Trial (clinicaltrials.gov/ct2/show/NCT02890693), a randomised controlled trial assessing the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardiometabolic and mental health of women with GDM and their offspring. A long-term follow-up of children is planned. Ethical approval has been obtained through the state Human Research Ethics Committee of the Canton de Vaud (study number 2016-00745). We aim to disseminate the findings through regional, national and international conferences and through peer-reviewed journals

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

    Science.gov (United States)

    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

  9. Geriatric study in Europe on health effects of air quality in nursing homes (GERIE study) profile: objectives, study protocol and descriptive data.

    Science.gov (United States)

    Annesi-Maesano, Isabella; Norback, Dan; Zielinski, Jan; Bernard, Alfred; Gratziou, Cristina; Sigsgaard, Torben; Sestini, Piersante; Viegi, Giovanni

    2013-11-21

    Indoor air pollution (IAP) constitutes a major global public health problem requiring increasing efforts in research and policymaking that may have special significance for elderly that are likely to spend most of their day indoors and appear to be particularly susceptible to adverse effects of chemical pollutants and bio-contaminants. Yet, evidence existing on the effects of IAP in elderly is scanty. The Geriatric study in Europe on health effects of air quality in nursing homes (GERIE) study aimed to assess health effects of major indoor air pollutants and thermal conditions in elderly (> 70 years) living stably in nursing homes (NH) across Europe. Respiratory effects were particularly considered as airways and lung constitute the first target of air pollutants. We describe here the rationale and the methods of the GERIE Study. 8 nursing homes were randomly selected in 7 European countries. Twenty individuals were randomly selected in each nursing home. Major indoor and outdoor air chemical pollutants (PM10, PM2.5, PM0.1, formaldehyde, NO2; O3, VOC, CO2) and bio-contaminants (moulds, allergens) were assessed objectively with standardized procedures. Major health status indicators were assessed through a standardized questionnaire, non-invasive clinical tests and blood and urine biomarkers as well as saliva for ADN. The GERIE study has given the opportunity to publish two reviews on respiratory health effects of indoor and outdoor air pollution in elderly. In addition it has provided the inventory of air quality and thermal conditions in 50 nursing homes across Europe and data on respiratory health status in 600 elderly aged 82 years in mean. Major future results will include the relationships between NH environment and health in elderly. The main long-term purpose of the GERIE study is to improve the health of elderly who permanently reside in nursing homes or of those who are exposed to indoor air pollution because of reduced mobility.

  10. Assessing the health effects associated with occupational radiation exposure in Korean radiation workers: protocol for a prospective cohort study.

    Science.gov (United States)

    Seo, Songwon; Lim, Wan Young; Lee, Dal Nim; Kim, Jung Un; Cha, Eun Shil; Bang, Ye Jin; Lee, Won Jin; Park, Sunhoo; Jin, Young Woo

    2018-03-30

    The cancer risk of radiation exposure in the moderate-to-high dose range has been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. Several epidemiological studies of Korean radiation workers have been conducted, but the data were analysed retrospectively in most cases. Moreover, groups with relatively high exposure, such as industrial radiographers, have been neglected. Therefore, we have launched a prospective cohort study of all Korean radiation workers to assess the health effects associated with occupational radiation exposure. Approximately 42 000 Korean radiation workers registered with the Nuclear Safety and Security Commission from 2016 to 2017 are the initial target population of this study. Cohort participants are to be enrolled through a nationwide self-administered questionnaire survey between 24 May 2016 and 30 June 2017. As of 31 March 2017, 22 982 workers are enrolled in the study corresponding to a response rate of 75%. This enrolment will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers. Survey data will be linked with the national dose registry, the national cancer registry, the national vital statistics registry and national health insurance data via personal identification numbers. Age-specific and sex-specific standardised incidence and mortality ratios will be calculated for overall comparisons of cancer risk. For dose-response assessment, excess relative risk (per Gy) and excess absolute risk (per Gy) will be estimated with adjustments for birth year and potential confounders, such as lifestyle factors and socioeconomic status. This study has received ethical approval from the institutional review board of the Korea Institute of Radiological and Medical Sciences (IRB No. K-1603-002-034). All participants provided written informed consent prior to enrolment. The findings

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

    Science.gov (United States)

    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

  12. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

    2015-12-02

    Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results

  13. Health status of and health-care provision to asylum seekers in Germany: protocol for a systematic review and evidence mapping of empirical studies.

    Science.gov (United States)

    Schneider, Christine; Mohsenpour, Amir; Joos, Stefanie; Bozorgmehr, Kayvan

    2014-11-29

    There are more than 100,000 asylum seekers registered in Germany, who are granted limited access to health services. This study aims to provide a systematic overview of the empirical literature on the health status of and health-care provision to asylum seekers in Germany in order to consolidate knowledge, avoid scientific redundance, and identify research gaps. A systematic review and evidence mapping of empirical literature on the health status of and health-care provision to asylum seekers in Germany will be performed. We will apply a three-tiered search strategy: 1. search in databases (PubMed/MEDLINE, Web of Science, IBSS, Sociological Abstracts, Worldwide Political Science Abstracts, CINAHL, Sowiport, Social Sciences Citation Index, ASSIA, MedPilot, DNB), dissertation and theses databases, and the internet (Google); 2. screening references of included studies; 3. contacting authors and civil society organizations for grey literature. Included will be studies which report quantitative and/or qualitative data or review articles on asylum seekers in Germany, published in German or English language. Outcome measures will include physical, mental, or social well-being, and all aspects of health-care provision (access, availability, affordability, and quality). Search results will be screened for eligibility by screening titles, abstracts and full texts. Data extraction comprises information on study characteristics, research aims, and domains of health or health-care services analyzed. The quality of studies will be appraised and documented by appropriate assessment tools. A descriptive evidence map will be drawn by categorizing all included articles by research design and the health conditions and/or domains of health-care provision analyzed. The body of evidence will be evaluated, and a narrative evidence synthesis will be performed by means of a multi-level approach, whereby quantitative and qualitative evidence are analyzed as separate streams and the product

  14. Environment and Health in Children Day Care Centres (ENVIRH – Study rationale and protocol

    Directory of Open Access Journals (Sweden)

    J. Araújo-Martins

    2014-11-01

    Full Text Available Background: 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. Methods – study design: 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. Results: 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. Discussion: 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. Resumo: Antecedentes: A qualidade do ar interior (IAQ é considerada um determinante importante da saúde humana. A associação entre a exposição a compostos orgânicos voláteis, partículas, ácaros, bolores e bactérias em

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

    Science.gov (United States)

    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

  16. Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study.

    Science.gov (United States)

    Dritsakis, Giorgos; Kikidis, Dimitris; Koloutsou, Nina; Murdin, Louisa; Bibas, Athanasios; Ploumidou, Katherine; Laplante-Lévesque, Ariane; Pontoppidan, Niels Henrik; Bamiou, Doris-Eva

    2018-02-15

    The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect 'big data', including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL. This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making. Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center's Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the

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

    Science.gov (United States)

    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

  18. Protocol for investigating genetic determinants of posttraumatic stress disorder in women from the Nurses' Health Study II

    Directory of Open Access Journals (Sweden)

    Smoller Jordan W

    2009-05-01

    Full Text Available Abstract Background One in nine American women will meet criteria for the diagnosis of posttraumatic stress disorder (PTSD in their lifetime. Although twin studies suggest genetic influences account for substantial variance in PTSD risk, little progress has been made in identifying variants in specific genes that influence liability to this common, debilitating disorder. Methods and design We are using the unique resource of the Nurses Health Study II, a prospective epidemiologic cohort of 68,518 women, to conduct what promises to be the largest candidate gene association study of PTSD to date. The entire cohort will be screened for trauma exposure and PTSD; 3,000 women will be selected for PTSD diagnostic interviews based on the screening data. Our nested case-control study will genotype1000 women who developed PTSD following a history of trauma exposure; 1000 controls will be selected from women who experienced similar traumas but did not develop PTSD. The primary aim of this study is to detect genetic variants that predict the development of PTSD following trauma. We posit inherited vulnerability to PTSD is mediated by genetic variation in three specific neurobiological systems whose alterations are implicated in PTSD etiology: the hypothalamic-pituitary-adrenal axis, the locus coeruleus/noradrenergic system, and the limbic-frontal neuro-circuitry of fear. The secondary, exploratory aim of this study is to dissect genetic influences on PTSD in the broader genetic and environmental context for the candidate genes that show significant association with PTSD in detection analyses. This will involve: conducting conditional tests to identify the causal genetic variant among multiple correlated signals; testing whether the effect of PTSD genetic risk variants is moderated by age of first trauma, trauma type, and trauma severity; and exploring gene-gene interactions using a novel gene-based statistical approach. Discussion Identification of

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

    Science.gov (United States)

    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. ©Linda G Park, Eileen G Collins, Janet K

  20. Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

    2014-08-30

    NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective

  1. 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.

    Science.gov (United States)

    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. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Tubach Florence

    2012-08-01

    Full Text Available Abstract 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

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

    Science.gov (United States)

    Tubach, Florence; Greacen, Tim; Saïas, Thomas; Dugravier, Romain; Guedeney, Nicole; Ravaud, Philippe; Tereno, Susana; Tremblay, Richard; Falissard, Bruno; Guedeney, Antoine

    2012-08-13

    Several studies suggest that the number of risk factors rather than their nature is key to mental health disorders in childhood. 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. 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, supervised psychologists rather than nurses

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

    NARCIS (Netherlands)

    Metz, M.J.; Elfeddali, I.; Krol, D.G.H.; Veerbeek, M.A.; De Beurs, E.; Beekman, A.T.F.; van der Feltz-Cornelis, C.M.

    2017-01-01

    Background 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

  5. Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial

    OpenAIRE

    Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

    2014-01-01

    Background NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. Method The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Be...

  6. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial.

    Science.gov (United States)

    Bölenius, Karin; Lämås, Kristina; Sandman, Per-Olof; Edvardsson, David

    2017-02-16

    The literature indicates that current home care service are largely task oriented with limited focus on the involvement of the older people themselves, and studies show that lack of involvement might reduce older people's quality of life. Person-centred care has been shown to improve the satisfaction with care and quality of life in older people cared for in hospitals and nursing homes, with limited published evidence about the effects and meanings of person-centred interventions in home care services for older people. This study protocol outlines a study aiming to evaluate such effects and meanings of a person-centred and health-promoting intervention in home aged care services. The study will take the form of a non-randomised controlled trial with a before/after approach. It will include 270 older people >65 years receiving home care services, 270 relatives and 65 staff, as well as a matched control group of equal size. All participants will be recruited from a municipality in northern Sweden. The intervention is based on the theoretical concepts of person-centredness and health-promotion, and builds on the four pedagogical phases of: theory apprehension, experimental learning, operationalization, and clinical supervision. Outcome assessments will focus on: a) health and quality of life (primary outcomes), thriving and satisfaction with care for older people; b) caregiver strain, informal caregiving engagement and relatives' satisfaction with care: c) job satisfaction and stress of conscience among care staff (secondary outcomes). Evaluation will be conducted by means of self-reported questionnaires and qualitative research interviews. Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services, and the results can point the way to establishing a more person-centred and health-promoting model for home care services for older people. NCT02846246 .

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

    Science.gov (United States)

    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.

  8. A two-state comparative implementation of peer-support intervention to link veterans to health-related services after incarceration: a study protocol.

    Science.gov (United States)

    Simmons, Molly M; Fincke, Benjamin G; Drainoni, Mari-Lynn; Kim, Bo; Byrne, Tom; Smelson, David; Casey, Kevin; Ellison, Marsha L; Visher, Christy; Blue-Howells, Jessica; McInnes, D Keith

    2017-09-12

    Approximately 600,000 persons are released from prison annually in the United States. Relatively few receive sufficient re-entry services and are at risk for unemployment, homelessness, poverty, substance abuse relapse and recidivism. Persons leaving prison who have a mental illness and/or a substance use disorder are particularly challenged. This project aims to create a peer mentor program to extend the reach and effectiveness of reentry services provided by the Department of Veterans' Affairs (VA). We will implement a peer support for reentry veterans sequentially in two states. Our outcome measures are 1) fidelity of the intervention, 2) linkage to VA health care and, 3) continued engagement in health care. The aims for this project are as follows: (1) Conduct contextual analysis to identify VA and community reentry resources, and describe how reentry veterans use them. (2) Implement peer-support, in one state, to link reentry veterans to Veterans' Health Administration (VHA) primary care, mental health, and SUD services. (3) Port the peer-support intervention to another, geographically, and contextually different state. This intervention involves a 2-state sequential implementation study (Massachusetts, followed by Pennsylvania) using a Facilitation Implementation strategy. We will conduct formative and summative analyses, including assessment of fidelity, and a matched comparison group to evaluate the intervention's outcomes of veteran linkage and engagement in VHA health care (using health care utilization measures). The study proceeds in 3 phases. We anticipate that a peer support program will be effective at improving the reentry process for veterans, particularly in linking them to health, mental health, and SUD services and helping them to stay engaged in those services. It will fill a gap by providing veterans with access to a trusted individual, who understands their experience as a veteran and who has experienced justice involvement. The outputs from

  9. Study protocol on ecological momentary assessment of health-related quality of life using a smartphone application

    DEFF Research Database (Denmark)

    Mareva, Silvana; Thomson, David M; Marenco, Pietro

    2016-01-01

    recall and current mood state may undermine their validity and reliability. Retrospective tools can be further criticized for their lack of ecology, as individuals are usually assessed in less natural settings such as hospitals and health centers, and may be obliged to spend time and money traveling...... to receive assessment. Ecological momentary assessment (EMA) is an alternative, as mobile assessment using mobile health (mHealth) technology has the potential to minimize biases and overcome many of these limitations. Employing an EMA methodology, we will use a smartphone application to collect data on real-time...... HRQoL, with an adapted version of the widely used WHOQOL-BREF questionnaire. We aim to recruit a total of 450 healthy participants. Participants will be prompted by the application to report their real-time HRQoL over 2 weeks together with information on mood and current activities. At the end of 2...

  10. Assessing the link between implementation fidelity and health outcomes for a trial of intensive case management by community health workers: a mixed methods study protocol.

    Science.gov (United States)

    Schmidt, Barbara; Watt, Kerrianne; McDermott, Robyn; Mills, Jane

    2017-07-17

    Better systems of care are required to address chronic disease in Indigenous people to ensure they can access all their care needs. Health research has produced evidence about effective models of care and chronic disease strategies to address Indigenous health, however the transfer of research findings into routine clinical practice has proven challenging. Complex interventions, such as those related to chronic disease, have many components that are often poorly implemented and hence rarely achieve implementation fidelity. Implementation fidelity is "the degree to which programs are implemented as intended by the program developer". Knowing if an intervention was implemented as planned is fundamental to knowing what has contributed to the success of an intervention. The aim of this study is to adapt the implementation fidelity framework developed by Keith et al. and apply it to the intervention implemented in phase 1 of the Getting Better at Chronic Care in North Queensland study. The objectives are to quantify the level of implementation fidelity achieved during phase 1 of the study, measure the association between implementation fidelity and health outcomes and to explore the features of the primary health care system that contributed to improved health outcomes. A convergent parallel mixed methods study design will be used to develop a process for assessing implementation fidelity. Information collected via a questionnaire and routine data generated during phase 1 of the study will be used to explain the context for the intervention in each site and develop an implementation fidelity score for each component of the intervention. A weighting will be applied to each component of the intervention to calculate the overall implementation score for each participating community. Statistical analysis will assess the level of association between implementation fidelity scores and health outcomes. Health services research seeks to find solutions to social and technical

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

    Directory of Open Access Journals (Sweden)

    Doyle Conor

    2011-10-01

    Full Text Available Abstract 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.

  12. 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

    Science.gov (United States)

    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

  13. Effect of Mobile-health on maternal health care service utilization in Eastern Ethiopia: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gelano, Tilayie Feto; Assefa, Nega; Bacha, Yadeta Dessie; Mahamed, Afendi Abdi; Roba, Kedir Teji; Hambisa, Mitiku Teshome

    2018-02-12

    Globally, the rapid development of mobile technology has created new ways of addressing public health challenges and shifted the paradigm of health care access and delivery. The primary aim of this study is to examine the effectiveness of Mobile-health on maternal health care service utilization in Eastern Ethiopia. Through, a cluster-randomized controlled trial, 640 participants will be selected based on their districts and respective health centers as the unit of randomization. All pregnant mothers who fulfill the inclusion criteria will be allocated to a mobile-phone-based intervention and existing standard of care or control with a 1:1 allocation ratio. The intervention consists of a series of 24 voice messages which will be sent every 2 weeks from the date of enrollment until the close-out time. The control group will receive existing standard of care without voice messages. Data related to outcome variables will be assessed at three phases of the data collection periods. The primary outcome measures will be the proportion of antenatal care visits and institutional delivery, whereas the secondary outcome measures will consist of the proportion of postnatal care visits and pregnancy outcomes. Risk ratios will be used to a measure the effect of intervention on the outcomes which will be estimated with 95% confidence interval and all the analyses will be done with consideration of clustering effect. This study should generate evidence on the effectiveness of mobile-phone-based voice messages for the early initiation of maternal health care service use and its uptake. It has been carefully designed with the assumption of obtaining higher levels of maternal health care service use among the treatment group as compared to the control. Pan African Clinical Trial Registry, www.panctr.org , ID: PACTR201704002216259 . Registered on 28 April 2017.

  14. Implementation of integration strategies between primary care units and a regional general hospital in Brazil to update and connect health care professionals: a quasi-experimental study protocol.

    Science.gov (United States)

    Bracco, Mario Maia; Mafra, Ana Carolina Cintra Nunes; Abdo, Alexandre Hannud; Colugnati, Fernando Antonio Basile; Dalla, Marcello Dala Bernardina; Demarzo, Marcelo Marcos Piva; Abrahamsohn, Ises; Rodrigues, Aline Pacífico; Delgado, Ana Violeta Ferreira de Almeida; Dos Prazeres, Glauber Alves; Teixeira, José Carlos; Possa, Silvio

    2016-08-12

    Better communication among field health care teams and points of care, together with investments focused on improving teamwork, individual management, and clinical skills, are strategies for achieving better outcomes in patient-oriented care. This research aims to implement and evaluate interventions focused on improving communication and knowledge among health teams based on points of care in a regional public health outreach network, assessing the following hypotheses: 1) A better-working communication process between hospitals and primary health care providers can improve the sharing of information on patients as well as patients' outcomes. 2) A skill-upgrading education tool offered to health providers at their work sites can improve patients' care and outcomes. A quasi-experimental study protocol with a mixed-methods approach (quantitative and qualitative) was developed to evaluate communication tools for health care professionals based in primary care units and in a general hospital in the southern region of São Paulo City, Brazil. The usefulness and implementation processes of the integration strategies will be evaluated, considering: 1) An Internet-based communication platform that facilitates continuity and integrality of care to patients, and 2) A tailored updating distance-learning course on ambulatory care sensitive conditions for clinical skills improvements. The observational study will evaluate a non-randomized cohort of adult patients, with historical controls. Hospitalized patients diagnosed with an ambulatory care sensitive condition will be selected and followed for 1 year after hospital discharge. Data will be collected using validated questionnaires and from patients' medical records. Health care professionals will be evaluated related to their use of education and communication tools and their demographic and psychological profiles. The primary outcome measured will be the patients' 30-day hospital readmission rates. A sample size of 560

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

    Science.gov (United States)

    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

  16. Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalized Prostate Cancer Survivorship Care: Protocol for a Realist Case Study of the Ned App.

    Science.gov (United States)

    Pham, Quynh; Cafazzo, Joseph A; Feifer, Andrew

    2017-10-12

    By 2030, prostate cancer will be the most commonly diagnosed cancer in North America. To mitigate this impending challenge, comprehensive support mechanisms for disease- and treatment-specific changes in health and well-being must be proactively designed and thoughtfully implemented for streamlined survivorship care. mHealth apps have been lauded as a promising complement to current outpatient treatment and monitoring strategies, but have not yet been widely used to support prostate cancer survivorship needs. A realist evaluation is needed to examine the impact of such apps on the prostate cancer survivorship experience. We seek to gain an understanding of how an mHealth app for prostate cancer survivorship care called Ned (No Evident Disease) is adopted and accepted by patients, caregivers, and clinicians. We also aim to determine the effect of Ned on health-related quality of life, satisfaction with cancer care, unmet needs, self-efficacy, and prostate cancer-related levels of anxiety. The Ned case study is a 12-month mixed-methods embedded single-case study with a nested within-group pre-post comparison of health outcomes. We will give 400 patients, 200 caregivers, and 10 clinicians access to Ned. Participants will be asked to complete study assessments at baseline, 2 months, 6 months, and 12 months. We will conduct 30 semistructured qualitative interviews with patients (n=20) and their caregivers (n=10) poststudy to gain insight into their experience with the app. We recruited our first survivor in October 2017 and anticipate completing this study by May 2019. This will, to our knowledge, be the first realist case study to evaluate an app for prostate cancer survivorship care. Prostate cancer survivors are set to increase in number and longevity, heightening the need for integrated survivorship solutions to provide them with optimal and durable outcomes. The knowledge gained from this study will comprehensively inform how and why Ned works, for whom, and in

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

    Science.gov (United States)

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

    Science.gov (United States)

    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

    2017-01-01

    Introduction 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. Aims and methods 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. Ethics and dissemination 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

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

    2016-08-23

    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. 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. 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, presented to funders and relevant local

  1. Protocol of specific health monitoring: ionizing radiation, 11 years later

    International Nuclear Information System (INIS)

    Castillejo Puertas, F. M.

    2016-01-01

    Since the approval on November 11 t h 2003 of the Protocol of Specific Health Monitoring for Workers Exposed to Ionizing Radiation a study has been carried out to discover its effectiveness. These areas were examined: the daily practice od accupational medicine and, in particular, its specific task in the application of the different clinical/labour criteria for workers exposed to ionizing radiation or at risk of radioactive contamination; the degree of its uses as well as the updates and improvements. For that purpose, a descriptive bibliographic revision has been used for the last 11 years. The results revealed the lack of updates of the Protocol as well as the few usable objective criteria, when the clinical/labour aptitudes are reflected upon. (Author)

  2. Ecological assessment of the direct and indirect effects of routine rotavirus vaccination in Merseyside, UK using data from multiple health systems: a study protocol.

    Science.gov (United States)

    Hungerford, Daniel; Vivancos, Roberto; French, Neil; Iturriza-Gomara, Miren; Cunliffe, Nigel

    2014-11-25

    Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Currently 67 countries include rotavirus vaccine in childhood immunisation programmes, but uptake in Western Europe has been slow. In July 2013, rotavirus vaccine was introduced into the UK's routine childhood immunisation programme. Prior to vaccine introduction in the UK, rotavirus was estimated to result in 750,000 diarrhoea episodes and 80,000 general practice (GP) consultations each year, together with 45% and 20% of hospital admissions and emergency department attendances for acute gastroenteritis, in children under 5 years of age. This paper describes a protocol for an ecological study that will assess rotavirus vaccine impact in the UK, to inform rotavirus immunisation policy in the UK and in other Western European countries. In Merseyside, UK, we will conduct an ecological study using a 'before and after' approach to examine changes in gastroenteritis and rotavirus incidence following the introduction of rotavirus vaccination. Data will be collected on mortality, hospital admissions, nosocomial infection, emergency department attendances, GP consultations and community health consultations to capture all healthcare providers in the region. We will assess both the direct and indirect effects of the vaccine on the study population. Comparisons of outcome indicator rates will be made in relation to vaccine uptake and socioeconomic status. The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC Reference: 14/SC/1140. Study outputs will be disseminated through scientific conferences and peer-reviewed publications. The study will demonstrate the impact of rotavirus vaccination on the burden of disease from a complete health system perspective. It will identify key areas that require improved data collection tools to maximise the usefulness of this surveillance approach and will provide a template for vaccine evaluations using

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

    Directory of Open Access Journals (Sweden)

    Alina Herrmann

    2017-08-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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

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

    Science.gov (United States)

    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

  5. Improving Health-Related Quality of Life of Patients With an Ostomy Using a Novel Digital Wearable Device: Protocol for a Pilot Study.

    Science.gov (United States)

    Rouholiman, Dara; Gamble, Jamison G; Dobrota, Sylvie D; Encisco, Ellen M; Shah, Ashish G; Grajales Iii, Francisco J; Chu, Larry F

    2018-03-26

    studies have demonstrated decreased health-related quality of life in patients with an ostomy bag. We aim to examine the extent to which the Ostom-i alert sensor affects the health-related quality of life of its users. The Ostom-i alert sensor has the potential to improve quality of life of users by giving them the freedom and confidence to partake in daily activities with the knowledge that they can check how full their ostomy bag is in a private, discrete manner. ClinicalTrials.gov NCT02319434; https://clinicaltrials.gov/ct2/show/NCT02319434 (Archived at WebCite at http://www.webcitation.org/6xhFDThmq). ©Dara Rouholiman, Jamison G Gamble, Sylvie D Dobrota, Ellen M Encisco, Ashish G Shah, Francisco J Grajales III, Larry F Chu. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 26.03.2018.

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

    Directory of Open Access Journals (Sweden)

    Pérez-Arechaederra Diana

    2010-09-01

    Full Text Available Abstract 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. 2Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ. 3Change 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

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

    Science.gov (United States)

    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

    Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei). ©Ronald Gimbel, Lu Shi, Joel E Williams, Cheryl J Dye, Liwei Chen, Paul Crawford, Eric A Shry, Sarah F Griffin, Karyn O Jones, Windsor W Sherrill, Khoa Truong, Jeanette R Little, Karen W Edwards, Marie Hing, Jennie B Moss. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 06.03.2017.

  8. Protocol for project IMPACT (improving millions hearts for provider and community transformation): a quasi-experimental evaluation of an integrated electronic health record and community health worker intervention study to improve hypertension management among South Asian patients.

    Science.gov (United States)

    Lopez, Priscilla M; Zanowiak, Jennifer; Goldfeld, Keith; Wyka, Katarzyna; Masoud, Ahmad; Beane, Susan; Kumar, Rashi; Laughlin, Phoebe; Trinh-Shevrin, Chau; Thorpe, Lorna; Islam, Nadia

    2017-12-06

    The Million Hearts® initiative aims to prevent heart disease and stroke in the United States by mobilizing public and private sectors around a core set of objectives, with particular attention on improving blood pressure control. South Asians in particular have disproportionately high rates of hypertension and face numerous cultural, linguistic, and social barriers to accessing healthcare. Interventions utilizing Health information technology (HIT) and community health worker (CHW)-led patient coaching have each been demonstrated to be effective at advancing Million Hearts® goals, yet few studies have investigated the potential impact of integrating these strategies into a clinical-community linkage initiative. Building upon this initiative, we present the protocol and preliminary results of a research study, Project IMPACT, designed to fill this gap in knowledge. Project IMPACT is a stepped wedge quasi-experimental study designed to test the feasibility, adoption, and impact of integrating CHW-led health coaching with electronic health record (EHR)-based interventions to improve hypertension control among South Asian patients in New York City primary care practices. EHR intervention components include the training and implementation of hypertension-specific registry reports, alerts, and order sets. Fidelity to the EHR intervention is assessed by collecting the type, frequency, and utilization of intervention components for each practice. CHW intervention components consist of health coaching sessions on hypertension and related risk factors for uncontrolled hypertensive patients. The outcome, hypertension control (informs the effectiveness of these interventions in team-based care approaches, thereby, helping to develop relevant sustainability strategies for improving hypertension control among targeted racial/ethnic minority populations at small primary care practices. This study protocol has been approved and is made available on Clinicaltrials.gov by NCT

  9. 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.

    Science.gov (United States)

    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

  10. 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

    Directory of Open Access Journals (Sweden)

    Villanueva Elmer V

    2007-10-01

    -class correlation 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

  11. Identifying How Patient Portals May Be Effectively Used Among Mental Health Populations to Support Digital Inclusion: A Study Protocol.

    Science.gov (United States)

    Strudwick, Gillian; Booth, Richard; Strauss, John

    2018-01-01

    Patient portals are secure online websites that allow patients access to their medical information from a particular healthcare organization. Currently, it is unknown how this technology can best be used to support patients with mental illness, and what types of indicators of portal adoption are meaningful to these patients. This study addresses this gap in our knowledge by obtaining the perspectives on this topic from patients, family members and Peer Support Workers.

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

    Science.gov (United States)

    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

  13. 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.

    Science.gov (United States)

    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.

  14. Enhancing Survivorship Care Planning for Patients With Localized Prostate Cancer Using a Couple-Focused mHealth Symptom Self-Management Program: Protocol for a Feasibility Study.

    Science.gov (United States)

    Song, Lixin; Dunlap, Kaitlyn L; Tan, Xianming; Chen, Ronald C; Nielsen, Matthew E; Rabenberg, Rebecca L; Asafu-Adjei, Josephine K; Koontz, Bridget F; Birken, Sarah A; Northouse, Laurel L; Mayer, Deborah K

    2018-02-26

    This project explores a new model of care that enhances survivorship care planning and promotes health for men with localized prostate cancer transitioning to posttreatment self-management. Survivorship care planning is important for patients with prostate cancer because of its high incidence rate in the United States, the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) for both men and their partners. A key component of comprehensive survivorship care planning is survivorship care plans (SCPs), documents that summarize cancer diagnosis, treatment, and plans for follow-up care. However, research concerning the effectiveness of SCPs on patient outcomes or health service use has thus far been inconclusive. SCPs that are tailored to individual patients' needs for information and care may improve effectiveness. This study aims to examine the feasibility of an enhanced survivorship care plan (ESCP) that integrates a symptom self-management mHealth program called Prostate Cancer Education and Resources for Couples (PERC) into the existing standardized SCP. The specific aims are to (1) examine the feasibility of delivering ESCPs and (2) to estimate the magnitude of benefit of ESCPs. We will use a two-group randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized prostate cancer and their partners. First, we will assess the feasibility of ESCP by recruitment, enrollment, and retention rates; program satisfaction with the ESCP; and perceived ease of use of the ESCP. To achieve the secondary aim, we will compare the ESCP users with the standardized SCP users and assess their primary outcomes of QOL (overall, physical, emotional, and social QOL); secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and number of visits to posttreatment

  15. 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.

    Science.gov (United States)

    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

  16. Improving the quality of perinatal mental health: a health visitor-led protocol.

    Science.gov (United States)

    Lewis, Anne; Ilot, Irene; Lekka, Chrysanthi; Oluboyede, Yemi

    2011-02-01

    The mental health of mothers is of significant concern to community practitioners. This paper reports on a case study exploring the success factors of a well established, health visitor-led protocol to identify and treat women with mild to moderate depression. Data were collected through interviews with a purposive sample of 12 community practitioners, a focus group of four health visitors and observation of a multidisciplinary steering group meeting. The protocol was described as an evidence-based tool and safety net that could be used flexibly to support clinical judgments and tailored to individual needs. Success factors included frontline clinician engagement and ownership, continuity of leadership to drive development and maintain momentum, comprehensive and on-going staff training, and strategic support for the protocol as a quality indicator at a time of organisational change. Quality and clinical leadership are continuing policy priorities. The protocol enabled frontline staff to lead a service innovation, providing a standardised multiprofessional approach to women's mental health needs through effective support, advice and treatment that can be measured and quality assured.

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

    Science.gov (United States)

    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.

  18. Electronic Health Information Legal Epidemiology Protocol 2014

    Data.gov (United States)

    U.S. Department of Health & Human Services — Authors: Cason Schmit, JD, Gregory Sunshine, JD, Dawn Pepin, JD, MPH, Tara Ramanathan, JD, MPH, Akshara Menon, JD, MPH, Matthew Penn, JD, MLIS The Health Information...

  19. 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.

    Science.gov (United States)

    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

  20. An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Jones, Hannah F; Adams, Clive E; Clifton, Andrew; Simpson, Jayne; Tosh, Graeme; Liddle, Peter F; Callaghan, Patrick; Yang, Min; Guo, Boliang; Furtado, Vivek

    2013-05-29

    Oral health is an important part of general physical health and is essential for self-esteem, self-confidence and overall quality of life. There is a well-established link between mental illness and poor oral health. Oral health problems are not generally well recognized by mental health professionals and many patients experience barriers to treatment. This is the protocol for a pragmatic cluster randomised trial that has been designed to fit within standard care. Dental awareness training for care co-ordinators plus a dental checklist for service users in addition to standard care will be compared with standard care alone for people with mental illness. The checklist consists of questions about service users' current oral health routine and condition. Ten Early Intervention in Psychosis (EIP) teams in Nottinghamshire, Derbyshire and Lincolnshire will be cluster randomised (five to intervention and five to standard care) in blocks accounting for location and size of caseload. The oral health of the service users will be monitored for one year after randomisation. Current Controlled Trials ISRCTN63382258.

  1. The Association of Health Literacy and Electronic Health Literacy With Self-Efficacy, Coping, and Caregiving Perceptions Among Carers of People With Dementia: Research Protocol for a Descriptive Correlational Study.

    Science.gov (United States)

    Efthymiou, Areti; Middleton, Nicos; Charalambous, Andreas; Papastavrou, Evridiki

    2017-11-13

    consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Carers' eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers' perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers' eHealth and health literacy level, which will also be explored. By confirming the above hypotheses, tailored eHealth literacy interventions for carers of people with dementia and their families will be developed as a direct outcome of this research. ©Areti Efthymiou, Nicos Middleton, Andreas Charalambous, Evridiki Papastavrou. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.11.2017.

  2. 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.

    Science.gov (United States)

    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.

  3. 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

    Science.gov (United States)

    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

  4. 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

    Science.gov (United States)

    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

  5. NEURAPRO-E study protocol

    DEFF Research Database (Denmark)

    Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby

    2017-01-01

    polyunsaturated fatty acids (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study......AIM: Recent research has indicated that preventative intervention is likely to benefit patients 'at-risk' for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega-3...... omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict...

  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

    NARCIS (Netherlands)

    Aalbers, T.; Baars, M.A.; Qin, L.; Lange, A.; Kessels, R.P.C.; Olde Rikkert, M.G.M.

    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,

  7. An mHealth App for Decision-Making Support in Wound Dressing Selection (WounDS): Protocol for a User-Centered Feasibility Study.

    Science.gov (United States)

    Jordan, Scott; McSwiggan, Jane; Parker, Joanne; Halas, Gayle A; Friesen, Marcia

    2018-04-24

    Primary care health professionals, especially family physicians, see a variety of wounds, and yet-despite the frequency of providing wound care-many family physicians do not feel confident in wound care management. This is partly due to a lack of formal wound education in Family Medicine programs. While there are numerous electronic wound care resources available in the UK and North America, none were identified that address the specific need in supporting clinical decision-making in wound dressing selection. At the same time, healthcare providers are increasingly using technology in personal and professional contexts, and a logical extension is to use technology for knowledge translation strategies. This work developed a prototype mobile health software application named WounDS, designed to support clinical decision-making in selecting wound dressings. This article presents the development and evaluation plan for the WounDS app. WounDS has been developed on the iOS platform. The primary specification included ease of use, in that one of the primary influences in user adoption would be the ability to receive a wound dressing recommendation in under 30 seconds and under 5 taps on the screen. The WounDS app guides users through a series of binary decisions for assessing the wound and provides a wound dressing recommendation. The selection algorithm is based in best practices using the Wound Bed Preparation Paradigm. Current work is underway to examine the implementation needs for WounDS to be most effectively utilized and to pilot test its feasibility and use in clinical care. Data will be collected through user trials, focus groups, and user metadata will be collected within the app. Optimizing these preconditions will enable a subsequent phase of study to determine effects on clinical decision-making and clinical outcomes. WounDS is designed for knowledge translation, use of technology in clinical decision-making, and continuity of care. The benefits of Woun

  8. Improving Physical Fitness and Cognitive Functions in Middle School Students: Study Protocol for the Chinese Childhood Health, Activity and Motor Performance Study (Chinese CHAMPS).

    Science.gov (United States)

    Zhou, Zhixiong; Dong, Shanshan; Yin, Jun; Fu, Quan; Ren, Hong; Yin, Zenong

    2018-05-14

    Background : Sedentary lifestyles and their associated harmful consequences are public health concerns that impact more than half of the world's youth population in both developed and developing countries. Methods : The Chinese Childhood Health; Activity and Motor Performance Study (Chinese CHAMPS) was a cluster randomized controlled trial to modify school physical activity policies and the physical education (PE) curriculum; using teacher training and parent engagement to increase opportunities and support students' physical activity and healthy eating. Using a 2 × 2 factorial design, the study tested the incremental effects of increasing the amount and intensity of physical activity, alongside adding support for healthy eating, on health-related and cognitive function outcomes in Chinese middle school students. Results : The intervention was implemented by PE teachers in 12 middle schools in three Chinese cities, with a targeted enrollment of 650 students from August 2015⁻June 2016. The assessment of the outcomes involved a test battery of physical fitness and cognitive functioning at both baseline and at the end of the intervention. Process information on implementation was also collected. Discussion : The Chinese CHAMPS is a multi-level intervention that is designed to test the influences of policy and environmental modifications on the physical activity and eating behaviors of middle school students. It also addresses some key weaknesses in school-based physical activity interventions.

  9. 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.

    Science.gov (United States)

    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.

  10. A school-based health promotion programme to increase help-seeking for substance use and mental health problems: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lubman, Dan I; Berridge, Bonita J; Blee, Fiona; Jorm, Anthony F; Wilson, Coralie J; Allen, Nicholas B; McKay-Brown, Lisa; Proimos, Jenny; Cheetham, Ali; Wolfe, Rory

    2016-08-08

    Adolescence is a high-risk time for the development of mental health and substance use problems. However, fewer than one in four 16-24 year-olds with a current disorder access health services, with those experiencing a substance use disorder being the least likely to seek professional help. Research indicates that young people are keeping their problems to themselves or alternatively, turning to peers or trusted adults in their lives for help. These help-seeking preferences highlight the need to build the mental health literacy of adolescents, to ensure that they know when and how to assist themselves and their peers to access support. The MAKINGtheLINK intervention aims to introduce these skills to adolescents within a classroom environment. This is a cluster randomised controlled trial (RCT) with schools as clusters and individual students as participants from 22 secondary schools in Victoria, Australia. Schools will be randomly assigned to either the MAKINGtheLINK intervention group or the waitlist control group. All students will complete a self-report questionnaire at baseline, immediately post intervention and 6 and 12 months post baseline. The primary outcome to be assessed is increased help-seeking behaviour (from both formal and informal sources) for alcohol and mental health issues, measured at 12 months post baseline. The findings from this research will provide evidence on the effectiveness of the MAKINGtheLINK intervention for teaching school students how to overcome prominent barriers associated with seeking help, as well as how to effectively support their peers. If deemed effective, the MAKINGtheLINK programme will be the first evidence-informed resource that is able to address critical gaps in the knowledge and behaviour of adolescents in relation to help-seeking. It could, therefore, be a valuable resource that could be readily implemented by classroom teachers. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12613000235707

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

    Science.gov (United States)

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

    2018-01-01

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

  12. Indicators and measurement tools for health system integration : a knowledge synthesis protocol

    OpenAIRE

    Oelke, Nelly Donszelmann; Suter, Esther; Lima, Maria Alice Dias da Silva; Vliet-Brown, Cheryl Van

    2015-01-01

    Background: Health system integration is a key component of health system reform with the goal of improving outcomes for patients, providers, and the health system. Although health systems continue to strive for better integration, current delivery of health services continues to be fragmented. A key gap in the literature is the lack of information on what successful integration looks like and how to measure achievement towards an integrated system. This multi-site study protocol builds on a ...

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

    Science.gov (United States)

    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.

  14. The macro-economic determinants of health and health inequalities—umbrella review protocol

    Directory of Open Access Journals (Sweden)

    Yannish Naik

    2017-11-01

    Full Text Available Abstract Background The economic determinants of health have been widely recognised as crucial factors affecting health; however, to date, no comprehensive review has been undertaken to summarise these factors and the ways in which they can influence health. We conceptualise the economy as a complex system made up of underlying approaches, regulation from institutions, markets, finance, labour, the public-private balance as well as production and distributional effects, which collectively impact on health through the effect of moderators. This protocol details the methods for an umbrella review to explore the macro-economic factors, strategies, policies and interventions that affect health outcomes and health inequalities. Methods We will identify relevant systematic reviews using search terms derived from the Journal of Economic Literature classification. Reviews will be included if they meet the Database of Abstracts and Reviews of Effects criteria for systematic reviews. Reviews of studies with and without controls will be included; both association and intervention studies will be included. Primary outcomes will include but are not limited to morbidity, mortality, prevalence and incidence of conditions and life expectancy. Secondary outcomes will include health inequalities by gender, ethnicity or socio-economic status. Six databases will be searched using tailored versions of our piloted search strategy to locate relevant reviews. Data will be extracted using a standardized pro forma, and the findings will be synthesized into a conceptual framework to address our review aim. Discussion Our umbrella review protocol provides a robust method to systematically appraise the evidence in this field, using new conceptual models derived specifically to address the study question. This will yield important information for policymakers, practitioners and researchers at the local, national and international level. It will also help set the future

  15. The macro-economic determinants of health and health inequalities-umbrella review protocol.

    Science.gov (United States)

    Naik, Yannish; Baker, Peter; Walker, Ian; Tillmann, Taavi; Bash, Kristin; Quantz, Darryl; Hillier-Brown, Frances; Bambra, Clare

    2017-11-03

    The economic determinants of health have been widely recognised as crucial factors affecting health; however, to date, no comprehensive review has been undertaken to summarise these factors and the ways in which they can influence health. We conceptualise the economy as a complex system made up of underlying approaches, regulation from institutions, markets, finance, labour, the public-private balance as well as production and distributional effects, which collectively impact on health through the effect of moderators. This protocol details the methods for an umbrella review to explore the macro-economic factors, strategies, policies and interventions that affect health outcomes and health inequalities. We will identify relevant systematic reviews using search terms derived from the Journal of Economic Literature classification. Reviews will be included if they meet the Database of Abstracts and Reviews of Effects criteria for systematic reviews. Reviews of studies with and without controls will be included; both association and intervention studies will be included. Primary outcomes will include but are not limited to morbidity, mortality, prevalence and incidence of conditions and life expectancy. Secondary outcomes will include health inequalities by gender, ethnicity or socio-economic status. Six databases will be searched using tailored versions of our piloted search strategy to locate relevant reviews. Data will be extracted using a standardized pro forma, and the findings will be synthesized into a conceptual framework to address our review aim. Our umbrella review protocol provides a robust method to systematically appraise the evidence in this field, using new conceptual models derived specifically to address the study question. This will yield important information for policymakers, practitioners and researchers at the local, national and international level. It will also help set the future research agenda in this field and guide the development of

  16. Study protocol for the Cities Changing Diabetes programme

    DEFF Research Database (Denmark)

    Napier, A David; Nolan, John J; Bagger, Malene

    2017-01-01

    and management are improving, complications remain common, and diabetes is among the leading causes of vision loss, amputation, neuropathy and renal and cardiovascular disease worldwide. We present a research protocol for exploring the drivers of type 2 diabetes and its complications in urban settings through...... the Cities Changing Diabetes (CCD) partnership programme. METHODS AND ANALYSIS: A global study protocol is implemented in eight collaborating CCD partner cities. In each city, academic institutions, municipal representatives and local stakeholders collaborate to set research priorities and plan...... Assessment explores the urban context in vulnerability to type 2 diabetes and identifies social factors and cultural determinants relevant to health, well-being and diabetes. ETHICS AND DISSEMINATION: The protocol steers the collection of primary and secondary data across the study sites. Research ethics...

  17. 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.

    Science.gov (United States)

    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.

  18. An evidence-based gamified mHealth intervention for overweight young adults with maladaptive eating habits: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Podina, Ioana R; Fodor, Liviu A; Cosmoiu, Ana; Boian, Rareș

    2017-12-12

    maladaptive eating habits. ISRCTN, ID: 70907354 . Registered on 6 February 2017. The ISRCTN registration is in line with the World Health Organization Trial Registration Data Set. The present paper represents the original version of the protocol. Any changes to the protocol will be communicated to ISRCTN.

  19. Exploration into Uric and Cardiovascular Disease: Uric Acid Right for heArt Health (URRAH) Project, A Study Protocol for a Retrospective Observational Study.

    Science.gov (United States)

    Desideri, Giovambattista; Virdis, Agostino; Casiglia, Edoardo; Borghi, Claudio

    2018-02-09

    The relevance of cardiovascular role played by levels of serum uric acid is dramatically growing, especially as cardiovascular risk factor potentially able to exert either a direct deleterious impact or a synergic effect with other cardiovascular risk factors. At the present time, it still remains undefined the threshold level of serum uric acid able to contribute to the cardiovascular risk. Indeed, the available epidemiological case studies are not homogeneous, and some preliminary data suggest that the so-called "cardiovascular threshold limit" may substantially differ from that identified as a cut-off able to trigger the acute gout attack. In such scenario, there is the necessity to clarify and quantify this threshold value, to insert it in the stratification of risk algorithm scores and, in turn, to adopt proper prevention and correction strategies. The clarification of the relationship between circulating levels of uric acid and cardio-nephro-metabolic disorders in a broad sample representative of general population is critical to identify the threshold value of serum uric acid better discriminating the increased risk associated with uric acid. The Uric acid Right for heArt Health (URRAH) project has been designed to define, as primary objective, the level of uricemia above which the independent risk of cardiovascular disease may increase in a significantly manner in a general Italian population.

  20. Can action research strengthen district health management and improve health workforce performance? A research protocol.

    Science.gov (United States)

    Mshelia, C; Huss, R; Mirzoev, T; Elsey, H; Baine, S O; Aikins, M; Kamuzora, P; Bosch-Capblanch, X; Raven, J; Wyss, K; Green, A; Martineau, T

    2013-08-30

    The single biggest barrier for countries in sub-Saharan Africa (SSA) to scale up the necessary health services for addressing the three health-related Millennium Development Goals and achieving Universal Health Coverage is the lack of an adequate and well-performing health workforce. This deficit needs to be addressed both by training more new health personnel and by improving the performance of the existing and future health workforce. However, efforts have mostly been focused on training new staff and less on improving the performance of the existing health workforce. The purpose of this paper is to disseminate the protocol for the PERFORM project and reflect on the key challenges encountered during the development of this methodology and how they are being overcome. The overall aim of the PERFORM project is to identify ways of strengthening district management in order to address health workforce inadequacies by improving health workforce performance in SSA. The study will take place in three districts each in Ghana, Tanzania and Uganda using an action research approach. With the support of the country research teams, the district health management teams (DHMTs) will lead on planning, implementation, observation, reflection and redefinition of the activities in the study. Taking into account the national and local human resource (HR) and health systems (HS) policies and practices already in place, 'bundles' of HR/HS strategies that are feasible within the context and affordable within the districts' budget will be developed by the DHMTs to strengthen priority areas of health workforce performance. A comparative analysis of the findings from the three districts in each country will add new knowledge on the effects of these HR/HS bundles on DHMT management and workforce performance and the impact of an action research approach on improving the effectiveness of the DHMTs in implementing these interventions. Different challenges were faced during the development of

  1. The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Clare Linda

    2012-07-01

    Full Text Available Abstract Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75 will be randomized to one of three conditions: control (an interview involving a general discussion about the center; goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement; or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring. All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life, cognitive (memory and executive function, and physical fitness (functional and metabolic domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com

  2. The AgeWell study of behavior change to promote health and wellbeing in later life: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Clare, Linda; Hindle, John V; Jones, Ian R; Thom, Jeanette M; Nelis, Sharon M; Hounsome, Barry; Whitaker, Christopher J

    2012-07-24

    Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT) will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75) will be randomized to one of three conditions: control (an interview involving a general discussion about the center); goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement); or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring). All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life), cognitive (memory and executive function), and physical fitness (functional and metabolic) domains. Cost-effectiveness will also be examined. This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com).

  3. 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).

    Science.gov (United States)

    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

  4. 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).

    Science.gov (United States)

    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

  5. 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

    Directory of Open Access Journals (Sweden)

    Andrea Schaller

    2016-07-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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

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

    Science.gov (United States)

    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

  7. 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.

    Science.gov (United States)

    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

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

    OpenAIRE

    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 ...

  9. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

    Directory of Open Access Journals (Sweden)

    Hare David L

    2011-02-01

    the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government. Discussion This manuscript presents the protocol for a randomised, multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients. The results of this trial will provide valuable new information about potential psychological and wellbeing benefits, cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression. Trial Registration Number Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609000386235

  10. The role of academic health centres in building equitable health systems: a systematic review protocol

    Science.gov (United States)

    Edelman, Alexandra; Taylor, Judy; Ovseiko, Pavel V; Topp, Stephanie M

    2017-01-01

    Introduction 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. Methods and analysis 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. Ethics and dissemination 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

  11. Exploring eHealth Ethics and Multi-Morbidity: Protocol for an Interview and Focus Group Study of Patient and Health Care Provider Views and Experiences of Using Digital Media for Health Purposes.

    Science.gov (United States)

    Townsend, Anne; Adam, Paul; Li, Linda C; McDonald, Michael; Backman, Catherine L

    2013-10-17

    eHealth is a broad term referring to the application of information and communication technologies in the health sector, ranging from health records to medical consultations (telemedicine) and multiple forms of health education, support, and tools. By providing increased and anytime access to information, opportunities to exchange experiences with others, and self-management support, eHealth has been heralded as transformational. It has the potential to accelerate the shift from traditional "passive patient" to an informed, engaged, and empowered "patient as partner," equipped to take part in shared decision-making, and take personal responsibility for self-managing their illness. The objective of our study is to examine how people with chronic illness use eHealth in their daily lives, how it affects patient-provider relationships, and the ethical and practical ramifications for patients, providers, and service delivery. This two-phase qualitative study is ongoing. We will purposively sample 60-70 participants in British Columbia, Canada. To be eligible, patient participants have to have arthritis and at least one other chronic health condition; health care providers (HCPs) need a caseload of patients with multi-morbidity (>25%). To date we have recruited 36 participants (18 patients, 18 HCPs). The participants attended 7 focus groups (FGs), 4 with patients and 3 with rehabilitation professionals and physicians. We interviewed 4 HCPs who were unable to attend a FG. In phase 2, we will build on FG findings and conduct 20-24 interviews with equal numbers of patients and HCPs (rehabilitation professionals and physicians). As in the FGs conducted in phase I, the interviews will use a semistructured, but flexible, discussion guide. All discussions are being audiotaped and transcribed verbatim. Constant comparisons and a narrative approach guides the analyses. A relational ethics conceptual lens is being applied to the data to identify emergent ethical issues. This study

  12. Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial.

    Science.gov (United States)

    Tebb, Kathleen P; Rodriguez, Felicia; Pollack, Lance M; Trieu, Sang Leng; Hwang, Loris; Puffer, Maryjane; Adams, Sally; Ozer, Elizabeth M; Brindis, Claire D

    2018-01-10

    Teen pregnancy rates in the USA remain higher than any other industrialised nation, and pregnancies among Hispanic adolescents are disproportionately high. Computer-based interventions represent a promising approach to address sexual health and contraceptive use disparities. Preliminary findings have demonstrated that the Health-E You/Salud iTu, computer application (app) is feasible to implement, acceptable to Latina adolescents and improves sexual health knowledge and interest in selecting an effective contraceptive method when used in conjunction with a healthcare visit. The app is now ready for efficacy testing. The purpose of this manuscript is to describe patient-centred approaches used both in developing and testing the Health-E You app and to present the research methods used to evaluate its effectiveness in improving intentions to use an effective method of contraception as well as actual contraceptive use. This study is designed to assess the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud  iTu, on its ability to reduce health disparities in unintended pregnancies among Latina adolescent girls. This study uses a cluster randomised control trial design in which 18 school-based health centers from the Los Angeles Unified School District were randomly assigned, at equal chance, to either the intervention ( Health-E You app) or control group. Analyses will examine differences between the control and intervention group's knowledge of and attitudes towards contraceptive use, receipt of contraception at the clinic visit and self-reported use of contraception at 3-month and 6-month follow-ups. The study began enrolling participants in August 2016, and a total of 1400 participants (700 per treatment group) are expected to be enrolled by March 2018. Ethics approval was obtained through the University of California, San Francisco Institutional Review Board. Results of this trial will be submitted for publication in peer

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

    Science.gov (United States)

    Dray, Julia; Bowman, Jenny; Freund, Megan; Campbell, Elizabeth; Wolfenden, Luke; Hodder, Rebecca K; Wiggers, John

    2014-07-18

    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. 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. 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. Australian New Zealand Clinical Trials Registry, ACTRN12611000606987, registered 14 June 2011.

  14. A multi-center prospective cohort study to evaluate the effect of differential pricing and health systems strengthening on access to medicines and management of hypertension and diabetes in Ghana: A study protocol.

    Science.gov (United States)

    Mobula, Linda Meta; Sarfo, Stephen; Arthur, Lynda; Burnham, Gilbert; Plange-Rhule, Jacob; Ansong, Daniel; Gavor, Edith; Ofori-Adjei, David

    2018-02-07

    Background: There is evidence to suggest that the prevalence of non-communicable diseases (NCDs), in particular cardiovascular diseases and diabetes, are being recognized as forming a substantial proportion of the burden of disease among populations in Low- and Middle-Income Countries (LMICs).  Access to treatment is likely a key barrier to the control and prevention of NCD outcomes.  Differential pricing, an approach used to price drugs based on the purchasing power of patients in different socioeconomic segments, has been shown to be beneficial and leads to improved access and affordability. Methods: This is a quasi-experimental study, with a pragmatic trial design, to be conducted over the course of three years. A mixed methods design will be used to evaluate the effects of health systems strengthening and differential pricing on the management of diabetes, hypertension and selected cancers in Ghana. A public private partnership was established between all sites that will receive multi-level interventions, including health systems strengthening  and access to medicines interventions. Study populations and sites: Study participants will include individuals with new or recently diagnosed hypertension and diabetes (n=3,300), who present to two major referral hospitals, Komfo Anokye Teaching Hospital and Tamale Teaching Hospital, as well as three district hospitals, namely Kings Medical Centre, Agogo Presbyterian District Hospital, and Atua Government Hospital. Discussion: The objective of this study aims to test approaches intended to improve access to drugs for the treatment of hypertension and diabetes, and improve disease control. Patients with these conditions will benefit from health systems strengthening interventions (education, counseling, improved management of disease), and increased access to innovative medicines via differential pricing. Pilot programs also will facilitate health system strengthening at the participating institutions, which includes

  15. 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.

    Science.gov (United States)

    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.

  16. 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

    OpenAIRE

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

    2016-01-01

    Background: 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.Methods/design: A pre–post quasi-experimental design with a control group will be used to undertake difference in differences analysis for as...

  17. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means...... the statistical principles for trial protocols in terms of design, analysis, and reporting of findings....

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

    Science.gov (United States)

    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

  19. Novel augmented reality solution for improving health literacy around antihypertensives in people living with type 2 diabetes mellitus: protocol of a technology evaluation study

    Science.gov (United States)

    Ahmadvand, Alireza; Drennan, Judy; Burgess, Jean; Clark, Michele; Kavanagh, David; Burns, Kara; Howard, Sarah; Kelly, Fleur; Campbell, Chris; Nissen, Lisa

    2018-01-01

    Introduction Low health literacy is common in people with type 2 diabetes mellitus (T2DM) (up to 40%), associated with decreased self-efficacy in managing T2DM and its important complications, mainly hypertension. This study introduces, for the first time, an easy-to-use solution based on augmented reality (AR) on smartphones, to enhance health literacy around antihypertensive medicines. It assesses the feasibility of the solution for improving health literacy, oriented specifically to angiotensin II receptor blockers; embedding the health literacy improvement into the use cycle of angiotensin II receptor blockers and providing continuous access to information as a form of patient engagement. Methods and analysis This is a technology evaluation study with one technology group (AR plus usual care) and one non-technology group (usual care). Both groups receive face-to-face communications with community pharmacists regarding angiotensin II receptor blockers; the technology group receive additional AR-enhanced digital consumer medicine information throughout the use of their medications. The primary outcome is the change in health literacy and the hypothesis is that the proportions of people who show high health literacy will be larger in the technology group. Mixed effects models will be used to analyse solution effectiveness on outcomes. Multiple regression models will be used to find additional variables that might affect the relationship between health literacy and the AR solution. Ethics and dissemination Queensland University of Technology (QUT) Human Research Ethics Committee has approved the study as a low-risk technology evaluation study (approval number: 1700000275). Findings will be disseminated via attending scientific conferences and publishing in peer-reviewed journals. Facilitated by QUT, two press releases have been published in public media and two presentations have been made in university classrooms. PMID:29705754

  20. Novel augmented reality solution for improving health literacy around antihypertensives in people living with type 2 diabetes mellitus: protocol of a technology evaluation study.

    Science.gov (United States)

    Ahmadvand, Alireza; Drennan, Judy; Burgess, Jean; Clark, Michele; Kavanagh, David; Burns, Kara; Howard, Sarah; Kelly, Fleur; Campbell, Chris; Nissen, Lisa

    2018-04-28

    Low health literacy is common in people with type 2 diabetes mellitus (T2DM) (up to 40%), associated with decreased self-efficacy in managing T2DM and its important complications, mainly hypertension. This study introduces, for the first time, an easy-to-use solution based on augmented reality (AR) on smartphones, to enhance health literacy around antihypertensive medicines. It assesses the feasibility of the solution for improving health literacy, oriented specifically to angiotensin II receptor blockers; embedding the health literacy improvement into the use cycle of angiotensin II receptor blockers and providing continuous access to information as a form of patient engagement. This is a technology evaluation study with one technology group (AR plus usual care) and one non-technology group (usual care). Both groups receive face-to-face communications with community pharmacists regarding angiotensin II receptor blockers; the technology group receive additional AR-enhanced digital consumer medicine information throughout the use of their medications. The primary outcome is the change in health literacy and the hypothesis is that the proportions of people who show high health literacy will be larger in the technology group. Mixed effects models will be used to analyse solution effectiveness on outcomes. Multiple regression models will be used to find additional variables that might affect the relationship between health literacy and the AR solution. Queensland University of Technology (QUT) Human Research Ethics Committee has approved the study as a low-risk technology evaluation study (approval number: 1700000275). Findings will be disseminated via attending scientific conferences and publishing in peer-reviewed journals. Facilitated by QUT, two press releases have been published in public media and two presentations have been made in university classrooms. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All

  1. Copenhagen infant mental health project: study protocol for a randomized controlled trial comparing circle of security –parenting and care as usual as interventions targeting infant mental health risks

    Directory of Open Access Journals (Sweden)

    Mette Skovgaard Væver

    2016-11-01

    Full Text Available Abstract Background Infant mental health is a significant public health issue as early adversity and exposure to early childhood stress are significant risk factors that may have detrimental long-term developmental consequences for the affected children. Negative outcomes are seen on a range of areas such as physical and mental health, educational and labor market success, social network and establishing of family. Secure attachment is associated with optimal outcomes in all developmental domains in childhood, and both insecure and disorganized attachment are associated with a range of later problems and psychopathologies. In disadvantaged populations insecure and disorganized attachment are common, which points to the need of identifying early risk and effective methods of addressing such problems. This protocol describes an experimental evaluation of an indicated group-based parental educational program, Circle of Security–Parenting (COS-P, currently being conducted in Denmark. Methods/design In a parallel randomized controlled trial of two intervention groups this study tests the efficacy of COS-P compared to Care as Usual (CAU in enhancing maternal sensitivity and child attachment in a community sample in the City of Copenhagen, Denmark. During the project a general population of an estimated 17.600 families with an infant aged 2–12 months are screened for two known infant mental health risks, maternal postnatal depression and infant social withdrawal. Eligible families (N = 314, who agree to participate, will be randomly allocated with a ratio of 2:1 into the COS-P intervention arm and into CAU. Data will be obtained at inclusion (baseline and at follow-up when the child is 12–16 months. The primary outcome is maternal sensitivity. Secondary outcomes include quality of infant attachment, language, cognitive and socioemotional development, family functioning, parental stress, parental mentalizing and maternal mental wellbeing

  2. 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.

    Science.gov (United States)

    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

  3. A school-based interdisciplinary approach to promote health and academic achievement among children in a deprived neighborhood: study protocol for a mixed-methods evaluation.

    Science.gov (United States)

    Abrahamse, Mariëlle E; Jonkman, Caroline S; Harting, Janneke

    2018-04-10

    The large number of children that grow up in poverty is concerning, especially given the negative developmental outcomes that can persist into adulthood. Poverty has been found as a risk factor to negatively affect academic achievement and health outcomes in children. Interdisciplinary interventions can be an effective way to promote health and academic achievement. The present study aims to evaluate a school-based interdisciplinary approach on child health, poverty, and academic achievement using a mixed-method design. Generally taken, outcomes of this study increase the knowledge about effective ways to give disadvantaged children equal chances early in their lives. An observational study with a mixed-methods design including both quantitative and qualitative data collection methods will be used to evaluate the interdisciplinary approach. The overall research project exists of three study parts including a longitudinal study, a cross-sectional study, and a process evaluation. Using a multi-source approach we will assess child health as the primary outcome. Child poverty and child academic achievement will be assessed as secondary outcomes. The process evaluation will observe the program's effects on the school environment and the program's implementation in order to obtain more knowledge on how to disseminate the interdisciplinary approach to other schools and neighborhoods. The implementation of a school-based interdisciplinary approach via primary schools combining the cross-sectoral domains health, poverty, and academic achievement is innovative and a step forward to reach an ethnic minority population. However, the large variety of the interventions and activities within the approach can limit the validity of the study. Including a process evaluation will therefore help to improve the interpretation of our findings. In order to contribute to policy and practice focusing on decreasing the unequal chances of children growing up in deprived neighborhoods, it is

  4. 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.

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

    Hanson, Claudia; Waiswa, Peter; Marchant, Tanya; Marx, Michael; Manzi, Fatuma; Mbaruku, Godfrey; Rowe, Alex; Tomson, Göran; Schellenberg, Joanna; Peterson, Stefan

    2014-04-02

    management and continuous surveys, and comparison districts-only continuous surveys. 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. PACTR201311000681314.

  7. HABIT-an early phase study to explore an oral health intervention delivered by health visitors to parents with young children aged 9-12 months: study protocol.

    Science.gov (United States)

    Eskyte, Ieva; Gray-Burrows, Kara; Owen, Jenny; Sykes-Muskett, Bianca; Zoltie, Tim; Gill, Susanne; Smith, Victoria; McEachan, Rosemary; Marshman, Zoe; West, Robert; Pavitt, Sue; Day, Peter

    2018-01-01

    Parental supervised brushing (PSB) when initiated in infancy can lead to long-term protective home-based oral health habits thereby reducing the risk of dental caries. However, PSB is a complex behaviour with many barriers reported by parents hindering its effective implementation. Within the UK, oral health advice is delivered universally to parents by health visitors and their wider teams when children are aged between 9 and 12 months. Nevertheless, there is no standardised intervention or training upon which health visitors can base this advice, and they often lack the specialised knowledge needed to help parents overcome barriers to performing PSB and limiting sugary foods and drinks.Working with health visitors and parents of children aged 9-24 months, we have co-designed oral health training and resources (Health Visitors delivering Advice in Britain on Infant Toothbrushing (HABIT) intervention) to be used by health visitors and their wider teams when providing parents of children aged 9-12 months with oral health advice.The aim of the study is to explore the acceptability of the HABIT intervention to parents and health visitors, to examine the mechanism of action and develop suitable objective measures of PSB. Six health visitors working in a deprived city in the UK will be provided with training on how to use the HABIT intervention. Health visitors will then each deliver the intervention to five parents of children aged 9-12 months. The research team will collect measures of PSB and dietary behaviours before and at 2 weeks and 3 months after the HABIT intervention. Acceptability of the HABIT intervention to health visitors will be explored through semi-structured diaries completed after each visit and a focus group discussion after delivery to all parents. Acceptability of the HABIT intervention and mechanism of action will be explored briefly during each home visit with parents and in greater details in 20-25 qualitative interviews after the

  8. Study protocol for the development of a European measure of best practice for people with long term mental health problems in institutional care (DEMoBinc)

    NARCIS (Netherlands)

    Killaspy, Helen; King, Michael; Wright, Christine; White, Sarah; McCrone, Paul; Kallert, Thomas; Cervilla, Jorge; Raboch, Jiri; Onchev, Georgi; Mezzina, Roberto; Wiersma, Durk; Kiejna, Andrzej; Ploumpidis, Dimitris; Caldas de Almeida, Jose Miguel

    2009-01-01

    Background: This study aims to build a measure for assessing and reviewing the living conditions, care and human rights of people with longer term mental health problems in psychiatric and social care institutions. Protection of their human rights is imperative since impaired mental capacity

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

    Science.gov (United States)

    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.

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

    NARCIS (Netherlands)

    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

  11. Impacts of online and group perinatal education: a mixed methods study protocol for the optimization of perinatal health services.

    Science.gov (United States)

    Roch, Geneviève; Borgès Da Silva, Roxane; de Montigny, Francine; Witteman, Holly O; Pierce, Tamarha; Semenic, Sonia; Poissant, Julie; Parent, André-Anne; White, Deena; Chaillet, Nils; Dubois, Carl-Ardy; Ouimet, Mathieu; Lapointe, Geneviève; Turcotte, Stéphane; Prud'homme, Alexandre; Painchaud Guérard, Geneviève; Gagnon, Marie-Pierre

    2018-05-29

    Prenatal education is a core component of perinatal care and services provided by health institutions. Whereas group prenatal education is the most common educational model, some health institutions have opted to implement online prenatal education to address accessibility issues as well as the evolving needs of future parents. Various studies have shown that prenatal education can be effective in acquisition of knowledge on labour and delivery, reducing psychological distress and maximising father's involvement. However, these results may depend on educational material, organization, format and content. Furthermore, the effectiveness of online prenatal education compared to group prenatal education remains unclear in the literature. This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status, as well as on networks of perinatal educational services maintained with community-based partners. This multipronged mixed methods study uses a collaborative research approach to integrate and mobilize knowledge throughout the process. It consists of: 1) a prospective cohort study with quantitative data collection and qualitative interviews with future and new parents; and 2) a multiple case study integrating documentary sources and interviews with stakeholders involved in the implementation of perinatal information service networks and collaborations with community partners. Perinatal health indicators and determinants will be compared between prenatal education groups (group prenatal education and online prenatal education) and standard care without these prenatal education services (control group). This study will provide knowledge about the impact of online prenatal education as a new technological service delivery model compared to traditional group prenatal education. Indicators related to the complementarity of these interventions and those available in community settings will

  12. A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Przytula, Kamila; Bailey, Stacy Cooper; Galanter, William L; Lambert, Bruce L; Shrestha, Neeha; Dickens, Carolyn; Falck, Suzanne; Wolf, Michael S

    2015-01-27

    The Northwestern University Center for Education and Research on Therapeutics (CERT), funded by the Agency for Healthcare Research and Quality, is one of seven such centers in the USA. The thematic focus of the Northwestern CERT is 'Tools for Optimizing Medication Safety.' Ensuring drug safety is essential, as many adults struggle to take medications, with estimates indicating that only half of adults take drugs as prescribed. This report describes the methods and rationale for one innovative project within the CERT: the 'Primary Care, Electronic Health Record-Based Strategy to Promote Safe and Appropriate Drug Use'. The overall objective of this 5-year study is to evaluate a health literacy-informed, electronic health record-based strategy for promoting safe and effective prescription medication use in a primary care setting. A total of 600 English and Spanish-speaking patients with diabetes will be consecutively recruited to participate in the study. Patients will be randomized to receive either usual care or the intervention; those in the intervention arm will receive a set of print materials designed to support medication use and prompt provider counseling and medication reconciliation. Participants will be interviewed in person after their index clinic visit and again one month later. Process outcomes related to intervention delivery will be recorded. A medical chart review will be performed at 6 months. Patient outcome measures include medication understanding, adherence and clinical measures (hemoglobin A1c, blood pressure, and cholesterol; exploratory outcomes only). Through this study, we will be able to examine the impact of a health literacy-informed, electronic health record-based strategy on medication understanding and adherence among diabetic primary care patients. The measurement of process outcomes will help inform how the strategy might ultimately be refined and disseminated to other sites. Strategies such as these are needed to address the

  13. 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

    Directory of Open Access Journals (Sweden)

    Shankar Prinja

    2016-05-01

    Full Text Available Background: 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. Methods/design: 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. Conclusions: The study will generate significant evidence on impact of the m-health intervention for maternal, neonatal, and child

  14. Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Myers, Bronwyn; Lund, Crick; Lombard, Carl; Joska, John; Levitt, Naomi; Butler, Christopher; Cleary, Susan; Naledi, Tracey; Milligan, Peter; Stein, Dan J; Sorsdahl, Katherine

    2018-03-16

    In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models

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

    Science.gov (United States)

    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

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

    Science.gov (United States)

    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

  17. The Parkin'Play study: protocol of a phase II randomized controlled trial to assess the effects of a health game on cognition in Parkinson's disease.

    Science.gov (United States)

    van de Weijer, Sjors C F; Duits, Annelien A; Bloem, Bastiaan R; Kessels, Roy P; Jansen, Jacobus F A; Köhler, Sebastian; Tissingh, Gerrit; Kuijf, Mark L

    2016-11-03

    In Parkinson's disease (PD), cognitive impairment is an important non-motor symptom heralding the development of dementia. Effective treatments to slow down the rate of cognitive decline in PD patients with mild cognitive impairment are lacking. Here, we describe the design of the Parkin'Play study, which assesses the effects of a cognitive health game intervention on cognition in PD. This study is a multicentre, phase-II, open-randomized clinical trial that aims to recruit 222 PD patients with mild cognitive impairment. Eligible patients have PD, Hoehn & Yahr stages I-III, are aged between 40 and 75 years, and have cognitive impairment but no dementia. The intervention group (n = 111) will be trained using a web-based health game targeting multiple cognitive domains. The control group (n = 111) will be placed on a waiting list. In order to increase compliance the health game adapts to the subjects' performance, is enjoyable, and can be played at home. From each group, 20 patients will undergo fMRI to test for potential functional brain changes underlying treatment. The primary outcome after 12 weeks of training is cognitive function, as assessed by a standard neuropsychological assessment battery and an online cognitive assessment. The neuropsychological assessment battery covers the following domains: executive function, memory, visual perception, visuoconstruction and language. A compound score for overall cognitive function will be calculated as the mean score of all test Z-scores based on the distribution of scores for both groups taken together. Secondary outcomes at follow-up visits up to 24 weeks include various motor and non-motor symptoms, compliance, and biological endpoints (fMRI). This study aims at evaluating whether a cognitive intervention among PD patients leads to an increased cognitive performance on targeted domains. Strengths of this study are a unique web-based health game intervention, the large sample size, a control group without

  18. Exploring the role of the nurse manager in supporting point-of-care nurses' adoption of electronic health records: protocol for a qualitative research study.

    Science.gov (United States)

    Strudwick, Gillian; Booth, Richard G; Bjarnadottir, Ragnhildur I; Collins, Sarah; Srivastava, Rani

    2017-10-12

    An increasing number of electronic health record (EHR) systems have been implemented in clinical practice environments where nurses work. Findings from previous studies have found that a number of intended benefits of the technology have not yet been realised to date, partially due to poor system adoption among health professionals such as nurses. Previous studies have suggested that nurse managers can support the effective adoption and use of the technology by nurses. However, no known studies have identified what role nurse managers have in supporting technology adoption, nor the specific strategies that managers can employ to support their staff. Therefore, the purpose of this research is to better understand the role of the nurse manager in point-of-care nurses' use of EHRs, and to identify strategies that may be effective in supporting clinical adoption. This study will use a qualitative descriptive design. Interviews with both nurse managers and point-of-care nursing staff will be conducted in a Canadian mental health and addiction healthcare organisation where an EHR has been implemented. A semistructured interview guide will be used, and interviews will be audio recorded. Transcripts will be analysed using a directed content analysis technique. Strategies to ensure the trustworthiness of the data analysis procedure and findings will be employed. Ethical approval for this study has been obtained. Dissemination strategies may include a paper submission to a peer-reviewed journal, a conference submission and meetings to share findings with the study site leadership team. Findings from this research will be used to inform a future study which aims to assess levels of competencies and perform a psychometric analysis of the Nursing Informatics Competency Assessment for the Nurse Leader instrument in a Canadian context. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  19. 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.

    Science.gov (United States)

    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

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

    Directory of Open Access Journals (Sweden)

    McElwaine Kathleen M

    2011-12-01

    Full Text Available Abstract 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

  1. Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Gao, Xiaoli; Lo, Edward Chin Man; McGrath, Colman; Ho, Samuel Mun Yin

    2013-04-30

    Dental caries (tooth decay) is highly prevalent and is largely attributable to unhealthy self-care behaviors (diet and oral hygiene). The conventional (health) education (CE), focusing on disseminating information and giving normative advice, often fails to achieve sustained behavioral changes. This study incorporates two innovative elements into CE: (i) motivational interviewing (MI), a client-centered counseling for changing behaviors, and (ii) an interactive caries risk assessment (RA) tool, which is devised to facilitate dental counseling and may enhance MI in several ways. Through a randomized, controlled, evaluator-blinded trial, three intervention schemes (CE, CE+MI, and CE+MI+RA) will be compared for their effectiveness in eliciting dentally healthy behaviors and preventing caries in preschool children. This study targets 3-year-old children who are at a critical stage for embedding health habits. Children with unfavorable dental behaviors (insufficient toothbrushing and/or frequent snacking) and their parents will be recruited from 12 participating kindergartens. Parent-child dyads (n=690) will be randomly assigned into three groups. In the first group (CE), oral health information and advice will be delivered to parents through pamphlets. In the second group (CE+MI), in addition to the pamphlets, individual MI counseling with each parent will be performed by one of two trained dental hygienists. In the third group (CE+MI+RA), besides pamphlets and MI, interactive RA will be integrated into MI to motivate parents and facilitate their informed decision making and goal planning. At baseline and after 12 and 24 months, parents will complete a questionnaire and children will undergo a dental examination. The effectiveness of the intervention schemes will be compared over 12 and 24 months. The primary outcome will be caries increment in children and proportion of caries-free children. Secondary outcomes will be changes in parental efficacy for protecting

  2. [Professional divers: analysis of critical issues and proposal of a health protocol for work fitness].

    Science.gov (United States)

    Pedata, Paola; Corvino, Anna Rita; Napolitano, Raffaele Carmine; Garzillo, Elpidio Maria; Furfaro, Ciro; Lamberti, Monica

    2016-01-20

    From many years now, thanks to the development of modern diving techniques, there has been a rapid spread of diving activities everywhere. In fact, divers are ever more numerous both among the Armed Forces and civilians who dive for work, like fishing, biological research and archeology. The aim of the study was to propose a health protocol for work fitness of professional divers keeping in mind the peculiar work activity, existing Italian legislation that is almost out of date and the technical and scientific evolution in this occupational field. We performed an analysis of the most frequently occurring diseases among professional divers and of the clinical investigation and imaging techniques used for work fitness assessment of professional divers. From analysis of the health protocol recommended by D.M. 13 January 1979 (Ministerial Decree), that is most used by occupational health physician, several critical issues emerged. Very often the clinical investigation and imaging techniques still used are almost obsolete, ignoring the execution of simple and inexpensive investigations that are more useful for work fitness assessment. Considering the out-dated legislation concerning diving disciplines, it is necessary to draw up a common health protocol that takes into account clinical and scientific knowledge and skills acquired in this area. This protocol's aim is to propose a useful tool for occupational health physicians who work in this sector.

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

    Science.gov (United States)

    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.

  4. 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

    Directory of Open Access Journals (Sweden)

    Séverine Erismann

    2016-03-01

    Full Text Available Abstract Background 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. Methods/Design 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

  5. 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.

    Science.gov (United States)

    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

  6. Dialectical behaviour therapy for treating adults and adolescents with emotional and behavioural dysregulation: study protocol of a coordinated implementation in a publicly funded health service.

    LENUS (Irish Health Repository)

    Flynn, Daniel

    2018-02-26

    In the Republic of Ireland, borderline personality disorder (BPD) is a feature of approximately 11-20% of clinical presentations to outpatient clinics within mental health services. These estimates are similar to other countries including the UK and USA. Dialectical behaviour therapy (DBT) is an intervention with a growing body of evidence that demonstrates its efficacy in treating individuals diagnosed with BPD. While a number of randomised controlled trials (RCTs) have demonstrated the efficacy of DBT, there is limited research which evaluates the effectiveness of this model when applied to real world settings. Funding was secured to co-ordinate DBT training in public community-based mental health services across Ireland. As no other study has evaluated a co-ordinated national implementation of DBT, the current study proposes to investigate the effectiveness of DBT in both adult and child\\/adolescent community mental health services across Ireland, evaluate the coordinated implementation of DBT at a national level, and complete a comprehensive economic evaluation comparing DBT versus treatment-as-usual.

  7. Methodological characteristics and treatment effect sizes in oral health randomised controlled trials: Is there a relationship? Protocol for a meta-epidemiological study.

    Science.gov (United States)

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2014-02-25

    It is fundamental that randomised controlled trials (RCTs) are properly conducted in order to reach well-supported conclusions. However, there is emerging evidence that RCTs are subject to biases which can overestimate or underestimate the true treatment effect, due to flaws in the study design characteristics of such trials. The extent to which this holds true in oral health RCTs, which have some unique design characteristics compared to RCTs in other health fields, is unclear. As such, we aim to examine the empirical evidence quantifying the extent of bias associated with methodological and non-methodological characteristics in oral health RCTs. We plan to perform a meta-epidemiological study, where a sample size of 60 meta-analyses (MAs) including approximately 600 RCTs will be selected. The MAs will be randomly obtained from the Oral Health Database of Systematic Reviews using a random number table; and will be considered for inclusion if they include a minimum of five RCTs, and examine a therapeutic intervention related to one of the recognised dental specialties. RCTs identified in selected MAs will be subsequently included if their study design includes a comparison between an intervention group and a placebo group or another intervention group. Data will be extracted from selected trials included in MAs based on a number of methodological and non-methodological characteristics. Moreover, the risk of bias will be assessed using the Cochrane Risk of Bias tool. Effect size estimates and measures of variability for the main outcome will be extracted from each RCT included in selected MAs, and a two-level analysis will be conducted using a meta-meta-analytic approach with a random effects model to allow for intra-MA and inter-MA heterogeneity. The intended audiences of the findings will include dental clinicians, oral health researchers, policymakers and graduate students. The aforementioned will be introduced to the findings through workshops, seminars, round

  8. 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).

    Science.gov (United States)

    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.

  9. Prayer Healing: A Case Study Research Protocol.

    Science.gov (United States)

    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

  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.

    Science.gov (United States)

    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

  11. Improving health outcomes for young people with long term conditions: The role of digital communication in current and future patient-clinician communication for NHS providers of specialist clinical services for young people - LYNC study protocol.

    Science.gov (United States)

    Griffiths, Frances E; Atherton, Helen; Barker, Jack R; Cave, Jonathan Ak; Dennick, Kathryn; Dowdall, Peter; Fraser, Joe; Huxley, Caroline; Kim, Sung-Wook; Madan, Jason J; Matharu, Harjit; Musumadi, Luhanga; Palmer, Tom M; Paul, Moli; Sankaranarayanan, Sailesh; Slowther, Anne-Marie; Sujan, Mark A; Sutcliffe, Paul A; Sturt, Jackie

    2015-01-01

    Young people living with long term conditions are vulnerable to health service disengagement. This endangers their long term health. Studies report requests for digital forms of communication - email, text, social media - with their health care team. Digital clinical communication is troublesome for the UK NHS. In this article we aim to present the research protocol for evaluating the impacts and outcomes of digital clinical communications for young people living with long term conditions and provide critical analysis of their use, monitoring and evaluation by NHS providers (LYNC study: Long term conditions, Young people, Networked Communications). The research involves: (a) patient and public involvement activities with 16-24 year olds with and without long term health conditions; (b) six literature reviews; (c) case studies - the main empirical part of the study - and (d) synthesis and a consensus meeting. Case studies use a mixed methods design. Interviews and non-participant observation of practitioners and patients communicating in up to 20 specialist clinical settings will be combined with data, aggregated at the case level (non-identifiable patient data) on a range of clinical outcomes meaningful within the case and across cases. We will describe the use of digital clinical communication from the perspective of patients, clinical staff, support staff and managers, interviewing up to 15 young people and 15 staff per case study. Outcome data includes emergency admissions, A&E attendance and DNA (did not attend) rates. Case studies will be analysed to understand impacts of digital clinical communication on patient health outcomes, health care costs and consumption, ethics and patient safety.

  12. An exploratory trial of a health education programme to promote healthy lifestyles through social and emotional competence in young children: Study protocol.

    Science.gov (United States)

    Bermejo-Martins, Elena; López-Dicastillo, Olga; Mujika, Agurtzane

    2018-01-01

    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.

  13. A health economic model for the development and evaluation of innovations in aged care: an application to consumer-directed care-study protocol.

    Science.gov (United States)

    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

  14. The effect of an affordable daycare program on health and economic well-being in Rajasthan, India: protocol for a cluster-randomized impact evaluation study

    Directory of Open Access Journals (Sweden)

    Arijit Nandi

    2016-06-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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. Trial registration (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

  15. A tailored, dialogue-based health communication application for patients with chronic low back pain: study protocol of a randomised controlled trial.

    Science.gov (United States)

    Dirmaier, Jörg; Härter, Martin; Weymann, Nina

    2013-06-14

    Chronic low back pain is a common chronic condition whose treatment success can be improved by active involvement of patients. Patient involvement can be fostered by web-based applications combining health information with decision support or behaviour change support. These so-called Interactive Health Communication Applications (IHCAs) can reach great numbers of patients at low financial cost and provide information and support at the time, place and learning speed patients prefer. However, high attrition often seems to decrease the effects of web-based interventions. Tailoring content and tone of IHCAs to the individual patient ́s needs might improve usage and therefore effectiveness. This study aims to evaluate a tailored IHCA for people with chronic low back pain combining health information with decision support and behaviour change support. The tailored IHCA will be tested regarding effectiveness and usage against a standard website with identical content in a single-blinded randomized trial with a parallel design. The IHCA contains information on chronic low back pain and its treatment options including health behaviour change recommendations. In the intervention group the content is delivered in dialogue form, tailored to relevant patient characteristics (health literacy, coping style). In the control group there is no tailoring, a standard web-page is used for presenting the content. Participants are unaware of group assignment. Eligibility criteria are age ≥ 18 years , self- reported chronic low back pain, and Internet access. To detect the expected small effect (Cohen's d = 0.2), the sample aims to include 414 patients, with assessments at baseline, directly after the first on-page visit, and at 3-month follow-up using online self-report questionnaires. It is expected that the tailored IHCA has larger effects on knowledge and patient empowerment (primary outcomes) compared to a standard website. Secondary outcomes are website usage

  16. A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

    Science.gov (United States)

    Hoque, Dewan Md Emdadul; Chowdhury, Mohiuddin Ahsanul Kabir; Rahman, Ahmed Ehsanur; Billah, Sk Masum; Bari, Sanwarul; Tahsina, Tazeen; Hasan, Mohammad Mehedi; Islam, Sajia; Islam, Tajul; Mori, Rintaro; Arifeen, Shams El

    2018-05-03

    Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured. A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000-30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities. The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings. NCT03032276 .

  17. Mac protocols for wireless sensor network (wsn): a comparative study

    International Nuclear Information System (INIS)

    Arshad, J.; Akram, Q.; Saleem, Y.

    2014-01-01

    Data communication between nodes is carried out under Medium Access Control (MAC) protocol which is defined at data link layer. The MAC protocols are responsible to communicate and coordinate between nodes according to the defined standards in WSN (Wireless Sensor Networks). The design of a MAC protocol should also address the issues of energy efficiency and transmission efficiency. There are number of MAC protocols that exist in the literature proposed for WSN. In this paper, nine MAC protocols which includes S-MAC, T-MAC, Wise-MAC, Mu-MAC, Z-MAC, A-MAC, D-MAC, B-MAC and B-MAC+ for WSN have been explored, studied and analyzed. These nine protocols are classified in contention based and hybrid (combination of contention and schedule based) MAC protocols. The goal of this comparative study is to provide a basis for MAC protocols and to highlight different mechanisms used with respect to parameters for the evaluation of energy and transmission efficiency in WSN. This study also aims to give reader a better understanding of the concepts, processes and flow of information used in these MAC protocols for WSN. A comparison with respect to energy reservation scheme, idle listening avoidance, latency, fairness, data synchronization, and throughput maximization has been presented. It was analyzed that contention based MAC protocols are less energy efficient as compared to hybrid MAC protocols. From the analysis of contention based MAC protocols in term of energy consumption, it was being observed that protocols based on preamble sampling consume lesser energy than protocols based on static or dynamic sleep schedule. (author)

  18. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Godfrey, Keith M; Cutfield, Wayne; Chan, Shiao-Yng; Baker, Philip N; Chong, Yap-Seng

    2017-03-20

    Improved maternal nutrition and glycaemic control before and during pregnancy are thought to benefit the health of the mother, with consequent benefits for infant body composition and later obesity risk. Maternal insulin resistance and glycaemia around conception and in early pregnancy may be key determinants of maternal physiology and placental function, affecting fetal nutrient supply and maternal-feto-placental communications throughout gestation, with implications for later postnatal health. This double-blind randomised controlled trial will recruit up to 1800 women, aged 18-38 years, who are planning a pregnancy in the United Kingdom (UK), Singapore and New Zealand, with a view to studying 600 pregnancies. The primary outcome is maternal glucose tolerance at 28 weeks' gestation following an oral glucose tolerance test. Secondary outcomes include metabolic, molecular and health-related outcomes in the mother and offspring, notably infant body composition. Participants will be randomly allocated to receive a twice-daily control nutritional drink, enriched with standard micronutrients, or a twice-daily intervention nutritional drink enriched with additional micronutrients, myo-inositol and probiotics, both demonstrated previously to assist in maintaining healthy glucose metabolism during pregnancy. Myo-inositol is a nutrient that enhances cellular glucose uptake. The additional micronutrients seek to address deficiencies of some B-group vitamins and vitamin D that are both common during pregnancy and that have been associated with maternal dysglycaemia, epigenetic changes and greater offspring adiposity. Women who conceive within a year of starting the nutritional drinks will be followed through pregnancy and studied with their infants at six time points during the first year of life. Blood, urine/stool, hair and cheek swabs will be collected from the mothers for genetic, epigenetic, hormone, nutrient and metabolite measurements, and assessments of the mother

  19. Study protocol for the development of a European measure of best practice for people with long term mental health problems in institutional care (DEMoBinc

    Directory of Open Access Journals (Sweden)

    Killaspy Helen

    2009-06-01

    Full Text Available Abstract Background This study aims to build a measure for assessing and reviewing the living conditions, care and human rights of people with longer term mental health problems in psychiatric and social care institutions. Protection of their human rights is imperative since impaired mental capacity secondary to mental illness can make them vulnerable to abuse and exploitation from others. They also constitute a major resource pressure for mental health services, social services, informal carers and society as a whole. Methods/Design This study uses an iterative methodology to develop a toolkit to assess internationally agreed domains of care that are considered most important for recovery. These domains are identified by collating results from: i a systematic review of the literature on institutional care for this service user group; ii a review of the relevant care standards in each participating country; iii Delphi exercises in partner countries with mental health professionals, service users, carers and advocates. Common domains and cross-cutting themes are agreed by the principal researchers and an international expert panel. Items are developed to assess these domains and incorporated into the toolkit which is designed to be administered through a face to face interview with the institution's manager. The toolkit is refined in response to inter-rater reliability testing, feedback from interviewers and interviewees regarding its utility, and feedback from key stakeholders in each country about its ability to deliver information that can be used within each country's established systems for quality assessment and review. Cross-validation of the toolkit ratings against service users' quality of life, autonomy and markers of recovery tests whether it can deliver a proxy-measure of the service users' experiences of care and the institution's promotion of their human rights and recovery. The ability of the toolkit to assess the "value for money

  20. Exploring eHealth Ethics and Multi-Morbidity: Protocol for an Interview and Focus Group Study of Patient and Health Care Provider Views and Experiences of Using Digital Media for Health Purposes

    OpenAIRE

    Townsend, Anne; Adam, Paul; Li, Linda C; McDonald, Michael; Backman, Catherine L

    2013-01-01

    Background eHealth is a broad term referring to the application of information and communication technologies in the health sector, ranging from health records to medical consultations (telemedicine) and multiple forms of health education, support, and tools. By providing increased and anytime access to information, opportunities to exchange experiences with others, and self-management support, eHealth has been heralded as transformational. It has the potential to accelerate the shift from tr...

  1. Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    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

  2. Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

    Science.gov (United States)

    Levasseur, Mélanie; Dubois, Marie-France; Filliatrault, Johanne; Vasiliadis, Helen-Maria; Lacasse-Bédard, Joanie; Tourigny, André; Levert, Marie-Josée; Gabaude, Catherine; Lefebvre, Hélène; Berger, Valérie; Eymard, Chantal

    2018-03-31

    The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. The Research

  3. A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

    Science.gov (United States)

    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.

  4. e-SCP-ECG+ Protocol: An Expansion on SCP-ECG Protocol for Health Telemonitoring—Pilot Implementation

    Directory of Open Access Journals (Sweden)

    George J. Mandellos

    2010-01-01

    Full Text Available 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.

  5. Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    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.

  6. Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sagedal Linda Reme

    2013-02-01

    Full Text Available Abstract Background The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, complications of pregnancy and delivery, and maternal weight retention up to 12 months postpartum. Methods/design Fit for Delivery is a randomized controlled trial that will include 600 women expecting their first child. To be eligible, women must be 18 years of age or older, of less than 20 weeks gestational age, with a singleton pregnancy, and have a Body Mass Index (BMI ≥ 19 kg/m2. The women will be randomly allocated to either an intervention group or a control group. The control group will receive standard prenatal care. The intervention group will, in addition, receive nutritional counseling by phone, access to twice-weekly exercise sessions, and information on healthy eating and physical activity provided in pamphlets, evening meetings and an interactive website. Both groups will be monitored by weighing (including bioimpedance measurements of percent body fat, blood tests, self-report questionnaires and hospital record review. Discussion Weight gained in pregnancy affects the health of both the mother and her unborn child, and simple models for efficient intervention are in high demand. The Fit for Delivery intervention provides concrete advice on limiting energy intake and practical training in increasing physical activity. This lifestyle intervention

  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

    Directory of Open Access Journals (Sweden)

    Fellows Jeffrey L

    2012-08-01

    Full Text Available Abstract 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

  8. Study protocol for “MOVEdiabetes”: a trial to promote physical activity for adults with type 2 diabetes in primary health care in Oman

    Directory of Open Access Journals (Sweden)

    Thamra S. Alghafri

    2017-01-01

    Full Text Available Abstract Background 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. Methods/design 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

  9. 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.

    Science.gov (United States)

    Fellows, Jeffrey L; Mularski, Richard; Waiwaiole, Lisa; Funkhouser, Kim; Mitchell, Julie; Arnold, Kathleen; Luke, Sabrina

    2012-08-01

    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). 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 six months, self-reported seven

  10. Characteristics of value-based health and social care from organisations' perspectives (OrgValue): a mixed-methods study protocol.

    Science.gov (United States)

    Ansmann, Lena; Hillen, Hendrik Ansgar; Kuntz, Ludwig; Stock, Stephanie; Vennedey, Vera; Hower, Kira Isabelle

    2018-04-27

    Health and social care systems are under pressure to organise care around patients' needs with constrained resources. Several studies reveal that care is constantly challenged by balancing economic requirements against individual patients' preferences and needs. Therefore, value-based health and social care aims to facilitate patient-centredness while taking the resources spent into consideration. The OrgValue project examines the implementation of patient-centredness while considering the health and social care organisations' resource orientation in the model region of the city of Cologne, Germany. First, the implementation status of patient-centredness as well as its facilitators and barriers-also in terms of resource orientation-will be assessed through face-to-face interviews with decision-makers (at least n=18) from health and social care organisations (HSCOs) in Cologne. Second, patients' understanding of patient-centredness and their preferences and needs will be revealed by conducting face-to-face interviews (at least n=15). Third, the qualitative results will provide the basis for a quantitative survey of decision-makers from all HSCOs in Cologne, which will include questions on patient-centredness, resource orientation and determinants of implementation. Fourth, qualitative interviews with decision-makers from different types of HSCOs will be conducted to develop a uniform measurement instrument on the cost and service structure of HSCOs. For all collected data, the relevant data protection regulations will be adhered to. Consultation and a positive vote from the ethics committee of the Medical Faculty of the University of Cologne have been obtained. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include a feedback report as well as research and development workshops for the organisations with the aim of initiating organisational learning and organisational development, presenting results in publications

  11. Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Freeman, Daniel; Sheaves, Bryony; Goodwin, Guy M; Yu, Ly-Mee; Harrison, Paul J; Emsley, Richard; Bostock, Sophie; Foster, Russell G; Wadekar, Vanashree; Hinds, Christopher; Espie, Colin A

    2015-05-28

    Insomnia, defined as repeated difficulties getting or staying asleep, is common in the general population. Such sleep difficulties are a problem in their own right, but increasingly it is being recognised that they may also be a contributory factor in the development of a wide range of mental health problems. Our focus is upon the relationship between insomnia and psychotic experiences, such as paranoia and hallucinations. Psychotic experiences commonly occur in mild forms in the general population and have been linked to disrupted sleep. These psychotic-like experiences raise the risk of development of a clinical disorder. Our aim is to reduce insomnia in a large general population group, and examine the effect on paranoia and hallucinations at the age when mental health problems typically emerge. The primary hypotheses are that cognitive behaviour therapy (CBT) for insomnia will reduce insomnia and also levels of paranoia and hallucinations. The theoretical links will be substantiated by a planned mediation analysis. Improvements in a number of other mental health outcomes are also predicted. We will carry out a parallel group, randomised controlled trial of 2,614 students with insomnia in universities across the UK. In the Oxford Access for Students Improving Sleep (OASIS) trial, participants will be randomised to digital CBT for insomnia (in addition to treatment as usual) or treatment as usual. Online assessments will take place at zero, three, 10 (post-treatment), and 22 (follow-up) weeks. Primary outcomes are insomnia and psychotic-like experiences (paranoia or hallucinatory experiences) at 10 weeks. Secondary outcomes are levels of mania, depression, anxiety, nightmares, psychological wellbeing, and the development of mental health disorders. All main analyses will be carried out at the end of the last follow-up assessment and will be based on the intention-to-treat principle. The trial is funded by the Wellcome Trust. This study will be the first large

  12. 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.

    Science.gov (United States)

    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

  13. 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.

    Science.gov (United States)

    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

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

    NARCIS (Netherlands)

    Nieuwenhuijsen, M.J.; Kruize, H.; Gidlow, C.; Andrusaityte, S.; Anto, J.M.; Basagana, X.; Cirach, M.; Dadvand, P.; Danileviciute, A.; Donaire-Gonzalez, D.; Garcia, J.; Jerrett, M.; Jones, M.; Julvez, J.; van Kempen, E.; van Kamp, I.; Maas, J.; Seto, E.; Smith, G.; Triguero, M.; Wendel-Vos, W.; Wright, J.; Zufferey, J.; van den Hazel, P.J.; Lawrence, R.; Grazuleviciene, R.

    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

  15. Evaluation of an Australian health literacy training program for socially disadvantaged adults attending basic education classes: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    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

  16. Interactive verification of Markov chains: Two distributed protocol case studies

    Directory of Open Access Journals (Sweden)

    Johannes Hölzl

    2012-12-01

    Full Text Available Probabilistic model checkers like PRISM only check probabilistic systems of a fixed size. To guarantee the desired properties for an arbitrary size, mathematical analysis is necessary. We show for two case studies how this can be done in the interactive proof assistant Isabelle/HOL. The first case study is a detailed description of how we verified properties of the ZeroConf protocol, a decentral address allocation protocol. The second case study shows the more involved verification of anonymity properties of the Crowds protocol, an anonymizing protocol.

  17. A novel dynamic exercise initiative for older people to improve health and well-being: study protocol for a randomised controlled trial.

    Science.gov (United States)

    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

  18. 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.

    Science.gov (United States)

    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

  19. 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

    Science.gov (United States)

    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

  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.

    Science.gov (United States)

    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. Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol.

    Science.gov (United States)

    Mahlknecht, Angelika; Nestler, Nadja; Bauer, Ulrike; Schüßler, Nadine; Schuler, Jochen; Scharer, Sebastian; Becker, Ralf; Waltering, Isabel; Hempel, Georg; Schwalbe, Oliver; Flamm, Maria; Osterbrink, Jürgen

    2017-01-18

    Pharmacotherapy in residents of nursing homes is critical due to the special vulnerability of this population. Medical care and interprofessional communication in nursing homes are often uncoordinated. As a consequence, polypharmacy and inappropriate medication use are common and may lead to hospitalizations and health hazards. The aim of this study is to optimize communication between the involved professional groups by specific training and by establishing a structured medication review process, and to improve medication appropriateness and patient-relevant health outcomes for residents of nursing homes. The trial is designed as single-arm study. It involves 300 nursing home residents aged ≥ 65 years and the members of the different professional groups practising in nursing home care (15-20 general practitioners, nurses, pharmacists). The intervention consists of interprofessional education on safe medication use in geriatric patients, and a systematic interprofessional therapy check (recording, reviewing and adapting the medication of the participating residents by means of a specific online platform). The intervention period is divided into two phases; total project period is 3 years. Primary outcome measure is the change in medication appropriateness according to the Medication Appropriateness Index. Secondary outcomes are cognitive performance, occurrence of delirium, agitation, tendency of falls, total number of drugs, number of potentially dangerous drug-drug interactions and appropriateness of recorded analgesic therapy regimens according to the Medication Appropriateness Index. Data are collected at t 0 (before the start of the intervention), t 1 (after the first intervention period) and t 2 (after the second intervention period). Cooperation and communication between the professional groups are investigated twice by qualitative interviews. The project aims to establish a structured system for monitoring of drug therapy in nursing home residents

  2. Study Application of RADIUS Protocol on Ethernet

    Institute of Scientific and Technical Information of China (English)

    GUO Fang; YANG Huan-yu; LI Hong

    2004-01-01

    This paper presents how to apply the RADIUS (Remote Authentication Dial In User Service)protocol ,which is generally applied to dial-up network, to the authentication & charge of Broad Band accessing control system on Ethernet. It is provided that the Broad Band accessing control system included a self-designed communication protocol is used in communicating between an terminal user and Network Access Server .The interface module on the servers side and the Radius system is also given in this article.

  3. Study protocol for the Integra Initiative to assess the benefits and costs of integrating sexual and reproductive health and HIV services in Kenya and Swaziland

    Directory of Open Access Journals (Sweden)

    Warren Charlotte E

    2012-11-01

    Full Text Available Abstract Background In sub-Saharan Africa (SSA there are strong arguments for the provision of integrated sexual and reproductive health (SRH and HIV services. Most HIV transmissions are sexually transmitted or associated with pregnancy, childbirth, and breastfeeding. Many of the behaviours that prevent HIV transmission also prevent sexually transmitted infections and unintended pregnancies. There is potential for integration to increase the coverage of HIV services, as individuals who use SRH services can benefit from HIV services and vice-versa, as well as increase cost-savings. However, there is a dearth of empirical evidence on effective models for integrating HIV/SRH services. The need for robust evidence led a consortium of three organizations – International Planned Parenthood Federation, Population Council and the London School of Hygiene & Tropical Medicine – to design/implement the Integra Initiative. Integra seeks to generate rigorous evidence on the feasibility, effectiveness, cost and impact of different models for delivering integrated HIV/SRH services in high and medium HIV prevalence settings in SSA. Methods/design A quasi-experimental study will be conducted in government clinics in Kenya and Swaziland – assigned into intervention/comparison groups. Two models of service delivery are investigated: integrating HIV care/treatment into 1 family planning and 2 postnatal care. A full economic-costing will be used to assess the costs of different components of service provision, and the determinants of variations in unit costs across facilities/service models. Health facility assessments will be conducted at four time-periods to track changes in quality of care and utilization over time. A two-year cohort study of family planning/postnatal clients will assess the effect of integration on individual outcomes, including use of SRH services, HIV status (known/unknown and pregnancy (planned/unintended. Household surveys within some

  4. INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.

    Science.gov (United States)

    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

  5. Influence of the day care, home and neighbourhood environment on young children's physical activity and health: protocol for the PLAYCE observational study.

    Science.gov (United States)

    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

  6. "Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Björklund, Katja; Liski, Antti; Samposalo, Hanna; Lindblom, Jallu; Hella, Juho; Huhtinen, Heini; Ojala, Tiina; Alasuvanto, Paula; Koskinen, Hanna-Leena; Kiviruusu, Olli; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Solantaus, Tytti; Santalahti, Päivi

    2014-10-07

    Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a

  7. Mobile Link - a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial.

    Science.gov (United States)

    Brody, Carinne; Tuot, Sovannary; Chhoun, Pheak; Swendenman, Dallas; Kaplan, Kathryn C; Yi, Siyan

    2018-04-19

    In Cambodia, HIV prevalence is concentrated in key populations including among female entertainment workers (FEWs) who may engage in direct or indirect sex work. Reaching FEWs with sexual and reproductive health (SRH) services has been difficult because of their hidden and stigmatized nature. Mobile-phone-based interventions may be an effective way to reach this population and connect them with the existing services. This article describes study design and implementation of a randomized controlled trial (RCT) of a mobile health intervention (the Mobile Link) aiming to improve SRH and related outcomes among FEWs in Cambodia. A two-arm RCT will be used to determine the effectiveness of a mobile-phone-based text/voice messaging intervention. The intervention will be developed through a participatory process. Focus group discussions and in-depth interviews have been conducted to inform and tailor behavior change theory-based text and voice messages. During the implementation phase, 600 FEWs will be recruited and randomly assigned into one of the two arms: (1) a control group and (2) a mobile phone message group (either text messages [SMS] or voice messages [VM], a delivery method chosen by participants). Participants in the control group will also receive a weekly monitoring survey, which will provide real-time information to implementing partners to streamline outreach efforts and be able to quickly identify geographic trends. The primary outcome measures will include self-reported HIV and sexually transmitted infections (STI) testing and treatment, condom use, contraceptive use, and gender-based violence (GBV). If the Mobile Link trial is successful, participants will report an increase in condom use, linkages to screening and treatment for HIV and STI, and contraception use as well as a reduction in GBV. This trial is unique in a number of ways. First, the option of participation mode (SMS or VM) allows participants to choose the message medium that best links them

  8. Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial.

    Science.gov (United States)

    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

  9. Incinerators and health. Exposure to dioxines of the population living near U.I.O.M. state of knowledge and protocol of an exposure study; Incinerateurs et sante. Exposition aux dioxines de la population vivant a proximite des UIOM. Etat des connaissances et protocole d'une etude d'exposition

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-11-15

    For several years, dioxines, very stable and ubiquitous pollutants that can be found in the food chain, have drawn continuous attention from actors implicated in waste management, from the general population and from scientists. Indeed, waste incineration is still a cause for concern for the general public in light of the significant emission of pollutants, specifically dioxines, emitted by certain waste incinerators that were recently shut down or brought up to standards. Between 1998 and 2003, the total number of incinerators in France decreased from 300 to 123, and their dioxin emissions were significantly reduced. Public health studies are nevertheless necessary because of the continued presence of dioxines in the environment. The Institut de veille sanitaire (National Institute of Public Health Surveillance) and the Agence francaise de securite sanitaire des aliments (French Food Safety Agency) convened a group of experts to better understand the dioxin exposure of people residing in close proximity to municipal solid waste incinerators (MSWIs) as well as the determinants of this exposure, specifically the consumption of local products. This report gathers the existing data necessary for the production of a study protocol. It contains four parts dealing respectively with: - the contribution of MSWIs to dioxin exposure by air and food consumption while identifying relevant criteria to select MSWIs for the protocol and the method determining the area(s) of study; - the most adapted food study method to estimate dioxin exposure via food consumption, specifically the consumption of food commodities produced in the local atmospheric deposition area of a MSWI and the identification of the type of population most appropriate for the study; - a selection of the most relevant biological indicators of dioxin exposure and PCBs, their levels as recorded in various countries and their variation factors; - and a proposal for a multicenter study protocol. This study will be

  10. Incinerators and health. Exposure to dioxines of the population living near U.I.O.M. state of knowledge and protocol of an exposure study; Incinerateurs et sante. Exposition aux dioxines de la population vivant a proximite des UIOM. Etat des connaissances et protocole d'une etude d'exposition

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-11-15

    For several years, dioxines, very stable and ubiquitous pollutants that can be found in the food chain, have drawn continuous attention from actors implicated in waste management, from the general population and from scientists. Indeed, waste incineration is still a cause for concern for the general public in light of the significant emission of pollutants, specifically dioxines, emitted by certain waste incinerators that were recently shut down or brought up to standards. Between 1998 and 2003, the total number of incinerators in France decreased from 300 to 123, and their dioxin emissions were significantly reduced. Public health studies are nevertheless necessary because of the continued presence of dioxines in the environment. The Institut de veille sanitaire (National Institute of Public Health Surveillance) and the Agence francaise de securite sanitaire des aliments (French Food Safety Agency) convened a group of experts to better understand the dioxin exposure of people residing in close proximity to municipal solid waste incinerators (MSWIs) as well as the determinants of this exposure, specifically the consumption of local products. This report gathers the existing data necessary for the production of a study protocol. It contains four parts dealing respectively with: - the contribution of MSWIs to dioxin exposure by air and food consumption while identifying relevant criteria to select MSWIs for the protocol and the method determining the area(s) of study; - the most adapted food study method to estimate dioxin exposure via food consumption, specifically the consumption of food commodities produced in the local atmospheric deposition area of a MSWI and the identification of the type of population most appropriate for the study; - a selection of the most relevant biological indicators of dioxin exposure and PCBs, their levels as recorded in various countries and their variation factors; - and a proposal for a multicenter study protocol. This study will be

  11. Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Woelk, Godfrey B; Kieffer, Mary Pat; Walker, Damilola; Mpofu, Daphne; Machekano, Rhoderick

    2016-02-16

    Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. Implementation of the protocol necessitated changes in the

  12. 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.

    Science.gov (United States)

    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

  13. Effect of a program of short bouts of exercise on bone health in adolescents involved in different sports: the PRO-BONE study protocol.

    Science.gov (United States)

    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

  14. Beyond communication: the role of standardized protocols in a changing health care environment.

    Science.gov (United States)

    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.

  15. Policies and protocols for preventing transmission of HIV infection in oral health care in South Africa.

    Science.gov (United States)

    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

  16. The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial.

    Science.gov (United States)

    Gustafson, David H; Landucci, Gina; McTavish, Fiona; Kornfield, Rachel; Johnson, Roberta A; Mares, Marie-Louise; Westergaard, Ryan P; Quanbeck, Andrew; Alagoz, Esra; Pe-Romashko, Klaren; Thomas, Chantelle; Shah, Dhavan

    2016-12-12

    Opioid dependence has devastating and increasingly widespread consequences and costs, and the most common outcome of treatment is early relapse. People who inject opioids are also at disproportionate risk for contracting the human immunodeficiency virus (HIV) and hepatitis C virus (HCV). This study tests an approach that has been shown to improve recovery rates: medication along with other supportive services (medication-assisted treatment, or MAT) against MAT combined with a smartphone innovation called A-CHESS (MAT + A-CHESS). This unblinded study will randomly assign 440 patients to receive MAT + A-CHESS or MAT alone. Eligible patients will meet criteria for having an opioid use disorder of at least moderate severity and will be taking methadone, injectable naltrexone, or buprenorphine. Patients with A-CHESS will have smartphones for 16 months; all patients will be followed for 24 months. The primary outcome is the difference between patients in the two arms in percentage of days using illicit opioids during the 24-month intervention. Secondary outcomes are differences between patients receiving MAT + A-CHESS versus MAT in other substance use, quality of life, retention in treatment, health service use, and, related to HIV and HCV, screening and testing rates, medication adherence, risk behaviors, and links to care. We will also examine mediators and moderators of the effects of MAT + A-CHESS. We will measure variables at baseline and months 4, 8, 12, 16, 20, and 24. At each point, patients will respond to a 20- to 30-min phone survey; urine screens will be collected at baseline and up to twice a month thereafter. We will use mixed-effects to evaluate the primary and secondary outcomes, with baseline scores functioning as covariates, treatment condition as a between-subject factor, and the outcomes reflecting scores for a given assessment at the six time points. Separate analyses will be conducted for each outcome. A-CHESS has been shown to

  17. Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    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

  18. Association between home visiting interventions and First Nations families' health and social outcomes in Manitoba, Canada: protocol for a study of linked population-based administrative data.

    Science.gov (United States)

    Brownell, Marni D; Nickel, Nathan C; Enns, Jennifer E; Chartier, Mariette; Campbell, Rhonda; Phillips-Beck, Wanda; Chateau, Dan; Burland, Elaine; Santos, Rob; Katz, Alan

    2017-10-10

    First Nations people are descendants of Canada's original inhabitants. In consequence of historical and ongoing structural injustices, many First Nations families struggle with challenging living conditions, including high rates of poverty, poor housing conditions, mental illness and social isolation. These risk factors impede caregivers' abilities to meet their children's basic physical and psychosocial needs. Home visiting programmes were developed to support child developmental health in families facing parenting challenges. However, whether home visiting is an effective intervention for First Nations families has not been examined. We are evaluating two home visiting programmes in Manitoba, Canada, to determine whether they promote nurturing family environments for First Nations children. This research builds on new and established relationships among academic researchers, government decision-makers and First Nations stakeholders. We will link health, education and social services data from the Manitoba Population Research Data Repository to data from two home visiting programmes in Manitoba. Logistic regression modelling will be used to assess whether programme participation is associated with improved child developmental health, better connections between families and social services, reduced instances of child maltreatment and being taken into out-of-home care by child welfare and reduced inequities for First Nations families. Non-participating individuals with similar sociodemographic characteristics will serve as comparators. We will use an interrupted time series approach to test for differences in outcomes before and after programme implementation and a propensity score analysis to compare differences between participants and non-participants. Approvals were granted by the Health Information Research Governance Committee of the First Nations Health and Social Secretariat of Manitoba and the University of Manitoba Health Research Ethics Board. Our

  19. Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Shah More, Neena; Das, Sushmita; Bapat, Ujwala; Rajguru, Mahesh; Alcock, Glyn; Joshi, Wasundhara; Pantvaidya, Shanti; Osrin, David

    2013-05-08

    The trial addresses the general question of whether community resource centers run by a non-government organization improve the health of women and children in slums. The resource centers will be run by the Society for Nutrition, Education and Health Action, and the trial will evaluate their effects on a series of public health indicators. Each resource center will be located in a vulnerable Mumbai slum area and will serve as a base for salaried community workers, supervised by officers and coordinators, to organize the collection and dissemination of health information, provision of services, home visits to identify and counsel families at risk, referral of individuals and families to appropriate services and support for their access, meetings of community members and providers, and events and campaigns on health issues. A cluster randomized controlled trial in which 20 urban slum areas with resource centers are compared with 20 control areas. Each cluster will contain approximately 600 households and randomized allocation will be in three blocked phases, of 12, 12 and 16 clusters. Any resident of an intervention cluster will be able to participate in the intervention, but the resource centers will target women and children, particularly women of reproductive age and children under 5.The outcomes will be assessed through a household census after 2 years of resource center operations. The primary outcomes are unmet need for family planning in women aged 15 to 49 years, proportion of children under 5 years of age not fully immunized for their ages, and proportion of children under 5 years of age with weight for height less than 2 standard deviations below the median for age and sex. Secondary outcomes describe adolescent pregnancies, home deliveries, receipt of conditional cash transfers for institutional delivery, other childhood anthropometric indices, use of public sector health and nutrition services, indices of infant and young child feeding, and consultation

  20. Optimizing the high-resolution manometry (HRM) study protocol.

    Science.gov (United States)

    Patel, A; Ding, A; Mirza, F; Gyawali, C P

    2015-02-01

    Intolerance of the esophageal manometry catheter may prolong high-resolution manometry (HRM) studies and increase patient distress. We assessed the impact of obtaining the landmark phase at the end of the study when the patient has acclimatized to the HRM catheter. 366 patients (mean age 55.4 ± 0.8 years, 62.0% female) undergoing esophageal HRM over a 1-year period were studied. The standard protocol consisted of the landmark phase, 10 5 mL water swallows 20-30 s apart, and multiple rapid swallows where 4-6 2 mL swallows were administered in rapid succession. The modified protocol consisted of the landmark phase at the end of the study after test swallows. Study duration, technical characteristics, indications, and motor findings were compared between standard and modified protocols. Of the 366 patients, 89.6% underwent the standard protocol (study duration 12.9 ± 0.3 min). In 10.4% with poor catheter tolerance undergoing the modified protocol, study duration was significantly longer (15.6 ± 1.0 min, p = 0.004) despite similar duration of study maneuvers. Only elevated upper esophageal sphincter basal pressures at the beginning of the study segregated modified protocol patients. The 95th percentile time to landmark phase in the standard protocol patients was 6.1 min; as many as 31.4% of modified protocol patients could not obtain their first study maneuver within this period (p = 0.0003). Interpretation was not impacted by shifting the landmark phase to the end of the study. Modification of the HRM study protocol with the landmark phase obtained at the end of the study optimizes study duration without compromising quality. © 2014 John Wiley & Sons Ltd.

  1. BMJ open the iMpact on practice, oUtcomes and costs of New roles for health pROfeSsionals: A study protocol for MUNROS

    NARCIS (Netherlands)

    C.M. Bond (Christine); H. Bruhn (Hanne); A.A. de Bont (Antoinette); N.J.A. van Exel (Job); R. Busse (Reinhard); M. Sutton (Matthew); R. Elliott (Robert)

    2016-01-01

    textabstractIntroduction: 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

  2. Is health coaching effective in changing the health status and behaviour of prisoners?-a systematic review protocol.

    Science.gov (United States)

    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 .

  3. Sleep, biological stress, and health among toddlers living in socioeconomically disadvantaged homes: A research protocol.

    Science.gov (United States)

    Ordway, Monica R; Sadler, Lois S; Canapari, Craig A; Jeon, Sangchoon; Redeker, Nancy S

    2017-12-01

    Healthy sleep is important to behavioral, neurobiological, and physiologic health. In older children and adults, stress biomarkers, such as cortisol and C-reactive protein, increase when they do not practice healthy sleep habits. However, little is known about the relationships among sleep health, stress, and health outcomes among very young children living with socioeconomic adversity, a group that is particularly at risk for poor future health. The NIH-funded study described in this protocol addresses this scientific gap to improve understanding of these relationships during a critical developmental period in children's lives-toddlerhood. We will use a longitudinal design with repeated measures to prospectively examine the relationships among sleep health, stress, and toddlers' health from age 12 to 24 months, to address the following aims: i) examine changes in subjective and objective sleep health measures; ii) examine changes in stress biomarkers; iii) examine the cross-sectional and longitudinal relationships between sleep health measures and stress response; and iv) examine the cross-sectional and longitudinal relationships between sleep health measures, stress biomarkers, and toddlers' behavioral health. The sample will include 113 toddlers and their caregivers. We are collecting subjective and objective data on sleep health, multi-systemic biomarkers of stress, and toddlers' behavioral health. Generalized linear models will be used in the data analyses. Results from this study will be used to support development and testing of interventions, such as those that may improve sleep, among young children at risk for toxic stress. © 2017 Wiley Periodicals, Inc.

  4. Extraction protocols for orthodontic treatment: A retrospective study

    Directory of Open Access Journals (Sweden)

    Vaishnevi N Thirunavukkarasu

    2016-01-01

    Full Text Available Background and Objectives: Various extraction protocols have been followed for successful orthodontic treatment. The purpose of this study was to evaluate the extraction protocols in patients who had previously undergone orthodontic treatment and also who had reported for continuing orthodontic treatment from other clinics. Materials and Methods: One hundred thirty eight patients who registered for orthodontic treatment at the Faculty of Dentistry were divided into 10 extraction protocols based on the Orthodontic treatment protocol given by Janson et al. and were evaluated for statistical significance. Results: The descriptive statistics of the study revealed a total of 40 (29% patients in protocol 1, 43 (31.2% in protocol 2, 18 (13% in protocol 3, 16 (11.6% in protocol 5, and 12 (8.7% in Type 3 category of protocol 9. The Type 3 category in protocol 9 was statistically significant compared to other studies. Midline shift and collapse of the arch form were noticed in these individuals. Conclusion: Extraction of permanent teeth such as canine and lateral incisors without rational reasons could have devastating consequences on the entire occlusion. The percentage of cases wherein extraction of permanent teeth in the crowded region was adopted as a treatment option instead of orthodontic treatment is still prevalent in dental practice. The shortage of orthodontists in Malaysia, the long waiting period, and lack of subjective need for orthodontic treatment at an earlier age group were the reasons for the patient's to choose extraction of the mal-aligned teeth such as the maxillary canine or maxillary lateral incisors.

  5. To evaluate if increased supervision and support of South African Government health workers' home visits improves maternal and child outcomes: study protocol for a randomized control trial.

    Science.gov (United States)

    Rotheram-Borus, Mary Jane; Le Roux, Karl; Le Roux, Ingrid M; Christodoulou, Joan; Laurenzi, Christina; Mbewu, Nokwanele; Tomlinson, Mark

    2017-08-07

    Concurrent epidemics of HIV, depression, alcohol abuse, and partner violence threaten maternal and child health (MCH) in South Africa. Although home visiting has been repeatedly demonstrated efficacious in research evaluations, efficacy disappears when programs are scaled broadly. In this cluster randomized controlled trial (RCT), we examine whether the benefits of ongoing accountability and supervision within an existing government funded and implemented community health workers (CHW) home visiting program ensure the effectiveness of home visiting. In the deeply rural, Eastern Cape of South Africa, CHW will be hired by the government and will be initially trained by the Philani Programme to conduct home visits with all pregnant mothers and their children until the children are 2 years old. Eight clinics will be randomized to receive either (1) the Accountable Care Condition in which additional monitoring and accountability systems that Philani routinely uses are implemented (4 clinics, 16 CHW, 450 households); or (2) a Standard Care Condition of initial Philani training, but with supervision and monitoring being delivered by local government structures and systems (4 clinics, 21 CHW, 450 households). In the Accountable Care Condition areas, the CHW's mobile phone reports, which are time-location stamped, will be monitored and data-informed supervision will be provided, as well as monitoring growth, medical adherence, mental health, and alcohol use outcomes. Interviewers will independently assess outcomes at pregnancy at 3, 6, 15, and 24 months post-birth. The primary outcome will be a composite score of documenting maternal HIV/TB testing, linkage to care, treatment adherence and retention, as well as child physical growth, cognitive functioning, and child behavior and developmental milestones. The proposed cluster RCT will evaluate whether routinely implementing supervision and accountability procedures and monitoring CHWs' over time will improve MCH outcomes

  6. Improving cardiometabolic and mental health in women with gestational diabetes mellitus and their offspring: study protocol for MySweetHeart Trial, a randomised controlled trial

    Science.gov (United States)

    Horsch, Antje; Gilbert, Leah; Lanzi, Stefano; Gross, Justine; Kayser, Bengt; Vial, Yvan; Simeoni, Umberto; Hans, Didier; Berney, Alexandre; Scholz, Urte; Barakat, Ruben; Puder, Jardena J

    2018-01-01

    Introduction Gestational diabetes mellitus (GDM) carries prenatal and perinatal risk for the mother and her offspring as well as longer-term risks for both the mother (obesity, diabetes, cardiovascular disease) and her child (obesity, type 2 diabetes). Compared with women without GDM, women with GDM are twice as likely to develop perinatal or postpartum depression. Lifestyle interventions for GDM are generally limited to physical activity and/or nutrition, often focus separately on the mother or the child and take place either during or after pregnancy, while their results are inconsistent. To increase efficacy of intervention, the multifactorial origins of GDM and the tight link between mental and metabolic as well as maternal and child health need to be heeded. This calls for an interdisciplinary transgenerational approach starting in, but continuing beyond pregnancy. Methods and analysis This randomised controlled trial will assess the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention aimed at improving the metabolic and mental health of 200 women with GDM and their offspring. Women with GDM at 24–32 weeks gestational age who understand French or English, and their offspring and partners can participate. The intervention components will be delivered on top of usual care during pregnancy and the first year postpartum. Metabolic and mental health outcomes will be measured at 24–32 weeks of pregnancy, shortly after birth and at 6–8 weeks and 1 year after childbirth. Data will be analysed using intention-to-treat analyses. The MySweetHeart Trial is linked to the MySweetHeart Cohort (clinicaltrials.gov/ct2/show/NCT02872974). Ethics and dissemination We will disseminate the findings through regional, national and international conferences and through peer-reviewed journals. Trial registration number NCT02890693; Pre-results. PMID:29487077

  7. Merging video coaching and an anthropologic approach to understand health care provider behavior toward hand hygiene protocols.

    Science.gov (United States)

    Boudjema, Sophia; Tarantini, Clément; Peretti-Watel, Patrick; Brouqui, Philippe

    2017-05-01

    We used videorecordings of routine care to analyze health care providers' deviance from protocols and organized follow-up interviews that were conducted by an anthropologist and a nurse. After consent, health care workers were recorded during routine care by an automatic video remote control. Each participant was invited to watch her or his recorded behaviors on 2 different videos showing routine practices and her or his deviance from protocols, and to comment on them. After this step an in-depth interview based on preestablished guidelines was organized and explanations regarding the observed deviance was discussed. This design was intended to reveal the HCWs' subjectivity; that is, how they perceive hand hygiene issues in their daily routine, what concrete difficulties they face, and how they try to resolve them. We selected 43 of 250 videorecordings created during the study, which allowed us to study 15 out of 20 health care professionals. Twenty out of 43 videos showed 1 or more breaches in the hand hygiene protocol. The breaches were frequently linked to glove abuse. Deviance from protocols was explained by the health care workers as the result of an adaptive behavior; that is, facing work constraints that were disconnected from infection control protocols. Professional practices and protocols should be revisited to create simple messages that are adapted to the mandatory needs in a real life clinic environment. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  8. Effects of a Physical Exercise Program (PEP-Aut on Autistic Children’s Stereotyped Behavior, Metabolic and Physical Activity Profiles, Physical Fitness, and Health-Related Quality of Life: A Study Protocol

    Directory of Open Access Journals (Sweden)

    José Pedro Ferreira

    2018-03-01

    Full Text Available Physical exercise has shown positive effects on symptomatology and on the reduction of comorbidities in population with autism spectrum disorder (ASD. However, there is still no consensus about the most appropriate exercise intervention model for children with ASD. The physical exercise program for children with autism (PEP-Aut protocol designed allow us to (i examine the multivariate associations between ASD symptoms, metabolic profile, physical activity level, physical fitness, and health-related quality of life of children with ASD; (ii assess the effects of a 40-week exercise program on all these aspects of children with ASD. The impact of the exercise program will be assessed based on the sequence of the two phases. Phase 1 is a 12-week cross-sectional study assessing the symptomatology, metabolic profile, physical fitness and physical activity levels, socioeconomic status profile, and health-related quality of life of participants. This phase is the baseline of the following phase. Phase 2 is a 48-week intervention study with a 40-week intervention with exercise that will take place in a specialized center for children with ASD in the city of Maceió-Alagoas, Brazil. The primary outcomes will be change in the symptomatic profile and the level of physical activity of children. Secondary outcomes will be anthropometric and metabolic profiles, aerobic function, grip strength, socioeconomic status, and health-related quality of life. The study will provide critical information on the efficacy of exercise for children with ASD and help guide design and delivery of future programs.

  9. A cross-sectional survey of the mental health needs of refugees and asylum seekers attending a refugee health clinic: a study protocol for using research to inform local service delivery.

    Science.gov (United States)

    Shawyer, Frances; Enticott, Joanne C; Doherty, Anne R; Block, Andrew A; Cheng, I-Hao; Wahidi, Sayed; Meadows, Graham N

    2014-12-24

    Refugees and asylum seekers have high rates of risk factors for mental disorders. In recent years, Australia has experienced a rapid increase in asylum seeker arrivals, creating new challenges for services in areas with high settlement numbers. This paper describes the design, including analytic framework, of a project set in a refugee health service in the state of Victoria, Australia, as part of their response to meeting the mental health needs of their burgeoning local population of refugees and asylum seekers. In order to assist service planning, the primary aim of this study is to determine: 1) an overall estimate of the prevalence of psychiatric disorders; 2) the specific prevalence of post-traumatic stress disorder 3) the perceived need and unmet need for mental health treatment. The secondary aim of the study is to establish matched risk ratios based on an Australian-born matched comparison group from the 2007 National Survey of Mental Health and Well-Being. A cross-sectional survey is used to estimate the prevalence of psychiatric disorders in refugees and asylum seekers attending a local refugee health service. Measures include the Kessler Psychological Distress Scale-10, the Post-Traumatic Stress Disorder-8, the General-practice User's Perceived-need Inventory together with service utilisation questions from the National Survey of Mental Health and Well-Being. Data collected from refugees and asylum seekers (n = 130) is matched to existing data from Australian-born residents drawn from the 2007 National Survey of Mental Health and Well-Being (n = 520) to produce estimates of the risk ratio. The paper describes a prototype for what is possible within regular services seeking to plan for and deliver high quality mental health care to refugees and asylum seekers. A novel project output will be the development and dissemination of an epidemiological methodology to reliably compare mental health status in a relatively small target sample with a matched

  10. Study Protocol: establishing good relationships between patients and health care providers while providing cardiac care. Exploring how patient-clinician engagement contributes to health disparities between indigenous and non-indigenous Australians in South Australia

    Directory of Open Access Journals (Sweden)

    Roe Yvette L

    2012-11-01

    Full Text Available Abstract Background Studies that compare Indigenous Australian and non-Indigenous patients who experience a cardiac event or chest pain are inconclusive about the reasons for the differences in-hospital and survival rates. The advances in diagnostic accuracy, medication and specialised workforce has contributed to a lower case fatality and lengthen survival rates however this is not evident in the Indigenous Australian population. A possible driver contributing to this disparity may be the impact of patient-clinician interface during key interactions during the health care process. Methods/Design This study will apply an Indigenous framework to describe the interaction between Indigenous patients and clinicians during the continuum of cardiac health care, i.e. from acute admission, secondary and rehabilitative care. Adopting an Indigenous framework is more aligned with Indigenous realities, knowledge, intellects, histories and experiences. A triple layered designed focus group will be employed to discuss patient-clinician engagement. Focus groups will be arranged by geographic clusters i.e. metropolitan and a regional centre. Patient informants will be identified by Indigenous status (i.e. Indigenous and non-Indigenous and the focus groups will be convened separately. The health care provider focus groups will be convened on an organisational basis i.e. state health providers and Aboriginal Community Controlled Health Services. Yarning will be used as a research method to facilitate discussion. Yarning is in congruence with the oral traditions that are still a reality in day-to-day Indigenous lives. Discussion This study is nestled in a larger research program that explores the drivers to the disparity of care and health outcomes for Indigenous and non-Indigenous Australians who experience an acute cardiac admission. A focus on health status, risk factors and clinical interventions may camouflage critical issues within a patient

  11. Bath Breakfast Project (BBP - Examining the role of extended daily fasting in human energy balance and associated health outcomes: Study protocol for a randomised controlled trial [ISRCTN31521726

    Directory of Open Access Journals (Sweden)

    Jeans Matthew

    2011-07-01

    Full Text Available Abstract Background Current guidance regarding the role of daily breakfast in human health is largely grounded in cross-sectional observations. However, the causal nature of these relationships has not been fully explored and what limited information is emerging from controlled laboratory-based experiments appears inconsistent with much existing data. Further progress in our understanding therefore requires a direct examination of how daily breakfast impacts human health under free-living conditions. Methods/Design The Bath Breakfast Project (BBP is a randomised controlled trial comparing the effects of daily breakfast consumption relative to extended fasting on energy balance and human health. Approximately 70 men and women will undergo extensive laboratory-based assessments of their acute metabolic responses under fasted and post-prandial conditions, to include: resting metabolic rate, substrate oxidation, dietary-induced thermogenesis and systemic concentrations of key metabolites/hormones. Physiological and psychological indices of appetite will also be monitored both over the first few hours of the day (i.e. whether fed or fasted and also following a standardised test lunch used to assess voluntary energy intake under controlled conditions. Baseline measurements of participants' anthropometric characteristics (e.g. DEXA will be recorded prior to intervention, along with an oral glucose tolerance test and acquisition of adipose tissue samples to determine expression of key genes and estimates of tissue-specific insulin action. Participants will then be randomly assigned either to a group prescribed an energy intake of ≥3000 kJ before 1100 each day or a group to extend their overnight fast by abstaining from ingestion of energy-providing nutrients until 1200 each day, with all laboratory-based measurements followed-up 6 weeks later. Free-living assessments of energy intake (via direct weighed food diaries and energy expenditure (via

  12. 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.

    Science.gov (United States)

    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

    2015-03-24

    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. 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. 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. Australian and New Zealand Clinical Trials Registry ACTRN12614000457640. Published by the BMJ Publishing Group Limited. For

  13. [The intervention mapping protocol: A structured process to develop, implement and evaluate health promotion programs].

    Science.gov (United States)

    Fassier, J-B; Lamort-Bouché, M; Sarnin, P; Durif-Bruckert, C; Péron, J; Letrilliart, L; Durand, M-J

    2016-02-01

    Health promotion programs are expected to improve population health and reduce social inequalities in health. However, their theoretical foundations are frequently ill-defined, and their implementation faces many obstacles. The aim of this article is to describe the intervention mapping protocol in health promotion programs planning, used recently in several countries. The challenges of planning health promotion programs are presented, and the six steps of the intervention mapping protocol are described with an example. Based on a literature review, the use of this protocol, its requirements and potential limitations are discussed. The intervention mapping protocol has four essential characteristics: an ecological perspective (person-environment), a participative approach, the use of theoretical models in human and social sciences and the use of scientific evidence. It comprises six steps: conduct a health needs assessment, define change objectives, select theory-based change techniques and practical applications, organize techniques and applications into an intervention program (logic model), plan for program adoption, implementation, and sustainability, and generate an evaluation plan. This protocol was used in different countries and domains such as obesity, tobacco, physical activity, cancer and occupational health. Although its utilization requires resources and a critical stance, this protocol was used to develop interventions which efficacy was demonstrated. The intervention mapping protocol is an integrated process that fits the scientific and practical challenges of health promotion. It could be tested in France as it was used in other countries, in particular to reduce social inequalities in health. Copyright © 2016. Published by Elsevier Masson SAS.

  14. Quantitative methods for studying design protocols

    CERN Document Server

    Kan, Jeff WT

    2017-01-01

    This book is aimed at researchers and students who would like to engage in and deepen their understanding of design cognition research. The book presents new approaches for analyzing design thinking and proposes methods of measuring design processes. These methods seek to quantify design issues and design processes that are defined based on notions from the Function-Behavior-Structure (FBS) design ontology and from linkography. A linkograph is a network of linked design moves or segments. FBS ontology concepts have been used in both design theory and design thinking research and have yielded numerous results. Linkography is one of the most influential and elegant design cognition research methods. In this book Kan and Gero provide novel and state-of-the-art methods of analyzing design protocols that offer insights into design cognition by integrating segmentation with linkography by assigning FBS-based codes to design moves or segments and treating links as FBS transformation processes. They propose and test ...

  15. Using mobile health technology to improve behavioral skill implementation through homework in evidence-based parenting intervention for disruptive behavior disorders in youth: study protocol for intervention development and evaluation.

    Science.gov (United States)

    Chacko, Anil; Isham, Andrew; Cleek, Andrew F; McKay, Mary M

    2016-01-01

    Disruptive behavior disorders (DBDs) (oppositional defiant disorder (ODD) and conduct disorder (CD)) are prevalent, costly, and oftentimes chronic psychiatric disorders of childhood. Evidence-based interventions that focus on assisting parents to utilize effective skills to modify children's problematic behaviors are first-line interventions for the treatment of DBDs. Although efficacious, the effects of these interventions are often attenuated by poor implementation of the skills learned during treatment by parents, often referred to as between-session homework. The multiple family group (MFG) model is an evidence-based, skills-based intervention model for the treatment of DBDs in school-age youth residing in urban, socio-economically disadvantaged communities. While data suggest benefits of MFG on DBD behaviors, similar to other skill-based interventions, the effects of MFG are mitigated by the poor homework implementation, despite considerable efforts to support parents in homework implementation. This paper focuses on the study protocol for the development and preliminary evaluation of a theory-based, smartphone mobile health (mHealth) application (My MFG) to support homework implementation by parents participating in MFG. This paper describes a study design proposal that begins with a theoretical model, uses iterative design processes to develop My MFG to support homework implementation in MFG through a series of pilot studies, and a small-scale pilot randomised controlled trial to determine if the intervention can demonstrate change (preliminary efficacy) of My MFG in outpatient mental health settings in socioeconomically disadvantaged communities. This preliminary study aims to understand the implementation of mHealth methods to improve the effectiveness of evidence-based interventions in routine outpatient mental health care settings for youth with disruptive behavior and their families. Developing methods to augment the benefits of evidence

  16. Epidemiological characterization of oral cancer. Study Protocol.

    Directory of Open Access Journals (Sweden)

    Alejandra Fernández

    2015-04-01

    Full Text Available Oral cancer is a disease of high impact globally. It ranks as the sixth more frequent one among all types of cancer. In spite of being a widely known pathology and easy access to the diagnosis, the lack of epidemiological data reported in the last 10 years in Chile called attention to. At the global level, the World Health Organization (WHO has developed a project called “GLOBOCAN” in order to collect epidemiological data of the global cancer, between its data, highlights the high incidence and high rate of mortality in the male sex, parameter that shows tendency to replicate in both America and Chile. In consequence to these data, a narrative review of the literature concerning the epidemiological profile of the different forms of oral cancer in the past 15 years was done. The diagnosis of oral cancer crosses transversely the Dental Science, forcing us to establish triads of work between oral and maxillofacial surgeons, pathologists and dentists of the various specialties, so as to allow a timely research, appropriate biopsies and histopathological studies finishes with the purpose of, on the one hand, obtain timely and accurate diagnostics, in addition, maintaining the epidemiological indicators.

  17. HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cooper, Kevin; McCormack, Kirsty; Breeman, Suzanne; Wood, Jessica; Scott, Neil W; Clark, Justin; Hawe, Jed; Hawthorn, Robert; Phillips, Kevin; Hyde, Angela; McDonald, Alison; Forrest, Mark; Wileman, Samantha; Scotland, Graham; Norrie, John; Bhattacharya, Siladitya

    2018-01-24

    Heavy menstrual bleeding (HMB) is a common problem affecting approximately 1.5 million women in England and Wales with a major impact on their physical, emotional, social and material quality of life. It is the fourth most common reason why women attend gynaecology outpatient clinics and accounts for one-fifth of all gynaecology outpatient referrals. Initial treatment in primary care is medical - either by means of oral or injected medication or the levonorgestrel-intrauterine system (Mirena®). If medical treatment fails then surgical treatment can be offered, either endometrial ablation (EA), which destroys the lining of the cavity of the uterus (endometrium), or hysterectomy, i.e. surgical removal of the uterus. While effective, conventional hysterectomy is invasive and carries a risk of complications due to injury to other pelvic structures. The procedure can be simplified and complications minimised by undertaking a 'supracervical' hysterectomy where the cervix is left in situ and only the body of the uterus removed. Recent advances in endoscopic technologies have facilitated increased use of laparoscopic supracervical hysterectomy (LASH) which can be performed as a day-case procedure and is relatively easy for the surgeon to learn. HEALTH (Hysterectomy or Endometrial AbLation Trial for Heavy menstrual bleeding) aims to address the question 'Is LASH superior to second generation EA for the treatment of HMB in terms of clinical and cost effectiveness?' Women aged < 50 years, with HMB, in whom medical treatment has failed and who are eligible for EA will be considered for trial entry. We aim to recruit women from approximately 30 active secondary care centres in the UK NHS who carry out both surgical procedures. All women who consent will complete a diary of pain symptoms from day 1 to day 14 after surgery, postal questionnaires at six weeks and six months after surgery and 15 months post randomisation. Healthcare utilisation questions will also be

  18. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

    NARCIS (Netherlands)

    Macready, Anna L.; Fallaize, Rosalind; Butler, Laurie T.; Ellis, Judi A.; Kuznesof, Sharron; Frewer, Lynn J.; Celis-Morales, Carlos; Livingstone, Katherine M.; Araújo-Soares, Vera; Fischer, Arnout R.H.; Stewart-Knox, Barbara J.; Mathers, John C.; Lovegrove, Julie A.

    2018-01-01

    Background: To determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    BACKGROUND: 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 syste...

  20. Determining the impact of smoking point of sale legislation among youth (Display) study: a protocol for an evaluation of public health policy.

    Science.gov (United States)

    Haw, Sally; Amos, Amanda; Eadie, Douglas; Frank, John; MacDonald, Laura; MacKintosh, Anne Marie; MacGregor, Andy; Miller, Martine; Pearce, Jamie; Sharp, Clare; Stead, Martine; Tisch, Catherine; van der Sluijs, Winfried

    2014-03-14

    Tobacco advertising and product promotions have been largely banned in the UK but point of sale (POS) tobacco advertising is one of the few places where tobacco products may be legitimately advertised. POS displays have been shown to increase susceptibility to smoking, experimentation and initiation into smoking. These displays may also influence perceived prevalence of smoking and the perception that tobacco products are easily obtained and are a 'normal' product. A ban of POS tobacco advertising was introduced in Scotland in large tobacco retail outlets of over 280 m2 internal sales floor areas (mainly supermarkets) in April 2013 and will be extended to include smaller tobacco retail outlets in April 2015. However, the impact of POS bans on smoking attitudes, behaviours and prevalence has yet to be determined. This study has a multi-modal before and after design and uses mixed methods to collect data, at baseline and then with longitudinal follow-up for 4 years, in four purposively selected communities. For the purposes of the study, community is defined as the catchment areas of the secondary schools selected for study. There are four main components to the on-going study. In each of the four communities, at baseline and in follow-up years, there will be: mapping and spatial analyses of tobacco retail outlets; tobacco advertising and marketing audits of tobacco retail outlets most used by young people; cross-sectional school surveys of secondary school pupils; and focus group interviews with purposive samples of secondary school pupils. The tobacco audit is supplemented by interviews and observations conducted with a panel of tobacco retailers recruited from four matched communities. This study examines the impact of the implementation of both a partial and comprehensive ban on point of sale (POS) tobacco advertising on attitudes to smoking, brand awareness, perceived ease of access to tobacco products and youth smoking prevalence. The results will be of

  1. Determining the impact of smoking point of sale legislation among youth (Display) study: a protocol for an evaluation of public health policy

    Science.gov (United States)

    2014-01-01

    Background Tobacco advertising and product promotions have been largely banned in the UK but point of sale (POS) tobacco advertising is one of the few places where tobacco products may be legitimately advertised. POS displays have been shown to increase susceptibility to smoking, experimentation and initiation into smoking. These displays may also influence perceived prevalence of smoking and the perception that tobacco products are easily obtained and are a ‘normal’ product. A ban of POS tobacco advertising was introduced in Scotland in large tobacco retail outlets of over 280m2 internal sales floor areas (mainly supermarkets) in April 2013 and will be extended to include smaller tobacco retail outlets in April 2015. However, the impact of POS bans on smoking attitudes, behaviours and prevalence has yet to be determined. Methods/design This study has a multi-modal before and after design and uses mixed methods to collect data, at baseline and then with longitudinal follow-up for 4 years, in four purposively selected communities. For the purposes of the study, community is defined as the catchment areas of the secondary schools selected for study. There are four main components to the on-going study. In each of the four communities, at baseline and in follow-up years, there will be: mapping and spatial analyses of tobacco retail outlets; tobacco advertising and marketing audits of tobacco retail outlets most used by young people; cross-sectional school surveys of secondary school pupils; and focus group interviews with purposive samples of secondary school pupils. The tobacco audit is supplemented by interviews and observations conducted with a panel of tobacco retailers recruited from four matched communities. Discussion This study examines the impact of the implementation of both a partial and comprehensive ban on point of sale (POS) tobacco advertising on attitudes to smoking, brand awareness, perceived ease of access to tobacco products and youth smoking

  2. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial

    Science.gov (United States)

    Macready, Anna L; Fallaize, Rosalind; Butler, Laurie T; Ellis, Judi A; Kuznesof, Sharron; Frewer, Lynn J; Celis-Morales, Carlos; Livingstone, Katherine M; Araújo-Soares, Vera; Fischer, Arnout RH; Stewart-Knox, Barbara J; Mathers, John C

    2018-01-01

    Background To determine the efficacy of behavior change techniques applied in dietary and physical activity intervention studies, it is first necessary to record and describe techniques that have been used during such interventions. Published frameworks used in dietary and smoking cessation interventions undergo continuous development, and most are not adapted for Web-based delivery. The Food4Me study (N=1607) provided the opportunity to use existing frameworks to describe standardized Web-based techniques employed in a large-scale, internet-based intervention to change dietary behavior and physical activity. Objective The aims of this study were (1) to describe techniques embedded in the Food4Me study design and explain the selection rationale and (2) to demonstrate the use of behavior change technique taxonomies, develop standard operating procedures for training, and identify strengths and limitations of the Food4Me framework that will inform its use in future studies. Methods The 6-month randomized controlled trial took place simultaneously in seven European countries, with participants receiving one of four levels of personalized advice (generalized, intake-based, intake+phenotype–based, and intake+phenotype+gene–based). A three-phase approach was taken: (1) existing taxonomies were reviewed and techniques were identified a priori for possible inclusion in the Food4Me study, (2) a standard operating procedure was developed to maintain consistency in the use of methods and techniques across research centers, and (3) the Food4Me behavior change technique framework was reviewed and updated post intervention. An analysis of excluded techniques was also conducted. Results Of 46 techniques identified a priori as being applicable to Food4Me, 17 were embedded in the intervention design; 11 were from a dietary taxonomy, and 6 from a smoking cessation taxonomy. In addition, the four-category smoking cessation framework structure was adopted for clarity of

  3. Evaluation of an electronic health record-supported obesity management protocol implemented in a community health center: a cautionary note.

    Science.gov (United States)

    Steglitz, Jeremy; Sommers, Mary; Talen, Mary R; Thornton, Louise K; Spring, Bonnie

    2015-07-01

    Primary care clinicians are well-positioned to intervene in the obesity epidemic. We studied whether implementation of an obesity intake protocol and electronic health record (EHR) form to guide behavior modification would facilitate identification and management of adult obesity in a Federally Qualified Health Center serving low-income, Hispanic patients. In three studies, we examined clinician and patient outcomes before and after the addition of the weight management protocol and form. In the Clinician Study, 12 clinicians self-reported obesity management practices. In the Population Study, BMI and order data from 5000 patients and all 40 clinicians in the practice were extracted from the EHR preintervention and postintervention. In the Exposure Study, EHR-documented outcomes for a sub-sample of 46 patients actually exposed to the obesity management form were compared to matched controls. Clinicians reported that the intake protocol and form increased their performance of obesity-related assessments and their confidence in managing obesity. However, no improvement in obesity management practices or patient weight-loss was evident in EHR records for the overall clinic population. Further analysis revealed that only 55 patients were exposed to the form. Exposed patients were twice as likely to receive weight-loss counseling following the intervention, as compared to before, and more likely than matched controls. However, their obesity outcomes did not differ. Results suggest that an obesity intake protocol and EHR-based weight management form may facilitate clinician weight-loss counseling among those exposed to the form. Significant implementation barriers can limit exposure, however, and need to be addressed. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cova Felix

    2011-02-01

    Full Text Available Abstract Background Depression is common and can have devastating effects on the life of adolescents. Psychological interventions are the first-line for treating or preventing depression among adolescents. This proposal aims to evaluate a school-based, universal psychological intervention to reduce depressive symptoms among student's aged 13-14 attending municipal state secondary schools in Santiago, Chile. Study design This is a cluster randomised controlled trial with schools as the main clusters. We compared this intervention with a control group in a study involving 22 schools, 66 classes and approximately 2,600 students. Students in the active schools attended 11 weekly and 3 booster sessions of an intervention based on cognitive-behavioural models. The control schools received their usual but enhanced counselling sessions currently included in their curriculum. Mean depression scores and indicators of levels of functioning were assessed at 3 and 12 months after the completion of the intervention in order to assess the effectiveness of the intervention. Direct and indirect costs were measured in both groups to assess the cost-effectiveness of this intervention. Discussion As far as we are aware this is the first cluster randomised controlled trial of a school intervention for depression among adolescents outside the Western world. Trial Registration ISRCTN19466209

  5. Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71% were completed according to protocol, 128 (16% discontinued and 42 (5% are still ongoing; for 61 (8% there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55. Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48% protocols and in 205 (49% of the publications. In most published studies (339; 81% this information corresponded between protocol and publication. Most studies were published in English (367; 88%; some in German (25; 6% or both languages (27; 6%. The local investigators were listed as (co-authors in the publications corresponding to 259 (62% studies.Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care

  6. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol

    Directory of Open Access Journals (Sweden)

    Jin Yan

    2017-04-01

    Full Text Available Abstract Background Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM. Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. Methods This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs, personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers’ development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject’s participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis

  7. Development and effectiveness of a mobile phone application conducting health behavioral intervention among men who have sex with men, a randomized controlled trial: study protocol.

    Science.gov (United States)

    Yan, Jin; Zhang, Aidi; Zhou, Liang; Huang, Zhulin; Zhang, Pan; Yang, Guoli

    2017-04-24

    Behavioral intervention is a key approach to HIV prevention among men who have sex with men (MSM). Widespread use of mobile phones provide us with novel opportunities to decrease HIV infection and transmission of MSM. The objective of the study was to design and develop a mobile phone application (app) aims to conduct behavioral intervention to MSM and to evaluate the efficacy of the app-based intervention compared to usual care, to analyze cost-effectiveness and mechanism of the intervention. This study involves 2 phases, phase 1 use qualitative method and phase 2 is a randomized controlled trial lasting for 18 months, they will be conducted in Chagnsha, Hunan Province, China. Phase 1 is to design and develop the app, procedures including retrieval of domestic apps related to prevention and treatment about HIV and sexually transmitted diseases (HIV/STDs), personal interviews with MSM about preferences and functional needs of the HIV prevention app, multidisciplinary experts focused group discussions of the app, software engineers' development and users test of the app will be performed. In phase 2, we will recruit 800 MSM by cooperating with the local center of disease control and prevention and nongovernmental organizations, and divide them into intervention and control group evenly. Intervention group participants will receive app-based HIV prevention. Control group participants will be provided with usual care including HIV/STDs knowledge brochure and free voluntary counseling services. Data will be collected at baseline, 6, 12 and 18 months since subject's participation. Effectiveness of the intervention includes HIV/STDs infection rates, adherence to regularly HIV testing, sexual risk behavior, consistent condom use and relative risk of HIV infection. Cost-effectiveness will be analyzed by decision-analytic modeling, and mechanism analysis of this app-based intervention will be performed by path analysis. This will be the first study of its kind in China to

  8. Effect of provision of an integrated neonatal survival kit and early cognitive stimulation package by community health workers on developmental outcomes of infants in Kwale County, Kenya: study protocol for a cluster randomized trial.

    Science.gov (United States)

    Pell, Lisa G; Bassani, Diego G; Nyaga, Lucy; Njagi, Isaac; Wanjiku, Catherine; Thiruchselvam, Thulasi; Macharia, William; Minhas, Ripudaman S; Kitsao-Wekulo, Patricia; Lakhani, Amyn; Bhutta, Zulfiqar A; Armstrong, Robert; Morris, Shaun K

    2016-09-08

    Each year, more than 200 million children under the age of 5 years, almost all in low- and middle-income countries (LMICs), fail to achieve their developmental potential. Risk factors for compromised development often coexist and include inadequate cognitive stimulation, poverty, nutritional deficiencies, infection and complications of being born low birthweight and/or premature. Moreover, many of these risk factors are closely associated with newborn morbidity and mortality. As compromised development has significant implications on human capital, inexpensive and scalable interventions are urgently needed to promote neurodevelopment and reduce risk factors for impaired development. This cluster randomized trial aims at evaluating the impact of volunteer community health workers delivering either an integrated neonatal survival kit, an early stimulation package, or a combination of both interventions, to pregnant women during their third trimester of pregnancy, compared to the current standard of care in Kwale County, Kenya. The neonatal survival kit comprises a clean delivery kit (sterile blade, cord clamp, clean plastic sheet, surgical gloves and hand soap), sunflower oil emollient, chlorhexidine, ThermoSpot(TM), Mylar infant sleeve, and a reusable instant heater. Community health workers are also equipped with a portable hand-held electric scale. The early cognitive stimulation package focuses on enhancing caregiver practices by teaching caregivers three key messages that comprise combining a gentle touch with making eye contact and talking to children, responsive feeding and caregiving, and singing. The primary outcome measure is child development at 12 months of age assessed with the Protocol for Child Monitoring (Infant and Toddler version). The main secondary outcome is newborn mortality. This study will provide evidence on effectiveness of delivering an innovative neonatal survival kit and/or early stimulation package to pregnant women in Kwale County

  9. The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Puchalski Ritchie, Lisa M; van Lettow, Monique; Makwakwa, Austine; Chan, Adrienne K; Hamid, Jemila S; Kawonga, Harry; Martiniuk, Alexandra L C; Schull, Michael J; van Schoor, Vanessa; Zwarenstein, Merrick; Barnsley, Jan; Straus, Sharon E

    2016-09-07

    Despite availability of effective treatment, tuberculosis (TB) remains an important cause of morbidity and mortality globally, with low- and middle-income countries most affected. In many such settings, including Malawi, the high burden of disease and severe shortage of skilled healthcare workers has led to task-shifting of outpatient TB care to lay health workers (LHWs). LHWs improve access to healthcare and some outcomes, including TB completion rates, but lack of training and supervision limit their impact. The goals of this study are to improve TB care provided by LHWs in Malawi by refining, implementing, and evaluating a knowledge translation strategy designed to address a recognized gap in LHWs' TB and job-specific knowledge and, through this, to improve patient outcomes. We are employing a mixed-methods design that includes a pragmatic cluster randomized controlled trial and a process evaluation using qualitative methods. Trial participants will include all health centers providing TB care in four districts in the South East Zone of Malawi. The intervention employs educational outreach, a point-of-care reminder tool, and a peer support network. The primary outcome is proportion of treatment successes, defined as the total of TB patients cured or completing treatment, with outcomes taken from Ministry of Health treatment records. With an alpha of 0.05, power of 0.80, a baseline treatment success of 0.80, intraclass correlation coefficient of 0.1 based on our pilot study, and an estimated 100 clusters (health centers providing TB care), a minimum of 6 patients per cluster is required to detect a clinically significant 0.10 increase in the proportion of treatment successes. Our process evaluation will include interviews with LHWs and patients, and a document analysis of LHW training logs, quarterly peer trainer meetings, and mentorship meeting notes. An estimated 10-15 LHWs and 10-15 patients will be required to reach saturation in each of 2 planned interview

  10. Will Mobile Diabetes Education Teams (MDETs in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gucciardi Enza

    2012-09-01

    Full Text Available Abstract Background There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs in primary care settings in Canada. Methods/design This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c of ≥8%. Clusters (that is, primary care sites will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months. Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions will be undertaken to assess the implementation process and effectiveness of the MDET intervention. Trial registration ClinicalTrials.gov NCT01553266

  11. Identification of a research protocol to study orthodontic tooth movement

    Directory of Open Access Journals (Sweden)

    Annalisa Dichicco

    2014-06-01

    Full Text Available Aim: The orthodontic movement is associated with a process of tissue remodeling together with the release of several chemical mediators in periodontal tissues. Each mediator is a potential marker of tooth movement and expresses biological processes as: tissue inflammation and bone remodeling. Different amounts of every mediator are present in several tissues and fluids of the oral cavity. Therefore, there are different methods that allow sampling with several degrees of invasiveness. Chemical mediators are also substances of different molecular nature, and multiple kind of analysis methods allow detection. The purpose of this study was to draft the best research protocol for an optimal study on orthodontic movement efficiency. Methods: An analysis of the international literature have been made, to identify the gold standard of each aspect of the protocol: type of mediator, source and method of sampling and analysis method. Results: From the analysis of the international literature was created an original research protocol for the study and the assessment of the orthodontic movement, by using the biomarkers of the tooth movement. Conclusions: The protocol created is based on the choice of the gold standard of every aspect already analyzed in the literature and in existing protocols for the monitoring of orthodontic tooth movement through the markers of tooth movement. Clinical trials re required for the evaluation and validation of the protocol created.

  12. Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sinha Rajesh

    2011-07-01

    Full Text Available Abstract Background Around a quarter of the world's neonatal and maternal deaths occur in India. Morbidity and mortality are highest in rural areas and among the poorest wealth quintiles. Few interventions to improve maternal and newborn health outcomes with government-mandated community health workers have been rigorously evaluated at scale in this setting. The study aims to assess the impact of a community mobilisation intervention with women's groups facilitated by ASHAs to improve maternal and newborn health outcomes among rural tribal communities of Jharkhand and Orissa. Methods/design The study is a cluster-randomised controlled trial and will be implemented in five districts, three in Jharkhand and two in Orissa. The unit of randomisation is a rural cluster of approximately 5000 population. We identified villages within rural, tribal areas of five districts, approached them for participation in the study and enrolled them into 30 clusters, with approximately 10 ASHAs per cluster. Within each district, 6 clusters were randomly allocated to receive the community intervention or to the control group, resulting in 15 intervention and 15 control clusters. Randomisation was carried out in the presence of local stakeholders who selected the cluster numbers and allocated them to intervention or control using a pre-generated random number sequence. The intervention is a participatory learning and action cycle where ASHAs support community women's groups through a four-phase process in which they identify and prioritise local maternal and newborn health problems, implement strategies to address these and evaluate the result. The cycle is designed to fit with the ASHAs' mandate to mobilise communities for health and to complement their other tasks, including increasing institutional delivery rates and providing home visits to mothers and newborns. The trial's primary endpoint is neonatal mortality during 24 months of intervention. Additional

  13. The effectiveness of a skin care program for the prevention of contact dermatitis in health care workers (the Healthy Hands Project): study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Soltanipoor, Maryam; Kezic, Sanja; Sluiter, Judith K; Rustemeyer, Thomas

    2017-02-28

    Health care workers (HCW) are at high risk for developing occupational hand dermatitis (HD) due to frequent exposure to 'wet work'. Amongst HCWs, nurses are at highest risk, with an estimated point prevalence of HD ranging between 12 and 30%. The burden of disease is high with chronicity, sick leave, risk of unemployment and impaired quality of life. Despite evidence from the medical literature on the risk factors and the importance of skin care in the prevention of HD, in practice, compliance to skin care protocols are below 30%. New preventive strategies are obviously needed. This is a cluster randomized controlled trial, focusing on nurses performing wet work. In total, 20 wards are recruited to include 504 participating nurses in the study at baseline. The wards will be randomized to an intervention or a control group and followed up for 18 months. The intervention consists of the facilitation of creams being available at the wards combined with the continuous electronic monitoring of their consumption with regular feedback on skin care performance in teams of HCWs. Both the intervention and the control group receive basic education on skin protection (as 'care as usual'). Every 6 months, participants of both groups will fill in the questionnaires regarding exposure to wet work and skin protective behavior. Furthermore, skin condition will be assessed and samples of the stratum corneum collected. The effect of the intervention will be measured by comparing the change in Hand Eczema Severity Index (HECSI score) from baseline to 12 months. The Natural Moisturizing Factor (NMF) levels, measured in the stratum corneum as an early biomarker of skin barrier damage, and the total consumption of creams per ward will be assessed as a secondary outcome. This trial will assess the clinical effectiveness of an intervention program to prevent hand dermatitis among health care workers TRIAL REGISTRATION: Netherlands Trial Register (NTR), identification number NTR5564

  14. Lean management in health care: definition, concepts, methodology and effects reported (systematic review protocol).

    Science.gov (United States)

    Lawal, Adegboyega K; Rotter, Thomas; Kinsman, Leigh; Sari, Nazmi; Harrison, Liz; Jeffery, Cathy; Kutz, Mareike; Khan, Mohammad F; Flynn, Rachel

    2014-09-19

    Lean is a set of operating philosophies and methods that help create a maximum value for patients by reducing waste and waits. It emphasizes the consideration of the customer's needs, employee involvement and continuous improvement. Research on the application and implementation of lean principles in health care has been limited. This is a protocol for a systematic review, following the Cochrane Effective Practice and Organisation of Care (EPOC) methodology. The review aims to document, catalogue and synthesize the existing literature on the effects of lean implementation in health care settings especially the potential effects on professional practice and health care outcomes. We have developed a Medline keyword search strategy, and this focused strategy will be translated into other databases. All search strategies will be provided in the review. The method proposed by the Cochrane EPOC group regarding randomized study designs, non-randomised controlled trials controlled before and after studies and interrupted time series will be followed. In addition, we will also include cohort, case-control studies, and relevant non-comparative publications such as case reports. We will categorize and analyse the review findings according to the study design employed, the study quality (low- versus high-quality studies) and the reported types of implementation in the primary studies. We will present the results of studies in a tabular form. Overall, the systematic review aims to identify, assess and synthesize the evidence to underpin the implementation of lean activities in health care settings as defined in this protocol. As a result, the review will provide an evidence base for the effectiveness of lean and implementation methodologies reported in health care. PROSPERO CRD42014008853.

  15. Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

    Science.gov (United States)

    Khan, Sameer; Rogers, Jason D; Otobo, Emamuzo; Patel, Nishant P; Ullman, Thomas; Colombel, Jean Fred; Moore, Shirley; Sands, Bruce E

    2015-01-01

    patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. Conclusions HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. Trial Registration ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr). PMID:25693610

  16. The protocol for the Be Our Ally Beat Smoking (BOABS study, a randomised controlled trial of an intensive smoking cessation intervention in a remote Aboriginal Australian health care setting

    Directory of Open Access Journals (Sweden)

    Marley Julia V

    2012-03-01

    Full Text Available Abstract Background Australian Aboriginal peoples and Torres Strait Islanders (Indigenous Australians smoke at much higher rates than non-Indigenous people and smoking is an important contributor to increased disease, hospital admissions and deaths in Indigenous Australian populations. Smoking cessation programs in Australia have not had the same impact on Indigenous smokers as on non-Indigenous smokers. This paper describes the protocol for a study that aims to test the efficacy of a locally-tailored, intensive, multidimensional smoking cessation program. Methods/Design This study is a parallel, randomised, controlled trial. Participants are Aboriginal and Torres Strait Islander smokers aged 16 years and over, who are randomly allocated to a 'control' or 'intervention' group in a 2:1 ratio. Those assigned to the 'intervention' group receive smoking cessation counselling at face-to-face visits, weekly for the first four weeks, monthly to six months and two monthly to 12 months. They are also encouraged to attend a monthly smoking cessation support group. The 'control' group receive 'usual care' (i.e. they do not receive the smoking cessation program. Aboriginal researchers deliver the intervention, the goal of which is to help Aboriginal peoples and Torres Strait Islanders quit smoking. Data collection occurs at baseline (when they enrol and at six and 12 months after enrolling. The primary outcome is self-reported smoking cessation with urinary cotinine confirmation at 12 months. Discussion Stopping smoking has been described as the single most important individual change Aboriginal and Torres Strait Islander smokers could make to improve their health. Smoking cessation programs are a major priority in Aboriginal and Torres Strait Islander health and evidence for effective approaches is essential for policy development and resourcing. A range of strategies have been used to encourage Aboriginal peoples and Torres Strait Islanders to quit

  17. Exploring factors impacting early childhood health among Aboriginal and Torres Strait Islander families and communities: protocol for a population-based cohort study using data linkage (the ‘Defying the Odds’ study)

    Science.gov (United States)

    Gubhaju, Lina; Jorm, Louisa; Preen, David; Jones, Jocelyn; Joshy, Grace; Shepherd, Carrington; McAullay, Daniel; Eades, Sandra; Ball, Stephen

    2018-01-01

    Introduction Empirical evidence on family and community risk and protective factors influencing the comparatively high rates of potentially preventable hospitalisations and deaths among Aboriginal and Torres Strait Islander infants and children is limited. As is evidence on geographical variation in these risks. The ‘Defying the Odds’ study aims to explore the impact of perinatal outcomes, maternal social and health outcomes and level of culturally secure service availability on the health outcomes of Western Australian (WA) Aboriginal infants and children aged 0–5 years. Methods and analysis The study combines a retrospective cohort study that uses state-wide linked health and administrative data from 12 data sources for multiple generations within Aboriginal families in WA, with specifically collected survey data from health and social services supporting Aboriginal families in regions of WA. Data sources include perinatal/birth registration, hospital, emergency department, mental health services, drug and alcohol service use, mortality, infectious disease notifications, and child protection and family services. Multilevel regression models will be used to examine the intensity of admissions and presentations, mortality, intensity of long stays and morbidity-free survival (no admissions) for Aboriginal children born in WA in 2000–2013. Relationships between maternal (and grand-maternal) health and social factors and child health outcomes will be quantified. Community-level variation in outcomes for Aboriginal children and factors contributing to this variation will be examined, including the availability of culturally secure services. Online surveys were sent to staff members at relevant services to explore the scope, reach and cultural security of services available to support Aboriginal families across selected regions of WA. Ethics and dissemination Ethics approvals have been granted for the study. Interpretation and dissemination are guided by the

  18. Dietary phytochemical intake from foods and health outcomes: a systematic review protocol and preliminary scoping

    Science.gov (United States)

    Guan, Vivienne X; Kent, Katherine

    2017-01-01

    Introduction Dietary phytochemicals are found in plant-based foods such as fruits, vegetables and grains and may be categorised in a nested hierarchical manner with many hundred individual phytochemicals identified to date. To associate phytochemical intakes with positive health outcomes, a fundamental step is to accurately estimate the dietary phytochemical intake from foods reported. The purpose of this systematic review protocol is to describe the process to be undertaken to summarise the evidence for food-based dietary phytochemical intakes and health outcomes for adults. Methods and analysis The review will be undertaken following the PRISMA guidelines and the Cochrane Handbook for Systematic Reviews of Interventions using the Review Manager software. Phytochemical subclasses (phenolic acids, flavanols, etc) will be used to search for relevant studies using the Web of Science and Scopus scientific databases. The retrieved studies will be screened based on inclusion of natural whole food items and health outcomes. Phytochemical studies related to cardiovascular disease, cancer, overweight, glucose tolerance, digestive, reproductive, macular and bone health and mental disorders, fatigue and immunity will be examined based on prior scoping. The evidence will be aggregated by the food types and health outcomes. Comparison of differences in the outcomes for randomised controlled trials and observational studies will be undertaken. The strength of the review lies in its focus on whole food items and health conditions rather than one type of phytochemical related to one single health condition. Subgroup and sensitivity analyses will be conducted where an adequate number of publications are found per phytochemical subclass. Dissemination By comparing the outcomes from experimental and observational studies, the review will determine whether the overall conclusions related to the phytochemical subclasses are the same between study types for the identified health

  19. Implementation of the Enhanced Moderated Online Social Therapy (MOST+) Model Within a National Youth E-Mental Health Service (eheadspace): Protocol for a Single Group Pilot Study for Help-Seeking Young People.

    Science.gov (United States)

    Rice, Simon; Gleeson, John; Leicester, Steven; Bendall, Sarah; D'Alfonso, Simon; Gilbertson, Tamsyn; Killackey, Eoin; Parker, Alexandra; Lederman, Reeva; Wadley, Greg; Santesteban-Echarri, Olga; Pryor, Ingrid; Mawren, Daveena; Ratheesh, Aswin; Alvarez-Jimenez, Mario

    2018-02-22

    using MOST+. Recruitment for the study commenced in October 2017. We expect to have initial results in March 2018, with more detailed qualitative and quantitative analyses to follow. This is the first Australia-wide research trial to pilot an online social media platform merging real-time clinical support, expert and peer moderation, interactive online therapy, and peer-to-peer social networking. The importance of the project stems from the need to develop innovative new models for the efficient delivery of responsive evidence-based online support to help-seeking young people. If successful, this research stands to complement and enhance e-mental health services in Australia. ©Simon Rice, John Gleeson, Steven Leicester, Sarah Bendall, Simon D'Alfonso, Tamsyn Gilbertson, Eoin Killackey, Alexandra Parker, Reeva Lederman, Greg Wadley, Olga Santesteban-Echarri, Ingrid Pryor, Daveena Mawren, Aswin Ratheesh, Mario Alvarez-Jimenez. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

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

    Science.gov (United States)

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

    2018-01-01

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

  1. Impacts of Urban Agriculture on the Determinants of Health: Scoping Review Protocol.

    Science.gov (United States)

    Audate, Pierre Paul; Fernandez, Melissa A; Cloutier, Geneviève; Lebel, Alexandre

    2018-03-27

    Since the 1990s, urban agriculture (UA) has contributed to improving food security in low- and middle- income countries. Now, it is implemented as a multifunctional intervention that can influence various determinants of health (eg, food security, social relationships). Studies of interest stem from several research disciplines, use a wide range of methods, and show results that are sometimes inconsistent. Current studies have not summarized the overall effects of UA on health and its determinants. The objective of this protocol is to develop a research strategy for a scoping review that characterizes studies of beneficial and adverse impacts of UA on health and its determinants in a wide range of disciplines. Initially, with the help of a library specialist, a list of publications will be obtained through a systematic search of seven electronic bibliographic databases: PubMed, Embase, MEDLINE (Embase), CINAHL Plus with full text, Academic Search Premier (EBSCO host), CAB Abstract (Ovid), and Web of Science. Secondly, a three-step screening by two independent reviewers will lead to a list of relevant publications that meet eligibility and inclusion criteria. Finally, data on the bibliography, type of participants, type of study, results of study, and countries will be extracted from included articles and analyzed to be presented in a peer-reviewed article. The findings are expected to identify research gaps that will inform needs for UA research in specific fields (eg, mental health), among certain population groups (eg, adults) or within different economic contexts (eg, low-, middle-, or high-income countries). Furthermore, the findings are expected to identify knowledge gaps and direct future research needs. This is an original study that seeks to integrate beneficial and adverse effects of UA on health at different level of influence (individuals, households, and community) in order to facilitate a better understanding of UA impacts. This protocol is a first of

  2. Study and development of a remote biometric authentication protocol

    OpenAIRE

    Bistarelli, Stefano; Claudio, Viti

    2003-01-01

    This paper reports the phases of study and implementation of a remote biometric authentication protocol developed during my internship at the I.i.t. of the C.n.r. in Pisa. Starting from the study of authentication history we had a look from the first system used since the 60ies to the latest technology; this helped us understand how we could realize a demonstration working protocol that could achieve a web remote authentication granting good reliability: to do this we choosed to modify the SS...

  3. A protocol to prevent and deal with aggressive behavior against health workers.

    Science.gov (United States)

    Altemir, María; Arteaga, Alfonso

    Violence against health workers is a highly prevalent phenomenon with serious psychological and labour consequences among professionals. This paper aims, first, to find out the main studies undertaken to date to describe and analyse the phenomenon, as well as to present different initiatives and protocols of action carried out. The second objective is to offer a procedure of action both to prevent aggression and to intervene in the event of receiving an aggression at work. After a bibliographic search in PubMed, Scopus and SciELO databases, the impact of the aggressions suffered by health professionals, the contexts in which aggressions are more frequent, their main consequences and different strategies and protocols conducted in Spain are reviewed. Given that rigorous reviews supporting such procedures are lacking in scientific journals, different action guidelines for professionals to prevent and to deal with hostile behaviour based on available evidence are developed and proposed. Finally, an easily consultable and applicable action procedure for health workers attacked in the workplace is presented. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  4. Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) - study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kamal, Ayeesha Kamran; Muqeet, Abdul; Farhat, Kashfa; Khalid, Wardah; Jamil, Anum; Gowani, Ambreen; Muhammad, Aliya Amin; Zaidi, Fabiha; Khan, Danyal; Elahi, Touseef; Sharif, Shahrukh; Raz, Sibtain; Zafar, Taha; Bokhari, Syedah Saira; Rahman, Nasir; Sultan, Fateh Ali Tipoo; Sayani, Saleem; Virani, Salim S

    2016-03-05

    the intervention and the control arm. We estimate that a sample size of 86 participants in each arm will be able to detect a difference of 1 point on the MMAS with a power of 90 % and significance level of 5 %. Accounting for an attrition rate of 15 %, we plan to enroll 100 participants in each arm (total study population = 200). We hypothesize that a linguistically tailored health IT intervention based on IVR and SMS will be associated with an improvement in adherence (to anti-platelet and lipid-lowering medications) and an improvement in health literacy in Pakistani patients with vascular disease. This innovative study will provide early data for the feasibility of the use of IT based prescriptions in an lower middle incorme country setting with limited numeracy and literacy skills. Clinical Trials.gov: NCT02354040 - 2 February 2015.

  5. Continuous sawmill studies: protocols, practices, and profits

    Science.gov (United States)

    Robert Mayer; Jan Wiedenbeck

    2005-01-01

    In today's global economy, the "opportunity cost" associated with suboptimal utilization of raw material and mill resources is significant. As a result, understanding the profit potential associated with different types of logs is critically important for sawmill survival. The conventional sawmill study typically has been conducted on a substantially...

  6. Study on Cloud Security Based on Trust Spanning Tree Protocol

    Science.gov (United States)

    Lai, Yingxu; Liu, Zenghui; Pan, Qiuyue; Liu, Jing

    2015-09-01

    Attacks executed on Spanning Tree Protocol (STP) expose the weakness of link layer protocols and put the higher layers in jeopardy. Although the problems have been studied for many years and various solutions have been proposed, many security issues remain. To enhance the security and credibility of layer-2 network, we propose a trust-based spanning tree protocol aiming at achieving a higher credibility of LAN switch with a simple and lightweight authentication mechanism. If correctly implemented in each trusted switch, the authentication of trust-based STP can guarantee the credibility of topology information that is announced to other switch in the LAN. To verify the enforcement of the trusted protocol, we present a new trust evaluation method of the STP using a specification-based state model. We implement a prototype of trust-based STP to investigate its practicality. Experiment shows that the trusted protocol can achieve security goals and effectively avoid STP attacks with a lower computation overhead and good convergence performance.

  7. The communities first (ComFi) study: protocol for a prospective controlled quasi-experimental study to evaluate the impact of area-wide regeneration on mental health and social cohesion in deprived communities.

    Science.gov (United States)

    White, James; Greene, Giles; Dunstan, Frank; Rodgers, Sarah; Lyons, Ronan A; Humphreys, Ioan; John, Ann; Webster, Chris; Palmer, Stephen; Elliott, Eva; Phillips, Ceri J; Fone, David

    2014-10-14

    Recent systematic reviews have highlighted the dearth of evidence on the effectiveness of regeneration on health and health inequalities. 'Communities First' is an area-wide regeneration scheme to improve the lives of people living in the most deprived areas in Wales (UK). This study will evaluate the impact of Communities First on residents' mental health and social cohesion. A prospective controlled quasi-experimental study of the association between residence in Communities First regeneration areas in Caerphilly county borough and change in mental health and social cohesion. The study population is the 4226 residents aged 18-74 years who responded to the Caerphilly Health and Social Needs Study in 2001 (before delivery) and 2008 (after delivery of Communities First). Data on the location, type and cost of Communities First interventions will be extracted from records collected by Caerphilly county borough council. The primary outcome is the change in mental health between 2001 and 2008. Secondary outcomes are changes: in common mental disorder case status (using survey and general practice data), social cohesion and mental health inequalities. Multilevel models will examine change in mental health and social cohesion between Communities First and control areas, adjusting for individual and household level confounding factors. Further models will examine the effects of (1) different types of intervention, (2) contamination across areas, (3) length of residence in a Communities First area, and (4) population migration. We will carry out a cost-consequences analysis to summarise the outcomes generated for participants, as well as service utilisation and utility gains. This study has had approval from the Information Governance Review Panel at Swansea University (Ref: 0266 CF). Findings will be disseminated through peer-review publications, international conferences, policy and practice partners in local and national government, and updates on our study website

  8. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity.

    Science.gov (United States)

    Giacobbi, Peter; Hingle, Melanie; Johnson, Thienne; Cunningham, James K; Armin, Julie; Gordon, Judith S

    2016-01-21

    This paper presents the protocol for an ongoing research study to develop and test the feasibility of a multi-behavioral mHealth app. Approximately 27 million women smoke in the US, and more than 180,000 women die of illnesses linked to smoking annually. Women report greater difficulties quitting smoking. Concerns about weight gain, negative body image, and low self-efficacy may be key factors affecting smoking cessation among women. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping women quit. Guided imagery has been successfully used to address body image concerns and self-efficacy in our 3 target behaviors-exercise, diet and smoking cessation. However, it has not been used simultaneously for smoking, diet, and exercise behavior in a single intervention. While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in person, which limits reach. mHealth apps delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. The objective of our study is to evaluate the feasibility of an mHealth app for women designed to simultaneously address smoking, diet, and physical activity behaviors. The objectives are supported by three specific aims: (1) develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among women smokers, (2) program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features, and (3) evaluate the feasibility, acceptability, and preliminary efficacy of the app with women smokers. We created the program content and designed the prototype application for use on the Android platform in collaboration with 9 participants in multiple focus groups and in-depth interviews. We programmed and tested the application's usability with 6 participants

  9. See Me Smoke-Free: Protocol for a Research Study to Develop and Test the Feasibility of an mHealth App for Women to Address Smoking, Diet, and Physical Activity

    Science.gov (United States)

    Johnson, Thienne; Gordon, Judith S

    2016-01-01

    Background This paper presents the protocol for an ongoing research study to develop and test the feasibility of a multi-behavioral mHealth app. Approximately 27 million women smoke in the US, and more than 180,000 women die of illnesses linked to smoking annually. Women report greater difficulties quitting smoking. Concerns about weight gain, negative body image, and low self-efficacy may be key factors affecting smoking cessation among women. Recent studies suggest that a multi-behavioral approach, including diet and physical activity, may be more effective at helping women quit. Guided imagery has been successfully used to address body image concerns and self-efficacy in our 3 target behaviors—exercise, diet and smoking cessation. However, it has not been used simultaneously for smoking, diet, and exercise behavior in a single intervention. While imagery is an effective therapeutic tool for behavior change, the mode of delivery has generally been in person, which limits reach. mHealth apps delivered via smart phones offer a unique channel through which to distribute imagery-based interventions. Objective The objective of our study is to evaluate the feasibility of an mHealth app for women designed to simultaneously address smoking, diet, and physical activity behaviors. The objectives are supported by three specific aims: (1) develop guided imagery content, user interface, and resources to reduce weight concern, and increase body image and self-efficacy for behavior change among women smokers, (2) program a prototype of the app that contains all the necessary elements of text, graphics, multimedia and interactive features, and (3) evaluate the feasibility, acceptability, and preliminary efficacy of the app with women smokers. Methods We created the program content and designed the prototype application for use on the Android platform in collaboration with 9 participants in multiple focus groups and in-depth interviews. We programmed and tested the application

  10. Statistical principles for prospective study protocols:

    DEFF Research Database (Denmark)

    Christensen, Robin; Langberg, Henning

    2012-01-01

    In the design of scientific studies it is essential to decide on which scientific questions one aims to answer, just as it is important to decide on the correct statistical methods to use to answer these questions. The correct use of statistical methods is crucial in all aspects of research...... to quantify relationships in data. Despite an increased focus on statistical content and complexity of biomedical research these topics remain difficult for most researchers. Statistical methods enable researchers to condense large spreadsheets with data into means, proportions, and difference between means......, risk differences, and other quantities that convey information. One of the goals in biomedical research is to develop parsimonious models - meaning as simple as possible. This approach is valid if the subsequent research report (the article) is written independent of whether the results...

  11. A parathyroid adenoma case study: Protocol review

    International Nuclear Information System (INIS)

    Sorensen, B.J.; Chu, J.M.G.

    1998-01-01

    Full text: Technetium-99m ( 99m Tc) Sestamibi as opposed to Thallous-201 Chloride and 99m Tc Sodium Pertechnetate subtraction, has become the radiopharmaceutical of choice for detection of parathyroid adenomas. A 17-year-old female patient presented to the department for a parathyroid 99m Tc Sestamibi scan to evaluate possible parathyroid adenoma/s. She was initially admitted with increasing serum Calcium levels, polyuria, abdominal pain and general malaise. The patient was injected with 900MBq of 99m Tc Sestamibi, and a pinhole dynamic at a distance of 10 cm from the neck was acquired followed by a 5-minute static image at 7 cm. Single Photon Emission Computed Tomography (SPECT) was then performed on a dual-head gamma camera followed by an anterior and posterior 10-minute static image. At 3 and 5 hours post injection the 10-minute static image was repeated. This study was reported as normal with uniform uptake and washout of the tracer over the 5-hour period. An ultrasound study was performed, and it showed a lesion believed to be a parathyroid adenoma measuring 2.2 x 0.8 x 0.4 cm in size in the right upper lobe of the thyroid. A subsequent thyroid scan was performed to confirm that it was non-functioning thyroid tissue. The patient was injected with 250MBq of 99m Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the 99m Tc Sestamibi and 99m Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess 99m Tc Sestamibi distribution on the right upper lobe of the thyroid, which washed out over time. This corresponded to the ultrasound findings and was confirmed at surgery to be a parathyroid adenoma. A 99m Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for 99m Tc Sestamibi parathyroid scans

  12. A parathyroid adenoma case study: Protocol review

    Energy Technology Data Exchange (ETDEWEB)

    Sorensen, B.J.; Chu, J.M.G. [Liverpool Hospital, NSW (Australia). Department of Nuclear Medicine and Clinical Ultrasound

    1998-06-01

    Full text: Technetium-99m ({sup 99m}Tc) Sestamibi as opposed to Thallous-201 Chloride and {sup 99m}Tc Sodium Pertechnetate subtraction, has become the radiopharmaceutical of choice for detection of parathyroid adenomas. A 17-year-old female patient presented to the department for a parathyroid {sup 99m}Tc Sestamibi scan to evaluate possible parathyroid adenoma/s. She was initially admitted with increasing serum Calcium levels, polyuria, abdominal pain and general malaise. The patient was injected with 900MBq of {sup 99m}Tc Sestamibi, and a pinhole dynamic at a distance of 10 cm from the neck was acquired followed by a 5-minute static image at 7 cm. Single Photon Emission Computed Tomography (SPECT) was then performed on a dual-head gamma camera followed by an anterior and posterior 10-minute static image. At 3 and 5 hours post injection the 10-minute static image was repeated. This study was reported as normal with uniform uptake and washout of the tracer over the 5-hour period. An ultrasound study was performed, and it showed a lesion believed to be a parathyroid adenoma measuring 2.2 x 0.8 x 0.4 cm in size in the right upper lobe of the thyroid. A subsequent thyroid scan was performed to confirm that it was non-functioning thyroid tissue. The patient was injected with 250MBq of {sup 99m}Tc Sodium Pertechnetate and scanned with a pinhole collimator at a distance of 7 cm. When the {sup 99m}Tc Sestamibi and {sup 99m}Tc Sodium Pertechnetate scan were viewed together, it was clear that there was excess {sup 99m}Tc Sestamibi distribution on the right upper lobe of the thyroid, which washed out over time. This corresponded to the ultrasound findings and was confirmed at surgery to be a parathyroid adenoma. A {sup 99m}Tc Sodium Pertechnetate scan and an ultrasound are now also routinely performed on patients presenting for {sup 99m}Tc Sestamibi parathyroid scans

  13. Effectiveness of a 16-month multi-component and environmental school-based intervention for recovery of poor income overweight/obese children and adolescents: study protocol of the health multipliers program

    Directory of Open Access Journals (Sweden)

    Pollyanna Fernandes Patriota

    2017-09-01

    Full Text Available Abstract Background Excess of weight is a serious public health concern in almost all countries, afflicting people of different ages and socioeconomic backgrounds. Studies have indicated the need for developing treatment strategies that intervene directly in the obesogenic environment. This study aims to evaluate the effectiveness of a multi-component and environmental school-based intervention, lasting 16 months, on the recovery of the nutritional status of low-income children and adolescents with overweight/ obesity. Methods/study design The study was conducted by the Center for Recovery and Nutritional Education (CREN in São Paulo, Brazil. Two schools located in poor neighborhoods were selected for the intervention, between March 2016 and June 2017. The participants were all students aged 8 to 12 years from the two participating schools. At the beginning of the intervention, anthropometric measurements were carried out to assess the nutritional status of the students. For convenience, students from one of the schools were considered as the control group, while those from the other school formed the experimental group. The intervention in the experimental group (n = 438 consists of the following weekly activities at school: psychological counseling in groups, theoretical/practical nutrition workshops, and supervised physical education classes. In addition, theoretical and practical educational activities are held regularly for parents, teachers, and cooks. Students with excess of weight (≥1 body mass index [BMI] –for-age Z score, n = 138 received clinical and nutritional care periodically at the outpatient care at CREN. Students enrolled in the control group (n = 353 participated in psychological counseling groups and theoretical/practical nutrition workshops for 6 months held in the school environment to provide motivation to entire classrooms. In the following 10 months, students with excess of weight from the control group (n

  14. The impact of mHealth interventions on health systems: a systematic review protocol.

    Science.gov (United States)

    Fortuin, Jill; Salie, Faatiema; Abdullahi, Leila H; Douglas, Tania S

    2016-11-25

    Mobile health (mHealth) has been described as a health enabling tool that impacts positively on the health system in terms of improved access, quality and cost of health care. The proposed systematic review will examine the impact of mHealth on health systems by assessing access, quality and cost of health care as indicators. The systematic review will include literature from various sources including published and unpublished/grey literature. The databases to be searched include: PubMed, Cochrane Library, Google Scholar, NHS Health Technology Assessment Database and Web of Science. The reference lists of studies will be screened and conference proceedings searched for additional eligible reports. Literature to be included will have mHealth as the primary intervention. Two authors will independently screen the search output, select studies and extract data; discrepancies will be resolved by consensus and discussion with the assistance of the third author. The systematic review will inform policy makers, investors, health professionals, technologists and engineers about the impact of mHealth in strengthening the health system. In particular, it will focus on three metrics to determine whether mHealth strengthens the health system, namely quality of, access to and cost of health care services. Systematic review registration: PROSPERO CRD42015026070.

  15. Adaptation, Implementation Plan, and Evaluation of an Online Tobacco Cessation Training Program for Health Care Professionals in Three Spanish-Speaking Latin American Countries: Protocol of the Fruitful Study.

    Science.gov (United States)

    Martínez, Cristina; Company, Assumpta; Guillen, Olga; Margalef, Mercè; Arrien, Martha Alicia; Sánchez, Claudia; Cáceres de León, Paula; Fernández, Esteve

    2017-01-27

    Tobacco cessation training programs to treat tobacco dependence have measureable effects on patients' smoking. Tobacco consumption in low- and middle-income countries (LMICs) is high and slowly decreasing, but these countries usually lack measures to face the epidemic, including tobacco cessation training programs for health professionals and organizations. Based on a previous online smoking cessation training program for hospital workers in Spain, the Fruitful Study aims to increase smoking cessation knowledge, attitudes, self-confidence, and performance interventions among health care professionals of three Spanish-speaking low- and middle-income Latin American and Caribbean (LAC) countries. The purpose of this paper is to describe the methodology and evaluation strategy of the Fruitful Study intended to adapt, implement, and test the effectiveness of an online, evidence-based tobacco cessation training program addressed to health professionals from Bolivia, Guatemala, and Paraguay. This study will use a mixed-methods design with a pre-post evaluation (quantitative approach) and in-depth interviews and focus groups (qualitative approach). The main outcomes will be (1) participants' attitudes, knowledge, and behaviors before and after the training; and (2) the level of implementation of tobacco control policies within the hospitals before and after the training. To date, adaptation of the materials, study enrollment, and training activities have been completed. During the adaptation, the main mismatches were language background and content adaptation. Several aids were developed to enable students' training enrollment, including access to computers, support from technicians, and reminders to correctly complete the course. Follow-up data collection is in progress. We have enrolled 281 hospital workers. Results are expected at the beginning of 2017 and will be reported in two follow-up papers: one about the formative evaluation and the other about the summative

  16. Effectiveness of a 16-month multi-component and environmental school-based intervention for recovery of poor income overweight/obese children and adolescents: study protocol of the health multipliers program.

    Science.gov (United States)

    Patriota, Pollyanna Fernandes; Filgueiras, Andrea Rocha; de Almeida, Viviane Belucci Pires; Alexmovitz, Guilherme Aparecido Costa; da Silva, Carlos Eduardo; de Carvalho, Vivian Fortuna Feres; Carvalho, Natália; de Albuquerque, Maria Paula; Domene, Semiramis Martins Alvares; do Prado, Wagner Luiz; Torres, Gustavo Enrique Salazar; de Oliveira, Ana Paula Reis; Sesso, Ricardo; Sawaya, Ana Lydia

    2017-09-15

    Excess of weight is a serious public health concern in almost all countries, afflicting people of different ages and socioeconomic backgrounds. Studies have indicated the need for developing treatment strategies that intervene directly in the obesogenic environment. This study aims to evaluate the effectiveness of a multi-component and environmental school-based intervention, lasting 16 months, on the recovery of the nutritional status of low-income children and adolescents with overweight/ obesity. The study was conducted by the Center for Recovery and Nutritional Education (CREN) in São Paulo, Brazil. Two schools located in poor neighborhoods were selected for the intervention, between March 2016 and June 2017. The participants were all students aged 8 to 12 years from the two participating schools. At the beginning of the intervention, anthropometric measurements were carried out to assess the nutritional status of the students. For convenience, students from one of the schools were considered as the control group, while those from the other school formed the experimental group. The intervention in the experimental group (n = 438) consists of the following weekly activities at school: psychological counseling in groups, theoretical/practical nutrition workshops, and supervised physical education classes. In addition, theoretical and practical educational activities are held regularly for parents, teachers, and cooks. Students with excess of weight (≥1 body mass index [BMI] -for-age Z score, n = 138) received clinical and nutritional care periodically at the outpatient care at CREN. Students enrolled in the control group (n = 353) participated in psychological counseling groups and theoretical/practical nutrition workshops for 6 months held in the school environment to provide motivation to entire classrooms. In the following 10 months, students with excess of weight from the control group (n = 125) were invited to attend the routine outpatient

  17. Protocol for the BRECAR study: a prospective cohort follow-up on the impact of breast reconstruction timing on health-related quality of life in women with breast cancer.

    Science.gov (United States)

    Herrera de la Muela, Maria; García López, Enrique; Frías Aldeguer, Laura; Gómez-Campelo, Paloma

    2017-12-19

    The completion of postmastectomy breast reconstruction (BR) in women with breast cancer can last from months to years, and to our knowledge, there is a lack of studies that analyse how the different types and times of reconstruction impact on the patient's quality of life and psychosocial adjustment.The primary aim of the BREast Cancer Reconstruction (BRECAR Study) is twofold. First, to describe health-related quality of life (HRQoL), overall satisfaction with surgery and psychological impact (body image, self-esteem, depression and anxiety) on women who will have undergone a mastectomy with planned BR, considering the varied timing of BR procedures (immediate BR (iBR), delayed BR (dBR) and two-stage BR (2sBR)). To measure the impact on surgical outcomes, we will obtain data prior to and after surgery (6-9 and at 18 months of follow-up). Second, to analyse sociodemographic, clinical and psychosocial factors associated with HRQoL, satisfaction with surgery and psychological impact. A prospective, observational, clinical cohort study of women diagnosed with breast cancer who have an indication for mastectomy treated at La Paz University Hospital (Madrid, Spain).Patients will be classified into one of three groups under conditions of routine clinical practice, based on the type of BR planned: the iBR group, the dBR group and the 2sBR group.Under typical clinical practice conditions, we will perform three visits: baseline visit (presurgery), V1 (6-9 months after diagnosis) and V2 (18 months after diagnosis). A sample size of 210 patients is estimated. The study protocol and informed consent form have been reviewed and approved by the Institutional Review Board of La Paz Hospital (no. PI-2036). Dissemination of results will be via journal articles and conference presentations. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  18. Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

    Science.gov (United States)

    Sanders-Pinheiro, Helady; Colugnati, Fernando Antonio Basile; Marsicano, Elisa Oliveira; De Geest, Sabina; Medina, José Osmar Pestana

    2018-02-20

    Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture

  19. Klokwerk + study protocol: An observational study to the effects of night-shift work on body weight and infection susceptibility and the mechanisms underlying these health effects.

    Science.gov (United States)

    Loef, Bette; van Baarle, Debbie; van der Beek, Allard J; van Kerkhof, Linda W; van de Langenberg, Daniëlla; Proper, Karin I

    2016-08-02

    Night-shift work may cause severe disturbances in the worker's circadian rhythm, which has been associated with the onset of health problems and diseases. As a substantial part of the workforce is exposed to night-shift work, harmful aspects of night-shift work should not be overlooked. The aim of the Klokwerk + study is to study the effects of night-shift work on body weight and infection susceptibility and the mechanisms underlying these health effects. First, we will study the relation between night-shift work exposure and body weight and between night-shift work exposure and infection susceptibility. Second, we will examine the mechanisms linking night-shift work exposure to body weight and infection susceptibility, with a specific focus on sleep, physical activity, diet, light exposure, vitamin D level, and immunological factors. Lastly, we will focus on the identification of biomarkers for chronic circadian disturbance associated with night-shift work. The design of this study is a prospective observational cohort study consisting of 1,960 health care workers aged 18-65 years. The study population will consist of a group of night-shift workers and an equally sized group of non-night-shift workers. During the study, there will be two measurement periods. As one of the main outcomes of this study is infection susceptibility, the measurement periods will take place at approximately the first (September/October) (T0) and the last month (April/May) (T1, after 6 months) of the flu season. The measurements will consist of questionnaires, anthropometric measurements, a smartphone application to determine infection susceptibility, food diaries, actigraphy, light sensors, and blood sample analyses. The Klokwerk + study will contribute to the current need for high-quality data on the health effects of night-shift work and its underlying behavioral and physiological mechanisms. The findings can be the starting point for the development of interventions that

  20. Klokwerk + study protocol: An observational study to the effects of night–shift work on body weight and infection susceptibility and the mechanisms underlying these health effects

    Directory of Open Access Journals (Sweden)

    Bette Loef

    2016-08-01

    Full Text Available Abstract Background Night–shift work may cause severe disturbances in the worker’s circadian rhythm, which has been associated with the onset of health problems and diseases. As a substantial part of the workforce is exposed to night–shift work, harmful aspects of night–shift work should not be overlooked. The aim of the Klokwerk + study is to study the effects of night–shift work on body weight and infection susceptibility and the mechanisms underlying these health effects. First, we will study the relation between night–shift work exposure and body weight and between night–shift work exposure and infection susceptibility. Second, we will examine the mechanisms linking night–shift work exposure to body weight and infection susceptibility, with a specific focus on sleep, physical activity, diet, light exposure, vitamin D level, and immunological factors. Lastly, we will focus on the identification of biomarkers for chronic circadian disturbance associated with night–shift work. Methods/design The design of this study is a prospective observational cohort study consisting of 1,960 health care workers aged 18–65 years. The study population will consist of a group of night–shift workers and an equally sized group of non–night–shift workers. During the study, there will be two measurement periods. As one of the main outcomes of this study is infection susceptibility, the measurement periods will take place at approximately the first (September/October (T0 and the last month (April/May (T1, after 6 months of the flu season. The measurements will consist of questionnaires, anthropometric measurements, a smartphone application to determine infection susceptibility, food diaries, actigraphy, light sensors, and blood sample analyses. Discussion The Klokwerk + study will contribute to the current need for high–quality data on the health effects of night–shift work and its underlying behavioral and physiological

  1. The effect of the mental health first-aid training course offered employees in Denmark: study protocol for a randomized waitlist-controlled superiority trial mixed with a qualitative study.

    Science.gov (United States)

    Jensen, Kamilla B; Morthorst, Britt R; Vendsborg, Per B; Hjorthøj, Carsten R; Nordentoft, Merete

    2015-04-14

    Studies show a high and growing prevalence of mental disorders in the population worldwide. 25% of the general population in Europe will during their lifetime experience symptoms related to a mental disorder. The Mental Health First Aid concept (MHFA) was founded in 2000 in Australia by Kitchener and Jorm, in order to provide the population with mental health first aid skills. The aim of the concept is, through an educational intervention (course), to increase confidence in how to help people suffering from mental health problems. Further, secondary aims are to increase the mental health literacy of the public by increasing knowledge, reduce stigma and initiate more supportive actions leading towards professional care. An investigation of the effect of MHFA offered a Danish population is needed. The design is a randomized waitlist-controlled superiority trial, in which 500 participants will be allocated to either the intervention group or the control group. The control group will attend the course six months later, hence waiting list design. From fall 2013 to spring 2014 participants will be educated to be "mental health first-aiders" following a manualized, two days MHFA course. All the participants will answer a questionnaire at base-line and at 6 months follow-up. The questionnaire is a back-translation of the questionnaire used in Australian trials. The trial will be complemented by a qualitative study, in which focus groups will be carried out. Outcomes measured are sensitive to interpretation, hence a challenge to uniform. This trial will add to the use of a mixed-methods design and exemplify how it can strengthen the analysis and take up the challenge of a sensitive outcome. https://clinicaltrials.gov identifier NCT02334020.

  2. Protocol: A grounded theory of 'recovery'-perspectives of adolescent users of mental health services.

    Science.gov (United States)

    Palmquist, Lucianne; Patterson, Sue; O'Donovan, Analise; Bradley, Graham

    2017-07-20

    Policies internationally endorse the recovery paradigm as the appropriate foundation for youth mental health services. However, given that this paradigm is grounded in the views of adults with severe mental illness, applicability to youth services and relevance to young people is uncertain, particularly as little is known about young people's views. A comprehensive understanding of the experiences and expectations of young people is critical to developing youth mental health services that are acceptable, accessible, effective and relevant. To inform development of policy and youth services, the study described in this protocol aims to develop a comprehensive account of the experiences and expectations of 12-17 year olds as they encounter mental disorders and transition through specialist mental health services. Data will be analysed to model recovery from the adolescents' perspective. This grounded theory study will use quantitative and qualitative data collected in interviews with 12-17 year olds engaged with specialist Child/Youth Mental Health Service in Queensland, Australia. Interviews will explore adolescents' expectations and experiences of mental disorder, and of services, as they transition through specialist mental health services, including the meaning of their experiences and ideas of 'recovery' and how their experiences and expectations are shaped. Data collection and analysis will use grounded theory methods. Adolescents' experiences will be presented as a mid-range theory. The research will provide tangible recommendations for youth-focused mental health policy and practice. Findings will be disseminated within academic literature and beyond to participants, health professionals, mental health advocacy groups and policy and decision makers via publications, research summaries, conferences and workshops targeting different audiences. Ethical and research governance approvals have been obtained from relevant Human Research Ethics committees and all

  3. The National Acupuncture Detoxification Association protocol, auricular acupuncture to support patients with substance abuse and behavioral health disorders: current perspectives

    Directory of Open Access Journals (Sweden)

    Stuyt EB

    2016-12-01

    Full Text Available Elizabeth B Stuyt,1 Claudia A Voyles2 1Department of Psychiatry, University of Colorado Health Sciences Center, Pueblo, CO, 2Department of Clinical Studies, AOMA Graduate School of Integrative Medicine, Austin, TX, USA Abstract: The National Acupuncture Detoxification Association (NADA-standardized 3- to 5-point ear acupuncture protocol, born of a community-minded response to turbulent times not unlike today, has evolved into the most widely implemented acupuncture-assisted protocol, not only for substance abuse, but also for broad behavioral health applications. This evolution happened despite inconsistent research support. This review highlights the history of the protocol and the research that followed its development. Promising, early randomized-controlled trials were followed by a mixed field of positive and negative studies that may serve as a whole to prove that NADA, despite its apparent simplicity, is neither a reductive nor an independent treatment, and the need to refine the research approaches. Particularly focusing on the last decade and its array of trials that elucidate aspects of NADA application and effects, the authors recommend that, going forward, research continues to explore the comparison of the NADA protocol added to accepted treatments to those treatments alone, recognizing that it is not a stand-alone procedure but a psychosocial intervention that affects the whole person and can augment outcomes from other treatment modalities. Keywords: National Acupuncture Detoxification Association (NADA, ear acupuncture, acudetox, addiction, mental health, trauma

  4. Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: Protocol for a Randomized Study Funded by the US Department of Veterans Affairs Health Services Research and Development Program.

    Science.gov (United States)

    Piette, John D; Krein, Sarah L; Striplin, Dana; Marinec, Nicolle; Kerns, Robert D; Farris, Karen B; Singh, Satinder; An, Lawrence; Heapy, Alicia A

    2016-04-07

    practice, and physical functioning. Outcomes will be measured at 3 and 6 months post recruitment and will include pain-related interference, treatment satisfaction, and treatment dropout. Our primary hypothesis is that AI-CBT will result in pain-related functional outcomes that are at least as good as the standard approach, and that by scaling back the intensity of contact that is not associated with additional gains in pain control, the AI-CBT approach will be significantly less costly in terms of therapy time. The trial is currently in the start-up phase. Patient enrollment will begin in the fall of 2016 and results of the trial will be available in the winter of 2019. This study will evaluate an intervention that increases patients' access to effective CBT pain management services while allowing health systems to maximize program expansion given constrained resources.

  5. Studying protocol-based pain management in the emergency department

    Directory of Open Access Journals (Sweden)

    Akkamahadevi Patil

    2017-01-01

    Full Text Available Background: Majority of the patients presenting to emergency department (ED have pain. ED oligoanalgesia remains a challenge. Aims: This study aims to study the effect of implementing a protocol-based pain management in the ED on (1 time to analgesia and (2 adequacy of analgesia obtained. Settings and Design: Cross-sectional study in the ED. Methods: Patients aged 18–65 years of age with pain of numeric rating scale (NRS ≥4 were included. A series of 100 patients presenting before introduction of the protocol-based pain management were grouped “pre-protocol,” and managed as per existing practice. Following this, a protocol for management of all patients presenting to ED with pain was implemented. Another series of 100 were grouped as “post-protocol” and managed as per the new pain management protocol. The data of patients from both the groups were collected and analyzed. Statistical Analysis Used: Descriptive statistical tests such as percentage, mean and standard deviation and inferential statistical tests such as Pearson coefficient, Student's t-test were applied. Differences were interpreted as significant when P < 0.05. Results: Mean time to administer analgesic was significantly lesser in the postprotocol group (preprotocol 20.30 min vs. postprotocol 13.05 min; P < 0.001. There was significant difference in the pain relief achieved (change in NRS between the two groups, with greater pain relief achieved in the postprotocol group (preprotocol group 4.6800 vs. postprotocol group 5.3600; P < 0.001. Patients' rating of pain relief (assessed on E5 scale was significantly higher in the postprotocol group (preprotocol 3.91 vs. postprotocol 4.27; P = 0.001. Patients' satisfaction (North American Spine Society scale with the overall treatment was also compared and found to be significantly higher in postprotocol group (mean: preprotocol 1.59 vs. postprotocol 1.39; P = 0.008. Conclusion: Protocol-based pain management provided timely and

  6. Study protocol: The Intensive Care Outcome Network ('ICON' study

    Directory of Open Access Journals (Sweden)

    Barber Vicki S

    2008-06-01

    Full Text Available Abstract Background Extended follow-up of survivors of ICU treatment has shown many patients suffer long-term physical and psychological consequences that affect their health-related quality of life. The current lack of rigorous longitudinal studies means that the true prevalence of these physical and psychological problems remains undetermined. Methods/Design The ICON (Intensive Care Outcome Network study is a multi-centre, longitudinal study of survivors of critical illness. Patients will be recruited prior to hospital discharge from 20–30 ICUs in the UK and will be assessed at 3, 6, and 12 months following ICU discharge for health-related quality of life as measured by the Short Form-36 (SF-36 and the EuroQoL (EQ-5D; anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS; and post traumatic stress disorder (PTSD symptoms as measured by the PTSD Civilian Checklist (PCL-C. Postal questionnaires will be used. Discussion The ICON study will create a valuable UK database detailing the prevalence of physical and psychological morbidity experienced by patients as they recover from critical illness. Knowledge of the prevalence of physical and psychological morbidity in ICU survivors is important because research to generate models of causality, prognosis and treatment effects is dependent on accurate determination of prevalence. The results will also inform economic modelling of the long-term burden of critical illness. Trial Registration ISRCTN69112866

  7. mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Miyamoto, Sheridan; Dharmar, Madan; Fazio, Sarina; Tang-Feldman, Yajarayma; Young, Heather M

    2018-02-15

    Chronic diseases, including diabetes mellitus, are the leading cause of mortality and disability in the United States. Current solutions focus primarily on diagnosis and pharmacological treatment, yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes. The objective of this clinical trial is to evaluate the impact of a mobile health (mHealth) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus. A randomized controlled trial was conducted at an academic health system in Northern California. A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics. Participants were randomized to either usual care or intervention. All participants received training on use of the health system patient portal. Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record (EHR) to track their daily activity and health behavior decisions. All participants completed a baseline survey and follow-up surveys at 3 and 9 months. Primary and secondary outcomes include diabetes self-efficacy, hemoglobin A 1c (HbA 1c ), and quality of life measures. Data collection for this trial, funded by the Patient-Centered Outcomes Research Institute, will be completed by December 2017. Results from the trial will be available mid-2018. This protocol details a patient-centered intervention using nurse health coaching, mHealth technologies, and integration of patient-generated data into the EHR. The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals, and by creating a complete feedback

  8. Indicators and measurement tools for health system integration: a knowledge synthesis protocol.

    Science.gov (United States)

    Oelke, Nelly D; Suter, Esther; da Silva Lima, Maria Alice Dias; Van Vliet-Brown, Cheryl

    2015-07-29

    Health system integration is a key component of health system reform with the goal of improving outcomes for patients, providers, and the health system. Although health systems continue to strive for better integration, current delivery of health services continues to be fragmented. A key gap in the literature is the lack of information on what successful integration looks like and how to measure achievement towards an integrated system. This multi-site study protocol builds on a prior knowledge synthesis completed by two of the primary investigators which identified 10 key principles that collectively support health system integration. The aim is to answer two research questions: What are appropriate indicators for each of the 10 key integration principles developed in our previous knowledge synthesis and what measurement tools are used to measure these indicators? To enhance generalizability of the findings, a partnership between Canada and Brazil was created as health system integration is a priority in both countries and they share similar contexts. This knowledge synthesis will follow an iterative scoping review process with emerging information from knowledge-user engagement leading to the refinement of research questions and study selection. This paper describes the methods for each phase of the study. Research questions were developed with stakeholder input. Indicator identification and prioritization will utilize a modified Delphi method and patient/user focus groups. Based on priority indicators, a search of the literature will be completed and studies screened for inclusion. Quality appraisal of relevant studies will be completed prior to data extraction. Results will be used to develop recommendations and key messages to be presented through integrated and end-of-grant knowledge translation strategies with researchers and knowledge-users from the three jurisdictions. This project will directly benefit policy and decision-makers by providing an easy

  9. What factors contribute to positive early childhood health and development in Australian Aboriginal children? Protocol for a population-based cohort study using linked administrative data (The Seeding Success Study)

    Science.gov (United States)

    Falster, Kathleen; Jorm, Louisa; Eades, Sandra; Lynch, John; Banks, Emily; Brownell, Marni; Craven, Rhonda; Einarsdóttir, Kristjana; Randall, Deborah

    2015-01-01

    Introduction Australian Aboriginal children are more likely than non-Aboriginal children to have developmental vulnerability at school entry that tracks through to poorer literacy and numeracy outcomes and multiple social and health disadvantages in later life. Empirical evidence identifying the key drivers of positive early childhood development in Aboriginal children, and supportive features of local communities and early childhood service provision, are lacking. Methods and analysis The study population will be identified via linkage of Australian Early Development Census data to perinatal and birth registration data sets. It will include an almost complete population of children who started their first year of full-time school in New South Wales (NSW), Australia, in 2009 and 2012. Early childhood health and development trajectories for these children will be constructed via linkage to a range of administrative data sets relating to birth outcomes, congenital conditions, hospital admissions, emergency department presentations, receipt of ambulatory mental healthcare services, use of general practitioner services, contact with child protection and out-of-home care services, receipt of income assistance and fact of death. Using multilevel modelling techniques, we will quantify the contributions of individual-level and area-level factors to variation in early childhood development outcomes in Aboriginal and non-Aboriginal children. Additionally, we will evaluate the impact of two government programmes that aim to address early childhood disadvantage, the NSW Aboriginal Maternal and Infant Health Service and the Brighter Futures Program. These evaluations will use propensity score matching methods and multilevel modelling. Ethics and dissemination Ethical approval has been obtained for this study. Dissemination mechanisms include engagement of stakeholders (including representatives from Aboriginal community controlled organisations, policy agencies, service

  10. Developing implementation strategies for firearm safety promotion in paediatric primary care for suicide prevention in two large US health systems: a study protocol for a mixed-methods implementation study.

    Science.gov (United States)

    Wolk, Courtney Benjamin; Jager-Hyman, Shari; Marcus, Steven C; Ahmedani, Brian K; Zeber, John E; Fein, Joel A; Brown, Gregory K; Lieberman, Adina; Beidas, Rinad S

    2017-06-24

    The promotion of safe firearm practices, or firearms means restriction, is a promising but infrequently used suicide prevention strategy in the USA. Safety Check is an evidence-based practice for improving parental firearm safety behaviour in paediatric primary care. However, providers rarely discuss firearm safety during visits, suggesting the need to better understand barriers and facilitators to promoting this approach. This study, Adolescent Suicide Prevention In Routine clinical Encounters, aims to engender a better understanding of how to implement the three firearm components of Safety Check as a suicide prevention strategy in paediatric primary care. The National Institute of Mental Health-funded Mental Health Research Network (MHRN), a consortium of 13 healthcare systems across the USA, affords a unique opportunity to better understand how to implement a firearm safety intervention in paediatric primary care from a system-level perspective. We will collaboratively develop implementation strategies in partnership with MHRN stakeholders. First, we will survey leadership of 82 primary care practices (ie, practices serving children, adolescents and young adults) within two MHRN systems to understand acceptability and use of the three firearm components of Safety Check (ie, screening, brief counselling around firearm safety and provision of firearm locks). Then, in collaboration with MHRN stakeholders, we will use intervention mapping and the Consolidated Framework for Implementation Research to systematically develop and evaluate a multilevel menu of implementation strategies for promoting firearm safety as a suicide prevention strategy in paediatric primary care. Study procedures have been approved by the University of Pennsylvania. Henry Ford Health System and Baylor Scott & White institutional review boards (IRBs) have ceded IRB review to the University of Pennsylvania IRB. Results will be submitted for publication in peer-reviewed journals. © Article

  11. What factors contribute to positive early childhood health and development in Australian Aboriginal children? Protocol for a population-based cohort study using linked administrative data (The Seeding Success Study).

    Science.gov (United States)

    Falster, Kathleen; Jorm, Louisa; Eades, Sandra; Lynch, John; Banks, Emily; Brownell, Marni; Craven, Rhonda; Einarsdóttir, Kristjana; Randall, Deborah

    2015-05-18

    Australian Aboriginal children are more likely than non-Aboriginal children to have developmental vulnerability at school entry that tracks through to poorer literacy and numeracy outcomes and multiple social and health disadvantages in later life. Empirical evidence identifying the key drivers of positive early childhood development in Aboriginal children, and supportive features of local communities and early childhood service provision, are lacking. The study population will be identified via linkage of Australian Early Development Census data to perinatal and birth registration data sets. It will include an almost complete population of children who started their first year of full-time school in New South Wales (NSW), Australia, in 2009 and 2012. Early childhood health and development trajectories for these children will be constructed via linkage to a range of administrative data sets relating to birth outcomes, congenital conditions, hospital admissions, emergency department presentations, receipt of ambulatory mental healthcare services, use of general practitioner services, contact with child protection and out-of-home care service