WorldWideScience

Sample records for complex intervention protocol

  1. Addressing the evidence to practice gap for complex interventions in primary care: a systematic review of reviews protocol.

    Science.gov (United States)

    Lau, Rosa; Stevenson, Fiona; Ong, Bie Nio; Dziedzic, Krysia; Eldridge, Sandra; Everitt, Hazel; Kennedy, Anne; Kontopantelis, Evangelos; Little, Paul; Qureshi, Nadeem; Rogers, Anne; Treweek, Shaun; Peacock, Richard; Murray, Elizabeth

    2014-06-23

    Getting the results of research implemented into routine healthcare is often a challenge. The disconnect between the development and implementation of evidence into practice is called the 'second translational gap' and is particularly apparent in primary care. To address this gap, we plan to identify, summarise and synthesise currently available evidence by undertaking a systematic review of reviews to: (1) explore barriers and facilitators of implementation of research evidence or complex interventions, and (2) assess the effectiveness of strategies in facilitating implementation of complex interventions in primary care. This is a protocol for a systematic review of reviews. We will search MEDLINE, EMBASE, the Cochrane Library, CINAHL and PsycINFO up until December 2013. We will check reference lists of included studies for further studies. Two authors will independently screen the titles and abstracts identified from the search; any discrepancies will be resolved by discussion and consensus. Full-text papers will be obtained and relevant reviews will be selected against inclusion criteria. Eligible reviews have to be based on predominantly primary care in developed countries and examine either factors to implementation or, the effectiveness of strategies to optimise implementation. Data from eligible reviews will be extracted using standardised data abstraction forms. For barriers and facilitators, data will be synthesised using an interpretative meta-synthesis approach. For implementation strategies, findings will be summarised and described narratively and synthesised using a framework approach. All findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Ethical approval is not required. The review findings will inform the work of the design and implementation of future studies and will be of interest to a wide audience including health professionals, researchers, health service or

  2. Development and testing of an implementation strategy for a complex housing intervention: protocol for a mixed methods study.

    Science.gov (United States)

    Watson, Dennis P; Young, Jeani; Ahonen, Emily; Xu, Huiping; Henderson, Macey; Shuman, Valery; Tolliver, Randi

    2014-10-17

    There is currently a lack of scientifically designed and tested implementation strategies. Such strategies are particularly important for highly complex interventions that require coordination between multiple parts to be successful. This paper presents a protocol for the development and testing of an implementation strategy for a complex intervention known as the Housing First model (HFM). Housing First is an evidence-based practice for chronically homeless individuals demonstrated to significantly improve a number of outcomes. Drawing on practices demonstrated to be useful in implementation and e-learning theory, our team is currently adapting a face-to-face implementation strategy so that it can be delivered over a distance. Research activities will be divided between Chicago and Central Indiana, two areas with significantly different barriers to HFM implementation. Ten housing providers (five from Chicago and five from Indiana) will be recruited to conduct an alpha test of each of four e-learning modules as they are developed. Providers will be requested to keep a detailed log of their experience completing the modules and participate in one of two focus groups. After refining the modules based on alpha test results, we will test the strategy among a sample of four housing organizations (two from Chicago and two from Indiana). We will collect and analyze both qualitative and quantitative data from administration and staff. Measures of interest include causal factors affecting implementation, training outcomes, and implementation outcomes. This project is an important first step in the development of an evidence-based implementation strategy to increase scalability and impact of the HFM. The project also has strong potential to increase limited scientific knowledge regarding implementation strategies in general.

  3. Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

    Directory of Open Access Journals (Sweden)

    Brafman-Kennedy Barbara

    2011-05-01

    Full Text Available Abstract Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS seeks to improve the care of breathless patients with advanced disease (regardless of cause through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed. This paper presents the protocol for Phase III. Methods/Design Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks and one for patients with non-malignant disease (intervention delivered over four weeks. The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol and one for patients with non-malignant conditions (eight week protocol. Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only. The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10. The trial includes economic evaluation. Analysis will be on an intention to treat basis. Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast

  4. 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

  5. A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial.

    Science.gov (United States)

    Nabulsi, Mona; Hamadeh, Haya; Tamim, Hani; Kabakian, Tamar; Charafeddine, Lama; Yehya, Nadine; Sinno, Durriyah; Sidani, Saadieh

    2014-01-15

    Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon, we hypothesize that a complex breastfeeding support intervention, which is centered on the three components mentioned above, would significantly increase breastfeeding rates. A multi-center randomized controlled trial. 443 healthy pregnant women in their first trimester will be randomized to control or intervention group. A "prenatal/postnatal" professional and peer breastfeeding support package continuing till 6 months postpartum, guided by the Social Network and Social Support Theory. Control group will receive standard prenatal and postnatal care. Mothers will be followed up from early pregnancy till five years after delivery. Total and exclusive breastfeeding rates, quality of life at 1, 3 and 6 months postpartum, maternal breastfeeding knowledge and attitudes at 6 months postpartum, maternal exclusive breastfeeding rates of future infants up to five years from baseline, cost-benefit and cost-effectiveness analyses of the intervention. Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS. Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality. In a country with limited healthcare resources like Lebanon, developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority. If positive, the results of this study would provide

  6. Evaluation of a complex, population-based injury claims management intervention for improving injury outcomes: study protocol

    Science.gov (United States)

    Collie, Alex; Gabbe, Belinda; Fitzharris, Michael

    2015-01-01

    Introduction Injuries resulting from road traffic crashes are a substantial cause of disability and death worldwide. Injured persons receiving compensation have poorer recovery and return to work than those with non-compensable injury. Case or claims management is a critical component of injury compensation systems, and there is now evidence that claims management can have powerful positive impacts on recovery, but can also impede recovery or exacerbate mental health concerns in some injured people. This study seeks to evaluate the impact of a population-based injury claims management intervention in the State of Victoria, Australia, on the health of those injured in motor vehicle crashes, their experience of the compensation process, and the financial viability of the compensation system. Methods and analysis Evaluation of this complex intervention involves a series of linked but stand-alone research projects to assess the anticipated process changes, impacts and outcomes of the intervention over a 5-year time frame. Linkage and analysis of routine administrative and health system data is supplemented with a series of primary studies collecting new information. Additionally, a series of ‘action’ research projects will be undertaken to inform the implementation of the intervention. A program logic model designed by the state government Transport Accident Commission in conjunction with the research team provides the evaluation framework. Ethics and dissemination Relatively few studies have comprehensively examined the impact of compensation system processes on the health of injured persons, their satisfaction with systems processes, and impacts on the financial performance of the compensation scheme itself. The wholesale, population-based transformation of an injury claims management model is a rare opportunity to document impacts of system-level policy change on outcomes of injured persons. Findings will contribute to the evidence base of information on the

  7. A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Skau, Jutta K H; Nordin, Awatef Binti Amer; Cheah, Julius C H; Ali, Roslinah; Zainal, Ramli; Aris, Tahir; Ali, Zainudin Mohd; Matzen, Priya; Biesma, Regien; Aagaard-Hansen, Jens; Hanson, Mark A; Norris, Shane A

    2016-04-27

    Over the past two decades, the population of Malaysia has grown rapidly and the prevalence of diabetes mellitus in Malaysia has dramatically increased, along with the frequency of obesity, hyperlipidaemia and hypertension. Early-life influences play an important role in the development of non-communicable diseases. Indeed, maternal lifestyle and conditions such as gestational diabetes mellitus or obesity can affect the risk of diabetes in the next generation. Lifestyle changes can help to prevent the development of type 2 diabetes mellitus. This is a protocol for an unblinded, community-based, randomised controlled trial in two arms to evaluate the efficacy of a complex behavioural change intervention, combining motivational interviewing provided by a community health promoter and access to a habit formation mobile application, among young Malaysian women and their spouses prior to pregnancy. Eligible subjects will be Malaysian women in the age group 20 to 39 years, who are nulliparous, not diagnosed with diabetes and own a smartphone. With an alpha-value of 0.05, a statistical power of 90 %, 264 subjects will need to complete the study. Subjects with their spouses will be randomised to either the intervention or the control arm for an 8-month period. The primary endpoint is change in waist circumference from baseline to end of intervention period and secondary endpoints are changes in anthropometric parameters, biochemical parameters, change in health literacy level, dietary habits, physical activity and stress level. Primary endpoint and the continuous secondary endpoints will be analysed in a linear regression model, whereas secondary endpoints on an ordinal scale will be analysed by using the chi-squared test. A multivariate linear model for the primary endpoint will be undertaken to account for potential confounders. This study has been approved by the Medical Research and Ethics Committee of the Ministry of Health Malaysia (protocol number: NMRR-14

  8. Feasible quantum communication complexity protocol

    International Nuclear Information System (INIS)

    Galvao, Ernesto F.

    2002-01-01

    I show that a simple multiparty communication task can be performed more efficiently with quantum communication than with classical communication, even with low detection efficiency η. The task is a communication complexity problem in which distant parties need to compute a function of the distributed inputs, while minimizing the amount of communication between them. A realistic quantum optical setup is suggested that can demonstrate a five-party quantum protocol with higher-than-classical performance, provided η>0.33

  9. A complex breastfeeding promotion and support intervention in a developing country: study protocol for a randomized clinical trial

    OpenAIRE

    Nabulsi, Mona; Hamadeh, Haya; Tamim, Hani; Kabakian, Tamar; Charafeddine, Lama; Yehya, Nadine; Sinno, Durriyah; Sidani, Saadieh

    2014-01-01

    Background Breastfeeding has countless benefits to mothers, children and community at large, especially in developing countries. Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates. Evidence reveals that antenatal breastfeeding education, professional lactation support, and peer lay support are individually effective at increasing breastfeeding duration and exclusivity, particularly in low-income settings. Given the complex nature of the breastfeed...

  10. A group randomized trial of a complexity-based organizational intervention to improve risk factors for diabetes complications in primary care settings: study protocol

    Directory of Open Access Journals (Sweden)

    Noel Polly H

    2008-03-01

    Full Text Available Abstract Background Most patients with type 2 diabetes have suboptimal control of their glucose, blood pressure (BP, and lipids – three risk factors for diabetes complications. Although the chronic care model (CCM provides a roadmap for improving these outcomes, developing theoretically sound implementation strategies that will work across diverse primary care settings has been challenging. One explanation for this difficulty may be that most strategies do not account for the complex adaptive system (CAS characteristics of the primary care setting. A CAS is comprised of individuals who can learn, interconnect, self-organize, and interact with their environment in a way that demonstrates non-linear dynamic behavior. One implementation strategy that may be used to leverage these properties is practice facilitation (PF. PF creates time for learning and reflection by members of the team in each clinic, improves their communication, and promotes an individualized approach to implement a strategy to improve patient outcomes. Specific objectives The specific objectives of this protocol are to: evaluate the effectiveness and sustainability of PF to improve risk factor control in patients with type 2 diabetes across a variety of primary care settings; assess the implementation of the CCM in response to the intervention; examine the relationship between communication within the practice team and the implementation of the CCM; and determine the cost of the intervention both from the perspective of the organization conducting the PF intervention and from the perspective of the primary care practice. Intervention The study will be a group randomized trial conducted in 40 primary care clinics. Data will be collected on all clinics, with 60 patients in each clinic, using a multi-method assessment process at baseline, 12, and 24 months. The intervention, PF, will consist of a series of practice improvement team meetings led by trained facilitators over 12

  11. Seeing the forests and the trees--innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol.

    Science.gov (United States)

    Ivers, Noah; Tricco, Andrea C; Trikalinos, Thomas A; Dahabreh, Issa J; Danko, Kristin J; Moher, David; Straus, Sharon E; Lavis, John N; Yu, Catherine H; Shojania, Kaveh; Manns, Braden; Tonelli, Marcello; Ramsay, Timothy; Edwards, Alun; Sargious, Peter; Paprica, Alison; Hillmer, Michael; Grimshaw, Jeremy M

    2014-08-12

    To improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions. We will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results. This study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision

  12. The Health and Sport Engagement (HASE) Intervention and Evaluation Project: protocol for the design, outcome, process and economic evaluation of a complex community sport intervention to increase levels of physical activity.

    Science.gov (United States)

    Mansfield, Louise; Anokye, Nana; Fox-Rushby, Julia; Kay, Tess

    2015-10-26

    Sport is being promoted to raise population levels of physical activity for health. National sport participation policy focuses on complex community provision tailored to diverse local users. Few quality research studies exist that examine the role of community sport interventions in raising physical activity levels and no research to date has examined the costs and cost-effectiveness of such provision. This study is a protocol for the design, outcome, process and economic evaluation of a complex community sport intervention to increase levels of physical activity, the Health and Sport Engagement (HASE) project part of the national Get Healthy Get Active programme led by Sport England. The HASE study is a collaborative partnership between local community sport deliverers and sport and public health researchers. It involves designing, delivering and evaluating community sport interventions. The aim is to engage previously inactive people in sustained sporting activity for 1×30 min a week and to examine associated health and well-being outcomes. The study uses mixed methods. Outcomes (physical activity, health, well-being costs to individuals) will be measured by a series of self-report questionnaires and attendance data and evaluated using interrupted time series analysis controlling for a range of sociodemographic factors. Resource use will be identified and measured using diaries, interviews and records and presented alongside effectiveness data as incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. A longitudinal process evaluation (focus groups, structured observations, in-depth interview methods) will examine the efficacy of the project for achieving its aim using the principles of thematic analysis. The results of this study will be disseminated through peer-reviewed publications, academic conference presentations, Sport England and national public health organisation policy conferences, and practice-based case studies

  13. The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial.

    Science.gov (United States)

    Geaney, Fiona; Scotto Di Marrazzo, Jessica; Kelly, Clare; Fitzgerald, Anthony P; Harrington, Janas M; Kirby, Ann; McKenzie, Ken; Greiner, Birgit; Perry, Ivan J

    2013-11-06

    Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council's framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic 'nudge' theoretical perspective. It will draw on a soft paternalistic "nudge" theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16

  14. The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial

    Science.gov (United States)

    2013-01-01

    Background Dietary behaviour interventions have the potential to reduce diet-related disease. Ample opportunity exists to implement these interventions in the workplace. The overall aim is to assess the effectiveness and cost-effectiveness of complex dietary interventions focused on environmental dietary modification alone or in combination with nutrition education in large manufacturing workplace settings. Methods/design A clustered controlled trial involving four large multinational manufacturing workplaces in Cork will be conducted. The complex intervention design has been developed using the Medical Research Council’s framework and the National Institute for Health and Clinical Excellence (NICE) guidelines and will be reported using the TREND statement for the transparent reporting of evaluations with non-randomized designs. It will draw on a soft paternalistic “nudge” theoretical perspective. Nutrition education will include three elements: group presentations, individual nutrition consultations and detailed nutrition information. Environmental dietary modification will consist of five elements: (a) restriction of fat, saturated fat, sugar and salt, (b) increase in fibre, fruit and vegetables, (c) price discounts for whole fresh fruit, (d) strategic positioning of healthier alternatives and (e) portion size control. No intervention will be offered in workplace A (control). Workplace B will receive nutrition education. Workplace C will receive nutrition education and environmental dietary modification. Workplace D will receive environmental dietary modification alone. A total of 448 participants aged 18 to 64 years will be selected randomly. All permanent, full-time employees, purchasing at least one main meal in the workplace daily, will be eligible. Changes in dietary behaviours, nutrition knowledge, health status with measurements obtained at baseline and at intervals of 3 to 4 months, 7 to 9 months and 13 to 16 months will be recorded. A process

  15. Interventions developed with the Intervention Mapping protocol in the field of cancer: A systematic review.

    Science.gov (United States)

    Lamort-Bouché, Marion; Sarnin, Philippe; Kok, Gerjo; Rouat, Sabrina; Péron, Julien; Letrilliart, Laurent; Fassier, Jean-Baptiste

    2018-04-01

    The Intervention Mapping (IM) protocol provides a structured framework to develop, implement, and evaluate complex interventions. The main objective of this review was to identify and describe the content of the interventions developed in the field of cancer with the IM protocol. Secondary objectives were to assess their fidelity to the IM protocol and to review their theoretical frameworks. Medline, Web of Science, PsycINFO, PASCAL, FRANCIS, and BDSP databases were searched. All titles and abstracts were reviewed. A standardized extraction form was developed. All included studies were reviewed by 2 reviewers blinded to each other. Sixteen studies were identified, and these reported 15 interventions. The objectives were to increase cancer screening participation (n = 7), early consultation (n = 1), and aftercare/quality of life among cancer survivors (n = 7). Six reported a complete participatory planning group, and 7 described a complete logic model of the problem. Ten studies described a complete logic model of change. The main theoretical frameworks used were the theory of planned behaviour (n = 8), the transtheoretical model (n = 6), the health belief model (n = 6), and the social cognitive theory (n = 6). The environment was rarely integrated in the interventions (n = 4). Five interventions were reported as effective. Culturally relevant interventions were developed with the IM protocol that were effective to increase cancer screening and reduce social disparities, particularly when they were developed through a participative approach and integrated the environment. Stakeholders' involvement and the role of the environment were heterogeneously integrated in the interventions. Copyright © 2017 John Wiley & Sons, Ltd.

  16. A group randomized trial of a complexity-based organizational intervention to improve risk factors for diabetes complications in primary care settings: study protocol

    OpenAIRE

    Noel Polly H; Culler Steven D; Pugh Jacqueline A; Parchman Michael L; Arar Nedal H; Romero Raquel L; Palmer Raymond F

    2008-01-01

    Abstract Background Most patients with type 2 diabetes have suboptimal control of their glucose, blood pressure (BP), and lipids – three risk factors for diabetes complications. Although the chronic care model (CCM) provides a roadmap for improving these outcomes, developing theoretically sound implementation strategies that will work across diverse primary care settings has been challenging. One explanation for this difficulty may be that most strategies do not account for the complex adapti...

  17. Effects of complex interventions in 'skin cancer prevention and treatment': protocol for a mixed-method systematic review with qualitative comparative analysis.

    Science.gov (United States)

    Beifus, Karolina; Breitbart, Eckhard; Köberlein-Neu, Juliane

    2017-09-05

    Occurring from ultraviolet radiation combined with impairing ozone levels, uncritical sun exposure and use of tanning beds an increasing number of people are affected by different types of skin cancer. But preventive interventions like skin cancer screening are still missing the evidence for effectiveness and therefore are criticised. Fundamental for an appropriate course of action is to approach the defined parameters as measures for effectiveness critically. A prerequisite should be the critical application of used parameter that are defined as measures for effectiveness. This research seeks to establish, through the available literature, the effects and conditions that prove the effectiveness of prevention strategies in skin cancer. A mixed-method approach is employed to combine quantitative to qualitative methods and answer what effects can display effectiveness considering time horizon, perspective and organisational level and what are essential and sufficient conditions to prove effectiveness and cost-effectiveness in skin cancer prevention strategies. A systematic review will be performed to spot studies from any design and assess the data quantitatively and qualitatively. Included studies from each key question will be summarised by characteristics like population, intervention, comparison, outcomes, study design, endpoints, effect estimator and so on. Beside statistical relevancies for a systematic review the qualitative method of qualitative comparative analysis (QCA) will be performed. The estimated outcomes from this review and QCA are the accomplishment and absence of effects that are appropriate for application in effectiveness assessments and further cost-effectiveness assessment. Formal ethical approval is not required as primary data will not be collected. International Prospective Register for Systematic Reviews number CRD42017053859. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  18. Protocol for the economic evaluation of a complex intervention to improve the mental health of maltreated infants and children in foster care in the UK (The BeST? services trial).

    Science.gov (United States)

    Deidda, Manuela; Boyd, Kathleen Anne; Minnis, Helen; Donaldson, Julia; Brown, Kevin; Boyer, Nicole R S; McIntosh, Emma

    2018-03-14

    Children who have experienced abuse and neglect are at increased risk of mental and physical health problems throughout life. This places an enormous burden on individuals, families and society in terms of health services, education, social care and judiciary sectors. Evidence suggests that early intervention can mitigate the negative consequences of child maltreatment, exerting long-term positive effects on the health of maltreated children entering foster care. However, evidence on cost-effectiveness of such complex interventions is limited. This protocol describes the first economic evaluation of its kind in the UK. An economic evaluation alongside the Best Services Trial (BeST?) has been prospectively designed to identify, measure and value key resource and outcome impacts arising from the New Orleans intervention model (NIM) (an infant mental health service) compared with case management (CM) (enhanced social work services as usual). A within-trial economic evaluation and long-term model from a National Health Service/Personal Social Service and a broader societal perspective will be undertaken alongside the National Institute for Health Research (NIHR)-Public Health Research Unit (PHRU)-funded randomised multicentre BeST?. BeST? aims to evaluate NIM compared with CM for maltreated children entering foster care in a UK context. Collection of Paediatric Quality of Life Inventory (PedsQL) and the recent mapping of PedsQL to EuroQol-5-Dimensions (EQ-5D) will facilitate the estimation of quality-adjusted life years specific to the infant population for a cost-utility analysis. Other effectiveness outcomes will be incorporated into a cost-effectiveness analysis (CEA) and cost-consequences analysis (CCA). A long-term economic model and multiple economic evaluation frameworks will provide decision-makers with a comprehensive, multiperspective guide regarding cost-effectiveness of NIM. The long-term population health economic model will be developed to synthesise

  19. The Glasgow 'Deep End' Links Worker Study Protocol: a quasi-experimental evaluation of a social prescribing intervention for patients with complex needs in areas of high socioeconomic deprivation.

    Science.gov (United States)

    Mercer, Stewart W; Fitzpatrick, Bridie; Grant, Lesley; Chng, Nai Rui; O'Donnell, Catherine A; Mackenzie, Mhairi; McConnachie, Alex; Bakhshi, Andisheh; Wyke, Sally

    2017-01-01

    'Social prescribing' can be used to link patients with complex needs to local (non-medical) community resources. The 'Deep End' Links Worker Programme is being tested in general practices serving deprived populations in Glasgow, Scotland. To assess the implementation and impact of the intervention at patient and practice levels. Study design : Quasi-experimental outcome evaluation with embedded theory-driven process evaluation in 15 practices randomized to receive the intervention or not. Complex intervention : Comprising a practice development fund, a practice-based community links practitioner (CLP), and management support. It aims to link patients to local community organizations and enhance practices' social prescribing capacity. Study population : For intervention practices, staff and adult patients involved in referral to a CLP, and a sample of community organization staff. For comparison practices, all staff and a random sample of adult patients. Sample size : 286 intervention and 484 comparator patients. Outcomes : Primary patient outcome is health-related quality of life (EQ-5D-5L). Secondary patient outcomes include capacity, depression/anxiety, self-esteem, and healthcare utilization. Practice outcome measures include team climate, job satisfaction, morale, and burnout. Outcomes measured at baseline and 9 months. Processes : Barriers and facilitators to implementation of the programme and possible mechanisms through which outcomes are achieved. Analysis plan : For outcome, intention-to-treat analysis with differences between groups tested using mixed-effects regression models. For process, case-study approach with thematic analysis. This evaluation will provide new evidence about the implementation and impact of social prescribing by general practices serving patients with complex needs living in areas of high deprivation.

  20. Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

    Science.gov (United States)

    Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

    2016-01-21

    International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in

  1. Automated Planning Enables Complex Protocols on Liquid-Handling Robots.

    Science.gov (United States)

    Whitehead, Ellis; Rudolf, Fabian; Kaltenbach, Hans-Michael; Stelling, Jörg

    2018-03-16

    Robotic automation in synthetic biology is especially relevant for liquid handling to facilitate complex experiments. However, research tasks that are not highly standardized are still rarely automated in practice. Two main reasons for this are the substantial investments required to translate molecular biological protocols into robot programs, and the fact that the resulting programs are often too specific to be easily reused and shared. Recent developments of standardized protocols and dedicated programming languages for liquid-handling operations addressed some aspects of ease-of-use and portability of protocols. However, either they focus on simplicity, at the expense of enabling complex protocols, or they entail detailed programming, with corresponding skills and efforts required from the users. To reconcile these trade-offs, we developed Roboliq, a software system that uses artificial intelligence (AI) methods to integrate (i) generic formal, yet intuitive, protocol descriptions, (ii) complete, but usually hidden, programming capabilities, and (iii) user-system interactions to automatically generate executable, optimized robot programs. Roboliq also enables high-level specifications of complex tasks with conditional execution. To demonstrate the system's benefits for experiments that are difficult to perform manually because of their complexity, duration, or time-critical nature, we present three proof-of-principle applications for the reproducible, quantitative characterization of GFP variants.

  2. Randomised controlled trial of a complex intervention by primary care nurses to increase walking in patients aged 60–74 years: protocol of the PACE-Lift (Pedometer Accelerometer Consultation Evaluation - Lift trial

    Directory of Open Access Journals (Sweden)

    Harris Tess

    2013-01-01

    Full Text Available Abstract Background Physical activity is essential for older peoples’ physical and mental health and for maintaining independence. Guidelines recommend at least 150 minutes weekly, of at least moderate intensity physical activity, with activity on most days. Older people’s most common physical activity is walking, light intensity if strolling, moderate if brisker. Less than 20% of United Kingdom 65–74 year olds report achieving the guidelines, despite most being able to. Effective behaviour change techniques include strategies such as goal setting, self-monitoring, building self-efficacy and relapse prevention. Primary care physical activity consultations allow individual tailoring of advice. Pedometers measure step-counts and accelerometers measure physical activity intensity. This protocol describes an innovative intervention to increase walking in older people, incorporating pedometer and accelerometer feedback within a primary care nurse physical activity consultation, using behaviour change techniques. Methods/Design Design: Randomised controlled trial with intervention and control (usual care arms plus process and qualitative evaluations. Participants: 300 people aged 60–74 years registered with 3 general practices within Oxfordshire and Berkshire West primary care trusts, able to walk outside and with no restrictions to increasing their physical activity. Intervention: 3 month pedometer and accelerometer based intervention supported by practice nurse physical activity consultations. Four consultations based on behaviour change techniques, physical activity diary, pedometer average daily steps and accelerometer feedback on physical activity intensity. Individual physical activity plans based on increasing walking and other existing physical activity will be produced. Outcomes: Change in average daily steps (primary outcome and average time spent in at least moderate intensity physical activity weekly (secondary outcome at 3 months

  3. Variation in radiographic protocols in paediatric interventional cardiology

    International Nuclear Information System (INIS)

    McFadden, S L; Hughes, C M; Winder, R J

    2013-01-01

    The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose. (paper)

  4. Variation in radiographic protocols in paediatric interventional cardiology.

    Science.gov (United States)

    McFadden, S L; Hughes, C M; Winder, R J

    2013-06-01

    The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose.

  5. Using the intervention mapping protocol to develop a maintenance programme for the SLIMMER diabetes prevention intervention.

    Science.gov (United States)

    Elsman, Ellen B M; Leerlooijer, Joanne N; Ter Beek, Josien; Duijzer, Geerke; Jansen, Sophia C; Hiddink, Gerrit J; Feskens, Edith J M; Haveman-Nies, Annemien

    2014-10-27

    Although lifestyle interventions have shown to be effective in reducing the risk for type 2 diabetes mellitus, maintenance of achieved results is difficult, as participants often experience relapse after the intervention has ended. This paper describes the systematic development of a maintenance programme for the extensive SLIMMER intervention, an existing diabetes prevention intervention for high-risk individuals, implemented in a real-life setting in the Netherlands. The maintenance programme was developed using the Intervention Mapping protocol. Programme development was informed by a literature study supplemented by various focus group discussions and feedback from implementers of the extensive SLIMMER intervention. The maintenance programme was designed to sustain a healthy diet and physical activity pattern by targeting knowledge, attitudes, subjective norms and perceived behavioural control of the SLIMMER participants. Practical applications were clustered into nine programme components, including sports clinics at local sports clubs, a concluding meeting with the physiotherapist and dietician, and a return session with the physiotherapist, dietician and physical activity group. Manuals were developed for the implementers and included a detailed time table and step-by-step instructions on how to implement the maintenance programme. The Intervention Mapping protocol provided a useful framework to systematically plan a maintenance programme for the extensive SLIMMER intervention. The study showed that planning a maintenance programme can build on existing implementation structures of the extensive programme. Future research is needed to determine to what extent the maintenance programme contributes to sustained effects in participants of lifestyle interventions.

  6. Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Waiswa, Peter; O'Connell, Thomas; Bagenda, Danstan; Mullachery, Pricila; Mpanga, Flavia; Henriksson, Dorcus Kiwanuka; Katahoire, Anne Ruhweza; Ssegujja, Eric; Mbonye, Anthony K; Peterson, Stefan Swartling

    2016-03-11

    Innovative and sustainable strategies to strengthen districts and other sub-national health systems and management are urgently required to reduce child mortality. Although highly effective evidence-based and affordable child survival interventions are well-known, at the district level, lack of data, motivation, analytic and planning capacity often impedes prioritization and management weaknesses impede implementation. The Community and District Empowerment for Scale-up (CODES) project is a complex management intervention designed to test whether districts when empowered with data and management tools can prioritize and implement evidence-based child survival interventions equitably. The CODES strategy combines management, diagnostic, and evaluation tools to identify and analyze the causes of bottlenecks to implementation, build capacity of district management teams to implement context-specific solutions, and to foster community monitoring and social accountability to increase demand for services. CODES combines UNICEF tools designed to systematize priority setting, allocation of resources and problem solving with Community dialogues based on Citizen Report Cards and U-Reports used to engage and empower communities in monitoring health service provision and to demand for quality services. Implementation and all data collection will be by the districts teams or local Community-based Organizations who will be supported by two local implementing partners. The study will be evaluated as a cluster randomized trial with eight intervention and eight comparison districts over a period of 3 years. Evaluation will focus on differences in uptake of child survival interventions and will follow an intention-to-treat analysis. We will also document and analyze experiences in implementation including changes in management practices. By increasing the District Health Management Teams' capacity to prioritize and implement context-specific solutions, and empowering communities to

  7. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study

    Directory of Open Access Journals (Sweden)

    F. Lauzier

    2017-07-01

    Full Text Available Abstract Background The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Discussion Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75–80 mmHg versus lower (60–65 mmHg mean arterial pressure (MAP targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. Conclusions In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated

  8. Protocol adherence for continuously titrated interventions in randomized trials: an overview of the current methodology and case study.

    Science.gov (United States)

    Lauzier, F; Adhikari, N K; Seely, A; Koo, K K Y; Belley-Côté, E P; Burns, K E A; Cook, D J; D'Aragon, F; Rochwerg, B; Kho, M E; Oczkowksi, S J W; Duan, E H; Meade, M O; Day, A G; Lamontagne, F

    2017-07-17

    The standard definition for protocol adherence is the proportion of all scheduled doses that are delivered. In clinical research, this definition has several limitations when evaluating protocol adherence in trials that study interventions requiring continuous titration. Building upon a specific case study, we analyzed a recent trial of a continuously titrated intervention to assess the impact of different definitions of protocol deviations on the interpretation of protocol adherence. The OVATION pilot trial was an open-label randomized controlled trial of higher (75-80 mmHg) versus lower (60-65 mmHg) mean arterial pressure (MAP) targets for vasopressor therapy in shock. In this trial, potential protocol deviations were defined as MAP values outside the targeted range for >4 consecutive hours during vasopressor therapy without synchronous and consistent adjustments of vasopressor doses. An adjudication committee reviewed each potential deviation to determine if it was clinically-justified or not. There are four reasons for this contextual measurement and reporting of protocol adherence. First, between-arm separation is a robust measure of adherence to complex protocols. Second, adherence assessed by protocol deviations varies in function of the definition of deviations and the frequency of measurements. Third, distinguishing clinically-justified vs. not clinically-justified protocol deviations acknowledges clinically sensible bedside decision-making and offers a clear terminology before the trial begins. Finally, multiple metrics exist to report protocol deviations, which provides different information but complementary information on protocol adherence. In trials of interventions requiring continuous titration, metrics used for defining protocol deviations have a considerable impact on the interpretation of protocol adherence. Definitions for protocol deviations should be prespecified and correlated with between-arm separation, if it can be measured.

  9. Anesthetic management of minimally invasive intervention in children's oncohematology: preoperative patient management protocol

    Directory of Open Access Journals (Sweden)

    V. V. Shchukin

    2013-01-01

    Full Text Available Preoperative patient management protocol in the complex anesthetic support of minimally invasive interventions in pediatric oncology is described. Choice of general anesthesia method was determined by the specific clinical situation by analyzing all of the following factors: airway management, necessity and anticipated duration of unconsciousness, the need for analgesia, necessity and duration of immobilization, prevention of hypothermia, the presence and severity of disturbances in the hemostatic system, comfort for the child and his representatives (parents. Basic techniques of child preoperative examination, as well as the methodology for predicting the risk of perioperative adverse events are described.

  10. Anesthetic management of minimally invasive intervention in children's oncohematology: preoperative patient management protocol

    Directory of Open Access Journals (Sweden)

    V. V. Shchukin

    2014-07-01

    Full Text Available Preoperative patient management protocol in the complex anesthetic support of minimally invasive interventions in pediatric oncology is described. Choice of general anesthesia method was determined by the specific clinical situation by analyzing all of the following factors: airway management, necessity and anticipated duration of unconsciousness, the need for analgesia, necessity and duration of immobilization, prevention of hypothermia, the presence and severity of disturbances in the hemostatic system, comfort for the child and his representatives (parents. Basic techniques of child preoperative examination, as well as the methodology for predicting the risk of perioperative adverse events are described.

  11. Partner randomized controlled trial: study protocol and coaching intervention

    Directory of Open Access Journals (Sweden)

    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  12. 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.

  13. Using mixed methods to develop and evaluate complex interventions in palliative care research.

    Science.gov (United States)

    Farquhar, Morag C; Ewing, Gail; Booth, Sara

    2011-12-01

    there is increasing interest in combining qualitative and quantitative research methods to provide comprehensiveness and greater knowledge yield. Mixed methods are valuable in the development and evaluation of complex interventions. They are therefore particularly valuable in palliative care research where the majority of interventions are complex, and the identification of outcomes particularly challenging. this paper aims to introduce the role of mixed methods in the development and evaluation of complex interventions in palliative care, and how they may be used in palliative care research. the paper defines mixed methods and outlines why and how mixed methods are used to develop and evaluate complex interventions, with a pragmatic focus on design and data collection issues and data analysis. Useful texts are signposted and illustrative examples provided of mixed method studies in palliative care, including a detailed worked example of the development and evaluation of a complex intervention in palliative care for breathlessness. Key challenges to conducting mixed methods in palliative care research are identified in relation to data collection, data integration in analysis, costs and dissemination and how these might be addressed. the development and evaluation of complex interventions in palliative care benefit from the application of mixed methods. Mixed methods enable better understanding of whether and how an intervention works (or does not work) and inform the design of subsequent studies. However, they can be challenging: mixed method studies in palliative care will benefit from working with agreed protocols, multidisciplinary teams and engaging staff with appropriate skill sets.

  14. [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.

  15. Understanding implementation and change in complex interventions

    DEFF Research Database (Denmark)

    Agergaard, Sine; Dankers, Silke; Munk, Mette

    2018-01-01

    and experiences of social inclusion in the PE context using a multi-method approach integrating quantitative and qualitative approaches. The multi-method approach allowed an integration of the findings with regard to the implementation as well as the effect of the intervention. First of all, standardized...... questionnaires provided a manipulation check of the delivery of the intervention, while qualitative observations and interviews identified the diversity in pupils’ reactions thereto. Secondly, quantitative findings on the effect of the intervention were related to qualitative findings pointing to ambiguities...

  16. Process evaluation of complex interventions: Medical Research Council guidance

    OpenAIRE

    Moore, G.F.; Audrey, S.; Barker, M.; Bond, L.; Bonell, C.; Hardeman, W.; Moore, L.; O'Cathain, A.; Tinati, T.; Wight, D.; Baird, J.

    2015-01-01

    Attempts to tackle problems such as smoking and obesity increasingly use complex interventions. These are commonly defined as interventions that comprise multiple interacting components, although additional dimensions of complexity include the difficulty of their implementation and the number of organisational levels they target.1 Randomised controlled trials are regarded as the gold standard for establishing the effectiveness of interventions, when randomisation is feasible. However, effect ...

  17. Process evaluation for complex interventions in health services research: analysing context, text trajectories and disruptions.

    Science.gov (United States)

    Murdoch, Jamie

    2016-08-19

    Process evaluations assess the implementation and sustainability of complex healthcare interventions within clinical trials, with well-established theoretical models available for evaluating intervention delivery within specific contexts. However, there is a need to translate conceptualisations of context into analytical tools which enable the dynamic relationship between context and intervention implementation to be captured and understood. In this paper I propose an alternative approach to the design, implementation and analysis of process evaluations for complex health interventions through a consideration of trial protocols as textual documents, distributed and enacted at multiple contextual levels. As an example, I conduct retrospective analysis of a sample of field notes and transcripts collected during the ESTEEM study - a cluster randomised controlled trial of primary care telephone triage. I draw on theoretical perspectives associated with Linguistic Ethnography to examine the delivery of ESTEEM through staff orientation to different texts. In doing so I consider what can be learned from examining the flow and enactment of protocols for notions of implementation and theoretical fidelity (i.e. intervention delivered as intended and whether congruent with the intervention theory). Implementation of the triage intervention required staff to integrate essential elements of the protocol within everyday practice, seen through the adoption and use of different texts that were distributed across staff and within specific events. Staff were observed deploying texts in diverse ways (e.g. reinterpreting scripts, deviating from standard operating procedures, difficulty completing decision support software), providing numerous instances of disruption to maintaining intervention fidelity. Such observations exposed tensions between different contextual features in which the trial was implemented, offering theoretical explanations for the main trial findings. The value of

  18. Interventions for paracetamol (acetaminophen) overdoses. Protocol for a Cochrane Review

    DEFF Research Database (Denmark)

    Brok, J; Buckley, N; Gluud, C

    2001-01-01

    Poisoning with paracetamol (acetaminophen) is a common cause of hepatotoxicity in the Western World. Inhibition of absorption, removal from the vascular system, antidotes, and liver transplantation are interventions for paracetamol poisoning.......Poisoning with paracetamol (acetaminophen) is a common cause of hepatotoxicity in the Western World. Inhibition of absorption, removal from the vascular system, antidotes, and liver transplantation are interventions for paracetamol poisoning....

  19. Sheltered Instruction Observation Protocol (SIOP). WWC Intervention Report

    Science.gov (United States)

    What Works Clearinghouse, 2009

    2009-01-01

    The Sheltered Instruction Observation Protocol (SIOP) is a framework for planning and delivering instruction in content areas such as science, history, and mathematics to limited-English proficient students. The goal of SIOP is to help teachers integrate academic language development into their lessons, allowing students to learn and practice…

  20. Complex intravenous anesthesia in interventional procedures

    International Nuclear Information System (INIS)

    Xie Zonggui; Hu Yuanming; Huang Yunlong; You Yong; Wu Juan; Huang Zengping; Li Jian

    2006-01-01

    Objective: To evaluate the value and safety of Diprivan and Fentany intravenous administration of analgesia in interventional procedures. Methods: Diprivan with Fentany intravenous administration for analgesia was used in eighty interventional procedures of sixty-five patients, without tracheal tube insertion. Vital signs including HR, BP, arterial oxygen saturation (SpO 2 ) and patients' reaction to operating were recorded. Results: Intravenous anesthesia was cared out successfully in eighty interventional procedures, with patients under sleeping condition during the operation, together with no pain and no agony memory of the procedure. The amount of Diprivan was 500±100 mg and Fentany was 0.2±0.025 mg. Mean arterial pressure and SpO 2 were 11.4±2.2 kPa, 10.6±2.1 kPa and 98±1.0, 96±1.5 respectively before and after ten minutes of the operation, with no significant difference. Conclusions: Diprivan with Fentany intravenous administration for interventional procedure analgesia possess good safety, painless and no agony memory of the procedure; therefor ought to be recommended. (authors)

  1. Successful implementation of a perioperative glycemic control protocol in cardiac surgery: barrier analysis and intervention using lean six sigma.

    Science.gov (United States)

    Martinez, Elizabeth A; Chavez-Valdez, Raul; Holt, Natalie F; Grogan, Kelly L; Khalifeh, Katherine W; Slater, Tammy; Winner, Laura E; Moyer, Jennifer; Lehmann, Christoph U

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

  2. Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

    Science.gov (United States)

    Martinez, Elizabeth A.; Chavez-Valdez, Raul; Holt, Natalie F.; Grogan, Kelly L.; Khalifeh, Katherine W.; Slater, Tammy; Winner, Laura E.; Moyer, Jennifer; Lehmann, Christoph U.

    2011-01-01

    Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU) in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period. PMID:22091218

  3. Successful Implementation of a Perioperative Glycemic Control Protocol in Cardiac Surgery: Barrier Analysis and Intervention Using Lean Six Sigma

    Directory of Open Access Journals (Sweden)

    Elizabeth A. Martinez

    2011-01-01

    Full Text Available Although the evidence strongly supports perioperative glycemic control among cardiac surgical patients, there is scant literature to describe the practical application of such a protocol in the complex ICU environment. This paper describes the use of the Lean Six Sigma methodology to implement a perioperative insulin protocol in a cardiac surgical intensive care unit (CSICU in a large academic hospital. A preintervention chart audit revealed that fewer than 10% of patients were admitted to the CSICU with glucose <200 mg/dL, prompting the initiation of the quality improvement project. Following protocol implementation, more than 90% of patients were admitted with a glucose <200 mg/dL. Key elements to success include barrier analysis and intervention, provider education, and broadening the project scope to address the intraoperative period.

  4. Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

    Science.gov (United States)

    Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

    2016-06-01

    To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  6. Study protocol: can a school gardening intervention improve children's diets?

    Science.gov (United States)

    Christian, Meaghan S; El Evans, Charlotte; Conner, Mark; Ransley, Joan K; Cade, Janet E

    2012-04-26

    The current academic literature suggests there is a potential for using gardening as a tool to improve children's fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT) devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS) Campaign for School Gardening, to determine if it has an effect on children's fruit and vegetable intake. Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as "Partner Schools" and the other to receive the less intensive intervention as "Associate Schools". Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention "Associate Schools" or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET) to collect data on dietary intake and a questionnaire exploring children's knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school's gardening activities. The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children's fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children's diets and school based interventions. ISRCTN11396528.

  7. Interventional management of low-flow priapism: A protocol proposal

    Directory of Open Access Journals (Sweden)

    Herney Andrés García-Perdomo

    2018-01-01

    Full Text Available Priapism is an involuntary prolonged erection that lasts for more than 4 h. Although several interventions have been proposed to manage the condition, these strategies are based on expert panel opinions, and little evidence exists regarding prognosis and outcomes. To synthetize information about interventions to treat priapism and to make evidence-based recommendations, we performed a literature search of Medline via Ovid, Scopus (including Embase and Lilacs from 1980 to the current day with the following keywords: ischemic priapism, erectile function, drainage, and shunt. The length of the ischemic priapism is an important variable for the prognosis because of the pathophysiology of this condition. Here, we propose a step-by-step approach based on the time and invasiveness of the intervention. However, it is important to note that we could not find any clinical trial that supports this approach, and more research is needed for the future statements.

  8. Application of Intervention Mapping to the Development of a Complex Physical Therapist Intervention.

    Science.gov (United States)

    Jones, Taryn M; Dear, Blake F; Hush, Julia M; Titov, Nickolai; Dean, Catherine M

    2016-12-01

    Physical therapist interventions, such as those designed to change physical activity behavior, are often complex and multifaceted. In order to facilitate rigorous evaluation and implementation of these complex interventions into clinical practice, the development process must be comprehensive, systematic, and transparent, with a sound theoretical basis. Intervention Mapping is designed to guide an iterative and problem-focused approach to the development of complex interventions. The purpose of this case report is to demonstrate the application of an Intervention Mapping approach to the development of a complex physical therapist intervention, a remote self-management program aimed at increasing physical activity after acquired brain injury. Intervention Mapping consists of 6 steps to guide the development of complex interventions: (1) needs assessment; (2) identification of outcomes, performance objectives, and change objectives; (3) selection of theory-based intervention methods and practical applications; (4) organization of methods and applications into an intervention program; (5) creation of an implementation plan; and (6) generation of an evaluation plan. The rationale and detailed description of this process are presented using an example of the development of a novel and complex physical therapist intervention, myMoves-a program designed to help individuals with an acquired brain injury to change their physical activity behavior. The Intervention Mapping framework may be useful in the development of complex physical therapist interventions, ensuring the development is comprehensive, systematic, and thorough, with a sound theoretical basis. This process facilitates translation into clinical practice and allows for greater confidence and transparency when the program efficacy is investigated. © 2016 American Physical Therapy Association.

  9. The pro children intervention: applying the intervention mapping protocol to develop a school-based fruit and vegetable promotion programme.

    Science.gov (United States)

    Pérez-Rodrigo, Carmen; Wind, Marianne; Hildonen, Christina; Bjelland, Mona; Aranceta, Javier; Klepp, Knut-Inge; Brug, Johannes

    2005-01-01

    The importance of careful theory-based intervention planning is recognized for fruit and vegetable promotion. This paper describes the application of the Intervention Mapping (IM) protocol to develop the Pro Children intervention to promote consumption of fruit and vegetable among 10- to 13-year-old schoolchildren. Based on a needs assessment, promotion of intake of fruit and vegetable was split into performance objectives and related personal, social and environmental determinants. Crossing the performance objectives with related important and changeable determinants resulted in a matrix of learning and change objectives for which appropriate educational strategies were identified. Theoretically similar but culturally relevant interventions were designed, implemented and evaluated in Norway, the Netherlands and Spain during 2 school years. Programme activities included provision of fruits and vegetables in the schools, guided classroom activities, computer-tailored feedback and advice for children, and activities to be completed at home with the family. Additionally, optional intervention components for community reinforcement included incorporation of mass media, school health services or grocery stores. School project committees were supported. The Pro Children intervention was carefully developed based on the IM protocol that resulted in a comprehensive school-based fruit and vegetable promotion programme, but culturally sensible and locally relevant. (c) 2005 S. Karger AG, Basel

  10. Ethnographic methods for process evaluations of complex health behaviour interventions.

    Science.gov (United States)

    Morgan-Trimmer, Sarah; Wood, Fiona

    2016-05-04

    This article outlines the contribution that ethnography could make to process evaluations for trials of complex health-behaviour interventions. Process evaluations are increasingly used to examine how health-behaviour interventions operate to produce outcomes and often employ qualitative methods to do this. Ethnography shares commonalities with the qualitative methods currently used in health-behaviour evaluations but has a distinctive approach over and above these methods. It is an overlooked methodology in trials of complex health-behaviour interventions that has much to contribute to the understanding of how interventions work. These benefits are discussed here with respect to three strengths of ethnographic methodology: (1) producing valid data, (2) understanding data within social contexts, and (3) building theory productively. The limitations of ethnography within the context of process evaluations are also discussed.

  11. Developing and Modeling Complex Social Interventions: Introducing the Connecting People Intervention

    Science.gov (United States)

    Webber, Martin; Reidy, Hannah; Ansari, David; Stevens, Martin; Morris, David

    2016-01-01

    Objectives: Modeling the processes involved in complex social interventions is important in social work practice, as it facilitates their implementation and translation into different contexts. This article reports the process of developing and modeling the connecting people intervention (CPI), a model of practice that supports people with mental…

  12. Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation.

    Science.gov (United States)

    Östbring, Malin Johansson; Eriksson, Tommy; Petersson, Göran; Hellström, Lina

    2018-01-30

    MIMeRiC RCT are known. This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions. ©Malin Johansson Östbring, Tommy Eriksson, Göran Petersson, Lina Hellström. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 30.01.2018.

  13. The Dutch 'Focus on Strength' intervention study protocol: programme design and production, implementation and evaluation plan.

    Science.gov (United States)

    Ten Hoor, G A; Kok, G; Rutten, G M; Ruiter, R A C; Kremers, S P J; Schols, A M J W; Plasqui, G

    2016-06-10

    Overweight youngsters are better in absolute strength exercises than their normal-weight counterparts; a physiological phenomenon with promising psychological impact. In this paper we describe the study protocol of the Dutch, school-based program 'Focus on Strength' that aims to improve body composition of 11-13 year old students, and with that to ultimately improve their quality of life. The development of this intervention is based on the Intervention Mapping (IM) protocol, which starts from a needs assessment, uses theory and empirical research to develop a detailed intervention plan, and anticipates program implementation and evaluation. This novel intervention targets first year students in preparatory secondary vocational education (11-13 years of age). Teachers are the program implementers. One part of the intervention involves a 30 % increase of strength exercises in the physical education lessons. The other part is based on Motivational Interviewing, promoting autonomous motivation of students to become more physically active outside school. Performance and change objectives are described for both teachers and students. The effectiveness of the intervention will be tested in a Randomized Controlled Trial in 9 Dutch high schools. Intervention Mapping is a useful framework for program planning a school-based program to improve body composition and motivation to exercise in 11-13 year old adolescents by a "Focus on Strength". NTR5676 , registered 8 February 2016 (retrospectively registered).

  14. Integrating technology into complex intervention trial processes: a case study.

    Science.gov (United States)

    Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

    2016-11-17

    Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

  15. Body Composition Changes after Weight-Loss Interventions among Obese Females: A Comparison of Three Protocols

    Directory of Open Access Journals (Sweden)

    Nayera E. Hassan

    2014-12-01

    Full Text Available AIM: To evaluate body composition changes after use of three different types of obesity management protocols: dietary measures and physical activity; acupuncture or laser acupuncture with healthy diet; aiming at achieving stable weight loss among obese Egyptian females. METHODS:  A randomized longitudinal prospective study included 76 obese adult females; aged 26 up to 55 years. Anthropometric, body composition, ultrasonographic and biochemical assessments were done. RESULTS: The three types of obesity management protocols showed significant improvement in body composition (decrease in fat% and increases in FFM and TBW and visceral fat by US. However, nutritional intervention showed highly significant improvement in the skin fold thickness at triceps and biceps sites and peripheral adiposity index.  Acupuncture intervention showed highly significant improvement in fasting blood glucose (decreased and lipid profile (decreased triglycerides, total cholesterol and LDL, and increased HDL. Laser intervention showed highly significant improvement in all the skin fold thickness and some parameters of lipid profile (decreased total cholesterol and LDL. CONCLUSIONS: The three obesity management protocols have significant effect on body composition, but acupuncture has the best effect in improving the lipid profile and fasting blood sugar. In addition, Laser intervention was recommended to improve skin fold thickness and subcutaneous fat.

  16. Protocol to Manage Heritage-Building Interventions Using Heritage Building Information Modelling (HBIM

    Directory of Open Access Journals (Sweden)

    Isabel Jordan-Palomar

    2018-03-01

    Full Text Available The workflow in historic architecture projects presents problems related to the lack of clarity of processes, dispersion of information and the use of outdated tools. Different heritage organisations have showed interest in innovative methods to resolve those problems and improve cultural tourism for sustainable economic development. Building Information Modelling (BIM has emerged as a suitable computerised system for improving heritage management. Its application to historic buildings is named Historic BIM (HBIM. HBIM literature highlights the need for further research in terms of the overall processes of heritage projects, its practical implementation and a need for better cultural documentation. This work uses Design Science Research to develop a protocol to improve the workflow in heritage interdisciplinary projects. Research techniques used include documentary analysis, semi-structured interviews and focus groups. HBIM is proposed as a virtual model that will hold heritage data and will articulate processes. As a result, a simple and visual HBIM protocol was developed and applied in a real case study. The protocol was named BIMlegacy and it is divided into eight phases: building registration, determine intervention options, develop design for intervention, planning the physical intervention, physical intervention, handover, maintenance and culture dissemination. It contemplates all the stakeholders involved.

  17. Problematisations of Complexity: On the Notion and Production of Diverse Complexities in Healthcare Interventions and Evaluations

    NARCIS (Netherlands)

    T. Broer (Tineke); R.A. Bal (Roland); Pickersgill, M. (Martyn)

    2017-01-01

    textabstractWithin the literature on the evaluation of health (policy) interventions, complexity is a much-debated issue. In particular, many claim that so-called ‘complex interventions’ pose different challenges to evaluation studies than apparently ‘simple interventions’ do. Distinct ways of doing

  18. Evaluation of complex community-based childhood obesity prevention interventions.

    Science.gov (United States)

    Karacabeyli, D; Allender, S; Pinkney, S; Amed, S

    2018-05-16

    Multi-setting, multi-component community-based interventions have shown promise in preventing childhood obesity; however, evaluation of these complex interventions remains a challenge. The objective of the study is to systematically review published methodological approaches to outcome evaluation for multi-setting community-based childhood obesity prevention interventions and synthesize a set of pragmatic recommendations. MEDLINE, CINAHL and PsycINFO were searched from inception to 6 July 2017. Papers were included if the intervention targeted children ≤18 years, engaged at least two community sectors and described their outcome evaluation methodology. A single reviewer conducted title and abstract scans, full article review and data abstraction. Directed content analysis was performed by three reviewers to identify prevailing themes. Thirty-three studies were included, and of these, 26 employed a quasi-experimental design; the remaining were randomized control trials. Body mass index was the most commonly measured outcome, followed by health behaviour change and psychosocial outcomes. Six themes emerged, highlighting advantages and disadvantages of active vs. passive consent, quasi-experimental vs. randomized control trials, longitudinal vs. repeat cross-sectional designs and the roles of process evaluation and methodological flexibility in evaluating complex interventions. Selection of study designs and outcome measures compatible with community infrastructure, accompanied by process evaluation, may facilitate successful outcome evaluation. © 2018 World Obesity Federation.

  19. Intervention mapping protocol for developing a theory-based diabetes self-management education program.

    Science.gov (United States)

    Song, Misoon; Choi, Suyoung; Kim, Se-An; Seo, Kyoungsan; Lee, Soo Jin

    2015-01-01

    Development of behavior theory-based health promotion programs is encouraged with the paradigm shift from contents to behavior outcomes. This article describes the development process of the diabetes self-management program for older Koreans (DSME-OK) using intervention mapping (IM) protocol. The IM protocol includes needs assessment, defining goals and objectives, identifying theory and determinants, developing a matrix to form change objectives, selecting strategies and methods, structuring the program, and planning for evaluation and pilot testing. The DSME-OK adopted seven behavior objectives developed by the American Association of Diabetes Educators as behavioral outcomes. The program applied an information-motivation-behavioral skills model, and interventions were targeted to 3 determinants to change health behaviors. Specific methods were selected to achieve each objective guided by IM protocol. As the final step, program evaluation was planned including a pilot test. The DSME-OK was structured as the 3 determinants of the IMB model were intervened to achieve behavior objectives in each session. The program has 12 weekly 90-min sessions tailored for older adults. Using the IM protocol in developing a theory-based self-management program was beneficial in terms of providing a systematic guide to developing theory-based and behavior outcome-focused health education programs.

  20. 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...

  1. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach.

    Science.gov (United States)

    Brendryen, Håvar; Johansen, Ayna; Nesvåg, Sverre; Kok, Gerjo; Duckert, Fanny

    2013-01-23

    Due to limited reporting of intervention rationale, little is known about what distinguishes a good intervention from a poor one. To support improved design, there is a need for comprehensive reports on novel and complex theory-based interventions. Specifically, the emerging trend of just-in-time tailoring of content in response to change in target behavior or emotional state is promising. The objective of this study was to give a systematic and comprehensive description of the treatment rationale of an online alcohol intervention called Balance. We used the intervention mapping protocol to describe the treatment rationale of Balance. The intervention targets at-risk drinking, and it is delivered by email, mobile phone text messaging, and tailored interactive webpages combining text, pictures, and prerecorded audio. The rationale of the current treatment was derived from a self-regulation perspective, and the overarching idea was to support continued self-regulation throughout the behavior change process. Maintaining the change efforts over time and coping adaptively during critical moments (eg, immediately before and after a lapse) are key factors to successful behavior change. Important elements of the treatment rationale to achieving these elements were: (1) emotion regulation as an inoculation strategy against self-regulation failure, (2) avoiding lapses by adaptive coping, and (3) avoiding relapse by resuming the change efforts after a lapse. Two distinct and complementary delivery strategies were used, including a day-to-day tunnel approach in combination with just-in-time therapy. The tunnel strategy was in accordance with the need for continuous self-regulation and it functions as a platform from which just-in-time therapy was launched. Just-in-time therapy was used to support coping during critical moments, and started when the client reports either low self-efficacy or that they were drinking above target levels. The descriptions of the treatment

  2. 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.

  3. Intervention Fidelity for a Complex Behaviour Change Intervention in Community Pharmacy Addressing Cardiovascular Disease Risk

    Science.gov (United States)

    McNamara, K. P.; O'Reilly, S. L.; George, J.; Peterson, G. M.; Jackson, S. L.; Duncan, G.; Howarth, H.; Dunbar, J. A.

    2015-01-01

    Background: Delivery of cardiovascular disease (CVD) prevention programs by community pharmacists appears effective and enhances health service access. However, their capacity to implement complex behavioural change processes during patient counselling remains largely unexplored. This study aims to determine intervention fidelity by pharmacists…

  4. Using the Intervention Mapping Protocol to develop an online video intervention for parents to prevent childhood obesity: Movie Models.

    Science.gov (United States)

    De Lepeleere, Sara; Verloigne, Maïté; Brown, Helen Elizabeth; Cardon, Greet; De Bourdeaudhuij, Ilse

    2016-08-08

    The increasing prevalence of childhood overweight/obesity caused by an unhealthy diet, insufficient physical activity (PA) and high levels of sedentary behaviour (SB) is a prominent public health concern. Parenting practices may contribute to healthy behaviour change in children, but well-researched examples are limited. The aim of this study is to describe the systematic development of an intervention for parents to prevent childhood overweight/obesity through the improvement of parenting practices. The six steps of the Intervention Mapping Protocol (IMP), a theory- and evidence-based tool to develop health-related interventions, were used as a framework to develop the 'Movie Models' programme. In Step 1, a needs assessment was performed to better understand the health problem of overweight/obesity in children and its association with diet, PA and SB. In Step 2, the programme goal (increasing the adoption of effective parenting practices) was sub-divided into performance objectives. Change objectives, which specify explicit actions required to accomplish the performance objectives, were also identified. Step 3 included the selection of theoretical methods (e.g. 'modelling' and 'images'), which were then translated into the practical strategy of online parenting videos. Step 4 comprised the development of a final intervention framework, and Step 5 included the planning of programme adoption and implementation. The final phase, Step 6, included the development of an effect- and process-evaluation plan. The IMP was used to structure the development of 'Movie Models', an intervention targeting specific parenting practices related to children's healthy diet, PA, SB, and parental self-efficacy. A clear framework for process analyses is offered, which aims to increase the potential effectiveness of an intervention and can be useful for those developing health promotion programmes. © The Author(s) 2016.

  5. Application of the Intervention Mapping protocol to develop Keys, a family child care home intervention to prevent early childhood obesity.

    Science.gov (United States)

    Mann, Courtney M; Ward, Dianne S; Vaughn, Amber; Benjamin Neelon, Sara E; Long Vidal, Lenita J; Omar, Sakinah; Namenek Brouwer, Rebecca J; Østbye, Truls

    2015-12-10

    Many families rely on child care outside the home, making these settings important influences on child development. Nearly 1.5 million children in the U.S. spend time in family child care homes (FCCHs), where providers care for children in their own residences. There is some evidence that children in FCCHs are heavier than those cared for in centers. However, few interventions have targeted FCCHs for obesity prevention. This paper will describe the application of the Intervention Mapping (IM) framework to the development of a childhood obesity prevention intervention for FCCHs Following the IM protocol, six steps were completed in the planning and development of an intervention targeting FCCHs: needs assessment, formulation of change objectives matrices, selection of theory-based methods and strategies, creation of intervention components and materials, adoption and implementation planning, and evaluation planning Application of the IM process resulted in the creation of the Keys to Healthy Family Child Care Homes program (Keys), which includes three modules: Healthy You, Healthy Home, and Healthy Business. Delivery of each module includes a workshop, educational binder and tool-kit resources, and four coaching contacts. Social Cognitive Theory and Self-Determination Theory helped guide development of change objective matrices, selection of behavior change strategies, and identification of outcome measures. The Keys program is currently being evaluated through a cluster-randomized controlled trial The IM process, while time-consuming, enabled rigorous and systematic development of intervention components that are directly tied to behavior change theory and may increase the potential for behavior change within the FCCHs.

  6. Scaling up complex interventions: insights from a realist synthesis.

    Science.gov (United States)

    Willis, Cameron D; Riley, Barbara L; Stockton, Lisa; Abramowicz, Aneta; Zummach, Dana; Wong, Geoff; Robinson, Kerry L; Best, Allan

    2016-12-19

    Preventing chronic diseases, such as cancer, cardiovascular disease and diabetes, requires complex interventions, involving multi-component and multi-level efforts that are tailored to the contexts in which they are delivered. Despite an increasing number of complex interventions in public health, many fail to be 'scaled up'. This study aimed to increase understanding of how and under what conditions complex public health interventions may be scaled up to benefit more people and populations.A realist synthesis was conducted and discussed at an in-person workshop involving practitioners responsible for scaling up activities. Realist approaches view causality through the linkages between changes in contexts (C) that activate mechanisms (M), leading to specific outcomes (O) (CMO configurations). To focus this review, three cases of complex interventions that had been successfully scaled up were included: Vibrant Communities, Youth Build USA and Pathways to Education. A search strategy of published and grey literature related to each case was developed, involving searches of relevant databases and nominations from experts. Data extracted from included documents were classified according to CMO configurations within strategic themes. Findings were compared and contrasted with guidance from diffusion theory, and interpreted with knowledge users to identify practical implications and potential directions for future research.Four core mechanisms were identified, namely awareness, commitment, confidence and trust. These mechanisms were activated within two broad scaling up strategies, those of renewing and regenerating, and documenting success. Within each strategy, specific actions to change contexts included building partnerships, conducting evaluations, engaging political support and adapting funding models. These modified contexts triggered the identified mechanisms, leading to a range of scaling up outcomes, such as commitment of new communities, changes in relevant

  7. Behaviour change interventions for the management of Raynaud's phenomenon: a systematic review protocol.

    Science.gov (United States)

    Daniels, Jo; Pauling, John D; Eccelston, Christopher

    2017-08-04

    Raynaud's phenomenon (RP) describes excessive peripheral vasospasm to cold exposure and/or emotional stress. RP episodes are associated with digital colour changes, pain and reduced quality of life. Pharmacological interventions are of low to moderate efficacy and often result in adverse effects such as facial flushing and headaches. Recommended lifestyle and behavioural interventions have not been evaluated. The objectives of the proposed systematic review are to assess the comparative safety and efficacy of behaviour change interventions for RP and identify what we can learn to inform future interventions. Studies eligible for inclusion include randomised controlled trials testing behaviour change interventions with a control comparator. A comprehensive search strategy will include peer review and grey literature up until 30 April 2017. Search databases will include Medline, Embase, PsychINFO and Cochrane. Initial sifting, eligibility, data extraction, risk of bias and quality assessment will be subject to review by two independent reviewers with a third reviewer resolving discrepancies. Risk of bias assessment will be performed using Cochrane risk of a bias assessment tool with quality of evidence assessed using Grading of Recommendations Assessment, Development and Evaluation(GRADE). A meta-analysis will be performed if there are sufficient data. Two subgroup analyses are planned: primary versus secondary RP outcomes; comparison of theoretically informed interventions with pragmatic interventions. This review does not require ethical approval as it will summarise published studies with non-identifiable data. This protocol complies with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Findings will be disseminated in peer-reviewed articles and reported according to PRISMA. This review will make a significant contribution to the management of RP where no review of behaviour-change interventions currently exist

  8. Using an intervention mapping approach to develop a discharge protocol for intensive care patients.

    Science.gov (United States)

    van Mol, Margo; Nijkamp, Marjan; Markham, Christine; Ista, Erwin

    2017-12-19

    Admission into an intensive care unit (ICU) may result in long-term physical, cognitive, and emotional consequences for patients and their relatives. The care of the critically ill patient does not end upon ICU discharge; therefore, integrated and ongoing care during and after transition to the follow-up ward is pivotal. This study described the development of an intervention that responds to this need. Intervention Mapping (IM), a six-step theory- and evidence-based approach, was used to guide intervention development. The first step, a problem analysis, comprised a literature review, six semi-structured telephone interviews with former ICU-patients and their relatives, and seven qualitative roundtable meetings for all eligible nurses (i.e., 135 specialized and 105 general ward nurses). Performance and change objectives were formulated in step two. In step three, theory-based methods and practical applications were selected and directed at the desired behaviors and the identified barriers. Step four designed a revised discharge protocol taking into account existing interventions. Adoption, implementation and evaluation of the new discharge protocol (IM steps five and six) are in progress and were not included in this study. Four former ICU patients and two relatives underlined the importance of the need for effective discharge information and supportive written material. They also reported a lack of knowledge regarding the consequences of ICU admission. 42 ICU and 19 general ward nurses identified benefits and barriers regarding discharge procedures using three vignettes framed by literature. Some discrepancies were found. For example, ICU nurses were skeptical about the impact of writing a lay summary despite extensive evidence of the known benefits for the patients. ICU nurses anticipated having insufficient skills, not knowing the patient well enough, and fearing legal consequences of their writings. The intervention was designed to target the knowledge

  9. Using the intervention mapping protocol to develop a community-based intervention for the prevention of childhood obesity in a multi-centre European project: the IDEFICS intervention.

    Science.gov (United States)

    Verbestel, Vera; De Henauw, Stefaan; Maes, Lea; Haerens, Leen; Mårild, Staffan; Eiben, Gabriele; Lissner, Lauren; Moreno, Luis A; Frauca, Natalia Lascorz; Barba, Gianvincenzo; Kovács, Eva; Konstabel, Kenn; Tornaritis, Michael; Gallois, Katharina; Hassel, Holger; De Bourdeaudhuij, Ilse

    2011-08-01

    The prevalence of childhood obesity has increased during the past decades and is now considered an urgent public health problem. Although stabilizing trends in obesity prevalence have been identified in parts of Europe, preventive efforts in children are still needed. Using the socio-ecological approach as the underlying theoretical perspective, the IDEFICS project aimed to develop, implement and evaluate a community-based intervention for the prevention of childhood obesity in eight European countries. The aim of the present manuscript was to describe the content and developmental process of the IDEFICS intervention. The intervention mapping protocol (IMP) was used to develop the community-based intervention for the prevention of childhood obesity in 3 to 10 years old children. It is a theory- and evidence-based tool for the structured planning and development of health promotion programs that requires the completion of six different steps. These steps were elaborated by two coordinating centers and discussed with the other participating centers until agreement was reached. Focus group research was performed in all participating centers to provide an informed basis for intervention development. The application of the IMP resulted in an overall intervention framework with ten intervention modules targeting environmental and personal factors through the family, the school and the community. The summary results of the focus group research were used to inform the development of the overall intervention. The cultural adaptation of the overall intervention was realised by using country specific focus group results. The need for cultural adaptation was considered during the entire process to improve program adoption and implementation. A plan was developed to evaluate program effectiveness and quality of implementation. The IDEFICS project developed a community-based intervention for the prevention of childhood obesity by using to the intervention mapping heuristic. The

  10. Protocol for the process evaluation of interventions combining performance-based financing with health equity in Burkina Faso.

    Science.gov (United States)

    Ridde, Valéry; Turcotte-Tremblay, Anne-Marie; Souares, Aurélia; Lohmann, Julia; Zombré, David; Koulidiati, Jean Louis; Yaogo, Maurice; Hien, Hervé; Hunt, Matthew; Zongo, Sylvie; De Allegri, Manuela

    2014-10-12

    The low quality of healthcare and the presence of user fees in Burkina Faso contribute to low utilization of healthcare and elevated levels of mortality. To improve access to high-quality healthcare and equity, national authorities are testing different intervention arms that combine performance-based financing with community-based health insurance and pro-poor targeting. There is a need to evaluate the implementation of these unique approaches. We developed a research protocol to analyze the conditions that led to the emergence of these intervention arms, the fidelity between the activities initially planned and those conducted, the implementation and adaptation processes, the sustainability of the interventions, the possibilities for scaling them up, and their ethical implications. The study adopts a longitudinal multiple case study design with several embedded levels of analyses. To represent the diversity of contexts where the intervention arms are carried out, we will select three districts. Within districts, we will select both primary healthcare centers (n =18) representing different intervention arms and the district or regional hospital (n =3). We will select contrasted cases in relation to their initial performance (good, fair, poor). Over a period of 18 months, we will use quantitative and qualitative data collection and analytical tools to study these cases including in-depth interviews, participatory observation, research diaries, and questionnaires. We will give more weight to qualitative methods compared to quantitative methods. Performance-based financing is expanding rapidly across low- and middle-income countries. The results of this study will enable researchers and decision makers to gain a better understanding of the factors that can influence the implementation and the sustainability of complex interventions aiming to increase healthcare quality as well as equity.

  11. Nursing intervention protocol for adult patients experiencing chronic low back pain

    Directory of Open Access Journals (Sweden)

    Nadia Mohamed Taha

    2015-12-01

    Full Text Available Aim: The aim of this study was to evaluate the effectiveness of a nursing intervention protocol targeting the knowledge and practice of adult patients experiencing low back pain. Design: A quasi-experimental research design. Methods: Pre-post assessment of outcome was used in this study. The study was conducted in the outpatient clinic of the physical therapy department at Zagazig University Hospital and Beni-Suef University Hospital, Egypt. Sample: 40 participants diagnosed with chronic low back pain (lasting for longer than six months. Seven of the 40 dropped out during the follow-up phase for personal or logistical reasons. Tools included sections for demographic characteristics, knowledge and practice assessment; in addition to the Oswestry Disability Index, and Visual Analogue Scale (VAS. Results: The application of an instruction protocol intervention for low back pain was effective in improving patient knowledge and practice, with associated amelioration of the severity of pain and disability among them. The effect was still apparent at the three-month follow-up. Conclusion: It is recommended that the study be replicated using a more robust randomized clinical trial design. Nonetheless, the instruction protocol with the designed booklet may be adopted as an element of the care services offered to patients suffering LBP, given the clear positive effects on patient knowledge, which would undoubtedly help them decide on the most preferential management approach.

  12. Bank robberies: A psychological protocol of intervention in financial institutions and principal effects.

    Science.gov (United States)

    Tabanelli, Maria Carla; Bonfiglioli, Roberta; Violante, Francesco S

    2013-03-26

    BACKGROUND: Robbery in workplaces represents a potentially traumatic experience for workers. OBJECTIVES: This article describes the set up and evaluation of a comprehensive psychological intervention designed to help to reduce the adverse consequences of bank robberies. PARTICIPANTS: The study population was selected among the employees of two Italian banks.METHODS: The psychological protocol was designed according to the results of a comprehensive non-systematic review of the scientific literature and it was evaluated at work site. RESULTS: The protocol consists of a "pre-event" formative intervention and "post-event" psychological support. The qualitative data collected allowed us to understand that the reactions after a robbery can differ depending on the phase during which the workers were exposed to the robbery. We noted that the main consequences can be classified in emotional/sentimental reactions, behavioral reactions, physiological reactions and experiences during the event; emotions/feelings following the robbery and psycho/physical state and emotions/feelings in the following days.CONCLUSIONS: In a working environment, the chance to take advantage of a specific protocol for the traumatic event of a bank robbery offers both the company and the workers important tools for well-being, including post-robbery psychological support and classroom instructions.

  13. Applying the Intervention Mapping protocol to develop a kindergarten-based, family-involved intervention to increase European preschool children's physical activity levels: the ToyBox-study.

    Science.gov (United States)

    De Craemer, M; De Decker, E; De Bourdeaudhuij, I; Verloigne, M; Duvinage, K; Koletzko, B; Ibrügger, S; Kreichauf, S; Grammatikaki, E; Moreno, L; Iotova, V; Socha, P; Szott, K; Manios, Y; Cardon, G

    2014-08-01

    Although sufficient physical activity is beneficial for preschoolers' health, activity levels in most preschoolers are low. As preschoolers spend a considerable amount of time at home and at kindergarten, interventions should target both environments to increase their activity levels. The aim of the current paper was to describe the six different steps of the Intervention Mapping protocol towards the systematic development and implementation of the physical activity component of the ToyBox-intervention. This intervention is a kindergarten-based, family-involved intervention implemented across six European countries. Based on the results of literature reviews and focus groups with parents/caregivers and kindergarten teachers, matrices of change objectives were created. Then, theory-based methods and practical strategies were selected to develop intervention materials at three different levels: (i) individual level (preschoolers); (ii) interpersonal level (parents/caregivers) and (iii) organizational level (teachers). This resulted in a standardized intervention with room for local and cultural adaptations in each participating country. Although the Intervention Mapping protocol is a time-consuming process, using this systematic approach may lead to an increase in intervention effectiveness. The presented matrices of change objectives are useful for future programme planners to develop and implement an intervention based on the Intervention Mapping protocol to increase physical activity levels in preschoolers. © 2014 World Obesity.

  14. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    OpenAIRE

    Smith Chad E.; Lyons Brian; Hannon James C.

    2014-01-01

    Purpose. Complex training (CT) involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the...

  15. Early Interventions Following the Death of a Parent: Protocol of a Mixed Methods Systematic Review.

    Science.gov (United States)

    Pereira, Mariana; Johnsen, Iren; Hauken, May Aa; Kristensen, Pål; Dyregrov, Atle

    2017-06-29

    Previous meta-analyses examined the effectiveness of interventions for bereaved children showing small to moderate effect sizes. However, no mixed methods systematic review was conducted on bereavement interventions following the loss of a parent focusing on the time since death in regard to the prevention of grief complications. The overall purpose of the review is to provide a rigorous synthesis of early intervention after parental death in childhood. Specifically, the aims are twofold: (1) to determine the rationales, contents, timeframes, and outcomes of early bereavement care interventions for children and/or their parents and (2) to assess the quality of current early intervention studies. Quantitative, qualitative, and mixed methods intervention studies that start intervention with parentally bereaved children (and/or their parents) up to 6 months postloss will be included in the review. The search strategy was based on the Population, Interventions, Comparator, Outcomes, and Study Designs (PICOS) approach, and it was devised together with a university librarian. The literature searches will be carried out in the Medical Literature Analysis and Retrieval System Online (MEDLINE), PsycINFO, Excerpta Medica Database (EMBASE), and Cumulative Index to Nursing and Allied Health Literature (CINAHL). The Mixed Methods Appraisal Tool will be used to appraise the quality of eligible studies. All data will be narratively synthetized following the Guidance on the Conduct of Narrative Synthesis in Systematic Reviews. The systematic review is ongoing and the data search has started. The review is expected to be completed by the end of 2017. Findings will be submitted to leading journals for publication. In accordance with the current diagnostic criteria for prolonged grief as well as the users' perspectives literature, this systematic review outlines a possible sensitive period for early intervention following the death of a parent. The hereby presented protocol ensures

  16. A complex-polarization-propagator protocol for magneto-chiral axial dichroism and birefringence dispersion

    DEFF Research Database (Denmark)

    Cukras, Janusz; Kauczor, Joanna; Norman, Patrick

    2016-01-01

    A computational protocol for magneto-chiral dichroism and magneto-chiral birefringence dispersion is presented within the framework of damped response theory, also known as complex polarization propagator theory, at the level of time-dependent Hartree–Fock and time-dependent density functional th...

  17. A pilot experience launching a national dose protocol for vascular and interventional radiology

    International Nuclear Information System (INIS)

    Vano, E.; Segarra, A.; Fernandez, J. M.; Ordiales, J. M.; Simon, R.; Gallego, J. J.; Del Cerro, J.; Casasola, E.; Verdu, J. F.; Ballester, T.; Sotil, J.; Aspiazu, A.; Garcia, M. A.; Moreno, F.; Carreras, F.; Canis, M.; Soler, M. M.; Palmero, J.; Ciudad, J.; Diaz, F.; Hernandez, J.; Gonzalez, M.; Rosales, P.

    2008-01-01

    The design of a national dose protocol for interventional radiology has been one of the tasks during the European SENTINEL Coordination Action. The present paper describes the pilot experience carried out in cooperation with the Spanish Society on Vascular and Interventional Radiology (SERVEI). A prospective sample of procedures was initially agreed. A common quality control of the X-ray systems was carried out, including calibration of the air kerma area product (KAP) meters. Occupational doses of the radiologists involved in the survey were also included in the survey. A total of 10 Spanish hospitals with interventional X-ray units were involved. Six hundred and sixty-four patient dose data were collected from 397 diagnostic and 267 therapeutic procedures. Occupational doses were evaluated in a sample of 635 values. The obtained KAP median/mean values (Gy.cm 2 ) for the gathered procedures were: biliary drainage (30.6/68.9), fistulography (4.5/9.8), lower limb arteriography (52.2/60.7), hepatic chemoembolisation (175.8/218.3), iliac stent (45.9/73.2) and renal arteriography (39.1/59.8). Occupational doses (mean monthly values, in mSv) were 1.9 (over apron); 0.3 (under apron) and 4.5 (on hands). With this National experience, a protocol was agreed among the SENTINEL partners to conduct future similar surveys in other European countries. (authors)

  18. Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

    Science.gov (United States)

    Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

    2017-06-01

    The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

  19. Efficacy of two types of palliative sedation therapy defined using intervention protocols: proportional vs. deep sedation.

    Science.gov (United States)

    Imai, Kengo; Morita, Tatsuya; Yokomichi, Naosuke; Mori, Masanori; Naito, Akemi Shirado; Tsukuura, Hiroaki; Yamauchi, Toshihiro; Kawaguchi, Takashi; Fukuta, Kaori; Inoue, Satoshi

    2018-06-01

    This study investigated the effect of two types of palliative sedation defined using intervention protocols: proportional and deep sedation. We retrospectively analyzed prospectively recorded data of consecutive cancer patients who received the continuous infusion of midazolam in a palliative care unit. Attending physicians chose the sedation protocol based on each patient's wish, symptom severity, prognosis, and refractoriness of suffering. The primary endpoint was a treatment goal achievement at 4 h: in proportional sedation, the achievement of symptom relief (Support Team Assessment Schedule (STAS) ≤ 1) and absence of agitation (modified Richmond Agitation-Sedation Scale (RASS) ≤ 0) and in deep sedation, the achievement of deep sedation (RASS ≤ - 4). Secondary endpoints included mean scores of STAS and RASS, deep sedation as a result, and adverse events. Among 398 patients who died during the period, 32 received proportional and 18 received deep sedation. The treatment goal achievement rate was 68.8% (22/32, 95% confidence interval 52.7-84.9) in the proportional sedation group vs. 83.3% (15/18, 66.1-100) in the deep sedation group. STAS decreased from 3.8 to 0.8 with proportional sedation at 4 h vs. 3.7 to 0.3 with deep sedation; RASS decreased from + 1.2 to - 1.7 vs. + 1.4 to - 3.7, respectively. Deep sedation was needed as a result in 31.3% (10/32) of the proportional sedation group. No fatal events that were considered as probably or definitely related to the intervention occurred. The two types of intervention protocol well reflected the treatment intention and expected outcomes. Further, large-scale cohort studies are promising.

  20. Use of a mobile social networking intervention for weight management: a mixed-methods study protocol.

    Science.gov (United States)

    Laranjo, Liliana; Lau, Annie Y S; Martin, Paige; Tong, Huong Ly; Coiera, Enrico

    2017-07-12

    Obesity and physical inactivity are major societal challenges and significant contributors to the global burden of disease and healthcare costs. Information and communication technologies are increasingly being used in interventions to promote behaviour change in diet and physical activity. In particular, social networking platforms seem promising for the delivery of weight control interventions.We intend to pilot test an intervention involving the use of a social networking mobile application and tracking devices ( Fitbit Flex 2 and Fitbit Aria scale) to promote the social comparison of weight and physical activity, in order to evaluate whether mechanisms of social influence lead to changes in those outcomes over the course of the study. Mixed-methods study involving semi-structured interviews and a pre-post quasi-experimental pilot with one arm, where healthy participants in different body mass index (BMI) categories, aged between 19 and 35 years old, will be subjected to a social networking intervention over a 6-month period. The primary outcome is the average difference in weight before and after the intervention. Secondary outcomes include BMI, number of steps per day, engagement with the intervention, social support and system usability. Semi-structured interviews will assess participants' expectations and perceptions regarding the intervention. Ethics approval was granted by Macquarie University's Human Research Ethics Committee for Medical Sciences on 3 November 2016 (ethics reference number 5201600716).The social network will be moderated by a researcher with clinical expertise, who will monitor and respond to concerns raised by participants. Monitoring will involve daily observation of measures collected by the fitness tracker and the wireless scale, as well as continuous supervision of forum interactions and posts. Additionally, a protocol is in place to monitor for participant misbehaviour and direct participants-in-need to appropriate sources of help

  1. A reliable, delay bounded and less complex communication protocol for multicluster FANETs

    Directory of Open Access Journals (Sweden)

    Wajiya Zafar

    2017-02-01

    Full Text Available Recently, Flying Ad-hoc Networks (FANETs, enabling ad-hoc networking between Unmanned Aerial Vehicles (UAVs is gaining importance in several military and civilian applications. The sensitivity of the applications requires adaptive; efficient; delay bounded and scalable communication network among UAVs for data transmission. Due to communication protocol complexity; rigidity; cost of commercial-off-the-shelf (COT components; limited radio bandwidth; high mobility and computational resources; maintaining the desired level of Quality of Service (QoS becomes a daunting task. For the first time in this research we propose multicluster FANETs for efficient network management; the proposed scheme considerably reduces communication cost and optimizes network performance as well as exploit low power; less complex and low cost IEEE 802.15.4 (MAC protocol for intercluster and intracluster communication. In this research both beacon enabled mode and beaconless modes have been investigated with Guaranteed Time Slots (GTS and virtual Time Division Multiple Access (TDMA respectively. The methodology plays a key role towards reserving bandwidth for latency critical applications; eliminate collisions and medium access delays. Moreover analysis ad-hoc routing protocols including two proactive (OLSR, DSDV and one reactive (AODV is also presented. The results shows that the proposed scheme guarantees high packet delivery ratios while maintaining acceptable levels of latency requirements comparable with more complex and dedicatedly designed protocols in literature.

  2. Control protocol: large scale implementation at the CERN PS complex - a first assessment

    International Nuclear Information System (INIS)

    Abie, H.; Benincasa, G.; Coudert, G.; Davydenko, Y.; Dehavay, C.; Gavaggio, R.; Gelato, G.; Heinze, W.; Legras, M.; Lustig, H.; Merard, L.; Pearson, T.; Strubin, P.; Tedesco, J.

    1994-01-01

    The Control Protocol is a model-based, uniform access procedure from a control system to accelerator equipment. It was proposed at CERN about 5 years ago and prototypes were developed in the following years. More recently, this procedure has been finalized and implemented at a large scale in the PS Complex. More than 300 pieces of equipment are now using this protocol in normal operation and another 300 are under implementation. These include power converters, vacuum systems, beam instrumentation devices, RF equipment, etc. This paper describes how the single general procedure is applied to the different kinds of equipment. The advantages obtained are also discussed. ((orig.))

  3. Voice Over the Internet Protocol as a Medium for Delivering Reading Intervention

    Directory of Open Access Journals (Sweden)

    Craig Wright

    2011-10-01

    Full Text Available Voice Over the Internet Protocol (VoIP holds promise as a platform by which services can be delivered to students in rural and remote regions who have reading difficulties. VoIP is an Internet-based protocol that allows two or more individuals to videoconference from remote locations. This study used a single-case research design to investigate whether VoIP would produce significant gains in reading ability in BM, a 10-year-old with long-standing word-level reading problems. BM was provided with a theoretically motivated reading intervention 4 times weekly. The intervention was delivered remotely using the Apple iChat software. Substantial growth in regular- and nonword reading covaried with onset and removal of treatment. Treatment gains were maintained at 10-week follow-up. Meaningful gains were also seen in text-reading accuracy and reading comprehension. VoIP-based instruction represents an important avenue for future research and is a teaching method that holds much promise for rural and remote students.

  4. Evaluation of protocolized angiography in performing the interventional procedure for hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Jiang Jianqiang; Shi Haibin; Liu Sheng; Yang Zhengqiang; Zhou Chungao; Zhou Weizhong

    2010-01-01

    Objective: To assess the clinical value of protocolized angiography,including the superior mesenteric artery (SMA), the celiac artery and the common hepatic artery angiography, in detecting the atypical tumor feeding arteries of hepatocellular carcinoma (HCC) during transarterial chemoembolization (TACE) procedure. Methods: The clinical data of all patients who received the initial TACE for HCC during the period of January 2005-December 2009 were collected and were retrospectively analyzed. Both the angiograms and procedure reports were reviewed. According to the angiography protocols used in interventional procedure the patients were divided into two groups. Group A included 526 patients who received the protocolized angiography, including the SMA, the celiac artery and the common hepatic artery, while Group B composed of 850 patients who underwent the routine angiography of the common hepatic artery. For all patients in both groups the atypical tumor feeding arteries were searched for when the tumor staining was incomplete. The anatomic variations of tumor feeding arteries were classified and were statistically analyzed. Results: The detection rate of tumor supply from the branches of SMA, left gastric artery, phrenic artery and celiac artery was 14.1%, 6.7%, 4.6% and 0.5% respectively in group A, while it was 8.9%, 3.3%, 2.6% and 0% respectively in group B. Significant difference in all above four detection rates existed between two groups (P 0.05). Conclusion: Compared with the conventional common hepatic arteriography during TACE, the diagnostic protocolized angiography, including the SMA, the celiac artery and the common hepatic artery, can markedly improve the detection rates of atypical tumor feeders of HCC, such as the accessory hepatic artery, which means that the tumor will be occluded more completely and be controlled more promptly. (authors)

  5. Developing a service user informed intervention to improve participation and ability to perform daily activities in primary Sjögren's syndrome: a mixed-methods study protocol.

    Science.gov (United States)

    Hackett, Katie L; Newton, Julia L; Deane, Katherine H O; Rapley, Tim; Deary, Vincent; Kolehmainen, Niina; Lendrem, Dennis; Ng, Wan-Fai

    2014-08-21

    A significant proportion of patients with primary Sjögren's syndrome (PSS) is functionally impaired and experience difficulties participating in various aspects of everyday life. There is currently no evidence of efficacy for non-pharmacological interventions aimed specifically at supporting the patients with PSS to improve their participation and ability to perform daily activities. This paper describes a research protocol for a mixed-methods study to develop an intervention to improve these outcomes. The protocol follows the Medical Research Council framework for complex interventions. We will use group concept mapping with the patients, adults who live with them and healthcare professionals to identify factors which prevent people with PSS from participating in daily life and performing daily activities. The factors will be prioritised by participants for importance and feasibility and will inform an intervention to be delivered within a National Health Service (NHS) setting. Evidence-based intervention techniques will be identified for the prioritised factors and combined into a deliverable intervention package. Key stakeholders will comment on the intervention content and mode of delivery through focus groups, and the data will be used to refine the intervention. The acceptability and feasibility of the refined intervention will be evaluated in a future study. The study has been approved by an NHS Research Ethics Committee, REC Reference: 13/NI/0190. The findings of this study will be disseminated in peer-reviewed journals and through presentation at national and international conferences. UKCRN Study ID: 15939. 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.

  6. Developing a theoretical framework for complex community-based interventions.

    Science.gov (United States)

    Angeles, Ricardo N; Dolovich, Lisa; Kaczorowski, Janusz; Thabane, Lehana

    2014-01-01

    Applying existing theories to research, in the form of a theoretical framework, is necessary to advance knowledge from what is already known toward the next steps to be taken. This article proposes a guide on how to develop a theoretical framework for complex community-based interventions using the Cardiovascular Health Awareness Program as an example. Developing a theoretical framework starts with identifying the intervention's essential elements. Subsequent steps include the following: (a) identifying and defining the different variables (independent, dependent, mediating/intervening, moderating, and control); (b) postulating mechanisms how the independent variables will lead to the dependent variables; (c) identifying existing theoretical models supporting the theoretical framework under development; (d) scripting the theoretical framework into a figure or sets of statements as a series of hypotheses, if/then logic statements, or a visual model; (e) content and face validation of the theoretical framework; and (f) revising the theoretical framework. In our example, we combined the "diffusion of innovation theory" and the "health belief model" to develop our framework. Using the Cardiovascular Health Awareness Program as the model, we demonstrated a stepwise process of developing a theoretical framework. The challenges encountered are described, and an overview of the strategies employed to overcome these challenges is presented.

  7. Mobile Health Technology Interventions for Suicide Prevention: Protocol for a Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Melia, Ruth; Francis, Kady; Duggan, Jim; Bogue, John; O'Sullivan, Mary; Chambers, Derek; Young, Karen

    2018-01-26

    Previous research has reported that two of the major barriers to help-seeking for individuals at risk of suicide are stigma and geographical isolation. Mobile technology offers a potential means of delivering evidence-based interventions with greater specificity to the individual, and at the time that it is needed. Despite documented motivation by at-risk individuals to use mobile technology to track mental health and to support psychological interventions, there is a shortfall of outcomes data on the efficacy of mobile health (mHealth) technology on suicide-specific outcomes. The objective of this study is to develop a protocol for a systematic review and meta-analysis that aims to evaluate the effectiveness of mobile technology-based interventions for suicide prevention. The search includes the Cochrane Central Register of Controlled Trials (CENTRAL: The Cochrane Library), MEDLINE, Embase, PsycINFO, CRESP and relevant sources of gray literature. Studies that have evaluated psychological or nonpsychological interventions delivered via mobile computing and communication technology, and have suicidality as an outcome measure will be included. Two authors will independently extract data and assess the study suitability in accordance with the Cochrane Collaboration Risk of Bias Tool. Studies will be included if they measure at least one suicide outcome variable (ie, suicidal ideation, suicidal intent, nonsuicidal self-injurious behavior, suicidal behavior). Secondary outcomes will be measures of symptoms of depression. Where studies are sufficiently homogenous and reported outcomes are amenable for pooled synthesis, meta-analysis will be performed. A narrative synthesis will be conducted if the data is unsuitable for a meta-analysis. The review is in progress, with findings expected by summer 2018. To date, evaluations of mobile technology-based interventions in suicide prevention have focused on evaluating content as opposed to efficacy. Indeed, previous research has

  8. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

    Directory of Open Access Journals (Sweden)

    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  9. Using the intervention mapping protocol to reduce European preschoolers’ sedentary behavior, an application to the ToyBox-Study

    Science.gov (United States)

    2014-01-01

    Background High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers’ sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Methods Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. Results The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers’ sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. Conclusions A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with

  10. Using the intervention mapping protocol to reduce European preschoolers' sedentary behavior, an application to the ToyBox-Study.

    Science.gov (United States)

    De Decker, Ellen; De Craemer, Marieke; De Bourdeaudhuij, Ilse; Verbestel, Vera; Duvinage, Kristin; Iotova, Violeta; Grammatikaki, Evangelia; Wildgruber, Andreas; Mouratidou, Theodora; Manios, Yannis; Cardon, Greet

    2014-02-19

    High levels of sedentary behavior are often measured in preschoolers, but only a few interventions have been developed to counteract this. Furthermore, detailed descriptions of interventions in preschoolers targeting different forms of sedentary behavior could not be located in the literature. The aim of the present paper was to describe the different steps of the Intervention Mapping Protocol used towards the development of an intervention component of the ToyBox-study focusing on decreasing preschoolers' sedentary behavior. The ToyBox-study focuses on the prevention of overweight in 4- to 6-year-old children by implementing a multi-component kindergarten-based intervention with family involvement in six different European countries. Applying the Intervention Mapping Protocol, six different steps were systematically completed for the structured planning and development of the intervention. A literature search and results from focus groups with parents/caregivers and kindergarten teachers were used as a guide during the development of the intervention and the intervention materials. The application of the different steps in the Intervention Mapping Protocol resulted in the creation of matrices of change objectives, followed by the selection of practical applications for five different intervention tools that could be used at the individual level of the preschool child, at the interpersonal level (i.e., parents/caregivers) and at the organizational level (i.e., kindergarten teachers). No cultural differences regarding preschoolers' sedentary behavior were identified between the participating countries during the focus groups, so cultural and local adaptations of the intervention materials were not necessary to improve the adoption and implementation of the intervention. A systematic and evidence-based approach was used for the development of this kindergarten-based family-involved intervention targeting preschoolers, with the inclusion of parental involvement. The

  11. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial

    Directory of Open Access Journals (Sweden)

    Alison Quinlan

    2017-11-01

    Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform

  12. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol.

    Science.gov (United States)

    Tomkins-Lane, Christy C; Lafave, Lynne M Z; Parnell, Jill A; Krishnamurthy, Ashok; Rempel, Jocelyn; Macedo, Luciana G; Moriartey, Stephanie; Stuber, Kent J; Wilson, Philip M; Hu, Richard; Andreas, Yvette M

    2013-11-14

    Because of symptoms, people with lumbar spinal stenosis (LSS) are often inactive, and this sedentary behaviour implies risk for diseases including obesity. Research has identified body mass index as the most powerful predictor of function in LSS. This suggests that function may be improved by targeting weight as a modifiable factor. An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS. The main components of this intervention include pedometer-based physical activity promotion and nutrition education. The Spinal Stenosis Pedometer and Nutrition Lifestyle INTERVENTION (SSPANLI) was developed and piloted with 10 individuals. The protocol for a randomized controlled trail comparing the SSPANLI intervention to usual non-surgical care follows. One hundred six (106) overweight or obese individuals with LSS will be recruited. Baseline and follow-up testing includes dual energy x-ray absorptiometry, blood draw, 3-day food record, 7-day accelerometry, questionnaire, maximal oxygen consumption, neurological exam, balance testing and a Self-Paced Walking Test. During Week 1, the intervention group will receive a pedometer, and a personalized consultation with both a Dietitian and an exercise specialist. For 12 weeks participants will log on to the e-health website to access personal step goals, walking maps, nutrition videos, and motivational quotes. Participants will also have access to in-person Coffee Talk meetings every 3 weeks, and meet with the Dietitian and exercise specialist at week 6. The control group will proceed with usual care for the 12-week period. Follow-up testing will occur at Weeks 13 and 24. This lifestyle intervention has the potential to provide a unique, non-surgical management option for people with LSS. Through decreased fat mass and increased function, we may reduce risk for obesity, chronic diseases of inactivity, and pain. The use of e-health interventions provides an

  13. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

    2017-11-09

    Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

  14. Interventions for sustained healthcare professional behaviour change: a protocol for an overview of reviews.

    Science.gov (United States)

    Dombrowski, Stephan U; Campbell, Pauline; Frost, Helen; Pollock, Alex; McLellan, Julie; MacGillivray, Steve; Gavine, Anna; Maxwell, Margaret; O'Carroll, Ronan; Cheyne, Helen; Presseau, Justin; Williams, Brian

    2016-10-13

    Failure to successfully implement and sustain change over the long term continues to be a major problem in health and social care. Translating evidence into routine clinical practice is notoriously complex, and it is recognised that to implement new evidence-based interventions and sustain them over time, professional behaviour needs to change accordingly. A number of theories and frameworks have been developed to support behaviour change among health and social care professionals, and models of sustainability are emerging, but few have translated into valid and reliable interventions. The long-term success of healthcare professional behavioural change interventions is variable, and the characteristics of successful interventions unclear. Previous reviews have synthesised the evidence for behaviour change, but none have focused on sustainability. In addition, multiple overlapping reviews have reported inconsistent results, which do not aid translation of evidence into practice. Overviews of reviews can provide accessible succinct summaries of evidence and address barriers to evidence-based practice. We aim to compile an overview of reviews, identifying, appraising and synthesising evidence relating to sustained social and healthcare professional behaviour change. We will conduct a systematic review of Cochrane reviews (an Overview). We plan to systematically search the Cochrane Database of Systematic Reviews. We will include all systematic reviews of randomised controlled trials comparing a healthcare professional targeted behaviour change intervention to a standard care or no intervention control group. Two reviewers will independently assess the eligibility of the reviews and the methodological quality of included reviews using the ROBIS tool. The quality of evidence within each comparison in each review will be judged based on the GRADE criteria. Disagreements will be resolved through discussion. Effects of interventions will be systematically tabulated and the

  15. Feasibility of a Facebook Intervention for Exercise Motivation and Cardiac Rehabilitation Adherence: Study Protocol.

    Science.gov (United States)

    Siegmund, Lee Anne; Ahmed, Haitham M; Crawford, Michael Todd; Bena, James Frank

    2017-08-18

    recruitment goal is 60 cardiac rehabilitation patients. Data collection is anticipated to be complete by July 2018. This pilot study will be the first to examine the effect of a Facebook intervention on patient adherence and motivation for exercise in a cardiac rehabilitation setting. Engagement in the Facebook group and participation in the study will help to determine the feasibility of using Facebook to affect adherence and motivation in cardiac rehabilitation patients, potentially improving outcomes through the use of a unique intervention. ClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813 (Archived by WebCite at http://www.webcitation.org/6sRsz8Zpa). ©Lee Anne Siegmund, Haitham M Ahmed, Michael Todd Crawford, James Frank Bena. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.08.2017.

  16. Taking stock: protocol for evaluating a family planning supply chain intervention in Senegal.

    Science.gov (United States)

    Cavallaro, Francesca L; Duclos, Diane; Baggaley, Rebecca F; Penn-Kekana, Loveday; Goodman, Catherine; Vahanian, Alice; Santos, Andreia C; Bradley, John; Paintain, Lucy; Gallien, Jérémie; Gasparrini, Antonio; Hasselback, Leah; Lynch, Caroline A

    2016-04-21

    In Senegal, only 12% of women of reproductive age in union (WRAU) were using contraceptives and another 29% had an unmet need for contraceptives in 2010-11. One potential barrier to accessing contraceptives is the lack of stock availability in health facilities where women seek them. Multiple supply chain interventions have been piloted in low- and middle-income countries with the aim of improving contraceptive availability in health facilities. However, there is limited evidence on the effect of these interventions on contraceptive availability in facilities, and in turn on family planning use in the population. This evaluation protocol pertains to a supply chain intervention using performance-based contracting for contraceptive distribution that was introduced throughout Senegal between 2012 and 2015. This multi-disciplinary research project will include quantitative, qualitative and economic evaluations. Trained researchers in the different disciplines will implement the studies separately but alongside each other, sharing findings throughout the project to inform each other's data collection. A non-randomised study with stepped-wedge design will be used to estimate the effect of the intervention on contraceptive stock availability in health facilities, and on the modern contraceptive prevalence rate among women in Senegal, compared to the current pull-based distribution model used for other commodities. Secondary data from annual Service Provision Assessments and Demographic and Health Surveys will be used for this study. Data on stock availability and monthly family planning consultations over a 4-year period will be collected from 200 health facilities in five regions to perform time series analyses. A process evaluation will be conducted to understand the extent to which the intervention was implemented as originally designed, the acceptability of third-party logisticians within the health system and potential unintended consequences. These will be assessed

  17. Acute effect of a complex training protocol of back squats on 30-m sprint times of elite male military athletes.

    Science.gov (United States)

    Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Serrano, Pablo Cáceres

    2016-03-01

    [Purpose] The aim of this study was to determine the acute effect temporal of a complex training protocol on 30 meter sprint times. A secondary objective was to evaluate the fatigue indexes of military athletes. [Subjects and Methods] Seven military athletes were the subjects of this study. The variables measured were times in 30-meter sprint, and average power and peak power of squats. The intervention session with complex training consisted of 4 sets of 5 repetitions at 30% 1RM + 4 repetitions at 60% 1RM + 3 repetitions of 30 meters with 120-second rests. For the statistical analysis repeated measures of ANOVA was used, and for the post hoc analysis, student's t-test was used. [Results] Times in 30 meter sprints showed a significant reduction between the control set and the four experimental sets, but the average power and peak power of squats did not show significant changes. [Conclusion] The results of the study show the acute positive effect of complex training, over time, in 30-meter sprint by military athletes. This effect is due to the post activation potentiation of the lower limbs' muscles in the 30 meters sprint.

  18. Developing a complex intervention for the outpatient management of incidentally diagnosed pulmonary embolism in cancer patients.

    Science.gov (United States)

    Palmer, June; Bozas, George; Stephens, Andrew; Johnson, Miriam; Avery, Ged; O'Toole, Lorcan; Maraveyas, Anthony

    2013-06-27

    Most patients with pulmonary embolism (PE) spend 5-7 days in hospital even though only 4.5% will develop serious complications during this time. In particular, the group of patients with incidentally diagnosed PE (i-PE) includes many patients with low risk features potentially ideal for outpatient management; however the evidence for their optimal management is lacking hence relative practices may vary considerably. We describe the development process, components, links and function of a nurse-led service for the management of patients with i-PE, developed in accordance to the UK Medical Research Council complex intervention guidance. Phase 0 (Theoretical underpinning): The Pulmonary Embolism Severity Index (PESI) was selected for patient risk assessment and the American Society of Clinical Oncology (ASCO) guideline for the management of PE in cancer patients (2007) was selected as quality measure. Historical registry and audit data from our centre regarding i-PE incidence and management for the period between 2006 and 2009 illustrating the then current practices were reviewed. Phase 1 (Modelling): Modelling of the pathway included the following: a) Identification of training needs, planning and implementation of training schemes and development of transferable competencies and training materials. b) Mapping patient pathways and flow and c) Production of key documentation and Standard Operating Procedures for the delivery of the service. Phase 2 (Implementation and testing of the intervention): During the initial 12 months of implementation, remedial action was taken to address identified deficiencies regarding patient referral to the pathway, compliance with treatment protocol, patient follow up, selection challenges from the use of PESI in cancer patients and challenges regarding the "first-pass" identification of i-PE. We have developed and piloted a complex intervention to manage cancer patients with incidental PE in an outpatient setting. Adherence to evidence

  19. Pain Intervention for people with Dementia in nursing homes (PID): study protocol for a quasi-experimental nurse intervention.

    Science.gov (United States)

    Koppitz, Andrea; Bosshard, Georg; Blanc, Geneviève; Hediger, Hannele; Payne, Sheila; Volken, Thomas

    2017-04-21

    It is estimated that 19 to 83% of people with dementia suffer from pain that is inadequately treated in the last months of life. A large number of healthcare workers who care for these people in nursing homes lack appropriate expertise and may therefore not always recognise, assess and treat pain in those with dementia who have complex problems on time, properly and efficiently. The aim of this intervention trial is to identify care needs of people with dementia suffering from pain living in a nursing home. A quasi-experimental nurse-led intervention trial based on a convenience sample of four nursing homes in the Swiss Canton of Zurich examines the effects on dementia patients (n = 411), the healthcare institution and the qualification level of the healthcare workers compared to historical controls, using an event analysis and a multilevel analysis. Healthcare workers will be individually trained how to assess, intervene and evaluate acute and chronic pain. There are three data-monitoring cycles (T0, T1, T2) and two intervention cycles (I1, I2) with a total study duration of 425 days. There is also a process evaluation based on Dobbins analyses that analyse in particular the potentials for change in clinical practice of change agents. The aim of the intervention trial is to improve pain management strategies in older people with dementia in nursing homes. Clinically significant findings will be expected that will help reduce suffering in the sense of "total pain" for people with dementia. The joint intra- and interdisciplinary collaboration between practice and supply-oriented (nursing) research will have both a lasting effect on the efficiency measurement and provide scientifically sound results. Nursing homes can integrate the findings from the intervention trial into their internal quality control process. The potential for improvements can be directly influenced by the nursing home itself. Registration trial number: DRKS00009726 on DRKS, registered 10

  20. Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review.

    Science.gov (United States)

    Carrazzone, Oreste Lemos; Belloti, João Carlos; Matsunaga, Fabio Teruo; Mansur, Nacime Salomão Barbachan; Matsumoto, Marcelo Hide; Faloppa, Flavio; Tamaoki, Marcel Jun Sugawara

    2017-11-21

    The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded

  1. Complex pharmaceutical care intervention in pulmonary care Part B. Patient opinion and process survey

    NARCIS (Netherlands)

    Stuurman-Bieze, A.GG; Kokenberg, M.E.A.P.; Tobi, H; de Boer, W.O.; van Doormaal, Jasperien E.; de Jong-van den Berg, Lolkje Theodora Wilhelmina; Tromp, Th.F.J.

    2005-01-01

    Objective: The IPMP study (Interventions on the principle of Pulmonary Medication Profiles) investigates and describes the results of complex pharmaceutical care interventions provided to selected pulmonary patients to improve their drug use. This paper describes the patients' opinions about the

  2. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol

    OpenAIRE

    Sharif Ishak, Sharifah Intan Zainun; Chin, Yit Siew; Mohd. Taib, Mohd. Nasir; Mohd. Shariff, Zalilah

    2016-01-01

    Abstract Background Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely ‘Eat Right, Be Positive About Your Body and Live Actively’ (EPaL), a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordere...

  3. The interventional effect of new drugs combined with the Stupp protocol on glioblastoma: A network meta-analysis.

    Science.gov (United States)

    Li, Mei; Song, Xiangqi; Zhu, Jun; Fu, Aijun; Li, Jianmin; Chen, Tong

    2017-08-01

    New therapeutic agents in combination with the standard Stupp protocol (a protocol about the temozolomide combined with radiotherapy treatment with glioblastoma was research by Stupp R in 2005) were assessed to evaluate whether they were superior to the Stupp protocol alone, to determine the optimum treatment regimen for patients with newly diagnosed glioblastoma. We implemented a search strategy to identify studies in the following databases: PubMed, Cochrane Library, EMBASE, CNKI, CBM, Wanfang, and VIP, and assessed the quality of extracted data from the trials included. Statistical software was used to perform network meta-analysis. The use of novel therapeutic agents in combination with the Stupp protocol were all shown to be superior than the Stupp protocol alone for the treatment of newly diagnosed glioblastoma, ranked as follows: cilengitide 2000mg/5/week, bevacizumab in combination with irinotecan, nimotuzumab, bevacizumab, cilengitide 2000mg/2/week, cytokine-induced killer cell immunotherapy, and the Stupp protocol. In terms of serious adverse effects, the intervention group showed a 29% increase in the incidence of adverse events compared with the control group (patients treated only with Stupp protocol) with a statistically significant difference (RR=1.29; 95%CI 1.17-1.43; P<0.001). The most common adverse events were thrombocytopenia, lymphopenia, neutropenia, pneumonia, nausea, and vomiting, none of which were significantly different between the groups except for neutropenia, pneumonia, and embolism. All intervention drugs evaluated in our study were superior to the Stupp protocol alone when used in combination with it. However, we could not conclusively confirm whether cilengitide 2000mg/5/week was the optimum regime, as only one trial using this protocol was included in our study. Copyright © 2017. Published by Elsevier B.V.

  4. Improving Transition to Employment for Youth With Physical Disabilities: Protocol for a Peer Electronic Mentoring Intervention.

    Science.gov (United States)

    Lindsay, Sally; Stinson, Jennifer; Stergiou-Kita, Mary; Leck, Joanne

    2017-11-16

    Although youth with disabilities have much to gain from employment readiness programs, they are often excluded from or have limited access to vocational programs. One encouraging approach to address gaps in vocational programming is through peer electronic mentoring (e-mentoring), which may facilitate a smoother transition to adulthood by offering support to enhance coping skills. Despite the increase in online communities, little is known about their impact on vocational mentoring for youth with physical disabilities and their parents. The aim of this paper is to develop, implement, and assess the feasibility of an online peer mentor employment readiness intervention for youth with physical disabilities and their parents to improve their self-determination, career maturity, and social support compared to controls. A mixed-methods feasibility randomized controlled trial (RCT) design will be conducted to develop and assess the feasibility, acceptability, and initial efficacy of the "Empowering Youth Towards Employment" intervention. Youth (aged 15 to 25) with physical disabilities and their parents will be randomly assigned to a control or experimental group (4-week, interactive intervention, moderated by peer mentors). Data collection is in progress. Planned analyses include pre-post measures to determine the impact of the intervention on self-determination, career maturity, and social support. A qualitative thematic analysis of the discussion forums will complement the surveys to better understand why certain outcomes may have occurred. Our intervention includes evidence-informed content and was co-created by a multi-disciplinary group of researchers and knowledge users. It has the potential for widespread implications as a cost-effective resource to supplement educational and vocational programming for youth with disabilities. Clinicaltrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58

  5. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782

  6. Using a theory driven approach to develop and evaluate a complex mental health intervention: the friendship bench project in Zimbabwe.

    Science.gov (United States)

    Chibanda, Dixon; Verhey, Ruth; Munetsi, Epiphany; Cowan, Frances M; Lund, Crick

    2016-01-01

    There is a paucity of data on how to deliver complex interventions that seek to reduce the treatment gap for mental disorders, particularly in sub-Saharan Africa. The need for well-documented protocols which clearly describe the development and the scale-up of programs and interventions is necessary if such interventions are to be replicated elsewhere. This article describes the use of a theory of change (ToC) model to develop a brief psychological intervention for common mental disorders and its' evaluation through a cluster randomized controlled trial in Zimbabwe. A total of eight ToC workshops were held with a range of stakeholders over a 6-month period with a focus on four key components of the program: formative work, piloting, evaluation and scale-up. A ToC map was developed as part of the process with defined causal pathways leading to the desired impact. Interventions, indicators, assumptions and rationale for each point along the causal pathway were considered. Political buy-in from stakeholders together with key resources, which included human, facility/infrastructure, communication and supervision were identified as critical needs using the ToC approach. Ten (10) key interventions with specific indicators, assumptions and rationale formed part of the final ToC map, which graphically illustrated the causal pathway leading to the development of a psychological intervention and the successful implementation of a cluster randomized controlled trial. ToC workshops can enhance stakeholder engagement through an iterative process leading to a shared vision that can improve outcomes of complex mental health interventions particularly where scaling up of the intervention is desired.

  7. Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS).

    Science.gov (United States)

    Hurley, Deirdre A; Murphy, Laura Currie; Hayes, David; Hall, Amanda M; Toomey, Elaine; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Matthews, James

    2016-04-26

    The Medical Research Council framework provides a useful general approach to designing and evaluating complex interventions, but does not provide detailed guidance on how to do this and there is little evidence of how this framework is applied in practice. This study describes the use of intervention mapping (IM) in the design of a theory-driven, group-based complex intervention to support self-management (SM) of patients with osteoarthritis (OA) and chronic low back pain (CLBP) in Ireland's primary care health system. The six steps of the IM protocol were systematically applied to develop the self-management of osteoarthritis and low back pain through activity and skills (SOLAS) intervention through adaptation of the Facilitating Activity and Self-management in Arthritis (FASA) intervention. A needs assessment including literature reviews, interviews with patients and physiotherapists and resource evaluation was completed to identify the programme goals, determinants of SM behaviour, consolidated definition of SM and required adaptations to FASA to meet health service and patient needs and the evidence. The resultant SOLAS intervention behavioural outcomes, performance and change objectives were specified and practical application methods selected, followed by organised programme, adoption, implementation and evaluation plans underpinned by behaviour change theory. The SOLAS intervention consists of six weekly sessions of 90-min education and exercise designed to increase participants' physical activity level and use of evidence-based SM strategies (i.e. pain self-management, pain coping, healthy eating for weight management and specific exercise) through targeting of individual determinants of SM behaviour (knowledge, skills, self-efficacy, fear, catastrophizing, motivation, behavioural regulation), delivered by a trained physiotherapist to groups of up to eight individuals using a needs supportive interpersonal style based on self-determination theory

  8. Can complex health interventions be evaluated using routine clinical and administrative data? - a realist evaluation approach.

    Science.gov (United States)

    Riippa, Iiris; Kahilakoski, Olli-Pekka; Linna, Miika; Hietala, Minni

    2014-12-01

    Interventions aimed at improving chronic care typically consist of multiple interconnected parts, all of which are essential to the effect of the intervention. Limited attention has been paid to the use of routine clinical and administrative data in the evolution of these complex interventions. The purpose of this study is to examine the feasibility of routinely collected data when evaluating complex interventions and to demonstrate how a theory-based, realist approach to evaluation may increase the feasibility of routine data. We present a case study of evaluating a complex intervention, namely, the chronic care model (CCM), in Finnish primary health care. Issues typically faced when evaluating the effects of a complex intervention on health outcomes and resource use are identified by using routine data in a natural setting, and we apply context-mechanism-outcome (CMO) approach from the realist evaluation paradigm to improve the feasibility of using routine data in evaluating complex interventions. From an experimentalist approach that dominates the medical literature, routine data collected from a single centre offered a poor starting point for evaluating complex interventions. However, the CMO approach offered tools for identifying indicators needed to evaluate complex interventions. Applying the CMO approach can aid in a typical evaluation setting encountered by primary care managers: one in which the intervention is complex, the primary data source is routinely collected clinical and administrative data from a single centre, and in which randomization of patients into two research arms is too resource consuming to arrange. © 2014 John Wiley & Sons, Ltd.

  9. Identifying the content of home-based health behaviour change interventions for frail older people: a systematic review protocol.

    Science.gov (United States)

    Jovicic, Ana; Gardner, Benjamin; Belk, Celia; Kharicha, Kalpa; Iliffe, Steve; Manthorpe, Jill; Goodman, Claire; Drennan, Vari; Walters, Kate

    2015-11-04

    Meeting the needs of the growing number of older people is a challenge for health and social care services. Home-based interventions aiming to modify health-related behaviours of frail older people have the potential to improve functioning and well-being. Previous reviews have focused on whether such interventions are effective, rather than what might make them effective. Recent advances in behavioural science make possible the identification of potential 'active ingredients' of effective interventions, such as component behaviour change techniques (BCTs), and intended intervention functions (IFs; e.g. to educate, to impart skills). This paper reports a protocol for a systematic review that seeks to (a) identify health behaviour change interventions for older frail people, (b) describe the content of these interventions, and (c) explore links between intervention content and effectiveness. The protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) 2015 guidelines. Studies will be identified through a systematic search of 15 electronic databases, supplemented by citation tracking. Studies will be retained for review where they report randomised controlled trials focusing on home-based health promotion delivered by a health professional for frail older people in community settings, written in English, and either published from 1980 onwards, or, for registered trials only, unpublished but completed with results obtainable from authors. Interventions will be coded for their content (BCTs, IFs) and for evidence of effectiveness (outcome data relating to behavioural and health outcomes). Analyses will describe characteristics of all interventions. Interventions for which effectiveness data are available will be categorised into those showing evidence of effectiveness versus those showing no such evidence. The potential for each intervention characteristic to contribute to change in behaviour or

  10. 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.

  11. Development of an Evidence-Informed Blog to Promote Healthy Eating Among Mothers: Use of the Intervention Mapping Protocol.

    Science.gov (United States)

    Dumas, Audrée-Anne; Lemieux, Simone; Lapointe, Annie; Provencher, Véronique; Robitaille, Julie; Desroches, Sophie

    2017-05-19

    Low adherence to dietary guidelines and a concurrent rise of obesity-related chronic diseases emphasize the need for effective interventions to promote healthy eating. There is growing recognition that behavior change interventions should draw on theories of behavior change. Online interventions grounded in theory lead to increased effectiveness for health behavior change; however, few theory-driven social media-based health promotion interventions have been described in the literature. The objective of this study was to describe the application of the Intervention Mapping (IM) protocol to develop an evidence-informed blog to promote healthy eating among French-Canadian mothers of preschool and school-aged children. The following six steps of the IM protocol were performed. In Step 1, a preliminary needs assessment included a literature search on theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults (ie, knowledge, beliefs about capabilities, beliefs about consequences, intention/goals) and a qualitative study including focus groups to identify female Internet users' perceptions of their use of healthy eating blogs. In Step 2, two behavioral outcomes were selected (ie, increase daily intakes of Vegetables and Fruits and Milk and Alternatives of mothers to reach Canadian dietary recommendations) and subsequently divided into six performance objectives inspired by national and international dietary recommendations such as planning for healthy meals. A matrix of change objectives was then created by crossing performance objectives with theoretical domains predicting Vegetables and Fruits intakes and Milk and Alternatives intakes in adults. Step 3 consisted of selecting theory-based intervention methods (eg, modeling and goal setting) and translating them into practical applications for the context of a dietary intervention delivered through a blog. A 6-month intervention was developed in Step 4 in which we aimed to

  12. Intervention complexity--a conceptual framework to inform priority-setting in health.

    Science.gov (United States)

    Gericke, Christian A; Kurowski, Christoph; Ranson, M Kent; Mills, Anne

    2005-04-01

    Health interventions vary substantially in the degree of effort required to implement them. To some extent this is apparent in their financial cost, but the nature and availability of non-financial resources is often of similar importance. In particular, human resource requirements are frequently a major constraint. We propose a conceptual framework for the analysis of interventions according to their degree of technical complexity; this complements the notion of institutional capacity in considering the feasibility of implementing an intervention. Interventions are categorized into four dimensions: characteristics of the basic intervention; characteristics of delivery; requirements on government capacity; and usage characteristics. The analysis of intervention complexity should lead to a better understanding of supply- and demand-side constraints to scaling up, indicate priorities for further research and development, and can point to potential areas for improvement of specific aspects of each intervention to close the gap between the complexity of an intervention and the capacity to implement it. The framework is illustrated using the examples of scaling up condom social marketing programmes, and the DOTS strategy for tuberculosis control in highly resource-constrained countries. The framework could be used as a tool for policy-makers, planners and programme managers when considering the expansion of existing projects or the introduction of new interventions. Intervention complexity thus complements the considerations of burden of disease, cost-effectiveness, affordability and political feasibility in health policy decision-making. Reducing the technical complexity of interventions will be crucial to meeting the health-related Millennium Development Goals.

  13. Implementing trials of complex interventions in community settings: The USC – Rancho Los Amigos Pressure Ulcer Prevention Study (PUPS)

    Science.gov (United States)

    Clark, Florence; Pyatak, Elizabeth A.; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B.; Garber, Susan L.; Diaz, Jesus; Florindez, Lucia I.; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

    2014-01-01

    Background Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)–Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to: (a) participant recruitment and retention, (b) intervention delivery and fidelity, (c) randomization and assessment, and (d) potential inadvertent treatment effects. Purpose We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Method Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. Results PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accord

  14. Implementing trials of complex interventions in community settings: the USC-Rancho Los Amigos pressure ulcer prevention study (PUPS).

    Science.gov (United States)

    Clark, Florence; Pyatak, Elizabeth A; Carlson, Mike; Blanche, Erna Imperatore; Vigen, Cheryl; Hay, Joel; Mallinson, Trudy; Blanchard, Jeanine; Unger, Jennifer B; Garber, Susan L; Diaz, Jesus; Florindez, Lucia I; Atkins, Michal; Rubayi, Salah; Azen, Stanley Paul

    2014-04-01

    Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we

  15. Evaluating complex health financing interventions: using mixed methods to inform further implementation of a novel PBI intervention in rural Malawi.

    Science.gov (United States)

    McMahon, Shannon A; Brenner, Stephan; Lohmann, Julia; Makwero, Christopher; Torbica, Aleksandra; Mathanga, Don P; Muula, Adamson S; De Allegri, Manuela

    2016-08-19

    Gaps remain in understanding how performance-based incentive (PBI) programs affect quality of care and service quantity, whether programs are cost effective and how programs could be tailored to meet client and provider needs while remaining operationally viable. In 2014, Malawi's Ministry of Health launched the Service Delivery Integration-PBI (SSDI-PBI) program. The program is unique in that no portion of performance bonuses are paid to individual health workers, and it shifts responsibility for infrastructure and equipment procurement from facility staff to implementing partners. This protocol outlines an approach that analyzes processes and outcomes, considers expected and unexpected consequences of the program and frames the program's outputs relative to its costs. Findings from this evaluation will inform the intended future scale-up of PBI in Malawi. This study employs a prospective controlled before-and-after triangulation design to assess effects of the PBI program by analyzing quantitative and qualitative data from intervention and control facilities. Guided by a theoretical framework, the evaluation consists of four main components: service provision, health worker motivation, implementation processes and costing. Quality and access outcomes are assessed along four dimensions: (1) structural elements (related to equipment, drugs, staff); (2) process elements (providers' compliance with standards); (3) outputs (service utilization); (4) experiential elements (experiences of service delivery). The costing component includes costs related to start-up, ongoing management, and the cost of incentives themselves. The cost analysis considers costs incurred within the Ministry of Health, funders, and the implementing agency. The evaluation relies on primary data (including interviews and surveys) and secondary data (including costing and health management information system data). Through the lens of a PBI program, we illustrate how complex interventions can be

  16. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons--a narrative review.

    Science.gov (United States)

    Goisser, Sabine; Kemmler, Wolfgang; Porzel, Simone; Volkert, Dorothee; Sieber, Cornel Christian; Bollheimer, Leo Cornelius; Freiberger, Ellen

    2015-01-01

    One of the many threats to independent life is the age-related loss of muscle mass and muscle function commonly referred to as sarcopenia. Another important health risk in old age leading to functional decline is obesity. Obesity prevalence in older persons is increasing, and like sarcopenia, severe obesity has been consistently associated with several negative health outcomes, disabilities, falls, and mobility limitations. Both sarcopenia and obesity pose a health risk for older persons per se, but in combination, they synergistically increase the risk for negative health outcomes and an earlier onset of disability. This combination of sarcopenia and obesity is commonly referred to as sarcopenic obesity. The present narrative review reports the current knowledge on the effects of complex interventions containing nutrition and exercise interventions in community-dwelling older persons with sarcopenic obesity. To date, several complex interventions with different outcomes have been conducted and have shown promise in counteracting either sarcopenia or obesity, but only a few studies have addressed the complex syndrome of sarcopenic obesity. Strong evidence exists on exercise interventions in sarcopenia, especially on strength training, and for obese older persons, strength exercise in combination with a dietary weight loss intervention demonstrated positive effects on muscle function and body fat. The differences in study protocols and target populations make it impossible at the moment to extract data for a meta-analysis or give state-of-the-art recommendations based on reliable evidence. A conclusion that can be drawn from this narrative review is that more exercise programs containing strength and aerobic exercise in combination with dietary interventions including a supervised weight loss program and/or protein supplements should be conducted in order to investigate possible positive effects on sarcopenic obesity.

  17. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons – a narrative review

    Science.gov (United States)

    Goisser, Sabine; Kemmler, Wolfgang; Porzel, Simone; Volkert, Dorothee; Sieber, Cornel Christian; Bollheimer, Leo Cornelius; Freiberger, Ellen

    2015-01-01

    One of the many threats to independent life is the age-related loss of muscle mass and muscle function commonly referred to as sarcopenia. Another important health risk in old age leading to functional decline is obesity. Obesity prevalence in older persons is increasing, and like sarcopenia, severe obesity has been consistently associated with several negative health outcomes, disabilities, falls, and mobility limitations. Both sarcopenia and obesity pose a health risk for older persons per se, but in combination, they synergistically increase the risk for negative health outcomes and an earlier onset of disability. This combination of sarcopenia and obesity is commonly referred to as sarcopenic obesity. The present narrative review reports the current knowledge on the effects of complex interventions containing nutrition and exercise interventions in community-dwelling older persons with sarcopenic obesity. To date, several complex interventions with different outcomes have been conducted and have shown promise in counteracting either sarcopenia or obesity, but only a few studies have addressed the complex syndrome of sarcopenic obesity. Strong evidence exists on exercise interventions in sarcopenia, especially on strength training, and for obese older persons, strength exercise in combination with a dietary weight loss intervention demonstrated positive effects on muscle function and body fat. The differences in study protocols and target populations make it impossible at the moment to extract data for a meta-analysis or give state-of-the-art recommendations based on reliable evidence. A conclusion that can be drawn from this narrative review is that more exercise programs containing strength and aerobic exercise in combination with dietary interventions including a supervised weight loss program and/or protein supplements should be conducted in order to investigate possible positive effects on sarcopenic obesity. PMID:26346071

  18. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  19. On the Amortized Complexity of Zero Knowledge Protocols for Multiplicative Relations

    DEFF Research Database (Denmark)

    Cramer, Ronald; Damgård, Ivan Bjerre; Pastro, Valerio

    2012-01-01

    We present a protocol that allows to prove in zero-knowledge that committed values xi, yi, zi, i = 1,…,l satisfy xiyi = zi, where the values are taken from a finite field. For error probability 2− u the size of the proof is linear in u and only logarithmic in l. Therefore, for any fixed error...... theoretically secure. Using this type of commitments we obtain, in the preprocessing model, a perfect zero-knowledge interactive proof for circuit satisfiability of circuit C where the proof has size O(|C|). We then generalize our basic scheme to a protocol that verifies l instances of an algebraic circuit D...... over K with v inputs, in the following sense: given committed values xi,j and zi, with i = 1,…,l and j = 1,…,v, the prover shows that D(xi,1,…,xi,v) = zi for i = 1,…,l. The interesting property is that the amortized complexity of verifying one circuit only depends on the multiplicative depth...

  20. A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol.

    Science.gov (United States)

    Stow, Ruth; Rushton, Alison; Ives, Natalie; Smith, Christina; Rick, Caroline

    2015-01-01

    Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%-42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability. Trial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20-25 g. The primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite. The complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this

  1. Audit protocol of compliance test on x-ray and interventional radiodiagnostic

    International Nuclear Information System (INIS)

    Endang Kunarsih; Fitria Sandra

    2011-01-01

    Testing protocol is a document that defined and implemented by the testing agency in conducting compliance testing to ensure that quality of testing implementation is planned and controlled in accordance with applicable regulations and standards. Testing protocol is required in filing an application to be a qualified testing agency. Auditors will review the testing protocol document to assess adequacy of the acceptance criteria before proceed to the next process. This paper presents the acceptance criteria required in an audit of the testing protocol document from the applicant of testing agency. (author)

  2. Surgical intervention of complex endo-perio lesions.

    Science.gov (United States)

    Adcock, John E; Bright, David

    2007-08-01

    Complex endo-perio lesions are infrequent, but pose treatment dilemmas. The lesions are complex with bone loss involving adjacent teeth that are not part of the initial endodontic lesion. The aggressive bone loss is not clearly understood and apparently has some differences from the usual apical periodontitis.

  3. Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

    Science.gov (United States)

    Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

    2015-12-04

    Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

  4. AHRQ series on complex intervention systematic reviews-paper 7: PRISMA-CI elaboration and explanation.

    Science.gov (United States)

    Guise, Jeanne-Marie; Butler, Mary; Chang, Christine; Viswanathan, Meera; Pigott, Terri; Tugwell, Peter

    2017-10-01

    Complex interventions are widely used in health care, public health, education, criminology, social work, business, and welfare. They have increasingly become the subject of systematic reviews and are challenging to effectively report. The Complex Interventions Methods Workgroup developed an extension to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Complex Interventions (PRISMA-CI). Following the EQUATOR Network guidance for Preferred Reporting Items for Systematic Reviews and Meta-Analysis extensions, this Explanation and Elaboration (EE) document accompanies the PRISMA-CI checklist to promote consistency in reporting of systematic reviews of complex interventions. The EE document explains the meaning and rationale for each unique PRISMA-CI checklist item and provides examples to assist systematic review authors in operationalizing PRISMA-CI guidance. The Complex Interventions Workgroup developed PRISMA-CI as an important start toward increased consistency in reporting of systematic reviews of complex interventions. Because the field is rapidly expanding, the Complex Interventions Methods Workgroup plans to re-evaluate periodically for the need to add increasing specificity and examples as the field matures. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  5. Understanding the implementation of complex interventions in health care: the normalization process model

    Directory of Open Access Journals (Sweden)

    Rogers Anne

    2007-09-01

    Full Text Available Abstract Background The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice. Methods A formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions. Results The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration. Conclusion The model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.

  6. Using the Intervention Mapping protocol to develop a family-based intervention for improving lifestyle habits among overweight and obese children: study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Stea, Tonje Holte; Haugen, Tommy; Berntsen, Sveinung; Guttormsen, Vigdis; Øverby, Nina Cecilie; Haraldstad, Kristin; Meland, Eivind; Abildsnes, Eirik

    2016-10-18

    In light of the high prevalence of childhood overweight and obesity, there is a need of developing effective prevention programs to address the rising prevalence and the concomitant health consequences. The main aim of the present study is to systematically develop and implement a tailored family-based intervention for improving lifestyle habits among overweight and obese children, aged 6-10 years old, enhancing parental self-efficacy, family engagement and parent-child interaction. A subsidiary aim of the intervention study is to reduce the prevalence of overweight and obesity among those participating in the intervention study. The Intervention Mapping protocol was used to develop a tailored family-based intervention for improving lifestyle habits among overweight and obese children. In order to gather information on local opportunities and barriers, interviews with key stakeholders and a 1-year pilot study was conducted. The main study has used a quasi-experimental controlled design. Locally based Healthy Life Centers and Public Health Clinics are responsible for recruiting families and conducting the intervention. The effect of the study will be measured both at completion of the 6 months intervention study and 6 and 18 months after the intervention period. An ecological approach was used as a basis for developing the intervention. The behavioral models and educational strategies include individual family counselling meetings, workshops focusing on regulation of family life, nutrition courses, and physical activity groups providing tailored information and practical learning sessions. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. A systematic and evidence-based approach was used for development of this family-based intervention study targeting overweight and obese children, 6-10 years old. This program, if feasible and effective, may be adjusted to local contexts and

  7. Health-social partnership intervention programme for community-dwelling older adults: a research protocol for a randomized controlled trial.

    Science.gov (United States)

    Wong, Kwan Ching; Wong, Frances Kam Yuet; Chang, Katherine Ka Pik

    2015-11-01

    This paper aims to describe the research protocol that will be used to determine the effectiveness of a health-social partnership intervention programme among community-dwelling older adults. Ageing in place is a preferred option for overcoming challenges of the increasing prevalence of chronic diseases and the risk for hospitalization associated with the ageing population. Nevertheless, our knowledge of how to implement this concept is limited. The integrated efforts of health and social services may help to enable older adults to live with a sense of control over their daily life and to be independent to the fullest extent possible in the community. This is a randomized, controlled trial. Participants are community-dwelling older adults referred from a community centre. Sample size calculation was based on power analysis. The intervention group will receive the programme with the standard protocols guided by a comprehensive assessment-intervention-evaluation framework. Home visits and telephones follow-up will be employed as means of conducting the interventions and monitoring their progress. The customary care group will receive placebo social calls. The duration of the interventions will be 3 months. The study was funded by the School of Nursing in Hong Kong. Research Ethics Committee approval was obtained in September 2014. The results of this research are expected to enable older adults to stay in the community with optimal health and well-being. Health and social sciences are integrated into the practice in this research protocol. The scarce literature on this topic means that this study can also provide an opportunity to bridge the caring gap among older adults. © 2015 John Wiley & Sons Ltd.

  8. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    Science.gov (United States)

    2012-01-01

    Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years) entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT) with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow-up. Discussion The present study

  9. A web-based computer-tailored smoking prevention programme for primary school children: intervention design and study protocol

    Directory of Open Access Journals (Sweden)

    Cremers Henricus-Paul

    2012-06-01

    Full Text Available Abstract Background Although the number of smokers has declined in the last decade, smoking is still a major health problem among youngsters and adolescents. For this reason, there is a need for effective smoking prevention programmes targeting primary school children. A web-based computer-tailored feedback programme may be an effective intervention to stimulate youngsters not to start smoking, and increase their knowledge about the adverse effects of smoking and their attitudes and self-efficacy regarding non-smoking. Methods & design This paper describes the development and evaluation protocol of a web-based out-of-school smoking prevention programme for primary school children (age 10-13 years entitled ‘Fun without Smokes’. It is a transformation of a postal mailed intervention to a web-based intervention. Besides this transformation the effects of prompts will be examined. This web-based intervention will be evaluated in a 2-year cluster randomised controlled trial (c-RCT with three study arms. An intervention and intervention + prompt condition will be evaluated for effects on smoking behaviour, compared with a no information control condition. Information about pupils’ smoking status and other factors related to smoking will be obtained using a web-based questionnaire. After completing the questionnaire pupils in both intervention conditions will receive three computer-tailored feedback letters in their personal e-mail box. Attitudes, social influences and self-efficacy expectations will be the content of these personalised feedback letters. Pupils in the intervention + prompt condition will - in addition to the personalised feedback letters - receive e-mail and SMS messages prompting them to revisit the ‘Fun without Smokes’ website. The main outcome measures will be ever smoking and the utilisation of the ‘Fun without Smokes’ website. Measurements will be carried out at baseline, 12 months and 24 months of follow

  10. Systematic review protocol of interventions to improve the psychological well-being of general practitioners.

    Science.gov (United States)

    Murray, Marylou; Murray, Lois; Donnelly, Michael

    2015-09-22

    The challenges and complexities faced by general practitioners are increasing, and there are concerns about their well-being. Consequently, attention has been directed towards developing and evaluating interventions and strategies to improve general practitioner well-being and their capacity to cope with workplace challenges. This systematic review aims to evaluate research evidence regarding the effectiveness of interventions designed to improve general practitioner well-being. Eligible studies will include programmes developed to improve psychological well-being that have assessed outcomes using validated tools pertaining to well-being and related outcomes. Only programmes that have been evaluated using controlled study designs will be reviewed. An appropriately developed search strategy will be applied to six electronic databases: the Cochrane Database of Systematic Reviews, MEDLINE, Embase, CINAHL, PsycINFO and Web of Science. Studies will be screened in two stages by two independent reviewers. A third reviewer will arbitrate when required. Pre-specified inclusion and exclusion criteria will be assessed during a pilot phase early on in the review process. The Cochrane data extraction form will be adapted and applied to each eligible study by two independent reviewers, and each study will be appraised critically using standardised checklists from the Cochrane Handbook. Methodological quality will be taken into account in the analysis of the data and the synthesis of results. A narrative synthesis will be undertaken if data is unsuited to a meta-analysis. The systematic review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidance. This will be the first systematic review on this topic, and the evidence synthesis will aid decision-making by general practitioners, policy makers and planners regarding ways in which to improve GP well-being. Findings will be disseminated at general practitioner meetings

  11. Feasibility and Preliminary Effectiveness of the Homework Intervention Strategy (eHIS) Program to Enhance Male Condom Use: Research Protocol.

    Science.gov (United States)

    Glowacka, Marta; Yardley, Lucy; Stone, Nicole; Graham, Cynthia A

    2018-01-02

    Although condoms are effective in reducing the risk of sexually transmitted infections (STIs) and unintended pregnancy, they are still often not used consistently and correctly. Negative impact on sensation and pleasure, ruining the mood, causing problems with maintaining erection, and condom slippage or breakage are some of the reasons given by men explaining why they do not want to use condoms. Although many interventions promoting condom use exist, some of them delivered online are complex and time- and resource-intensive. The Homework Intervention Strategy (eHIS) program, adapted from the existing face-to-face Kinsey Institute Homework Intervention Strategy (KIHIS) program, aims to address these issues by encouraging men to focus on sensation and pleasure when trying different types of condoms and lubricants in a low-pressure situation (on their own, without a partner present). The objectives of this study are to assess the feasibility, acceptability, and users' engagement with the eHIS program, its preliminary effectiveness in increasing condom use frequency and consistency, as well as the feasibility of the program's evaluation approach, including choice of measures and participant recruitment and retaining strategies (primary outcomes). Secondary outcomes include condom use experience, condom use attitudes, condom use self-efficacy, condom use errors and problems, and condom fit-and-feel. All of these will be analyzed in the context of participants' demographics, sexual history, and previous condom use. The study has a pre-post-test, within-subjects design. Men aged 18 to 69 and living in the United Kingdom are recruited through posters, leaflets, social media, and emails. Study participants are asked to complete T1 (baseline) measures before entering the eHIS website. After completing the T1 measures, they can order a free condoms and lubricants kit and have access to the eHIS website for 4 weeks. During that time they are asked to practice using different

  12. Theory, training and timing: psychosocial interventions in complex emergencies.

    Science.gov (United States)

    Yule, William

    2006-06-01

    The Asian tsunami of December 2004 galvanised mental health and emergency agencies in a way that no other recent disaster has done. The loss of life and forced migration focused national and international agencies on the need to provide appropriate psychosocial care from the very beginning. The prior academic arguments surrounding early intervention paled into insignificance against the urgent need to reduce distress and prevent chronic mental health problems. This chapter notes that there was a major, planned and early intervention following the earthquake in Bam, exactly one year earlier. The lessons from that are only now beginning to filter through and help shape better responses to disasters. It is argued that too many non-governmental organizations (NGOs) and even IGOs are following theoretical positions that have little empirical justification. There is an urgent need for training for mental health and NGO personnel alike to deliver evidence-based psychological first aid. There is no justification for mental health responses to be delayed until weeks after a disaster happens.

  13. Intervention complexity--a conceptual framework to inform priority-setting in health.

    Science.gov (United States)

    Gericke, Christian A.; Kurowski, Christoph; Ranson, M. Kent; Mills, Anne

    2005-01-01

    Health interventions vary substantially in the degree of effort required to implement them. To some extent this is apparent in their financial cost, but the nature and availability of non-financial resources is often of similar importance. In particular, human resource requirements are frequently a major constraint. We propose a conceptual framework for the analysis of interventions according to their degree of technical complexity; this complements the notion of institutional capacity in considering the feasibility of implementing an intervention. Interventions are categorized into four dimensions: characteristics of the basic intervention; characteristics of delivery; requirements on government capacity; and usage characteristics. The analysis of intervention complexity should lead to a better understanding of supply- and demand-side constraints to scaling up, indicate priorities for further research and development, and can point to potential areas for improvement of specific aspects of each intervention to close the gap between the complexity of an intervention and the capacity to implement it. The framework is illustrated using the examples of scaling up condom social marketing programmes, and the DOTS strategy for tuberculosis control in highly resource-constrained countries. The framework could be used as a tool for policy-makers, planners and programme managers when considering the expansion of existing projects or the introduction of new interventions. Intervention complexity thus complements the considerations of burden of disease, cost-effectiveness, affordability and political feasibility in health policy decision-making. Reducing the technical complexity of interventions will be crucial to meeting the health-related Millennium Development Goals. PMID:15868020

  14. The value of arthroscopy in the treatment of complex ankle fractures - a protocol of a randomised controlled trial.

    Science.gov (United States)

    Braunstein, Mareen; Baumbach, Sebastian F; Regauer, Markus; Böcker, Wolfgang; Polzer, Hans

    2016-05-12

    An anatomical reconstruction of the ankle congruity is the important prerequisite in the operative treatment of acute ankle fractures. Despite anatomic restoration patients regularly suffer from residual symptoms after these fractures. There is growing evidence, that a poor outcome is related to the concomitant traumatic intra-articular pathology. By supplementary ankle arthroscopy anatomic reduction can be confirmed and associated intra-articular injuries can be treated. Nevertheless, the vast majority of complex ankle fractures are managed by open reduction and internal fixation (ORIF) only. Up to now, the effectiveness of arthroscopically assisted fracture treatment (AORIF) has not been conclusively determined. Therefore, a prospective randomised study is needed to sufficiently evaluate the effect of AORIF compared to ORIF in complex ankle fractures. We perform a randomised controlled trial at Munich University Clinic enrolling patients (18-65 years) with an acute ankle fracture (AO 44 A2, A3, B2, B3, C1 - C3 according to AO classification system). Patients meeting the inclusion criteria are randomised to either intervention group (AORIF, n = 37) or comparison group (ORIF, n = 37). Exclusion criteria are fractures classified as AO type 44 A1 or B1, pilon or plafond-variant injury or open fractures. Primary outcome is the AOFAS Score (American Orthopaedic Foot and Ankle Society). Secondary outcome parameter are JSSF Score (Japanese Society of Surgery of the Foot), Olerud and Molander Score, Karlsson Score, Tegner Activity Scale, SF-12, radiographic analysis, arthroscopic findings of intra-articular lesions, functional assessments, time to return to work/sports and complications. This study protocol is accordant to the SPIRIT 2013 recommendation. Statistical analysis will be performed using SPSS 22.0 (IBM). The subjective and functional outcome of complex ankle fractures is regularly unsatisfying. As these injuries are very common it is essential to

  15. Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol.

    Science.gov (United States)

    Connolly, Bronwen; O'Neill, Brenda; Salisbury, Lisa; McDowell, Kathryn; Blackwood, Bronagh

    2015-09-29

    Patients admitted to the intensive care unit with critical illness often experience significant physical impairments, which typically persist for many years following resolution of the original illness. Physical rehabilitation interventions that enhance restoration of physical function have been evaluated across the continuum of recovery following critical illness including within the intensive care unit, following discharge to the ward and beyond hospital discharge. Multiple systematic reviews have been published appraising the expanding evidence investigating these physical rehabilitation interventions, although there appears to be variability in review methodology and quality. We aim to conduct an overview of existing systematic reviews of physical rehabilitation interventions for adult intensive care patients across the continuum of recovery. This protocol has been developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. We will search the Cochrane Systematic Review Database, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials, MEDLINE, Excerpta Medica Database and Cumulative Index to Nursing and Allied Health Literature databases. We will include systematic reviews of randomised controlled trials of adult patients, admitted to the intensive care unit and who have received physical rehabilitation interventions at any time point during their recovery. Data extraction will include systematic review aims and rationale, study types, populations, interventions, comparators, outcomes and quality appraisal method. Primary outcomes of interest will focus on findings reflecting recovery of physical function. Quality of reporting and methodological quality will be appraised using the PRISMA checklist and the Assessment of Multiple Systematic Reviews tool. We anticipate the findings from this novel overview of systematic reviews will contribute to the

  16. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Harvey, Allison G; Dong, Lu; Lee, Jason Y; Gumport, Nicole B; Hollon, Steven D; Rabe-Hesketh, Sophia; Hein, Kerrie; Haman, Kirsten; McNamara, Mary E; Weaver, Claire; Martinez, Armando; Notsu, Haruka; Zieve, Garret; Armstrong, Courtney C

    2017-11-14

    The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT). Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings. ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.

  17. Effect of two complex training protocols of back squats in blood indicators of muscular damage in military athletes.

    Science.gov (United States)

    Ojeda, Álvaro Huerta; Ríos, Luis Chirosa; Barrilao, Rafael Guisado; Ríos, Ignacio Chirosa; Serrano, Pablo Cáceres

    2016-05-01

    [Purpose] The aim of this study was to determine the variations in the blood muscular damage indicators post application of two complex training programs for back squats. [Subjects and Methods] Seven military athletes were the subjects of this study. The study had a quasi-experimental cross-over intra-subject design. Two complex training protocols were applied, and the variables to be measured were cortisol, metabolic creatine kinase, and total creatine kinase. For the statistical analysis, Student's t-test was used. [Results] Twenty-four hours post effort, a significant decrease in cortisol level was shown for both protocols; however, the metabolic creatine kinase and total creatine kinase levels showed a significant increase. [Conclusion] Both protocols lowered the indicator of main muscular damage in the blood supply (cortisol). This proved that the work weight did not generate significant muscular damage in the 24-hour post-exercise period.

  18. An exploration of clinical interventions provided by pharmacists within a complex asthma service

    OpenAIRE

    Lemay, Kate S.; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L.; Krass, Ines; Armour, Carol L.

    2015-01-01

    Background: Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service...

  19. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  20. Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Myles Judy

    2009-07-01

    service utilisation. Discussion This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments. Trial Registration ISRCTN 93681536

  1. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-01-01

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  2. Education: A Complex and Empowering Social Work Intervention at the End of Life

    Science.gov (United States)

    Cagle, John G.; Kovacs, Pamela J.

    2009-01-01

    Education is a frequently used social work intervention. Yet it seems to be an underappreciated and a deceptively complex intervention that social workers may not be adequately prepared to use. Reliable, accessible information is essential as it helps prevent unnecessary crises, facilitates coping, and promotes self-determination. This article…

  3. Reducing sick leave of Dutch vocational school students: adaptation of a sick leave protocol using the intervention mapping process.

    Science.gov (United States)

    de Kroon, Marlou L A; Bulthuis, Jozien; Mulder, Wico; Schaafsma, Frederieke G; Anema, Johannes R

    2016-12-01

    Since the extent of sick leave and the problems of vocational school students are relatively large, we aimed to tailor a sick leave protocol at Dutch lower secondary education schools to the particular context of vocational schools. Four steps of the iterative process of Intervention Mapping (IM) to adapt this protocol were carried out: (1) performing a needs assessment and defining a program objective, (2) determining the performance and change objectives, (3) identifying theory-based methods and practical strategies and (4) developing a program plan. Interviews with students using structured questionnaires, in-depth interviews with relevant stakeholders, a literature research and, finally, a pilot implementation were carried out. A sick leave protocol was developed that was feasible and acceptable for all stakeholders. The main barriers for widespread implementation are time constraints in both monitoring and acting upon sick leave by school and youth health care. The iterative process of IM has shown its merits in the adaptation of the manual 'A quick return to school is much better' to a sick leave protocol for vocational school students.

  4. A Pilot Study Involving the Effect of Two Different Complex Training Protocols on Lower Body Power

    Directory of Open Access Journals (Sweden)

    Smith Chad E.

    2014-09-01

    Full Text Available Purpose. Complex training (CT involves the coupling of two exercises ostensibly to enhance the effect of the second exercise. Typically, the first exercise is a strength exercise and the second exercise is a power exercise involving similar muscles. In most cases, CT is designed to enhance power. The purpose of this study was twofold. First, this study was designed to determine if lower body power could be enhanced using complex training protocols. Second, this study investigated whether the inclusion of a power exercise instead of a strength exercise as the first exercise in CT would produce differences in lower body power. Methods. Thirty-six recreationally-trained men and women aged 20 to 29 years attending a college physical education course were randomly assigned to one of three groups: squat and countermovement squat jumps (SSJ, kettlebell swings and countermovement squat jumps (KSJ, and a control (CON. Training involving CT lasted 6 weeks. All participants were pre- and posttested for vertical jump performance in order to assess lower body power. Results. Vertical jump scores improved for all groups (p < 0.01. The results also indicated that there were no statistically significant differences between group scores across time (p = 0.215. The statistical power for this analysis was low (0.312, most likely due to the small sample size. However, the results did reveal a trend suggesting that the training improvements were greater for both the SSJ and KSJ groups compared with the CON (by 171% and 107%, respectively although significance was not reached. Conclusions. Due to the observed trend, a replication of this study with a greater number of participants over a longer period of time is warranted.

  5. The effectiveness of workplace interventions to increase physical activity and decrease sedentary behaviour in adults: protocol for a systematic review.

    Science.gov (United States)

    Loitz, Christina C; Potter, Robert J; Walker, Jessica L; McLeod, Nicole C; Johnston, Nora J

    2015-12-12

    A physically active lifestyle plays a preventative role in the development of various chronic diseases and mental health conditions. Unfortunately, few adults achieve the minimum amount of physical activity and spend excessive time sitting. Developing targeted interventions to increase active living among adults is an important endeavour for public health. One plausible context to reach adults is the workplace. This systematic review aims to review the effectiveness of workplace interventions on increasing physical activity and decreasing sedentary behaviour in the workplace. An advisory group of practitioners will work in collaboration with the research team to inform the systematic review and knowledge mobilization. Fifteen electronic databases will be searched to identify studies examining the effectiveness of workplace interventions on physical activity and sedentary behaviour. All experimental designs and observational studies (non-experimental intervention studies) meeting the study criteria will be included. Studies examining generally healthy, employed, adult participants will be included for the review. Interventions will focus on increasing physical activity and/or decreasing sedentary behaviour from the individual to policy level. The primary outcome variables will be reported or observed physical activity and/or sedentary behaviour in the workplace. Secondary outcomes will include variables ranging from return on investment to quality of life. Study quality will be assessed for risk of bias following the protocol identified in the Cochrane Handbook for Systematic Reviews of Interventions and supplemented by the guidelines developed by the Cochrane Effective Practice and Organisation of Care group, using RevMan. The quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. Meta-analyses, forest plots, and harvest plots will be used where appropriate to assess the direction, size, and

  6. Conducting systematic reviews of intervention questions I: Writing the review protocol, formulating the question and searching the literature.

    Science.gov (United States)

    O'Connor, A M; Anderson, K M; Goodell, C K; Sargeant, J M

    2014-06-01

    This article is the fourth of six articles addressing systematic reviews in animal agriculture and veterinary medicine. Previous articles in the series have introduced systematic reviews, discussed study designs and hierarchies of evidence, and provided details on conducting randomized controlled trials, a common design for use in systematic reviews. This article describes development of a review protocol and the first two steps in a systematic review: formulating a review question, and searching the literature for relevant research. The emphasis is on systematic reviews of questions related to interventions. The review protocol is developed prior to conducting the review and specifies the plan for the conduct of the review, identifies the roles and responsibilities of the review team and provides structured definitions related to the review question. For intervention questions, the review question should be defined by the PICO components: population, intervention, comparison and outcome(s). The literature search is designed to identify all potentially relevant original research that may address the question. Search terms related to some or all of the PICO components are entered into literature databases, and searches for unpublished literature also are conducted. All steps of the literature search are documented to provide transparent reporting of the process. © 2014 Blackwell Verlag GmbH.

  7. An exploration of clinical interventions provided by pharmacists within a complex asthma service.

    Science.gov (United States)

    Lemay, Kate S; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L; Krass, Ines; Armour, Carol L

    2015-01-01

    Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions) they choose to deliver. To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient's asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service). The most frequently delivered interventions were in the themes 'Education on asthma', 'Addressing trigger factors', 'Medications - safe and effective use' and 'Explore patient perspectives'. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were able to use their clinical judgement to assess patients and provide clinical pharmacy

  8. An exploration of clinical interventions provided by pharmacists within a complex asthma service

    Science.gov (United States)

    Lemay, Kate S.; Saini, Bandana; Bosnic-Anticevich, Sinthia; Smith, Lorraine; Stewart, Kay; Emmerton, Lynne; Burton, Deborah L.; Krass, Ines; Armour, Carol L.

    2014-01-01

    Background: Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions) they choose to deliver. Objective: To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Methods: Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient’s asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Results: Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service). The most frequently delivered interventions were in the themes ’Education on asthma’, ’Addressing trigger factors’, ’Medications - safe and effective use’ and ’Explore patient perspectives’. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Conclusion: Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were able to use their

  9. An exploration of clinical interventions provided by pharmacists within a complex asthma service

    Directory of Open Access Journals (Sweden)

    LeMay KS

    2015-03-01

    Full Text Available Background: Pharmacists in Australia are accessible health care professionals, and their provision of clinical pharmacy interventions in a range of areas has been proven to improve patient outcomes. Individual clinical pharmacy interventions in the area of asthma management have been very successful. An understanding of the nature of these interventions will inform future pharmacy services. What we do not know is when pharmacists provide a complex asthma service, what elements of that service (interventions they choose to deliver. Objective: To explore the scope and frequency of asthma-related clinical interventions provided by pharmacists to patients in an evidence-based complex asthma service. Methods: Pharmacists from 4 states/territories of Australia were trained in asthma management. People with asthma had 3 or 4 visits to the pharmacy. Guided by a structured patient file, the pharmacist assessed the patient’s asthma and management and provided interventions where and when considered appropriate, based on their clinical decision making skills. The interventions were recorded in a checklist in the patient file. They were then analysed descriptively and thematically. Results: Pharmacists provided 22,909 clinical pharmacy interventions over the service to 570 patients (398 of whom completed the service. The most frequently delivered interventions were in the themes ‘Education on asthma’, ‘Addressing trigger factors’, ‘Medications – safe and effective use’ and ‘Explore patient perspectives’. The patients had a high and ongoing need for interventions. Pharmacists selected interventions based on their assessment of perceived need then revisited and reinforced these interventions. Conclusion: Pharmacists identified a number of areas in which patients required interventions to assist with their asthma management. Many of these were perceived to require continuing reinforcement over the duration of the service. Pharmacists were

  10. 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.

  11. A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

    Science.gov (United States)

    Nieuwsma, Jason A; Wray, Laura O; Voils, Corrine I; Gierisch, Jennifer M; Dundon, Margaret; Coffman, Cynthia J; Jackson, George L; Merwin, Rhonda; Vair, Christina; Juntilla, Karen; White-Clark, Courtney; Jeffreys, Amy S; Harris, Amy; Owings, Michael; Marr, Johnpatrick; Edelman, David

    2017-09-01

    Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.

  12. An interdisciplinary knowledge translation intervention in long-term care: Study protocol for the vitamin D and osteoporosis study (ViDOS pilot cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kennedy Courtney C

    2012-05-01

    Full Text Available Abstract Background Knowledge translation (KT research in long-term care (LTC is still in its early stages. This protocol describes the evaluation of a multifaceted, interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes. Methods and design The Vitamin D and Osteoporosis Study (ViDOS is underway in 40 LTC homes (n = 19 intervention, n = 21 control across Ontario, Canada. The primary objectives of this study are to assess the feasibility of delivering the KT intervention, and clinically, to increase the percent of LTC residents prescribed ≥800 IU of vitamin D daily. Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician. The target audience within each LTC home is the Professional Advisory Committee (PAC, an interdisciplinary team who meets quarterly. The key elements of the intervention are three interactive educational sessions led by an expert opinion leader, action planning using a quality improvement cycle, audit and feedback reports, nominated internal champions, and reminders/point-of-care tools. Control homes do not receive any intervention, however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy. Primary outcomes are feasibility measures (recruitment, retention, attendance at educational sessions, action plan items identified and initiated, internal champions identified, performance reports provided and reviewed, and vitamin D (≥800 IU/daily prescribing at 6 and 12 months. Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications, and falls and fractures. Qualitative methods will examine the experience of the LTC team with the KT intervention. Homes are centrally randomized to intervention and control groups in blocks of variable size using

  13. Health coaching interventions for persons with chronic conditions: a systematic review and meta-analysis protocol.

    Science.gov (United States)

    Boehmer, Kasey R; Barakat, Suzette; Ahn, Sangwoo; Prokop, Larry J; Erwin, Patricia J; Murad, M Hassan

    2016-09-01

    Chronic conditions are increasingly more common and negatively impact quality of life, disability, morbidity, and mortality. Health coaching has emerged as a possible intervention to help individuals with chronic conditions adopt health supportive behaviors that improve both quality of life and health outcomes. We planned a systematic review and meta-analysis of the contemporary health coaching literature published in the last decade to evaluate the effect of health coaching on clinically important, disease-specific, functional, and behavioral outcomes. We will include randomized controlled trials or quasi-experimental studies that compared health coaching to alternative interventions or usual care. To enable adoption of effective interventions, we aim to explore how the effect of intervention is modified by the intervention components, delivering personnel (i.e., health professionals vs trained lay or peer persons), dose, frequency, and setting. Analysis of intervention outcomes will be reported and classified using an existing theoretical framework, the Theory of Patient Capacity, to identify the areas of patients' capacity to access and use healthcare and enact self-care where coaching may be an effective intervention. This systematic review and meta-analysis will identify and synthesize evidence to inform the practice of health coaching by providing evidence on components and characteristics of the intervention essential for success in individuals with chronic health conditions. PROSPERO CRD42016039730.

  14. Effectiveness of interventions for the development of leadership skills among nurses: a systematic review protocol.

    Science.gov (United States)

    Darragh, Michael; Traynor, Victoria; Joyce-McCoach, Joanne

    2016-06-01

    What interventions are the most effective for the development of leadership skills for nurses?The review objective is to systematically review the evidence to identify the effectiveness of interventions for the development of leadership skills among nurses. Centre for Evidence-based Initiatives in Health Care - University of Wollongong: an Affiliate Center of the Joanna Briggs Institute.

  15. Sheltered Instruction Observation Protocol[R] (SIOP[R]). What Works Clearinghouse Intervention Report

    Science.gov (United States)

    What Works Clearinghouse, 2013

    2013-01-01

    The "Sheltered Instruction Observation Protocol"[R] ("SIOP"[R]) is a framework for planning and delivering instruction in content areas such as science, history, and mathematics to English language learners as well as other students. The goal of "SIOP"[R] is to help teachers integrate academic language development…

  16. Using logic model methods in systematic review synthesis: describing complex pathways in referral management interventions.

    Science.gov (United States)

    Baxter, Susan K; Blank, Lindsay; Woods, Helen Buckley; Payne, Nick; Rimmer, Melanie; Goyder, Elizabeth

    2014-05-10

    There is increasing interest in innovative methods to carry out systematic reviews of complex interventions. Theory-based approaches, such as logic models, have been suggested as a means of providing additional insights beyond that obtained via conventional review methods. This paper reports the use of an innovative method which combines systematic review processes with logic model techniques to synthesise a broad range of literature. The potential value of the model produced was explored with stakeholders. The review identified 295 papers that met the inclusion criteria. The papers consisted of 141 intervention studies and 154 non-intervention quantitative and qualitative articles. A logic model was systematically built from these studies. The model outlines interventions, short term outcomes, moderating and mediating factors and long term demand management outcomes and impacts. Interventions were grouped into typologies of practitioner education, process change, system change, and patient intervention. Short-term outcomes identified that may result from these interventions were changed physician or patient knowledge, beliefs or attitudes and also interventions related to changed doctor-patient interaction. A range of factors which may influence whether these outcomes lead to long term change were detailed. Demand management outcomes and intended impacts included content of referral, rate of referral, and doctor or patient satisfaction. The logic model details evidence and assumptions underpinning the complex pathway from interventions to demand management impact. The method offers a useful addition to systematic review methodologies. PROSPERO registration number: CRD42013004037.

  17. Using the Intervention Mapping protocol to develop a family-based intervention for improving lifestyle habits among overweight and obese children: study protocol for a quasi-experimental trial

    Directory of Open Access Journals (Sweden)

    Tonje Holte Stea

    2016-10-01

    Full Text Available Abstract Background In light of the high prevalence of childhood overweight and obesity, there is a need of developing effective prevention programs to address the rising prevalence and the concomitant health consequences. The main aim of the present study is to systematically develop and implement a tailored family-based intervention for improving lifestyle habits among overweight and obese children, aged 6–10 years old, enhancing parental self-efficacy, family engagement and parent-child interaction. A subsidiary aim of the intervention study is to reduce the prevalence of overweight and obesity among those participating in the intervention study. Methods/design The Intervention Mapping protocol was used to develop a tailored family-based intervention for improving lifestyle habits among overweight and obese children. In order to gather information on local opportunities and barriers, interviews with key stakeholders and a 1-year pilot study was conducted. The main study has used a quasi-experimental controlled design. Locally based Healthy Life Centers and Public Health Clinics are responsible for recruiting families and conducting the intervention. The effect of the study will be measured both at completion of the 6 months intervention study and 6 and 18 months after the intervention period. An ecological approach was used as a basis for developing the intervention. The behavioral models and educational strategies include individual family counselling meetings, workshops focusing on regulation of family life, nutrition courses, and physical activity groups providing tailored information and practical learning sessions. Parents will be educated on how to use these strategies at home, to further support their children in improving their behaviors. Discussion A systematic and evidence-based approach was used for development of this family-based intervention study targeting overweight and obese children, 6–10 years old. This program, if

  18. A childhood obesity prevention programme in Barcelona (POIBA Project): Study protocol of the intervention

    Science.gov (United States)

    Sánchez-Martínez, Francesca; Juárez, Olga; Serral, Gemma; Valmayor, Sara; Puigpinós, Rosa; Pasarín, María Isabel; Díez, Élia; Ariza, Carles

    2018-01-01

    Background Childhood obesity preventive interventions should promote a healthy diet and physical activity at home and school. This study aims to describe a school-based childhood obesity preventive programme (POIBA Project) targeting 8-to-12- year-olds. Design and methods Evaluation study of a school-based intervention with a pre-post quasi-experimental design and a comparison group. Schools from disadvantaged neighbourhoods are oversampled. The intervention consists of 9 sessions, including 58 activities of a total duration between 9 and 13 hours, and the booster intervention of 2 sessions with 8 activities lasting 3 or 4 hours. They are multilevel (individual, family and school) and multicomponent (classroom, physical activity and family). Data are collected through anthropometric measurements, physical fitness tests and lifestyle surveys before and after the intervention and the booster intervention. In the intervention group, families complete two questionnaires about their children’s eating habits and physical activity. The outcome variable is the cumulative incidence rate of obesity, obtained from body mass index values and body fat assessed by triceps skinfold thickness. The independent variables are socio-demographic, contextual, eating habits, food frequency, intensity of physical activity and use of new technologies. Expected impact for public health It is essential to implement preventive interventions at early ages and to follow its effects over time. Interventions involving diet and physical activity are the most common, being the most effective setting the school. The POIBA Project intervenes in both the school and family setting and focuses on the most disadvantaged groups, in which obesity is most pronounced and difficult to prevent. Significance for public health Overweight and obesity are a major public health concern that predispose affected individuals to the development of chronic diseases. Of importance, obesity is more common among

  19. A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Morrison, Deborah; Wyke, Sally; Thomson, Neil C; McConnachie, Alex; Agur, Karolina; Saunderson, Kathryn; Chaudhuri, Rekha; Mair, Frances S

    2014-05-24

    The financial costs associated with asthma care continue to increase while care remains suboptimal. Promoting optimal self-management, including the use of asthma action plans, along with regular health professional review has been shown to be an effective strategy and is recommended in asthma guidelines internationally. Despite evidence of benefit, guided self-management remains underused, however the potential for online resources to promote self-management behaviors is gaining increasing recognition. The aim of this paper is to describe the protocol for a pilot evaluation of a website 'Living well with asthma' which has been developed with the aim of promoting self-management behaviors shown to improve outcomes. The study is a parallel randomized controlled trial, where adults with asthma are randomly assigned to either access to the website for 12 weeks, or usual asthma care for 12 weeks (followed by access to the website if desired). Individuals are included if they are over 16-years-old, have a diagnosis of asthma with an Asthma Control Questionnaire (ACQ) score of greater than, or equal to 1, and have access to the internet. Primary outcomes for this evaluation include recruitment and retention rates, changes at 12 weeks from baseline for both ACQ and Asthma Quality of Life Questionnaire (AQLQ) scores, and quantitative data describing website usage (number of times logged on, length of time logged on, number of times individual pages looked at, and for how long). Secondary outcomes include clinical outcomes (medication use, health services use, lung function) and patient reported outcomes (including adherence, patient activation measures, and health status). Piloting of complex interventions is considered best practice and will maximise the potential of any future large-scale randomized controlled trial to successfully recruit and be able to report on necessary outcomes. Here we will provide results across a range of outcomes which will provide estimates of

  20. Online Support Program for Parents of Children With a Chronic Kidney Disease Using Intervention Mapping: A Development and Evaluation Protocol.

    Science.gov (United States)

    Geense, Wytske W; van Gaal, Betsie Gi; Knoll, Jacqueline L; Cornelissen, Elisabeth Am; Schoonhoven, Lisette; Kok, Gerjo

    2016-01-13

    The care for children with a chronic kidney disease (CKD) is complex. Parents of these children may experience high levels of stress in managing their child's disease, potentially leading to negative effects on their child's health outcomes. Although the experienced problems are well known, adequate (online) support for these parents is lacking. The objective of the study is to describe the systematic development of an online support program for parents of children with CKD, and how this program will be evaluated. Intervention Mapping (IM) was used for the development of the program. After conducting a needs assessment, defining program objectives, searching for theories, and selecting practical applications, the online program e-Powered Parents was developed. e-Powered Parents consist of three parts: (1) an informative part with information about CKD and treatments, (2) an interactive part where parents can communicate with other parents and health care professionals by chat, private messages, and a forum, and (3) a training platform consisting of four modules: Managing stress, Setting limits, Communication, and Coping with emotions. In a feasibility study, the potential effectiveness and effect size of e-Powered Parents will be evaluated using an explorative randomized controlled trial with parents of 120 families. The outcomes will be the child's quality of life, parental stress and fatigue, self-efficacy in the communication with health care professionals, and family management. A process evaluation will provide insight in parents' experiences, including their experienced level of support. Study results are expected to be published in the summer of 2016. Although the development of e-Powered Parents using IM was time-consuming, IM has been a useful protocol. IM provided us with a systematic framework for structuring the development process. The participatory planning group was valuable as well; knowledge, experiences, and visions were shared, ensuring us that

  1. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol

    Directory of Open Access Journals (Sweden)

    Sharifah Intan Zainun Sharif Ishak

    2016-10-01

    Full Text Available Abstract Background Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely ‘Eat Right, Be Positive About Your Body and Live Actively’ (EPaL, a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordered eating among secondary school adolescents aged 13–14 years old. Methods/Design Following quasi-experimental design, the intervention is conducted in two secondary schools located in the district of Hulu Langat, Selangor, Malaysia. Adolescents aged 13–14 years will be included in the study. A peer-education strategy is adopted to convey knowledge and teach skills relevant to achieving a healthy lifestyle. The intervention mainly promoted: healthy eating, positive body image and active lifestyle. The following parameters will be assessed: body weight, disordered eating status, stages of change (for healthy diet, breakfast, food portion size, screen viewing and physical activity, body image, health-related quality of life, self-esteem, eating and physical activity behaviours; and knowledge, attitude and practice towards a healthy lifestyle. Assessment will be conducted at three time points: baseline, post-intervention and 3-month follow-up. Discussion It is hypothesized that EPaL intervention will contribute in preventing overweight and disordered eating by giving the positive effects on body weight status, healthy lifestyle behaviour, as well as health-related quality of life of peer educators and participants. It may serve as a model for similar future interventions designed for the Malaysian community, specifically adolescents. Trial registration UMIN Clinical Trial Registration UMIN000024349 (Date of registration: 11th. October 2016

  2. School-based intervention to prevent overweight and disordered eating in secondary school Malaysian adolescents: a study protocol.

    Science.gov (United States)

    Sharif Ishak, Sharifah Intan Zainun; Chin, Yit Siew; Mohd Taib, Mohd Nasir; Mohd Shariff, Zalilah

    2016-10-20

    Obesity, eating disorders and unhealthy weight-loss practices have been associated with diminished growth in adolescents worldwide. Interventions that address relevant behavioural dimensions have been lacking in Malaysia. This paper describes the protocol of an integrated health education intervention namely 'Eat Right, Be Positive About Your Body and Live Actively' (EPaL), a primary prevention which aimed to promote healthy lifestyle in preventing overweight and disordered eating among secondary school adolescents aged 13-14 years old. Following quasi-experimental design, the intervention is conducted in two secondary schools located in the district of Hulu Langat, Selangor, Malaysia. Adolescents aged 13-14 years will be included in the study. A peer-education strategy is adopted to convey knowledge and teach skills relevant to achieving a healthy lifestyle. The intervention mainly promoted: healthy eating, positive body image and active lifestyle. The following parameters will be assessed: body weight, disordered eating status, stages of change (for healthy diet, breakfast, food portion size, screen viewing and physical activity), body image, health-related quality of life, self-esteem, eating and physical activity behaviours; and knowledge, attitude and practice towards a healthy lifestyle. Assessment will be conducted at three time points: baseline, post-intervention and 3-month follow-up. It is hypothesized that EPaL intervention will contribute in preventing overweight and disordered eating by giving the positive effects on body weight status, healthy lifestyle behaviour, as well as health-related quality of life of peer educators and participants. It may serve as a model for similar future interventions designed for the Malaysian community, specifically adolescents. UMIN Clinical Trial Registration UMIN000024349 (Date of registration: 11th. October 2016, retrospectively registered).

  3. [A Group Cognitive-Behavioural Intervention to Prevent Depression Relapse in Individuals Having Recently Returned to Work: Protocol and Feasibility].

    Science.gov (United States)

    Lecomte, Tania; Corbière, Marc

    Workplace depression is one of the major causes for sick leave and loss of productivity at work. Many studies have investigated factors predicting return to work for people with depression, including studies evaluating return to work programs and organizational factors. Yet, a paucity of studies have targeted the prevention of depressive relapses at work, even though more than half of those having had a depression will have a depressive relapse in the near future.Objectives This article describes a research protocol involving a novel group intervention based on cognitive behavioural principles with the aim to optimize return to work and diminish risk of depressive relapses.Method This pilot study follows a randomized controlled trial design, with half the participants (N=25) receiving the group intervention and the other half (N=25) receiving usual services. The theoretical and empirical underpinnings of the intervention are described, along with a detailed presentation of the intervention and of the study's objectives. The group intervention consists of 8 sessions whereby Cognitive behavioural therapy (CBT) principles and techniques are applied to the following themes: (1) Coping with stress at work; (2) Recognizing and modifying my dysfunctional beliefs linked to work; (3) Overcoming obstacles linked to work functioning and maintaining work; (4) Negotiating needed work adjustments with the support of the immediate supervisor; (5) Finding my strengths and competencies related to work; (6) Accepting criticism and asserting myself appropriately at work; (7) Uncovering my best coping strategies for work.Results Qualitative information pertaining to the first two cohorts' participants' subjective appreciation of the group experience revealed that the intervention was perceived as very useful by all, with group support, namely harmony and interpersonal support, as well as CBT strategies being mentioned specifically.Conclusion Finally, the potential relevance of the

  4. Sarcopenic obesity and complex interventions with nutrition and exercise in community-dwelling older persons – a narrative review

    Directory of Open Access Journals (Sweden)

    Goisser S

    2015-08-01

    Full Text Available Sabine Goisser,1 Wolfgang Kemmler,2 Simone Porzel,3 Dorothee Volkert,1 Cornel Christian Sieber,1,4 Leo Cornelius Bollheimer,1,4 Ellen Freiberger1 1Institute for Biomedicine of Aging (IBA, Friedrich-Alexander-Universität (FAU Erlangen-Nürnberg, Nuremberg, 2Institute of Medical Physics (IMP, Friedrich-Alexander-Universität (FAU Erlangen-Nürnberg, 3Nutricia GmbH, Danone Medical Nutrition, Erlangen, 4Department of Internal Medicine and Geriatrics, St John of God Hospital (Barmherzige Brüder, Regensburg, Germany Abstract: One of the many threats to independent life is the age-related loss of muscle mass and muscle function commonly referred to as sarcopenia. Another important health risk in old age leading to functional decline is obesity. Obesity prevalence in older persons is increasing, and like sarcopenia, severe obesity has been consistently associated with several negative health outcomes, disabilities, falls, and mobility limitations. Both sarcopenia and obesity pose a health risk for older persons per se, but in combination, they synergistically increase the risk for negative health outcomes and an earlier onset of disability. This combination of sarcopenia and obesity is commonly referred to as sarcopenic obesity. The present narrative review reports the current knowledge on the effects of complex interventions containing nutrition and exercise interventions in community-dwelling older persons with sarcopenic obesity. To date, several complex interventions with different outcomes have been conducted and have shown promise in counteracting either sarcopenia or obesity, but only a few studies have addressed the complex syndrome of sarcopenic obesity. Strong evidence exists on exercise interventions in sarcopenia, especially on strength training, and for obese older persons, strength exercise in combination with a dietary weight loss intervention demonstrated positive effects on muscle function and body fat. The differences in study

  5. School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Haugland, Bente Storm Mowatt; Raknes, Solfrid; Haaland, Aashild Tellefsen; Wergeland, Gro Janne; Bjaastad, Jon Fauskanger; Baste, Valborg; Himle, Joe; Rapee, Ron; Hoffart, Asle

    2017-03-04

    Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

  6. Towards culture change in the operating theatre: embedding a complex educational intervention to improve teamwork climate.

    Science.gov (United States)

    Bleakley, Alan; Allard, Jon; Hobbs, Adrian

    2012-01-01

    Changing teamwork climate in healthcare through a collective shift in attitudes and values may be a necessary precursor to establishing a positive teamwork culture, where innovations can be more readily embedded and sustained. A complex educational intervention was initiated across an entire UK Trust's surgical provision, and then sustained. Attitudes towards teamwork were measured longitudinally to examine if the intervention produced sustainable results. The research aimed to test whether sustaining a complex education intervention to improve teamwork would result in an incremental, longitudinal improvement in attitudes and values towards teamwork. The intervention's larger aim is to progress the historical default position of multi-professional work to authentic inter-professional teamwork, as a positive values climate translates in time into behavioural change defining a safety culture. Attitudes were measured at three points across all surgical team personnel over a period of 4 years, using a validated Safety Attitudes Questionnaire with a focus on the 'teamwork climate' domain. Pre- and post-intervention 'teamwork climate' scores were compared to give a longitudinal measure as a test of sustainability. Mean 'teamwork climate' scores improved incrementally and significantly following the series of educational interventions, showing that practitioners' valuing of teamwork activity can be improved and sustained. Longitudinal positive change in attitudes and values towards teamwork can be sustained, suggesting that a deliberate, designed complex intervention can shape a safety climate as a necessary prerequisite for the establishment of a sustainable safety culture.

  7. Capturing the experiences of patients across multiple complex interventions: a meta-qualitative approach.

    Science.gov (United States)

    Webster, Fiona; Christian, Jennifer; Mansfield, Elizabeth; Bhattacharyya, Onil; Hawker, Gillian; Levinson, Wendy; Naglie, Gary; Pham, Thuy-Nga; Rose, Louise; Schull, Michael; Sinha, Samir; Stergiopoulos, Vicky; Upshur, Ross; Wilson, Lynn

    2015-09-08

    The perspectives, needs and preferences of individuals with complex health and social needs can be overlooked in the design of healthcare interventions. This study was designed to provide new insights on patient perspectives drawing from the qualitative evaluation of 5 complex healthcare interventions. Patients and their caregivers were recruited from 5 interventions based in primary, hospital and community care in Ontario, Canada. We included 62 interviews from 44 patients and 18 non-clinical caregivers. Our team analysed the transcripts from 5 distinct projects. This approach to qualitative meta-evaluation identifies common issues described by a diverse group of patients, therefore providing potential insights into systems issues. This study is a secondary analysis of qualitative data; therefore, no outcome measures were identified. We identified 5 broad themes that capture the patients' experience and highlight issues that might not be adequately addressed in complex interventions. In our study, we found that: (1) the emergency department is the unavoidable point of care; (2) patients and caregivers are part of complex and variable family systems; (3) non-medical issues mediate patients' experiences of health and healthcare delivery; (4) the unanticipated consequences of complex healthcare interventions are often the most valuable; and (5) patient experiences are shaped by the healthcare discourses on medically complex patients. Our findings suggest that key assumptions about patients that inform intervention design need to be made explicit in order to build capacity to better understand and support patients with multiple chronic diseases. Across many health systems internationally, multiple models are being implemented simultaneously that may have shared features and target similar patients, and a qualitative meta-evaluation approach, thus offers an opportunity for cumulative learning at a system level in addition to informing intervention design and

  8. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. 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

    Cognitive behavior therapy (CBT) is the first-line of treatment for overweight and obesity patients whose problems originate in maladaptive eating habits (e.g., emotional eating). However, in-person CBT is currently difficult to access by large segments of the population. The proposed SIGMA intervention (i.e., the Self-help, Integrated, and Gamified Mobile-phone Application) is a mHealth intervention based on CBT principles. It specifically targets overweight young adults with underlying maladaptive behaviors and cognitions regarding food. The SIGMA app was designed as a serious game and intended to work as a standalone app for weight maintenance or alongside a calorie-restrictive diet for weight loss. It uses a complex and novel scoring system that allows points earned within the game to be supplemented by points earned during outdoor activities with the help of an embedded pedometer. The efficacy of the SIGMA mHealth intervention will be investigated within a randomized, placebo-controlled trial. The intervention will be set to last 2 months with a 3-month follow-up. Selected participants will be young overweight adults with non-clinical maladaptive eating habits embodied by food cravings, binge eating, and emotional eating. The primary outcomes will be represented by changes in (1) self-reported maladaptive thoughts related to eating and body weight, (2) self-reported maladaptive eating behaviors in the range of urgent food cravings, emotional eating or binge eating, (3) as well as biased attentional processing of food items as indexed by reaction times. Secondary outcomes will be represented by changes in weight, Body Mass Index, general mood, and physical activity as indexed by the number of steps per day. Through an evidence-based cognitive behavioral approach and a user-friendly game interface, the SIGMA intervention offers a significant contribution to the development of a cost-effective and preventive self-help tool for young overweight adults with

  10. 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

    approach will provide a comprehensive foundation to co-design a theory-based intervention with service users, health care providers, and administrators to improve sexual health service use among university students and ultimately improve their overall health and well-being. ©Christine Cassidy, Audrey Steenbeek, Donald Langille, Ruth Martin-Misener, Janet Curran. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.11.2017.

  11. Systematic review and network meta-analysis of interventions for fibromyalgia: a protocol

    NARCIS (Netherlands)

    Busse, Jason W.; Ebrahim, Shanil; Connell, Gaelan; Coomes, Eric A.; Bruno, Paul; Malik, Keshena; Torrance, David; Ngo, Trung; Kirmayr, Karin; Avrahami, Daniel; Riva, John J.; Struijs, Peter; Brunarski, David; Burnie, Stephen J.; LeBlanc, Frances; Steenstra, Ivan A.; Mahood, Quenby; Thorlund, Kristian; Montori, Victor M.; Sivarajah, Vishalini; Alexander, Paul; Jankowski, Milosz; Lesniak, Wiktoria; Faulhaber, Markus; Bała, Małgorzata M.; Schandelmaier, Stefan; Guyatt, Gordon H.

    2013-01-01

    Fibromyalgia is associated with substantial socioeconomic loss and, despite considerable research including numerous randomized controlled trials (RCTs) and systematic reviews, there exists uncertainty regarding what treatments are effective. No review has evaluated all interventional studies for

  12. Data acquisition for a patient-directed intervention protocol in the dynamic intensive care unit setting.

    Science.gov (United States)

    Chlan, Linda; Patterson, Robert P; Heiderscheit, Annie

    2011-07-01

    Methods to easily, accurately, and efficiently obtain data in an ICU-based clinical trial can be challenging in this high-tech setting. Patient medical status and the dynamic nature of this clinical setting further complicate data collection. The purpose of this paper is to describe the modifications of commercially available headphones and the application of a data logging device to capture frequency and length of protocol use (music listening or headphones only for noise cancellation) without burdening participants or busy ICU nurses. With the automatic capture of protocol use by research participants, there have been no instances of lost data for this clinical trial. Copyright © 2011 Elsevier Inc. All rights reserved.

  13. MAP-IT: A Practical Tool for Planning Complex Behavior Modification Interventions.

    Science.gov (United States)

    Hansen, Sylvia; Kanning, Martina; Lauer, Romy; Steinacker, Jürgen M; Schlicht, Wolfgang

    2017-09-01

    Health research often aims to prevent noncommunicable diseases and to improve individual and public health by discovering intervention strategies that are effective in changing behavior and/or environments that are detrimental to one's health. Ideally, findings from original research support practitioners in planning and implementing effective interventions. Unfortunately, interventions often fail to overcome the translational block between science and practice. They often ignore theoretical knowledge, overlook empirical evidence, and underrate the impact of the environment. Accordingly, sustainable changes in individual behavior and/or the environment are difficult to achieve. Developing theory-driven and evidence-based interventions in the real world is a complex task. Existing implementation frameworks and theories often do not meet the needs of health practitioners. The purpose of this article is to synthesize existing frameworks and to provide a tool, the Matrix Assisting Practitioner's Intervention Planning Tool (MAP-IT), that links research to practice and helps practitioners to design multicomponent interventions. In this article, we use physical activity of older adults as an example to explain the rationale of MAP-IT. In MAP-IT, individual as well as environmental mechanisms are listed and behavior change techniques are linked to these mechanisms and to intervention components. MAP-IT is theory-driven and evidence-based. It is time-saving and helpful for practitioners when planning complex interventions.

  14. Sustainability of knowledge translation interventions in healthcare decision-making: protocol for a scoping review.

    Science.gov (United States)

    Tricco, Andrea C; Cogo, Elise; Ashoor, Huda; Perrier, Laure; McKibbon, K Ann; Grimshaw, Jeremy M; Straus, Sharon E

    2013-05-14

    Knowledge translation (KT also known as research utilisation, translational medicine and implementation science) is a dynamic and iterative process that includes the synthesis, dissemination, exchange and ethically sound application of knowledge to improve health. After the implementation of KT interventions, their impact on relevant outcomes should be monitored. The objectives of this scoping review are to: (1) conduct a systematic search of the literature to identify the impact on healthcare outcomes beyond 1 year, or beyond the termination of funding of the initiative of KT interventions targeting chronic disease management for end-users including patients, clinicians, public health officials, health services managers and policy-makers; (2) identify factors that influence sustainability of effective KT interventions; (3) identify how sustained change from KT interventions should be measured; and (4) develop a framework for assessing sustainability of KT interventions. Comprehensive searches of relevant electronic databases (eg, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), websites of funding agencies and websites of healthcare provider organisations will be conducted to identify relevant material. We will include experimental, quasi-experimental and observational studies providing information on the sustainability of KT interventions targeting chronic disease management in adults and focusing on end-users including patients, clinicians, public health officials, health services managers and policy-makers. Two reviewers will pilot-test the screening criteria and data abstraction form. They will then screen all citations, full articles and abstract data in duplicate independently. The results of the scoping review will be synthesised descriptively and used to develop a framework to assess the sustainability of KT interventions. Our results will help inform end-users (ie, patients, clinicians, public health officials, health services managers

  15. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    OpenAIRE

    Arija Victoria; Martín Núria; Canela Teresa; Anguera Carme; Castelao Ana I; García-Barco Montserrat; García-Campo Antoni; González-Bravo Ana I; Lucena Carme; Martínez Teresa; Fernández-Barrés Silvia; Pedret Roser; Badia Waleska; Basora Josep

    2012-01-01

    Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of t...

  16. Implementation of an audit with feedback knowledge translation intervention to promote medication error reporting in health care: a protocol.

    Science.gov (United States)

    Hutchinson, Alison M; Sales, Anne E; Brotto, Vanessa; Bucknall, Tracey K

    2015-05-19

    Health professionals strive to deliver high-quality care in an inherently complex and error-prone environment. Underreporting of medical errors challenges attempts to understand causative factors and impedes efforts to implement preventive strategies. Audit with feedback is a knowledge translation strategy that has potential to modify health professionals' medical error reporting behaviour. However, evidence regarding which aspects of this complex, multi-dimensional intervention work best is lacking. The aims of the Safe Medication Audit Reporting Translation (SMART) study are to: 1. Implement and refine a reporting mechanism to feed audit data on medication errors back to nurses 2. Test the feedback reporting mechanism to determine its utility and effect 3. Identify characteristics of organisational context associated with error reporting in response to feedback A quasi-experimental design, incorporating two pairs of matched wards at an acute care hospital, is used. Randomisation occurs at the ward level; one ward from each pair is randomised to receive the intervention. A key stakeholder reference group informs the design and delivery of the feedback intervention. Nurses on the intervention wards receive the feedback intervention (feedback of analysed audit data) on a quarterly basis for 12 months. Data for the feedback intervention come from medication documentation point-prevalence audits and weekly reports on routinely collected medication error data. Weekly reports on these data are obtained for the control wards. A controlled interrupted time series analysis is used to evaluate the effect of the feedback intervention. Self-report data are also collected from nurses on all four wards at baseline and at completion of the intervention to elicit their perceptions of the work context. Additionally, following each feedback cycle, nurses on the intervention wards are invited to complete a survey to evaluate the feedback and to establish their intentions to change

  17. A Nutrition Education Intervention Trial for Adolescent Girls in Isfahan: Study Design and Protocol

    Directory of Open Access Journals (Sweden)

    Morvarid Ghasab Shirazi

    2016-11-01

    Full Text Available BackgroundNutrition behaviors of adolescent girls is of serious health concerns. Although nutrition education interventions in Iran have met with some success, most of them could not promote nutrition behavioral changes. The aim of our study is to determine a school-based nutrition education intervention to improve adolescents’ nutrition behaviors and behavioral mediators based on the social cognitive theory (SCT.Materials and MethodsThis study is a single-blind randomized controlled trial. Eligible participants will be all student girls in grade 6 and 7, their parents and teachers in Isfahan governmental schools. This multi com­ponent school-based intervention include adolescents’ nutrition education package, parents’ nutrition massages, participatory homework, parents and teachers nutrition education package, supportive group, and collaboration with decision makers. Changing in nutrition behaviors including breakfast, fruit and vegetable, snack and fast food consumption will be examined, as primary outcome. Secondary outcome will be behavioral mediators such as knowledge, self-efficacy, intention, situation, self-regulation, social support, outcome expectations and expectancies, in adolescent girls. The outcomes will be assessed at baseline, and after 3 and 6-month follow-up.DiscussionThis study evaluates a school-based, guided SCT intervention, designed to improve healthy dietary behaviors, nutrition knowledge of adolescent girls. Few behavioral interventions have targeted this high-risk population in Iran. The intervention seems to be promising and has the potential to bridge the gap of the limited program outcomes of nutrition education in Iranian adolescents.

  18. A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

    Science.gov (United States)

    Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

    2014-01-30

    Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention

  19. Developing a complex intervention for diet and activity behaviour change in obese pregnant women (the UPBEAT trial); assessment of behavioural change and process evaluation in a pilot randomised controlled trial.

    Science.gov (United States)

    Poston, Lucilla; Briley, Annette L; Barr, Suzanne; Bell, Ruth; Croker, Helen; Coxon, Kirstie; Essex, Holly N; Hunt, Claire; Hayes, Louise; Howard, Louise M; Khazaezadeh, Nina; Kinnunen, Tarja; Nelson, Scott M; Oteng-Ntim, Eugene; Robson, Stephen C; Sattar, Naveed; Seed, Paul T; Wardle, Jane; Sanders, Thomas A B; Sandall, Jane

    2013-07-15

    Complex interventions in obese pregnant women should be theoretically based, feasible and shown to demonstrate anticipated behavioural change prior to inception of large randomised controlled trials (RCTs). The aim was to determine if a) a complex intervention in obese pregnant women leads to anticipated changes in diet and physical activity behaviours, and b) to refine the intervention protocol through process evaluation of intervention fidelity. We undertook a pilot RCT of a complex intervention in obese pregnant women, comparing routine antenatal care with an intervention to reduce dietary glycaemic load and saturated fat intake, and increase physical activity. Subjects included 183 obese pregnant women (mean BMI 36.3 kg/m2). Compared to women in the control arm, women in the intervention arm had a significant reduction in dietary glycaemic load (33 points, 95% CI -47 to -20), (p change. Physical discomfort and sustained barriers to physical activity were common at 28 weeks' gestation. Process evaluation identified barriers to recruitment, group attendance and compliance, leading to modification of intervention delivery. This pilot trial of a complex intervention in obese pregnant women suggests greater potential for change in dietary intake than for change in physical activity, and through process evaluation illustrates the considerable advantage of performing an exploratory trial of a complex intervention in obese pregnant women before undertaking a large RCT. ISRCTN89971375.

  20. Developing a Return to Work Intervention for Breast Cancer Survivors with the Intervention Mapping Protocol: Challenges and Opportunities of the Needs Assessment

    Directory of Open Access Journals (Sweden)

    Jean-Baptiste Fassier

    2018-02-01

    Full Text Available Return to work (RTW is an important step for breast cancer survivors (BCSs. However, they face many barriers that affect particularly women with low socioeconomic status (SES. Health care, workplace, and insurance actors lack knowledge and collaborate poorly. No intervention to date has proven effective to reduce social disparities in employment after breast cancer. The intervention mapping (IM protocol is being used in France to develop, implement, and evaluate an intervention to facilitate and sustain RTW after breast cancer [FAciliter et Soutenir le retour au TRAvail après un Cancer du Sein (FASTRACS project]. The research question of this study was to elicit the needs for RTW after breast cancer from various stakeholders’ point of view. The aim of this study was to describe the process and the preliminary results of the needs assessment of the FASTRACS project. Different methods were followed to (a establish and work with a planning group and (b conduct a needs assessment to create a logic model of the problem. A planning group was organized to gather the stakeholders with the research team. A review of the literature and indicators was conducted to identify the magnitude of the problem and the factors influencing RTW. A qualitative inquiry was conducted with 12 focus groups and 48 individual semi-structured interviews to explore the needs and experience of the stakeholders. The results of these tasks were the proposition of a charter of partnership to structure the participative process, a review of the scientific evidence and indicators, and the description by the stakeholders of their needs and experience. Many stakeholders disagreed with the concept of “early intervention.” They advocated for a better support of BCSs during their RTW, emphasized as a process. Anticipation, intersectoral collaboration, and workplace accommodation were mentioned to fit the needs of the BCS and their environment. A logic model of the problem was

  1. Developing a Return to Work Intervention for Breast Cancer Survivors with the Intervention Mapping Protocol: Challenges and Opportunities of the Needs Assessment.

    Science.gov (United States)

    Fassier, Jean-Baptiste; Lamort-Bouché, Marion; Broc, Guillaume; Guittard, Laure; Péron, Julien; Rouat, Sabrina; Carretier, Julien; Fervers, Béatrice; Letrilliart, Laurent; Sarnin, Philippe

    2018-01-01

    Return to work (RTW) is an important step for breast cancer survivors (BCSs). However, they face many barriers that affect particularly women with low socioeconomic status (SES). Health care, workplace, and insurance actors lack knowledge and collaborate poorly. No intervention to date has proven effective to reduce social disparities in employment after breast cancer. The intervention mapping (IM) protocol is being used in France to develop, implement, and evaluate an intervention to facilitate and sustain RTW after breast cancer [ FAciliter et Soutenir le retour au TRAvail après un Cancer du Sein (FASTRACS) project]. The research question of this study was to elicit the needs for RTW after breast cancer from various stakeholders' point of view. The aim of this study was to describe the process and the preliminary results of the needs assessment of the FASTRACS project. Different methods were followed to (a) establish and work with a planning group and (b) conduct a needs assessment to create a logic model of the problem. A planning group was organized to gather the stakeholders with the research team. A review of the literature and indicators was conducted to identify the magnitude of the problem and the factors influencing RTW. A qualitative inquiry was conducted with 12 focus groups and 48 individual semi-structured interviews to explore the needs and experience of the stakeholders. The results of these tasks were the proposition of a charter of partnership to structure the participative process, a review of the scientific evidence and indicators, and the description by the stakeholders of their needs and experience. Many stakeholders disagreed with the concept of "early intervention." They advocated for a better support of BCSs during their RTW, emphasized as a process. Anticipation, intersectoral collaboration, and workplace accommodation were mentioned to fit the needs of the BCS and their environment. A logic model of the problem was elaborated from these

  2. A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

    Science.gov (United States)

    Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

    2014-03-01

    India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

  3. The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rodrigues, Marcela Perdomo; Dos Santos, Luciana Kaercher John; Fuchs, Flavio Danni; Fuchs, Sandra Costa; Moreira, Leila Beltrami

    2017-07-21

    The effectiveness of nonpharmacological interventions in blood pressure reduction has been evidenced by several studies. Nevertheless, as adherence to a low-sodium diet is poor, interventions regarding habit changing should be of a motivational nature in order to develop the ability of overcoming obstacles regarding sodium-restriction behavior. The present study aims to describe the protocol and randomization of a clinical trial design in order to evaluate the effectiveness of an educational intervention based on Dietary Sodium Restriction Questionnaire (DSRQ) scores. The effectiveness measures are the DSRQ score variation and reduction in urinary sodium values from baseline to after 2 and 6 months. This parallel, randomized clinical trial will include 120 participants, recruited and randomized as follows: 60 of them to be allocated to a sodium-restriction educational intervention group whose results are based on the DSRQ application; and the other 60 allocated to a control group with usual care. Educational orientation and usual care sessions will be conducted once a month for a period of 6 months. Both spot urine collection - estimating sodium intake - and the DSRQ will be applied at the baseline, in the eighth week and at the end of the follow-up. There will also be blood collection and 24-h ambulatory blood pressure monitoring (ABPM) at the beginning and end of the follow-up. Anthropometric measurements, blood pressure measurement and 24-h food recall will be collected during follow-up. The study "The effectiveness of an educational intervention to sodium restriction in patients with hypertension" is based on the results of the DSRQ application, whose objective is to evaluate aspects related to nonadherence to the recommendation of a low-sodium diet, identifying adherence barriers and facilitators, contributing to the planning of interventions for improving the adoption of a low-sodium diet and, consequently, hypertension control. Clinical

  4. Study protocol: a randomised controlled trial investigating the effect of a healthy lifestyle intervention for people with severe mental disorders

    Directory of Open Access Journals (Sweden)

    Castle David

    2011-01-01

    Full Text Available Abstract Background The largest single cause of death among people with severe mental disorders is cardiovascular disease (CVD. The majority of people with schizophrenia and bipolar disorder smoke and many are also overweight, considerably increasing their risk of CVD. Treatment for smoking and other health risk behaviours is often not prioritized among people with severe mental disorders. This protocol describes a study in which we will assess the effectiveness of a healthy lifestyle intervention on smoking and CVD risk and associated health behaviours among people with severe mental disorders. Methods/Design 250 smokers with a severe mental disorder will be recruited. After completion of a baseline assessment and an initial face-to-face intervention session, participants will be randomly assigned to either a multi-component intervention for smoking cessation and CVD risk reduction or a telephone-based minimal intervention focusing on smoking cessation. Randomisation will be stratified by site (Newcastle, Sydney, Melbourne, Australia, Body Mass Index (BMI category (normal, overweight, obese and type of antipsychotic medication (typical, atypical. Participants will receive 8 weekly, 3 fortnightly and 6 monthly sessions delivered face to face (typically 1 hour or by telephone (typically 10 minutes. Assessments will be conducted by research staff blind to treatment allocation at baseline, 15 weeks, and 12-, 18-, 24-, 30- and 36-months. Discussion This study will provide comprehensive data on the effect of a healthy lifestyle intervention on smoking and CVD risk among people with severe mental disorders. If shown to be effective, this intervention can be disseminated to treating clinicians using the treatment manuals. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR identifier: ACTRN12609001039279

  5. Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

    OpenAIRE

    Brady, Marian C; Stott, David J; Norrie, John; Chalmers, Campbell; St George, Bridget; Sweeney, Petrina M; Langhorne, Peter

    2011-01-01

    Abstract Background Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a compl...

  6. Maltese Antibiotic Stewardship Programme in the Community (MASPIC): protocol of a prospective quasiexperimental social marketing intervention.

    Science.gov (United States)

    Saliba-Gustafsson, Erika A; Borg, Michael A; Rosales-Klintz, Senia; Nyberg, Anna; StålsbyLundborg, Cecilia

    2017-09-24

    Antibiotic misuse is a key driver of antibiotic resistance. In 2015/2016, Maltese respondents reported the highest proportions of antibiotic consumption in Europe. Since antibiotics are prescription-only medicines in Malta, research on effective strategies targeting general practitioners' (GPs) knowledge and behaviour is needed. Multifaceted behaviour change (BC) interventions are likely to be effective. Social marketing (SM) can provide the tools to promote sustained BC; however, its utilisation in Europe is limited. This paper aims to describe the design and methods of a multifaceted SM intervention aimed at changing Maltese GPs' antibiotic prescribing behaviour for patients with acute respiratory tract infections (aRTIs). This 4-year quasiexperimental intervention study will be carried out in Malta and includes three phases: preintervention, intervention and postintervention. The preintervention phase intends to gain insight into the practices and attitudes of GPs, pharmacists and parents through interviews, focus group discussions and antibiotic prescribing surveillance. A 6-month intervention targeting GPs will be implemented following assessment of their prescribing intention and readiness for BC. The intervention will likely comprise: prescribing guidelines, patient educational materials, delayed antibiotic prescriptions and GP education. Outcomes will be evaluated in the postintervention phase through questionnaires based on the theory of planned behaviour and stages-of-change theory, as well as postintervention surveillance. The primary outcome will be the antibiotic prescribing rate for all patients with aRTIs. Secondary outcomes will include the proportion of diagnosis-specific antibiotic prescription and symptomatic relief medication prescribed, and the change in GPs stage-of-change and their intention to prescribe antibiotics. The project received ethical approval from the University of Malta's Research Ethics Committee. Should this intervention

  7. Maltese Antibiotic Stewardship Programme in the Community (MASPIC): protocol of a prospective quasiexperimental social marketing intervention

    Science.gov (United States)

    Saliba-Gustafsson, Erika A; Borg, Michael A; Rosales-Klintz, Senia; Nyberg, Anna; StålsbyLundborg, Cecilia

    2017-01-01

    Introduction Antibiotic misuse is a key driver of antibiotic resistance. In 2015/2016, Maltese respondents reported the highest proportions of antibiotic consumption in Europe. Since antibiotics are prescription-only medicines in Malta, research on effective strategies targeting general practitioners’ (GPs) knowledge and behaviour is needed. Multifaceted behaviour change (BC) interventions are likely to be effective. Social marketing (SM) can provide the tools to promote sustained BC; however, its utilisation in Europe is limited. This paper aims to describe the design and methods of a multifaceted SM intervention aimed at changing Maltese GPs’ antibiotic prescribing behaviour for patients with acute respiratory tract infections (aRTIs). Methods and analysis This 4-year quasiexperimental intervention study will be carried out in Malta and includes three phases: preintervention, intervention and postintervention. The preintervention phase intends to gain insight into the practices and attitudes of GPs, pharmacists and parents through interviews, focus group discussions and antibiotic prescribing surveillance. A 6-month intervention targeting GPs will be implemented following assessment of their prescribing intention and readiness for BC. The intervention will likely comprise: prescribing guidelines, patient educational materials, delayed antibiotic prescriptions and GP education. Outcomes will be evaluated in the postintervention phase through questionnaires based on the theory of planned behaviour and stages-of-change theory, as well as postintervention surveillance. The primary outcome will be the antibiotic prescribing rate for all patients with aRTIs. Secondary outcomes will include the proportion of diagnosis-specific antibiotic prescription and symptomatic relief medication prescribed, and the change in GPs stage-of-change and their intention to prescribe antibiotics. Ethics and dissemination The project received ethical approval from the University of

  8. Online peer support interventions for chronic conditions: a scoping review protocol.

    Science.gov (United States)

    Munce, Sarah Elizabeth Patricia; Shepherd, John; Perrier, Laure; Allin, Sonya; Sweet, Shane N; Tomasone, Jennifer R; Nelson, Michelle L A; Guilcher, Sara J T; Hossain, Saima; Jaglal, Susan

    2017-09-24

    Peer support is receiving increasing attention as both an effective and cost-effective intervention method to support the self-management of chronic health conditions. Given that an increasing proportion of Canadians have internet access and the increasing implementation of web-based interventions, online peer support interventions are a promising option to address the burden of chronic diseases. Thus, the specific research question of this scoping review is the following: What is known from the existing literature about the key characteristics of online peer support interventions for adults with chronic conditions? METHODS AND ANALYSIS: We will use the methodological frameworks used by Arksey and O'Malley as well as Levac and colleagues for the current scoping review. To be eligible for inclusion, studies must report on adults (≥18 years of age) with one of the Public Health Agency of Canada chronic conditions or HIV/AIDS. We will limit our review to peer support interventions delivered through online formats. All study designs will be included. Only studies published from 2012 onwards will be included to ensure relevance to the current healthcare context and feasibility. Furthermore, only English language studies will be included. Studies will be identified by searching a variety of databases. Two reviewers will independently screen the titles and abstracts identified by the literature search for inclusion (ie, level 1 screening), the full text articles (ie, level 2 screening) and then perform data abstraction. Abstracted data will include study characteristics, participant population, key characteristics of the intervention and outcomes collected. This review will identify the key features of online peer support interventions and could assist in the future development of other online peer support programmes so that effective and sustainable programmes can be developed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  9. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  10. Behavioural intervention to increase physical activity among patients with coronary heart disease: protocol for a randomised controlled trial.

    Science.gov (United States)

    Alsaleh, Eman; Blake, Holly; Windle, Richard

    2012-12-01

    Although physical activity has significant health benefits in the treatment of patients with coronary heart disease, patients often do not follow prescribed physical activity recommendations. Behavioural strategies have been shown to be efficacious in increasing physical activity among those patients with coronary heart disease who are attending structured cardiac rehabilitation programmes. Research has also shown that tailoring consultation according to patients' needs and sending motivational reminders are successful ways of motivating patients to be physically active. However, there is a lack of evidence for the efficacy of behavioural interventions based on individualised consultation in promoting physical activity among those patients with coronary heart disease who are not attending structured physical activity programmes. This paper outlines the study protocol for a trial which is currently underway, to examine the effect of a behavioural change intervention delivered through individualised consultation calls and motivational reminder text messages on the level of physical activity among patients with coronary heart disease. Two large hospitals in Jordan. Eligible patients aged between 18 and 70 years, who are clinically stable, are able to perform physical activity and who have access to a mobile telephone have been randomly allocated to control or intervention group. Two-group randomised controlled trial. Behavioural intervention will be compared with usual care in increasing physical activity levels among patients with coronary heart disease. The control group (n=85) will receive advice from their doctors about physical activity as they would in usual practice. The intervention group (n=71) will receive the same advice, but will also receive behavioural change intervention (goal-setting, feed-back, self-monitoring) that will be delivered over a period of six months. Intervention will be delivered through individually tailored face-to-face and telephone

  11. The Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations

    Directory of Open Access Journals (Sweden)

    Auld Garry

    2011-07-01

    Full Text Available Abstract Background The number of overweight children in America has doubled to an estimated 10 million in the past 20 years. Establishing healthy dietary behaviors must begin early in childhood and include parents. The Healthy Toddlers intervention focuses on promoting healthy eating habits in 1- to 3-year-old children utilizing the Social Cognitive Theory and a learner-centered approach using Adult Learning principles. This Healthy Toddlers Trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mothers of toddlers. The intervention focuses on: (a promoting healthy eating behaviors in toddlers while dietary habits are forming; and (b providing initial evidence for the potential of Healthy Toddlers as a feasible intervention within existing community-based programs. Methods/Design This describes the study protocol for a randomized control trial, a multi-state project in Colorado, Michigan, and Wisconsin with economically and educationally disadvantaged mother-toddler dyads; toddlers are between 12 and 36 months. The Healthy Toddlers intervention consists of eight in-home lessons and four reinforcement telephone contacts, focusing on fruit, vegetable, and sweetened beverage consumption and parental behaviors, taught by paraprofessional instructors. Healthy Toddlers uses a randomized, experimental, short-term longitudinal design with intervention and control groups. In-home data collection (anthropometric measurements, feeding observations, questionnaires, 3-day dietary records occurs at baseline, immediately following the intervention, and 6 months after the intervention. Main toddler outcomes include: a increased fruit and vegetable consumption and decreased sweetened beverage consumption; and b improved toddler-eating skills (self-feeding and self-serving. Main parent outcomes include: a improved psychosocial attributes (knowledge

  12. Study protocol: can a school gardening intervention improve children’s diets?

    Directory of Open Access Journals (Sweden)

    Christian Meaghan S

    2012-04-01

    Full Text Available Abstract Background The current academic literature suggests there is a potential for using gardening as a tool to improve children’s fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS Campaign for School Gardening, to determine if it has an effect on children’s fruit and vegetable intake. Method/Design Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as “Partner Schools” and the other to receive the less intensive intervention as “Associate Schools”. Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention “Associate Schools” or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET to collect data on dietary intake and a questionnaire exploring children’s knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school’s gardening activities. Discussion The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children’s fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children’s diets and school based interventions. Trial registration ISRCTN11396528

  13. Study protocol: can a school gardening intervention improve children’s diets?

    Science.gov (United States)

    2012-01-01

    Background The current academic literature suggests there is a potential for using gardening as a tool to improve children’s fruit and vegetable intake. This study is two parallel randomised controlled trials (RCT) devised to evaluate the school gardening programme of the Royal Horticultural Society (RHS) Campaign for School Gardening, to determine if it has an effect on children’s fruit and vegetable intake. Method/Design Trial One will consist of 26 schools; these schools will be randomised into two groups, one to receive the intensive intervention as “Partner Schools” and the other to receive the less intensive intervention as “Associate Schools”. Trial Two will consist of 32 schools; these schools will be randomised into either the less intensive intervention “Associate Schools” or a comparison group with delayed intervention. Baseline data collection will be collected using a 24-hour food diary (CADET) to collect data on dietary intake and a questionnaire exploring children’s knowledge and attitudes towards fruit and vegetables. A process measures questionnaire will be used to assess each school’s gardening activities. Discussion The results from these trials will provide information on the impact of the RHS Campaign for School Gardening on children’s fruit and vegetable intake. The evaluation will provide valuable information for designing future research in primary school children’s diets and school based interventions. Trial registration ISRCTN11396528 PMID:22537179

  14. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

    LENUS (Irish Health Repository)

    Murray, Elizabeth

    2010-10-20

    Abstract Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

  15. Normalisation process theory: a framework for developing, evaluating and implementing complex interventions

    Directory of Open Access Journals (Sweden)

    Ong Bie

    2010-10-01

    Full Text Available Abstract Background The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation. Discussion In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. Summary The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.

  16. Potential uses of Bayesian networks as tools for synthesis of systematic reviews of complex interventions.

    Science.gov (United States)

    Stewart, G B; Mengersen, K; Meader, N

    2014-03-01

    Bayesian networks (BNs) are tools for representing expert knowledge or evidence. They are especially useful for synthesising evidence or belief concerning a complex intervention, assessing the sensitivity of outcomes to different situations or contextual frameworks and framing decision problems that involve alternative types of intervention. Bayesian networks are useful extensions to logic maps when initiating a review or to facilitate synthesis and bridge the gap between evidence acquisition and decision-making. Formal elicitation techniques allow development of BNs on the basis of expert opinion. Such applications are useful alternatives to 'empty' reviews, which identify knowledge gaps but fail to support decision-making. Where review evidence exists, it can inform the development of a BN. We illustrate the construction of a BN using a motivating example that demonstrates how BNs can ensure coherence, transparently structure the problem addressed by a complex intervention and assess sensitivity to context, all of which are critical components of robust reviews of complex interventions. We suggest that BNs should be utilised to routinely synthesise reviews of complex interventions or empty reviews where decisions must be made despite poor evidence. Copyright © 2013 John Wiley & Sons, Ltd.

  17. Effectiveness of Psychosocial Interventions in Complex Palliative Care Patients: A Quasi-Experimental, Prospective Multicenter Study.

    Science.gov (United States)

    Mateo-Ortega, Dolors; Gómez-Batiste, Xavier; Maté, Jorge; Beas, Elba; Ela, Sara; Lasmarias, Cristina; Limonero, Joaquín T

    2018-03-13

    To determine whether specific psychosocial interventions can ease discomfort in palliative care (PC) patients, particularly in those with high levels of pain or emotional distress. Changes in the psychological parameters of 8333 patients were assessed in a quasi-experimental, prospective, multicenter, single group pretest/post-test study. Psychosocial care was delivered by 29 psychosocial care teams (PSTs; 137 professionals). Pre- and post-intervention changes in these variables were assessed: mood, anxiety, and emotional distress. Patients were classified as complex, when presented with high levels of anxiety, mood, suffering (or perception of time as slow), and distress (or unease, or discomfort), or noncomplex. These groups were compared to assess changes in suffering-related parameters from baseline. Psychosocial interventions reduced patients' suffering. These interventions were more effective in complex patients. After successive psychosocial interventions, the level of suffering in complex patients decreased until close to parity with noncomplex patients, suggesting that patients with major complexity could benefit most from specific psychosocial treatment. These findings support the importance of assessing and treating patients' psychosocial needs.

  18. Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

    Science.gov (United States)

    McMullen, Heather; Griffiths, Chris; Leber, Werner; Greenhalgh, Trisha

    2015-05-31

    Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting

  19. 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

  20. Interventions for preventing mother-to-child HIV transmission: protocol of an overview of systematic reviews.

    Science.gov (United States)

    Wariki, Windy Mariane Virenia; Ota, Erika; Mori, Rintaro; Wiysonge, Charles S; Horvath, Hacsi; Read, Jennifer S

    2017-06-21

    Various interventions to prevent mother-to-child-transmission (MTCT) of HIV have been investigated and implemented. A number of systematic reviews assessing the efficacy of interventions for the prevention of MTCT of HIV reported antiretroviral prophylaxis, caesarean section before labour and before ruptured membranes, and complete avoidance of breastfeeding were efficacious for preventing MTCT of HIV. Recent WHO guidelines recommend lifelong antiretroviral therapy for all pregnant women for treatment of the woman's own HIV infection and for prevention of MTCT of HIV. Therefore, the objective of this overview is to evaluate the currently available systematic reviews of interventions for preventing MTCT of HIV, and to identify the current best evidence-based interventions for reducing the risk of MTCT of HIV. We will include only peer-reviewed systematic reviews of randomised or quasi-randomised controlled trials assessing the effects of interventions for preventing MTCT of HIV that target both HIV-infected women and children aged 2 years and younger born to HIV-infected women. We will search the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effectiveness, Ovid MEDLINE and EMBASE. We will assess review eligibility, the methodological quality of included systematic reviews using A Measurement Tool to Assess The Systematic Reviews and will extract data, comparing our results and resolving discrepancies by consensus. Finally, we will independently assess the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation. Ethics approval is not required. We will publish the results in a peer-reviewed journal and present at conferences, which will inform future research and will be useful for healthcare managers, administrators and policymakers to guide resource allocation decisions and optimisation of interventions to prevent the MTCT of HIV. © Article author(s) (or their employer(s) unless

  1. Discharge interventions for older patients leaving hospital: protocol for a systematic meta-review.

    Science.gov (United States)

    O'Connell Francischetto, Elaine; Damery, Sarah; Davies, Sarah; Combes, Gill

    2016-03-16

    There is an increased need for additional care and support services for the elderly population. It is important to identify what support older people need once they are discharged from hospital and to ensure continuity of care. There is a large evidence base focusing on enhanced discharge services and their impact on patients. The services show some potential benefits, but there are inconsistent findings across reviews. Furthermore, it is unclear what elements of enhanced discharge interventions could be most beneficial to older people. This meta-review aims to identify existing systematic reviews of discharge interventions for older people, identify potentially effective elements of enhanced discharge services for this patient group and identify areas where further work may still be needed. The search will aim to identify English language systematic reviews that have assessed the effectiveness of discharge interventions for older people. The following databases will be searched: Medline, Embase, PsycINFO, HMIC, Social Policy and Practice, CINAHL, the Cochrane Library, ASSIA, Social Science Citation Index and the Grey Literature Report. The search strategy will comprise the keywords 'systematic reviews', 'older people' and 'discharge'. Discharge interventions must aim to support older patients before, during and/or after discharge from hospital. Outcomes of interest will include mortality, readmissions, length of hospital stay, patient health status, patient and carer satisfaction and staff views. Abstract, title and full text screening will be conducted independently by two reviewers. Data extracted from reviews will include review characteristics, patient population, review quality score, outcome measures and review findings, and a narrative synthesis will be conducted. This review will identify existing reviews of discharge interventions and appraise how these interventions can impact outcomes in older people such as readmissions, health status, length of

  2. Study protocol: intervention in maternal perception of preschoolers' weight among Mexican and Mexican-American mothers.

    Science.gov (United States)

    Flores-Peña, Yolanda; He, Meizi; Sosa, Erica T; Avila-Alpirez, Hermelinda; Trejo-Ortiz, Perla M

    2018-05-30

    Childhood obesity is a public health issue negatively affecting children's physical and psychosocial health. Mothers are children's primary caregivers, thus key players in childhood obesity prevention. Studies have indicated that mothers underestimate their children's weight. If mothers are unaware of their children's weight problem, they are less likely to participate in activities preventing and treating excess weight. The "Healthy Change" intervention is designed to change maternal perception of child's weight (MPCW) through peer-led group health education in childcare settings. The "Healthy Change" is a multicenter two-arm randomized trial in four centers. Three centers are in Mexican States (Nuevo Leon, Tamaulipas, and Zacatecas). The fourth center is in San Antonio, Texas, USA. A total of 360 mother-child pairs (90 pairs per center) are to be randomly and evenly allocated to either the intervention or the control group. Intervention group will receive four-session group obesity prevention education. Control group will receive a four-session personal and food hygiene education. The education is delivered by trained peer-mother promotoras. Data will be collected using questionnaires and focus groups. The primary outcome is a change in proportion of mothers with accurate MPCW. Secondary outcomes include change in maternal feeding styles and practices, maternal self-efficacy and actions for managing child excessive weight gain. McNemar's Test will be used to test the primary outcome. The GLM Univariate procedure will be used to determine intervention effects on secondary outcomes. The models will include the secondary outcome measures as the dependent variables, treatment condition (intervention/control) as the fixed factor, and confounding factors (e.g., mother's education, children's gender and age) as covariates. Sub-analyses will be performed to compare intervention effects on primary and secondary outcomes between the samples from Mexico and Texas, USA

  3. An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rachyla, Iryna; Pérez-Ara, Marian; Molés, Mar; Campos, Daniel; Mira, Adriana; Botella, Cristina; Quero, Soledad

    2018-05-31

    Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet

  4. Promoting mental wellbeing: developing a theoretically and empirically sound complex intervention.

    Science.gov (United States)

    Millar, S L; Donnelly, M

    2014-06-01

    This paper describes the development of a complex intervention to promote mental wellbeing using the revised framework for developing and evaluating complex interventions produced by the UK Medical Research Council (UKMRC). Application of the first two phases of the framework is described--development and feasibility and piloting. The theoretical case and evidence base were examined analytically to explicate the theoretical and empirical foundations of the intervention. These findings informed the design of a 12-week mental wellbeing promotion programme providing early intervention for people showing signs of mental health difficulties. The programme is based on the theoretical constructs of self-efficacy, self-esteem, purpose in life, resilience and social support and comprises 10 steps. A mixed methods approach was used to conduct a feasibility study with community and voluntary sector service users and in primary care. A significant increase in mental wellbeing was observed following participation in the intervention. Qualitative data corroborated this finding and suggested that the intervention was feasible to deliver and acceptable to participants, facilitators and health professionals. The revised UKMRC framework can be successfully applied to the development of public health interventions. © The Author 2013. Published by Oxford University Press on behalf of Faculty of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  5. Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial.

    Science.gov (United States)

    L'Engle, Kelly L; Green, Kimberly; Succop, Stacey M; Laar, Amos; Wambugu, Samuel

    2015-01-23

    of resources used for the intervention. This study and protocol was fully funded, but it was terminated prior to review from ethics boards and study implementation. This cluster-RCT would have provided insights into the health effects, motivational qualities, and cost-effectiveness of mHealth interventions for PLHIV in public sector settings. We are seeking funding from alternate sources to implement the trial.

  6. Protocol for "Academic interventions for children and students with low socioeconomic status: A systematic review"

    DEFF Research Database (Denmark)

    Bøg, Martin; Dietrichson, Jens; Filges, Trine

    . The review will focus on interventions performed by pre-schools, schools, and local stakeholders, where studies have used a treatment-control/comparison design and have measured effects on test scores, grade point averages, and/or take up of high school/upper secondary school. We will use a broad search...

  7. Economic evaluation of Community Level Interventions for Pre-eclampsia (CLIP) in South Asian and African countries: a study protocol.

    Science.gov (United States)

    Khowaja, Asif R; Mitton, Craig; Bryan, Stirling; Magee, Laura A; Bhutta, Zulfiqar A; von Dadelszen, Peter

    2015-05-26

    Globally, hypertensive disorders of pregnancy, particularly pre-eclampsia and eclampsia, are the leading cause of maternal and neonatal mortality, and impose substantial burdens on the families of pregnant women, their communities, and healthcare systems. The Community Level Interventions for Pre-eclampsia (CLIP) Trial evaluates a package of care applied at both community and primary health centres to reduce maternal and perinatal disabilities and deaths resulting from the failure to identify and manage pre-eclampsia at the community level. Economic evaluation of health interventions can play a pivotal role in priority setting and inform policy decisions for scale-up. At present, there is a paucity of published literature on the methodology of economic evaluation of large, multi-country, community-based interventions in the area of maternal and perinatal health. This study protocol describes the application of methodology for economic evaluation of the CLIP in South Asia and Africa. A mixed-design approach i.e. cost-effectiveness analysis (CEA) and qualitative thematic analysis will be used alongside the trial to prospectively evaluate the economic impact of CLIP from a societal perspective. Data on health resource utilization, costs, and pregnancy outcomes will be collected through structured questionnaires embedded into the pregnancy surveillance, cross-sectional survey and budgetary reviews. Qualitative data will be collected through focus groups (FGs) with pregnant women, household male-decision makers, care providers, and district level health decision makers. The incremental cost-effectiveness ratio will be calculated for healthcare system and societal perspectives, taking into account the country-specific model inputs (costs and outcome) from the CLIP Trial. Emerging themes from FGs will inform the design of the model, and help to interpret findings of the CEA. The World Health Organization (WHO) strongly recommends cost-effective interventions as a key

  8. Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol.

    Science.gov (United States)

    Rosell-Murphy, Magdalena; Bonet-Simó, Josep M; Baena, Esther; Prieto, Gemma; Bellerino, Eva; Solé, Francesc; Rubio, Montserrat; Krier, Ilona; Torres, Pascuala; Mimoso, Sonia

    2014-03-25

    Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver.Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. CONTROLled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Primary Health Care network (9 PHCTs). Primary informal caregivers of patients receiving home health care from participating PHCTs. Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.Data analysisDependent variables: Caregiver burden (short-form Zarit test), caregivers' social support (Medical Outcomes Study), and caregivers' reported quality of life (SF-12)INDEPENDENT VARIABLES: a) Caregiver: sociodemographic data

  9. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

    Directory of Open Access Journals (Sweden)

    Welch Martha G

    2012-02-01

    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  10. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU.

    Science.gov (United States)

    Welch, Martha G; Hofer, Myron A; Brunelli, Susan A; Stark, Raymond I; Andrews, Howard F; Austin, Judy; Myers, Michael M

    2012-02-07

    The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group). The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as

  11. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.

    Science.gov (United States)

    Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

    2016-05-10

    The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and

  12. Using qualitative comparative analysis in a systematic review of a complex intervention.

    Science.gov (United States)

    Kahwati, Leila; Jacobs, Sara; Kane, Heather; Lewis, Megan; Viswanathan, Meera; Golin, Carol E

    2016-05-04

    Systematic reviews evaluating complex interventions often encounter substantial clinical heterogeneity in intervention components and implementation features making synthesis challenging. Qualitative comparative analysis (QCA) is a non-probabilistic method that uses mathematical set theory to study complex phenomena; it has been proposed as a potential method to complement traditional evidence synthesis in reviews of complex interventions to identify key intervention components or implementation features that might explain effectiveness or ineffectiveness. The objective of this study was to describe our approach in detail and examine the suitability of using QCA within the context of a systematic review. We used data from a completed systematic review of behavioral interventions to improve medication adherence to conduct two substantive analyses using QCA. The first analysis sought to identify combinations of nine behavior change techniques/components (BCTs) found among effective interventions, and the second analysis sought to identify combinations of five implementation features (e.g., agent, target, mode, time span, exposure) found among effective interventions. For each substantive analysis, we reframed the review's research questions to be designed for use with QCA, calibrated sets (i.e., transformed raw data into data used in analysis), and identified the necessary and/or sufficient combinations of BCTs and implementation features found in effective interventions. Our application of QCA for each substantive analysis is described in detail. We extended the original review findings by identifying seven combinations of BCTs and four combinations of implementation features that were sufficient for improving adherence. We found reasonable alignment between several systematic review steps and processes used in QCA except that typical approaches to study abstraction for some intervention components and features did not support a robust calibration for QCA. QCA was

  13. The effectiveness of information and communication technology-based psychological interventions for paediatric chronic pain: protocol for a systematic review, meta-analysis and intervention content analysis.

    Science.gov (United States)

    Traynor, Angeline; Morrissey, Eimear; Egan, Jonathan; McGuire, Brian E

    2016-10-18

    Resource and geographic barriers are the commonly cited constraints preventing the uptake of psychological treatment for chronic pain management. For adults, there is some evidence to support the use of information and communication technology (ICT) as a mode of treatment delivery. However, mixed findings have been reported for the effectiveness and acceptability of psychological interventions delivered using information and communication technology for children and adolescents. This is a protocol for a review that aims to (i) evaluate the effectiveness of psychological interventions delivered using information and communication technology for children and adolescents with chronic pain and (ii) identify the intervention components and usability factors in technology-based treatments associated with behaviour change. We will conduct a systematic review to evaluate the effectiveness of psychological interventions for paediatric chronic pain delivered using ICT. We plan to directly compare ICT-based, psychological interventions with active control, treatment as usual or waiting list control conditions. This systematic review will be reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance. Published and unpublished randomised controlled trials will be included and the literature search will comprise Ovid MEDLINE, Ovid Embase, PsycINFO and the Cochrane Library on Wiley, including CENTRAL and Cochrane Database of Systematic Reviews. Grey literature including theses, dissertations, technical and research reports will also be examined. Two review authors will independently conduct study selection, relevant data extraction and assessment of methodological quality. Risk of bias in included studies will be assessed using the Cochrane Collaboration risk of bias tool criteria. Two qualified coders will independently code behaviour change techniques according to the behaviour change taxonomy (v1) of 93 hierarchically

  14. 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

  15. Understanding the impact of visual arts interventions for people living with dementia: a realist review protocol.

    Science.gov (United States)

    Windle, Gill; Gregory, Samantha; Newman, Andrew; Goulding, Anna; O'Brien, Dave; Parkinson, Clive

    2014-08-15

    Arts-based activities are being increasingly suggested as a valuable activity for people living with dementia in terms of countering the negative aspects of their condition. The potential for such programmes to improve a broad range of psychosocial outcomes is suggested in some studies. However, there is largely an absence of rigorous methodology to demonstrate the benefits, and research results are mixed. Practice variability in terms of the content, contexts and implementation of such interventions raises challenges in terms of identifying an optimal arts programme model that could be adopted by other service providers. Understanding how interventions may have the best chance at broad implementation success and uptake is limited. A realist review will be undertaken. This aims to understand how visual arts interventions influence outcomes in people living with dementia. The review will explore how the context, that is the circumstances which enable or constrain, affect outcomes through the activation of mechanisms. An early scoping search and a stakeholder survey formulated the preliminary programme theory. A systematic literature search across a broad range of disciplines (arts, humanities, social sciences, health) will be undertaken to identify journal articles and grey literature. Data will be extracted in relation to the programme theory, contextual factors, mechanisms and outcomes and their configurations, background information about the study design and participant characteristics, detail about the quantity ('dose') of an intervention, theoretical perspectives proposed by the authors of the paper and further theorising by the reviewer. Thematic connections/patterns will be sought across the extracted data, identifying patterns amongst contextual factors, the mechanisms they trigger and the associated outcomes. Along with stakeholder engagement and validation, this review will help inform the development of an optimal, replicable arts intervention for people

  16. Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

    2016-01-01

    Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline

  17. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial.

    Science.gov (United States)

    Arija, Victoria; Martín, Núria; Canela, Teresa; Anguera, Carme; Castelao, Ana I; García-Barco, Montserrat; García-Campo, Antoni; González-Bravo, Ana I; Lucena, Carme; Martínez, Teresa; Fernández-Barrés, Silvia; Pedret, Roser; Badia, Waleska; Basora, Josep

    2012-05-24

    Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions.The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0-6-12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin.Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient's nutritional status using the MNA test, diet, anthropometry, and biochemical parameters.Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention.The SPSS/PC program will be used for statistical analysis. The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at

  18. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arija Victoria

    2012-05-01

    Full Text Available Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain. These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA, food intake, dentures, degree of dependency (Barthel test, cognitive state (Pfeiffer test, mood status (Yesavage test, and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits up to 6 months. The North American Nursing Diagnosis Association (NANDA methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of

  19. STARS experiential group intervention: a complex trauma treatment approach for survivors of human trafficking.

    Science.gov (United States)

    Hopper, Elizabeth K; Azar, Naomi; Bhattacharyya, Sriya; Malebranche, Dominique A; Brennan, Kelsey E

    2018-01-01

    This is the abstract that was submitted online with the paper: Despite the fact that many survivors of human trafficking have experienced complex trauma, there are no established interventions designed to specifically address these impacts. Leaders in the field of complex trauma have advocated for the need for somatic approaches to intervention. This paper presents STARS Experiential Group treatment, the first structured bodybased group intervention that has been designed to address complex trauma in survivors of human trafficking. Three pilot groups were run in residential settings with adolescent and adult survivors of sex trafficking. Two adaptations were utilized, with one focusing on application of expressive arts modalities and the other incorporating theater games. Qualitative results, using thematic analysis, identified several themes related to challenges and potential benefits of these groups. Potential benefits of the STARS groups were found in the areas of Interpersonal Relationships, Regulation, and Self/ Identity, with fourteen sub-themes further describing positive impacts. Challenges within these areas are explored, to inform the development of group interventions for trafficking survivors. The results of this paper suggest that experiential, somatically-oriented group treatment shows promise as an important element of holistic intervention with trafficking survivors.

  20. [Effects of a preventive intervention program for improving self-complexity on depression among college students].

    Science.gov (United States)

    Kawahito, Junko; Hori, Masashi; Otsuka, Yasumasa

    2010-06-01

    The present study developed an intervention program for self-complexity (SC; Linville, 1987), and examined the effects of this program on college students. Participants (N = 40) were randomly assigned to an intervention group or a control group. The intervention group received one session of psycho-education about SC, and kept daily records of self-aspects (social roles, interpersonal relationships, specific events/behaviors, traits, abilities, etc.) for one week. All participants were asked to complete a self-report questionnaire three times (pre, post, and follow-up). The questionnaire was comprised of items evaluating depression (The Center for Epidemiologic Studies Depression Scale), SC, positive self-complexity (P-SC), and negative self-complexity (N-SC). The results indicated that P-SC at the post-test was significantly increased and P-SC at the follow-up test was marginally increased in the intervention group, compared with the control group. Furthermore, structured equation modeling revealed that in the intervention group, high P-SC was related to low level of depressed mood after the program.

  1. Early intervention services of children with physical disabilities: complexity of child and family needs.

    Science.gov (United States)

    Ziviani, Jenny; Darlington, Yvonne; Feeney, Rachel; Rodger, Sylvia; Watter, Pauline

    2014-04-01

    To gain insight into the special issues confronting parents when accessing early intervention for children with physical disabilities where child and/or family characteristics indicate complex needs within the unique Australian context. Qualitative interviews with families receiving early intervention for their children with physical disabilities (N=10). Families with complex circumstances such as having children with high support needs, those from culturally and linguistically diverse backgrounds, and single-parent families were recruited to the study. Families where parents had mental or health issues, parents/other family members had an identified disability, and/or where families lived in regional or rural locations were also purposively sampled. Participants highlighted issues around (i) the nature of early intervention services provided; (ii) the ways in which services were structured; and (ii) managing their child's needs/planning into the future. Parents stressed the importance of having access to a variety of early intervention services aside from therapy. They also emphasised the need for greater clarity about what to expect from services, the intensity of therapy, other services they could access and how long they would be able to receive these. Despite their complex circumstances and needs, participants' experiences of accessing early intervention services were largely consistent with the broader research literature. Of the parents interviewed, those with health problems and single mothers expressed most apprehension about managing their child's needs and planning for the future. © 2013 Occupational Therapy Australia.

  2. Identification of behaviour change components in swallowing interventions for head and neck cancer patients: protocol for a systematic review.

    Science.gov (United States)

    Govender, Roganie; Smith, Christina H; Taylor, Stuart A; Grey, Daphne; Wardle, Jane; Gardner, Benjamin

    2015-06-20

    Dysphagia (difficulty in swallowing) is a predictable consequence of head and neck cancer and its treatment. Loss of the ability to eat and drink normally has a devastating impact on quality of life for survivors of this type of cancer. Most rehabilitation programmes involve behavioural interventions that include swallowing exercises to help improve swallowing function. Such interventions are complex; consisting of multiple components that may influence outcomes. These interventions usually require patient adherence to recommended behaviour change advice. To date, reviews of this literature have explored whether variation in effectiveness can be attributed to the type of swallowing exercise, the use of devices to facilitate use of swallowing muscles, and the timing (before, during or after cancer treatment). This systematic review will use a behavioural science lens to examine the content of previous interventions in this field. It aims to identify (a) which behaviour change components are present, and (b) the frequency with which they occur in interventions deemed to be effective and non-effective. Clinical trials of behavioural interventions to improve swallowing outcomes in patients with head and neck cancers will be identified via a systematic and comprehensive search of relevant electronic health databases, trial registers, systematic review databases and Web of Science. To ascertain behaviour change intervention components, we will code the content for its theory basis, intervention functions and specific behaviour change techniques, using validated tools: the Theory Coding Scheme, Behaviour Change Wheel and Behaviour Change Technique Taxonomy v1. Study quality will be assessed for descriptive purposes only. Given the specialisation and focus of this review, a small yield of studies with heterogeneous outcome measures is anticipated. Therefore, narrative synthesis is considered more appropriate than meta-analysis. We will also compare the frequency of

  3. Maltese Antibiotic Stewardship Programme in the Community (MASPIC): protocol of a prospective quasiexperimental social marketing intervention

    OpenAIRE

    Saliba-Gustafsson, Erika A; Borg, Michael A; Rosales-Klintz, Senia; Nyberg, Anna; StålsbyLundborg, Cecilia

    2017-01-01

    Introduction Antibiotic misuse is a key driver of antibiotic resistance. In 2015/2016, Maltese respondents reported the highest proportions of antibiotic consumption in Europe. Since antibiotics are prescription-only medicines in Malta, research on effective strategies targeting general practitioners’ (GPs) knowledge and behaviour is needed. Multifaceted behaviour change (BC) interventions are likely to be effective. Social marketing (SM) can provide the tools to promote sustained BC; however...

  4. Reducing occupational stress with a B-vitamin focussed intervention: a randomized clinical trial: study protocol

    OpenAIRE

    Stough, Con; Simpson, Tamara; Lomas, Justine; McPhee, Grace; Billings, Clare; Myers, Stephen; Oliver, Chris; Downey, Luke A

    2014-01-01

    Background Workplace stress in Australia and other western countries has been steadily increasing over the past decade. It can be observed not only in terms of increased compensation claims but also costs due to absenteeism, loss of productivity at work and reduced psychological and physiological health and well-being. Given the cost and pervasive effects of stress in the modern workforce, time efficient and cost-effective interventions capable of reducing occupational stress (or strain) and ...

  5. Recruitment for exercise or physical activity interventions: a protocol for systematic review.

    Science.gov (United States)

    Hoover, Jeffrey C; Alenazi, Aqeel M; Alothman, Shaima; Alshehri, Mohammed M; Rucker, Jason; Kluding, Patricia

    2018-03-27

    Recruiting participants into research trials is essential for the advancement of scientific knowledge that depends on clinical research studies. For the field of exercise and physical activity, there is an added difficulty in recruiting participants because participants must be willing to participate in an intervention that requires a significant commitment of both time and physical effort. Therefore, we have planned a systematic review to analyse how methodological factors, intervention characteristics and participant demographics impact recruitment rates in specific populations. This information will help researchers improve the design and recruitment approach in future studies. A mixed methods systematic review will be performed on studies that implement physical activity interventions and present data on participant recruitment. We plan on searching the Pubmed, Cumulative Index to Nursing and Allied Health Literature and Online Resource for Recruitment research in Clinical Trials databases for potentially eligible articles from database inception through 10 February 2017. A standardised approach will be used to identify studies through a review of titles, abstracts and reference lists. The process for each eligible study is to determine their eligibility, extract data from eligible studies and rate each eligible study's methodological quality. Exploratory multivariate regression models will be used to determine the effects of methodological factors, intervention characteristics and participant demographics on the recruitment variables of interest. Because all of the data used in this systematic review has been published, this review does not require ethical approval. The results of this review will be disseminated through peer-reviewed publication as well as through conference presentations. CRD42017057284. © 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

  6. 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.

  7. Addressing the Needs of Adolescents with Autism Spectrum Disorder: Considerations and Complexities for High School Interventions

    Science.gov (United States)

    Kucharczyk, Suzanne; Reutebuch, Colleen K.; Carter, Erik W.; Hedges, Susan; El Zein, Farah; Gustafson, Jenny R.

    2015-01-01

    The outcomes of students with autism spectrum disorder (ASD) are driving the field to address how secondary education might be optimally designed and delivered. We conducted 28 focus groups across four states to explore the contexts, considerations, and complexities associated with delivering and combining evidence-based interventions to meet the…

  8. Use of Movement Imagery in Neurorehabilitation: Researching Effects of a Complex Intervention

    Science.gov (United States)

    Braun, Susy M.; Wade, Derick T.; Beurskens, Anna J. H. M.

    2011-01-01

    Since the beginning of the new millennium, the use of mental practice and movement imagery within several medical professions in rehabilitation and therapy has received an increased attention. Before this introduction in healthcare, the use of movement imagery was mainly researched in sports science. Mental practice is a complex intervention. When…

  9. A school-based intervention program in promoting leisure-time physical activity: trial protocol.

    Science.gov (United States)

    Kawabata, Masato; Chua, Khai Leng; Chatzisarantis, Nikos L D

    2018-04-02

    Regular participation in moderate-to-vigorous physical activity (MVPA) is important to manage obesity. Physical education (PE) is considered to play an important role in promoting lifelong participation in physical activity (PA) because it provides an existing network where cost-effective interventions can be implemented to produce sustainable change in health behavior. However, the association between compulsory school PA (e.g., PE lessons) and body composition levels has received mixed support in the literature. Therefore, the present study aimed to investigate whether a school-based intervention targeting salient PA benefits and barriers grounded on the theory of planned behavior would promote young people's participation in MVPA during leisure time and reduce body mass index (BMI) of overweight students. A total of 171 students from 3 secondary schools in Singapore underwent the control condition followed by the intervention condition. Both the conditions consisted of PE lessons twice per week over 4 weeks. In the control condition, PE teachers encouraged students to participate in PA during leisure time without providing persuasive message. While in the intervention condition, PE teachers delivered persuasive messages that targeted the salient benefits and barriers associated with PA to the students at the last 5 to 10 min of each PE lesson. PA levels over a week were measured objectively with wrist-mounted GENEActiv Original accelerometers and subjectively with self-reporting questionnaires three times (Baseline, Post 1, and Post 2) in each condition. Student's self-reported PA level was measured using the Leisure-Time Physical Activity Participation Questionnaire and the International Physical Activity Questionnaire, and their attitudes, intentions, subjective norms and perceived behavior control towards leisure-time PA were measured with a questionnaire based on the theory of planned behavior. Furthermore, students' intention, determination and

  10. Protocol: a multi-level intervention program to reduce stress in 9-1-1 telecommunicators.

    Science.gov (United States)

    Meischke, Hendrika; Lilly, Michelle; Beaton, Randal; Calhoun, Rebecca; Tu, Ann; Stangenes, Scott; Painter, Ian; Revere, Debra; Baseman, Janet

    2018-05-02

    Nationwide, emergency response systems depend on 9-1-1 telecommunicators to prioritize, triage, and dispatch assistance to those in distress. 9-1-1 call center telecommunicators (TCs) are challenged by acute and chronic workplace stressors: tense interactions with citizen callers in crisis; overtime; shift-work; ever-changing technologies; and negative work culture, including co-worker conflict. This workforce is also subject to routine exposures to secondary traumatization while handling calls involving emergency situations and while making time urgent, high stake decisions over the phone. Our study aims to test the effectiveness of a multi-part intervention to reduce stress in 9-1-1 TCs through an online mindfulness training and a toolkit containing workplace stressor reduction resources. The study employs a randomized controlled trial design with three data collection points. The multi-part intervention includes an individual-level online mindfulness training and a call center-level organizational stress reduction toolkit. 160 TCs will be recruited from 9-1-1 call centers, complete a baseline survey at enrollment, and are randomly assigned to an intervention or a control group. Intervention group participants will start a 7-week online mindfulness training developed in-house and tailored to 9-1-1 TCs and their call center environment; control participants will be "waitlisted" and start the training after the study period ends. Following the intervention group's completion of the mindfulness training, all participants complete a second survey. Next, the online toolkit with call-center wide stress reduction resources is made available to managers of all participating call centers. After 3 months, a third survey will be completed by all participants. The primary outcome is 9-1-1 TCs' self-reported symptoms of stress at three time points as measured by the C-SOSI (Calgary Symptoms of Stress Inventory). Secondary outcomes will include: perceptions of social work

  11. Protocol for systematic review of school-based interventions to prevent and control obesity in African learners.

    Science.gov (United States)

    Adom, Theodosia; Puoane, Thandi; De Villiers, Anniza; Kengne, André Pascal

    2017-03-27

    The increasing prevalence of obesity and overweight in childhood in developing countries is a public health concern to many governments. Schools play a significant role in the obesity epidemic as well as provide favourable environments for change in behaviours in childhood which can be carried on into adulthood. There is dearth of information on intervention studies in poor-resource settings. This review will summarise the available evidence on school-based interventions that focused on promoting healthy eating and physical activity among learners aged 6-15 years in Africa and to identify factors that lead to successful interventions or potential barriers to success of these programmes within the African context. This protocol is developed following the guidelines of PRIMSA-P 2015. Relevant search terms and keywords generated from the subject headings and the African search filter will be used to conduct a comprehensive search of MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Register Academic Search Complete (EbscoHost) and ISI Web of Science (Science Citation Index) for published literature on school-based interventions to prevent and control obesity in learners in Africa. Grey literature will be also be obtained. The searches will cover 1 January 2000 to 30 June 2016. No language limitations will be applied. Full-text articles of eligible studies will be screened. Risk of bias and quality of reporting will be assessed. Data will be extracted, synthesised and presented by country and major regional groupings. Meta-analysis will be conducted for identical variables across studies, where data allow. This protocol is developed following the guidelines of PRISMA-P 2015. No primary data will be collected hence ethics is not a requirement. The findings will be submitted for publication in peer-reviewed journals, in conferences and in policy documents for decision-making, where needed. Published by the BMJ Publishing Group Limited. For permission to use

  12. On the Amortized Complexity of Zero Knowledge Protocols for Multiplicative Relations

    DEFF Research Database (Denmark)

    Cramer, Ronald; Damgård, Ivan Bjerre; Pastro, Valerio

    2011-01-01

    require the strong RSA assumption, we only need the assumption required by the commitment scheme itself, namely factoring. We generalize this to a protocol that verifies $l$ instances of an algebraic circuit $D$ over $K$ with $v$ inputs, in the following sense: given committed values $x_{i,j}$ and $z...

  13. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care

    Directory of Open Access Journals (Sweden)

    Schalm Corinne

    2010-10-01

    Full Text Available Abstract Background There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? Methods/design The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research

  14. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in long-term care.

    Science.gov (United States)

    Sales, Anne E; Schalm, Corinne

    2010-10-13

    There is considerable evidence about the effectiveness of audit coupled with feedback, although few audit with feedback interventions have been conducted in long-term care (LTC) settings to date. In general, the effects have been found to be modest at best, although in settings where there has been little history of audit and feedback, the effects may be greater, at least initially. The primary purpose of the Data for Improvement and Clinical Excellence (DICE) Long-Term Care project is to assess the effects of an audit with feedback intervention delivered monthly over 13 months in four LTC facilities. The research questions we addressed are:1. What effects do feedback reports have on processes and outcomes over time?2. How do different provider groups in LTC and home care respond to feedback reports based on data targeted at improving quality of care? The research team conducting this study comprises researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of monthly feedback reports in nine LTC units in four facilities in Edmonton, Alberta. Data for the feedback reports comes from the Resident Assessment Instrument Minimum Data Set (RAI) version 2.0, a standardized instrument mandated for use in LTC facilities throughout Alberta. Feedback reports consist of one page, front and back, presenting both graphic and textual information. Reports are delivered to all staff working in the four LTC facilities. The primary evaluation uses a controlled interrupted time series design both adjusted and unadjusted for covariates. The concurrent process evaluation uses observation and self-report to assess uptake of the feedback reports. Following the project phase described in this protocol, a similar intervention will be conducted in home care settings in Alberta. Depending on project findings, if they are judged useful by decision makers participating in this research team, we plan dissemination and spread of the feedback

  15. Supporting Policy In health with Research: an Intervention Trial (SPIRIT)—protocol for a stepped wedge trial

    Science.gov (United States)

    2014-01-01

    Introduction Governments in different countries have committed to better use of evidence from research in policy. Although many programmes are directed at assisting agencies to better use research, there have been few tests of the effectiveness of such programmes. This paper describes the protocol for SPIRIT (Supporting Policy In health with Research: an Intervention Trial), a trial designed to test the effectiveness of a multifaceted programme to build organisational capacity for the use of research evidence in policy and programme development. The primary aim is to determine whether SPIRIT results in an increase in the extent to which research and research expertise is sought, appraised, generated and used in the development of specific policy products produced by health policy agencies. Methods and analysis A stepped wedge cluster randomised trial involving six health policy agencies located in Sydney, Australia. Policy agencies are the unit of randomisation and intervention. Agencies were randomly allocated to one of three start dates (steps) to receive the 1-year intervention programme, underpinned by an action framework. The SPIRIT intervention is tailored to suit the interests and needs of each agency and includes audit, feedback and goal setting; a leadership programme; staff training; the opportunity to test systems to assist in the use of research in policies; and exchange with researchers. Outcome measures will be collected at each agency every 6 months for 30 months (starting at the beginning of step 1). Ethics and dissemination Ethics approval was granted by the University of Western Sydney Human Research and Ethics Committee HREC Approval H8855. The findings of this study will be disseminated broadly through peer-reviewed publications and presentations at conferences and used to inform future strategies. PMID:24989620

  16. Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Collins, Karen; Reed, Malcolm; Lifford, Kate; Burton, Maria; Edwards, Adrian; Ring, Alistair; Brain, Katherine; Harder, Helena; Robinson, Thompson; Cheung, Kwok Leung; Morgan, Jenna; Audisio, Riccardo; Ward, Susan; Richards, Paul; Martin, Charlene; Chater, Tim; Pemberton, Kirsty; Nettleship, Anthony; Murray, Christopher; Walters, Stephen; Bortolami, Oscar; Armitage, Fiona; Leonard, Robert; Gath, Jacqui; Revell, Deirdre; Green, Tracy; Wyld, Lynda

    2017-07-31

    While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing 'Age Gap Cohort Study' (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. 115550. European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsor's Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*. © 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.

  17. Diagnostic reference levels and complexity indices in interventional radiology: a national programme

    Energy Technology Data Exchange (ETDEWEB)

    Ruiz-Cruces, R.; Perez-Martinez, M.; Pastor-Vega, J.M.; Canete, S. [University of Malaga, School of Medicine, Malaga (Spain); Vano, E.; Fernandez-Soto, J.M.; Sanchez-Casanueva, R.; Gallego-Beuter, J.J. [Complutense University, San Carlos Hospital, Medical School, Madrid (Spain); Carrera-Magarino, F.; Moreno-Rodriguez, F.; Moreno-Sanchez, T. [Juan Ramon Jimenez University Hospital, Huelva (Spain); Soler-Cantos, M.M.; Canis-Lopez, M. [Reina Sofia University Hospital, Cordoba (Spain); Hernandez-Armas, J.; Diaz-Romero, F.J. [University Hospital of Canary Islands, Tenerife (Spain); Rosales-Espizua, F.; Lopez-Medina, A.; Gonzalez-de-Garay, M. [Basurto Hospital, Bilbao (Spain); Martin-Palanca, A. [Virgen de la Victoria University Hospital, Malaga (Spain); Gil-Agudo, A.; Zarca-Diaz, M.A.; Zapata-Jimenez, J.C. [General University Hospital, Ciudad Real (Spain); Parra-Osorio, V.; Munoz Ruiz-Canela, J.J.; Moreno-Saiz, C.; Galan-Montenegro, P. [Carlos Haya University Hospital, Malaga (Spain)

    2016-12-15

    To propose national diagnostic reference levels (DRLs) for interventional radiology and to evaluate the impact of the procedural complexity on patient doses. Eight interventional radiology units from Spanish hospitals were involved in this project. The participants agreed to undergo common quality control procedures for X-ray systems. Kerma area product (KAP) was collected from a sample of 1,649 procedures. A consensus document established the criteria to evaluate the complexity of seven types of procedures. DRLs were set as the 3rd quartile of KAP values. The KAP (3rd quartile) in Gy cm{sup 2} for the procedures included in the survey were: lower extremity arteriography (n = 784) 78; renal arteriography (n = 37) 107; transjugular hepatic biopsies (THB) (n = 30) 45; biliary drainage (BD) (n = 314) 30; uterine fibroid embolization (UFE) (n = 56) 214; colon endoprostheses (CE) (n = 31) 169; hepatic chemoembolization (HC) (n = 269) 303; femoropopliteal revascularization (FR) (n = 62) 119; and iliac stent (n = 66) 170. The complexity involved the increases in the following KAP factors from simple to complex procedures: THB x4; BD x13; UFE x3; CE x3; HC x5; FR x5 and IS x4. The evaluation of the procedure complexity in patient doses will allow the proper use of DRLs for the optimization of interventional radiology. (orig.)

  18. Community pharmacist intervention in depressed primary care patients (PRODEFAR study: randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Travé Pere

    2009-08-01

    Full Text Available Abstract Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75 diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain. Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9, anxiety (STAI-S, health-related quality of life (EuroQol-5D, satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI. Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical

  19. Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

    2014-11-20

    Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of

  20. Efficacy of interventions to improve physical activity levels in individuals with stroke: a systematic review protocol

    Science.gov (United States)

    Aguiar, Larissa Tavares; Martins, Júlia Caetano; Nadeau, Sylvie; Britto, Raquel Rodrigues; Teixeira-Salmela, Luci F; Faria, Christina D C M

    2017-01-01

    Introduction Stroke is a leading health problem worldwide and an important cause of disability. Stroke survivors show low levels of physical activity, and increases in physical activity levels may improve function and health status. Therefore, the aims are to identify which interventions that have been employed to increase physical activity levels with stroke survivors, to verify their efficacy and to identify the gaps in the literature. Methods and analysis A systematic review of randomised controlled trials that investigated the efficacy of interventions aiming at increasing physical activity levels of stroke survivors will be conducted. Electronic searches will be performed in the MEDLINE, Physiotherapy Evidence Database (PEDro), Excerpta Medica (EMBASE), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) and Scientific Electronic Library Online (SCIELO) databases. Hand searches of the reference lists of the included studies or relevant reviews will also be employed. Two independent reviewers will screen all the retrieved titles, abstracts and full texts. A third reviewer will be referred to solve any disagreements. The quality of the included studies will be assessed by the PEDro Rating Scale. This systematic review will also include a qualitative synthesis. Meta-analyses will be performed, if the studies are sufficiently homogeneous. This review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement. The quality of the evidence regarding physical activity will be assessed, according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Discussion This systematic review will provide information on which interventions are effective for increasing physical activity levels of stroke survivors. This evidence may be important for clinical decision-making and will allow the identification of gaps in the literature that may be useful for the definition of future research

  1. Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

    Science.gov (United States)

    Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne

    2017-02-07

    Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected

  2. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

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    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  3. Comparing interventions and exploring neural mechanisms of exercise in Parkinson disease: a study protocol for a randomized controlled trial.

    Science.gov (United States)

    Earhart, Gammon M; Duncan, Ryan P; Huang, John L; Perlmutter, Joel S; Pickett, Kristen A

    2015-02-05

    Effective treatment of locomotor dysfunction in Parkinson disease (PD) is essential, as gait difficulty is an early and major contributor to disability. Exercise is recommended as an adjunct to traditional treatments for improving gait, balance, and quality of life. Among the exercise approaches known to improve walking, tango and treadmill training have recently emerged as two promising therapies for improving gait, disease severity and quality of life, yet these two interventions have not been directly compared to each other. Prior studies have been helpful in identifying interventions effective in improving gait function, but have done little to elucidate the neural mechanisms underlying functional improvements. The primary objective of the proposed work is to compare the effects of three community-based exercise programs, tango, treadmill training and stretching, on locomotor function in individuals with PD. In addition, we aim to determine whether and how these interventions alter functional connectivity of locomotor control networks in the brain. One hundred and twenty right-handed individuals with idiopathic PD who are at least 30 years of age will be assigned in successive waves to one of three community-based exercise groups: tango dancing, treadmill training or stretching (control). Each group will receive three months of exercise training with twice weekly one-hour group classes. Each participant will be evaluated at three time points: pre-intervention (baseline), post-intervention (3 months), and follow-up (6 months). All evaluations will include assessment of gait, balance, disease severity, and quality of life. Baseline and post-intervention evaluations will also include task-based functional magnetic resonance imaging (fMRI) and resting state functional connectivity MRI. All MRI and behavioral measures will be conducted with participants OFF anti-Parkinson medication, with behavioral measures also assessed ON medication. This study will provide

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

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    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.

  5. 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

  6. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

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    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  7. Intervention development for the indicated prevention of depression in later life: The “DIL” protocol in Goa, India

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    Amit Dias, MD

    2017-06-01

    Full Text Available Because depression is a major source of the global burden of illness-related disability, developing effective strategies for reducing its incidence is an important public health priority, especially in low-income countries, where resources for treating depression are scarce. We describe in this report an intervention development project, funded by the US National Institute of Mental Health, to address “indicated” prevention of depression in older adults attending rural and urban primary care clinics in Goa, India. Specifically, participants in the “DIL” (“Depression in Later Life” trial were older adults living with mild, subsyndromal symptoms of depression and anxiety and thus at substantial risk for transitioning to fully syndromal major depression and anxiety disorders. Building upon the MANAS treatment trial (“Promoting Mental Health” led by Patel et al. in the same locale, we present here lessons learned in the development and implementation of a protocol utilizing lay health counsellors (LHCs who deliver a multi-component depression prevention intervention organized conceptually around Problem Solving Therapy for Primary Care (PST, with additional components addressing brief behavioural treatment of sleep disturbances such as insomnia, meeting basic social casework needs, and education in self-management of prevalent comorbid chronic diseases, such as diabetes mellitus. To our knowledge, DIL is the first randomized clinical trial addressing the prevention of depressive disorders ever conducted in a low- or middle-income country.

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

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    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.

  9. Research Paper: Production of A Protocol on Early Intervention for Speech and Language Delays in Early Childhood: An Novice Experience in Iran

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    Roshanak Vameghi

    2016-01-01

    Results The result of this study is presented as 7 intervention packages, including the following domains of disorders: prelingual lingual speech and language hearing impairment, speech sound, dysphagia, stuttering, and dysarthria  Conclusion Most studies have confirmed the effectiveness and need for early interventions for children with speech and language impairment. However, most do not explain the details of these interventions. Before the present study, no systematic and evidence-based protocol existed for early intervention in childhood speech and language impairments, in Iran; and due to language differences, as well as possible differences in the speech and language developmental process of children of different communities, making direct use of non-Persian references was not possible and effective. Thus, there was a clear demand for the production of such a protocol.

  10. Development and preliminary evaluation of a rehabilitation consult for survivors of head and neck cancer: an intervention mapping protocol.

    Science.gov (United States)

    McEwen, Sara E; Davis, Aileen M; Jones, Jennifer M; Martino, Rosemary; Poon, Ian; Rodriguez, Ana Maria; Ringash, Jolie

    2015-01-09

    Evidence suggests that rehabilitation interventions can improve function and quality of life in survivors of head and neck cancer (HNC), but there is a lack of coordinated, integrated services, and those offered are inconsistent. To address these gaps, we will develop and conduct preliminary evaluation of a rehabilitation consult, built on the theoretical foundations of goal setting and self-management, and composed of a brief functional evaluation, a resource compendium, and collaborative goal-setting and action planning processes. The development of the rehabilitation consult will be guided by intervention mapping, which consists of six steps: 1. Needs assessment; 2. Definition of program objectives; 3. Selection of theory-based intervention methods; 4. Production and pretesting; 5. Adoption, implementation and sustainability planning; 6. Process and effect evaluation. Within the intervention mapping framework, an iterative process of constructing drafts and mini-evaluations with consumers and experts will be used, modifying the rehabilitation consult intervention until a version suitable for formal evaluation is established. The rehabilitation consult will then be evaluated using a prospective, mixed method, single group design with 30 survivors of head and neck cancer. Outcomes will be assessed pre- and post-intervention and at 6-month follow-up. Survivors of head and neck cancer have among the most complex rehabilitation needs of all cancer patients. The rehabilitation consult is expected to improve knowledge and uptake of rehabilitation resources and strategies in survivors of head and neck cancer and thereby improve long-term function and quality of life. If the rehabilitation consult is effective in cancer patients with such high and diverse needs, this project will produce a toolkit that will be adaptable for other types of cancer in other jurisdictions.

  11. Biofeedback interventions for people with cerebral palsy: a systematic review protocol.

    Science.gov (United States)

    MacIntosh, Alexander; Vignais, Nicolas; Biddiss, Elaine

    2017-01-13

    Cerebral palsy is a life-long disability that affects motor control and activities of daily living. Depending on the type of cerebral palsy, some individuals may have trouble performing tasks with one or both of their arms and/or legs. Different strategies exist to help develop motor capacity. Biofeedback therapy is a commonly applied rehabilitation strategy. In biofeedback therapy, information about the motor behavior while completing a task is given back to the individual to help improve their performance. This can provide valuable information that would otherwise be unknown to the individual. Biofeedback may also have a unique method of operation in clinical populations, such as people with cerebral palsy. Therefore, it is important to identify the most effective mechanisms for specific populations. This review aims to evaluate the effects of biofeedback interventions that have been used towards improving motor performance and motor learning in people with cerebral palsy. Using a customized strategy, MEDLINE, CINAHL, Embase, PsycINFO, Cochrane Central Register of Controlled Trials, SCOPUS, SPORTDiscus, and PEDro databases will be searched. Two independent reviewers will screen titles and abstracts, review full texts for inclusion criteria, and extract data from relevant articles using a standardized template. Quality of evidence and risk of bias will be assessed through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Several studies have investigated biofeedback-based interventions for people with cerebral palsy. However, there is a great variety and limited consensus regarding how to implement biofeedback mechanisms. This systematic review will consolidate the current evidence to direct future study and develop effective biofeedback rehabilitation strategies. PROSPERO ID: CRD42016047612.

  12. Exercise intervention to prevent falls and enhance mobility in community dwellers after stroke: a protocol for a randomised controlled trial

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    Barker Ruth N

    2009-07-01

    Full Text Available Abstract Background Stroke is the most common disabling neurological condition in adults. Falls and poor mobility are major contributors to stroke-related disability. Falls are more frequent and more likely to result in injury among stroke survivors than among the general older population. Currently there is good evidence that exercise can enhance mobility after stroke, yet ongoing exercise programs for general community-based stroke survivors are not routinely available. This randomised controlled trial will investigate whether exercise can reduce fall rates and increase mobility and physical activity levels in stroke survivors. Methods and design Three hundred and fifty community dwelling stroke survivors will be recruited. Participants will have no medical contradictions to exercise and be cognitively and physically able to complete the assessments and exercise program. After the completion of the pre-test assessment, participants will be randomly allocated to one of two intervention groups. Both intervention groups will participate in weekly group-based exercises and a home program for twelve months. In the lower limb intervention group, individualised programs of weight-bearing balance and strengthening exercises will be prescribed. The upper limb/cognition group will receive exercises aimed at management and improvement of function of the affected upper limb and cognition carried out in the seated position. The primary outcome measures will be falls (measured with 12 month calendars and mobility. Secondary outcome measures will be risk of falling, physical activity levels, community participation, quality of life, health service utilisation, upper limb function and cognition. Discussion This study aims to establish and evaluate community-based sustainable exercise programs for stroke survivors. We will determine the effects of the exercise programs in preventing falls and enhancing mobility among people following stroke. This program, if

  13. Behind the scenes of the PRIME intervention: designing a complex intervention to improve malaria care at public health centres in Uganda

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    Deborah D. DiLiberto

    2015-10-01

    Full Text Available Background: In Uganda, health system challenges limit access to good quality healthcare and contribute to slow progress on malaria control. We developed a complex intervention (PRIME, which was designed to improve quality of care for malaria at public health centres. Objective: Responding to calls for increased transparency, we describe the PRIME intervention's design process, rationale, and final content and reflect on the choices and challenges encountered during the design of this complex intervention. Design: To develop the intervention, we followed a multistep approach, including the following: 1 formative research to identify intervention target areas and objectives; 2 prioritization of intervention components; 3 review of relevant evidence; 4 development of intervention components; 5 piloting and refinement of workshop modules; and 6 consolidation of the PRIME intervention theories of change to articulate why and how the intervention was hypothesized to produce desired outcomes. We aimed to develop an intervention that was evidence-based, grounded in theory, and appropriate for the study context; could be evaluated within a randomized controlled trial; and had the potential to be scaled up sustainably. Results: The process of developing the PRIME intervention package was lengthy and dynamic. The final intervention package consisted of four components: 1 training in fever case management and use of rapid diagnostic tests for malaria (mRDTs; 2 workshops in health centre management; 3 workshops in patient-centred services; and 4 provision of mRDTs and antimalarials when stocks ran low. Conclusions: The slow and iterative process of intervention design contrasted with the continually shifting study context. We highlight the considerations and choices made at each design stage, discussing elements we included and why, as well as those that were ultimately excluded. Reflection on and reporting of ‘behind the scenes’ accounts of intervention

  14. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living.

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    Fraser, Kimberly D; Sales, Anne E; O'Rourke, Hannah M; Schalm, Corinne

    2012-01-18

    Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence--Long-Term Care. We will offer dissemination strategies

  15. Data for improvement and clinical excellence: protocol for an audit with feedback intervention in home care and supportive living

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    Fraser Kimberly D

    2012-01-01

    Full Text Available Abstract Background Although considerable evidence exists about the effectiveness of audit coupled with feedback, very few audit-with-feedback interventions have been done in either home care or supportive living settings to date. With little history of audit and feedback in home care or supportive living there is potential for greater effects, at least initially. This study extends the work of an earlier study designed to assess the effects of an audit-with-feedback intervention. It will be delivered quarterly over a one-year period in seven home care offices and 11 supportive living sites. The research questions are the same as in the first study but in a different environment. They are as follows: 1. What effects do feedback reports have on processes and outcomes over time? 2. How do different provider groups in home care and supportive living sites respond to feedback reports based on quality indicator data? Methods The research team conducting this study includes researchers and decision makers in continuing care in the province of Alberta, Canada. The intervention consists of quarterly feedback reports in 19 home care offices and supportive living sites across Alberta. Data for the feedback reports are based on the Resident Assessment Instrument Home Care tool, a standardized instrument mandated for use in home care and supportive living environments throughout Alberta. The feedback reports consist of one page, printed front and back, presenting both graphic and textual information. Reports are delivered to all employees working in each site. The primary evaluation uses a controlled interrupted time-series design, both adjusted and unadjusted for covariates. The concurrent process evaluation includes observation, focus groups, and self-reports to assess uptake of the feedback reports. The project described in this protocol follows a similar intervention conducted in our previous study, Data for Improvement and Clinical Excellence

  16. Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol.

    Science.gov (United States)

    Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

    2018-01-31

    Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or 'third -wave' CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016-0107). The Ffindings will be used to improve the intervention per user

  17. Psychosocial Distress of Patients with Psoriasis: Protocol for an Assessment of Care Needs and the Development of a Supportive Intervention.

    Science.gov (United States)

    Zill, Jördis Maria; Dirmaier, Jörg; Augustin, Matthias; Dwinger, Sarah; Christalle, Eva; Härter, Martin; Mrowietz, Ulrich

    2018-02-07

    Psoriasis is a chronic inflammatory disease that is often associated with a number of somatic and mental comorbidity. Patients with psoriasis show an increased risk of depression and (social) anxiety. The aims of this study are 1) to explore the psychosocial distress of patients with psoriasis and to assess their care needs; and 2) to develop a supportive intervention based on the prior results. A multi-stage design with four phases combining quantitative and qualitative methodology will be used and conducted in two centers. 1) A scoping review and focus groups will be used to design a questionnaire to assess the psychosocial distress and care needs of the patients. 2) The questionnaire developed in phase 1 will be used in a cross-sectional survey to assess the extent of psychosocial distress and supportive care needs in 400 patients with psoriasis. 3) A systematic review and meta-analysis will be conducted to identify psychosocial and psychoeducational interventions for patients with psoriasis and to describe their effectiveness. 4) Based on the results of the phases 2 and 3 a manualized supportive intervention will be developed and the feasibility and acceptance of the intervention will be assessed. Currently, phase 1 of the project has been completed and the recruitment for phase 2 has been started. The systematic review and meta-analysis of phase 3 are conducted simultaneously to phase 2 and results are expected soon. Phase 4 has not been started yet. The expected results of this study will show the extent of psychosocial distress of patients with psoriasis in Germany and supplement previous research with findings about the supportive care needs of this patient group. Moreover, the developed intervention will help to address the psychosocial support needs of patients with psoriasis. Research shows that psychosocial support is strongly needed. ©Jördis Maria Zill, Jörg Dirmaier, Matthias Augustin, Sarah Dwinger, Eva Christalle, Martin Härter, Ulrich Mrowietz

  18. Multisystemic engagement & nephrology based educational intervention: a randomized controlled trial protocol on the kidney team at home-study

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    Ismail Sohal Y

    2012-07-01

    Full Text Available Abstract Background Living donor kidney transplantation (LDKT is the most successful form of renal replacement therapy in terms of wait time and survival rates. However, we observed a significant inequality in the number of LDKT performed between the Dutch and the non-Dutch patients. The objective of this study is to adapt, implement and test an educational home-based intervention to contribute to the reduction of this inequality. Our aim is to establish this through guided communication together with the social network of the patients in an attempt that well-informed decisions regarding renal replacement therapy can be made: Multisystemic Engagement & Nephrology. This manuscript is a detailed description of the Kidney Team At Home-study protocol. Methods and design All patients (>18 yrs that are referred to the pre-transplantation outpatient clinic are eligible to participate in the study. Patients will be randomly assigned to either an experimental or a control group. The control group will continue to receive standard care. The experimental group will receive standard care plus a home-based educational intervention. The intervention consists of two sessions at the patient’s home, an initial session with the patient and a second session for which individuals from their social network are invited to take part. Based on the literature and behavioural change theories we hypothesize that reducing hurdles in knowledge, risk perception, subjective norm, self-efficacy, and communication contribute to well-informed decision making and reducing inequality in accessing LDKT programs. A change in these factors is consequently our primary outcome-measure. Based on power calculations, we aim to include 160 patients over a period of two years. Discussion If we are able to show that this home-based group educational intervention contributes to 1 achieving well-informed decision regarding treatment and 2 reducing the inequality in LDKT, the quality of life

  19. Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

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    St George Bridget

    2011-07-01

    Full Text Available Abstract Background Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. Methods After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. Results We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures

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

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    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

  1. Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation.

    Science.gov (United States)

    Skidmore, Elizabeth R; Dawson, Deirdre R; Whyte, Ellen M; Butters, Meryl A; Dew, Mary Amanda; Grattan, Emily S; Becker, James T; Holm, Margo B

    2014-04-01

    To examine the feasibility of a strategy training clinical trial in a small group of adults with stroke-related cognitive impairments in inpatient rehabilitation, and to explore the impact of strategy training on disability. Non-randomized two-group intervention pilot study. Two inpatient rehabilitation units within an academic health centre. Individuals with a primary diagnosis of acute stroke, who were admitted to inpatient rehabilitation and demonstrated cognitive impairments were included. Individuals with severe aphasia; dementia; major depressive disorder, bipolar, or psychotic disorder; recent drug or alcohol abuse; and anticipated length of stay less than five days were excluded. Participants received strategy training or an attention control session in addition to usual rehabilitation care. Sessions in both groups were 30-40 minutes daily, five days per week, for the duration of inpatient rehabilitation. We assessed feasibility through participants' recruitment and retention; research intervention session number and duration; participants' comprehension and engagement; intervention fidelity; and participants' satisfaction. We assessed disability at study admission, inpatient rehabilitation discharge, 3 and 6 months using the Functional Independence Measure. Participants in both groups (5 per group) received the assigned intervention (>92% planned sessions; >94% fidelity) and completed follow-up testing. Strategy training participants in this small sample demonstrated significantly less disability at six months (M (SE) = 117 (3)) than attention control participants (M(SE) = 96 (14); t 8 = 7.87, P = 0.02). It is feasible and acceptable to administer both intervention protocols as an adjunct to acute inpatient rehabilitation, and strategy training shows promise for reducing disability.

  2. 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.

  3. The Social Living Complex: A New, All Day, Yearlong Intervention Model for Individuals with Autism Spectrum Disorder and Their Parents

    Science.gov (United States)

    Doenyas, Ceymi

    2016-01-01

    We propose an unprecedented intervention for individuals with autism spectrum disorder (ASD) and their parents: the social living complex. Unlike existing social skills interventions, peer-mediated interventions here are not limited to the school/experiment duration and setting. Whereas other supported living services house adults with ASD only,…

  4. Children with medical complexity: a scoping review of interventions to support caregiver stress.

    Science.gov (United States)

    Edelstein, H; Schippke, J; Sheffe, S; Kingsnorth, S

    2017-05-01

    Caring for children with chronic and complex medical needs places extraordinary stress on parents and other family members. A scoping review was undertaken to identify and describe the full range of current interventions for reducing caregiver stress. Applying a broad definition of caregiver stress, a systematic search of three scientific databases (CINAHL, Embase and Ovid Medline), a general internet search and hand searching of key peer-reviewed articles were conducted. Inclusion criteria were as follows: (i) published in English between 2004-2016; (ii) focused on familial caregivers, defined as parents, siblings or extended family; (iii) targeted children/youth with medical complexity between the ages of 1-24 years; and (iv) described an intervention and impact on caregiver stress. Data on type of intervention, study design and methods, measures and overall findings were extracted. Forty-nine studies were included from a list of 22 339 unique titles. Six domains of interventions were found: care coordination models (n = 23); respite care (n = 8); telemedicine (n = 5); peer and emotional support (n = 6); insurance and employment benefits (n = 4); and health and related supports (n = 3). Across studies, there was a wide variety of designs, outcomes and measures used. Positive findings of reductions in caregiver stress were noted within an emerging body of evidence on effective interventions for families of children with medical complexity. A commonality across domains was a significant focus on streamlining services and reducing the burden of care related to varied pressures experienced, including time, finances, care needs and service access, among others. There was non-conclusive evidence however around which of the six identified intervention domains or combination thereof are most effective for reducing stress. These promising findings demonstrate that stress reduction is possible with the right support and that multiple

  5. Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT

    Directory of Open Access Journals (Sweden)

    Julie A Luker

    2016-05-01

    Full Text Available Abstract Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT. Methods A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Results Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to ‘get staff on board’, and developing different ways of working. Conclusions The AVERT stroke rehabilitation trial required commitment to deliver

  6. Harnessing complexity: taking advantage of context and relationships in dissemination of school-based interventions.

    Science.gov (United States)

    Butler, Helen; Bowes, Glenn; Drew, Sarah; Glover, Sara; Godfrey, Celia; Patton, George; Trafford, Lea; Bond, Lyndal

    2010-03-01

    Schools and school systems are increasingly asked to use evidence-based strategies to promote the health and well-being of students. The dissemination of school-based health promotion research, however, offers particular challenges to conventional approaches to dissemination. Schools and education systems are multifaceted organizations that sit within constantly shifting broader contexts. This article argues that health promotion dissemination needs to be rethought for school communities as complex systems and that this requires understanding and harnessing the dynamic ecology of the sociopolitical context. In developing this argument, the authors draw on their experience of the dissemination process of a multilevel school-based intervention in a complex educational context. Building on this experience, they argue for the need to move beyond conventional dissemination strategies to a focus on active partnerships between developers and users of school-based intervention research and offer a conceptual tool for planning dissemination.

  7. A randomised, family-focused dietary intervention to evaluate the Atlantic diet: the GALIAT study protocol

    Directory of Open Access Journals (Sweden)

    Maria del Mar Calvo-Malvar

    2016-08-01

    Full Text Available Abstract Background The traditional diet of northwestern Spain and northern Portugal follows an ‘Atlantic diet’ pattern. Adherence to the Atlantic diet has been related to the good metabolic health and low coronary mortality recorded for these regions. Methods The GALIAT (Galicia Alimentación Atlántica [Galicia Atlantic Diet] study is a randomised, controlled, dietary intervention clinical trial designed to examine the effect of the Atlantic diet on the lipid profile, glucose metabolism, inflammation makers and adiposity of the general population. The trial involved 250 randomly selected families (715 adults and children over 3 years of age from a town in Spain’s northwest, randomly allocated to follow either a control diet (C group or the Atlantic diet (AD group for a period of 6 months. The families of the AD group received educational sessions on food, diet and gastronomy and were provided written supporting material with nutritional recommendations and recipes for the preparation of menus. They also attended cooking classes. Throughout the study period, these families were provided a range of foods (free of charge that form part of the traditional Atlantic diet. The C group families took part in none of the above activities, nor were they provided with any food. Lipid profile variables (primary variables, and anthropometric, inflammation marker and glucose metabolism status (secondary variables, were measured at baseline, three and six months. Discussion The GALIAT study is the first clinical trial to examine the effects of the Atlantic diet on metabolic and cardiovascular health and adiposity. If the study hypothesis is confirmed, this dietary pattern could be included in strategies to promote health. Trial registration ClinicalTrials.gov, NCT02391701 on March 18, 2015.

  8. A randomised, family-focused dietary intervention to evaluate the Atlantic diet: the GALIAT study protocol.

    Science.gov (United States)

    Calvo-Malvar, Maria Del Mar; Leis, Rosaura; Benítez-Estévez, Alfonso Javier; Sánchez-Castro, Juan; Gude, Francisco

    2016-08-18

    The traditional diet of northwestern Spain and northern Portugal follows an 'Atlantic diet' pattern. Adherence to the Atlantic diet has been related to the good metabolic health and low coronary mortality recorded for these regions. The GALIAT (Galicia Alimentación Atlántica [Galicia Atlantic Diet]) study is a randomised, controlled, dietary intervention clinical trial designed to examine the effect of the Atlantic diet on the lipid profile, glucose metabolism, inflammation makers and adiposity of the general population. The trial involved 250 randomly selected families (715 adults and children over 3 years of age) from a town in Spain's northwest, randomly allocated to follow either a control diet (C group) or the Atlantic diet (AD group) for a period of 6 months. The families of the AD group received educational sessions on food, diet and gastronomy and were provided written supporting material with nutritional recommendations and recipes for the preparation of menus. They also attended cooking classes. Throughout the study period, these families were provided a range of foods (free of charge) that form part of the traditional Atlantic diet. The C group families took part in none of the above activities, nor were they provided with any food. Lipid profile variables (primary variables), and anthropometric, inflammation marker and glucose metabolism status (secondary variables), were measured at baseline, three and six months. The GALIAT study is the first clinical trial to examine the effects of the Atlantic diet on metabolic and cardiovascular health and adiposity. If the study hypothesis is confirmed, this dietary pattern could be included in strategies to promote health. ClinicalTrials.gov, NCT02391701 on March 18, 2015.

  9. Service user experiences of REFOCUS: a process evaluation of a pro-recovery complex intervention.

    Science.gov (United States)

    Wallace, Genevieve; Bird, Victoria; Leamy, Mary; Bacon, Faye; Le Boutillier, Clair; Janosik, Monika; MacPherson, Rob; Williams, Julie; Slade, Mike

    2016-09-01

    Policy is increasingly focused on implementing a recovery-orientation within mental health services, yet the subjective experience of individuals receiving a pro-recovery intervention is under-studied. The aim of this study was to explore the service user experience of receiving a complex, pro-recovery intervention (REFOCUS), which aimed to encourage the use of recovery-supporting tools and support recovery-promoting relationships. Interviews (n = 24) and two focus groups (n = 13) were conducted as part of a process evaluation and included a purposive sample of service users who received the complex, pro-recovery intervention within the REFOCUS randomised controlled trial (ISRCTN02507940). Thematic analysis was used to analyse the data. Participants reported that the intervention supported the development of an open and collaborative relationship with staff, with new conversations around values, strengths and goals. This was experienced as hope-inspiring and empowering. However, others described how the recovery tools were used without context, meaning participants were unclear of their purpose and did not see their benefit. During the interviews, some individuals struggled to report any new tasks or conversations occurring during the intervention. Recovery-supporting tools can support the development of a recovery-promoting relationship, which can contribute to positive outcomes for individuals. The tools should be used in a collaborative and flexible manner. Information exchanged around values, strengths and goals should be used in care-planning. As some service users struggled to report their experience of the intervention, alternative evaluation approaches need to be considered if the service user experience is to be fully captured.

  10. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health

  11. Shifting effects in randomised controlled trials of complex interventions: a new kind of performance bias?

    Science.gov (United States)

    Gold, C; Erkkilä, J; Crawford, M J

    2012-11-01

    Randomised controlled trials (RCTs) aim to provide unbiased estimates of treatment effects. However, the process of implementing trial procedures may have an impact on the performance of complex interventions that rely strongly on the intuition and confidence of therapists. We aimed to examine whether shifting effects over the recruitment period can be observed that might indicate such impact. Three RCTs investigating music therapy vs. standard care were included. The intervention was performed by experienced therapists and based on established methods. We examined outcomes of participants graphically, analysed cumulative effects and tested for differences between first vs. later participants. We tested for potential confounding population shifts through multiple regression models. Cumulative differences suggested trends over the recruitment period. Effect sizes tended to be less favourable among the first participants than later participants. In one study, effects even changed direction. Age, gender and baseline severity did not account for these shifting effects. Some trials of complex interventions have shifting effects over the recruitment period that cannot be explained by therapist experience or shifting demographics. Replication and further research should aim to find out which interventions and trial designs are most vulnerable to this new kind of performance bias. © 2012 John Wiley & Sons A/S.

  12. Complex interventions required to comprehensively educate allied health practitioners on evidence-based practice

    Directory of Open Access Journals (Sweden)

    Dizon JM

    2011-05-01

    Full Text Available Janine Margarita Dizon1,2, Karen Grimmer-Somers11International Centre for Allied Health Evidence, University of South Australia, Adelaide, SA, Australia; 2University of Santo Tomas, Manila, PhilippinesAbstract: There is currently no strong evidence regarding the most effective training approach for allied health professionals that will support them to consistently apply the best research evidence in daily practice. Current evidence-based practice training tends to be 'one size fits all', and is unlikely to be appropriate for all allied health disciplines because of the variability in their tasks and scope of practice. The scant body of evidence regarding the effectiveness of evidence-based practice training for allied health practitioners provides some support for improving knowledge and skills, but equivocal evidence about influencing behaviors and attitudes. We propose a new model of evidence-based practice training, based on the concept of complex interventions reported in the literature. We believe that by offering training in evidence-based practice based on complex interventions relevant to the needs of the attendees, using fixed and variable components, there may be greater success in significantly influencing knowledge skills, attitudes, and behaviors.Keywords: complex interventions, evidence-based practice training, allied health

  13. A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.

    Science.gov (United States)

    Herrman, Helen; Humphreys, Cathy; Halperin, Stephen; Monson, Katherine; Harvey, Carol; Mihalopoulos, Cathrine; Cotton, Susan; Mitchell, Penelope; Glynn, Tony; Magnus, Anne; Murray, Lenice; Szwarc, Josef; Davis, Elise; Havighurst, Sophie; McGorry, Patrick; Tyano, Sam; Kaplan, Ida; Rice, Simon; Moeller-Saxone, Kristen

    2016-12-07

    Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. Australian New Zealand Clinical Trials Registry ACTRN12615000501549 . Retrospectively registered 19 May 2015.

  14. Assessing the complexity of interventions within systematic reviews: development, content and use of a new tool (iCAT_SR

    Directory of Open Access Journals (Sweden)

    Simon Lewin

    2017-04-01

    Full Text Available Abstract Background Health interventions fall along a spectrum from simple to more complex. There is wide interest in methods for reviewing ‘complex interventions’, but few transparent approaches for assessing intervention complexity in systematic reviews. Such assessments may assist review authors in, for example, systematically describing interventions and developing logic models. This paper describes the development and application of the intervention Complexity Assessment Tool for Systematic Reviews (iCAT_SR, a new tool to assess and categorise levels of intervention complexity in systematic reviews. Methods We developed the iCAT_SR by adapting and extending an existing complexity assessment tool for randomized trials. We undertook this adaptation using a consensus approach in which possible complexity dimensions were circulated for feedback to a panel of methodologists with expertise in complex interventions and systematic reviews. Based on these inputs, we developed a draft version of the tool. We then invited a second round of feedback from the panel and a wider group of systematic reviewers. This informed further refinement of the tool. Results The tool comprises ten dimensions: (1 the number of active components in the intervention; (2 the number of behaviours of recipients to which the intervention is directed; (3 the range and number of organizational levels targeted by the intervention; (4 the degree of tailoring intended or flexibility permitted across sites or individuals in applying or implementing the intervention; (5 the level of skill required by those delivering the intervention; (6 the level of skill required by those receiving the intervention; (7 the degree of interaction between intervention components; (8 the degree to which the effects of the intervention are context dependent; (9 the degree to which the effects of the interventions are changed by recipient or provider factors; (10 and the nature of the causal

  15. Effects of falls prevention interventions on falls outcomes for hospitalised adults: protocol for a systematic review with meta-analysis.

    Science.gov (United States)

    Slade, Susan C; Carey, David L; Hill, Anne-Marie; Morris, Meg E

    2017-11-12

    Falls are a major global public health problem and leading cause of accidental or unintentional injury and hospitalisation. Falls in hospital are associated with longer length of stay, readmissions and poor outcomes. Falls prevention is informed by knowledge of reversible falls risk factors and accurate risk identification. The extent to which hospital falls are prevented by evidence-based practice, patient self-management initiatives, environmental modifications and optimisation of falls prevention systems awaits confirmation. Published reviews have mainly evaluated community settings and residential care facilities. A better understanding of hospital falls and the most effective strategies to prevent them is vital to keeping people safe. To evaluate the effectiveness of falls prevention interventions on reducing falls in hospitalised adults (acute and subacute wards, rehabilitation, mental health, operating theatre and emergency departments). We also summarise components of effective falls prevention interventions. This protocol has been registered. The systematic review will be informed by Cochrane guidelines and reported according to the Preferred Reporting Items for Systematic review and Meta-Analysis statement. randomised controlled trials, quasi-randomised trials or controlled clinical trials that evaluate falls prevention interventions for use by hospitalised adults or employees. Electronic databases will be searched using key terms including falls, accidental falls, prevention, hospital, rehabilitation, emergency, mental health, acute and subacute. Pairs of independent reviewers will conduct all review steps. Included studies will be evaluated for risk of bias. Data for variables such as age, participant characteristics, settings and interventions will be extracted and analysed with descriptive statistics and meta-analysis where possible. The results will be presented textually, with flow charts, summary tables, statistical analysis (and meta

  16. Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.

    Science.gov (United States)

    Granich, Joanna; Dass, Alena; Busacca, Margherita; Moore, Dennis; Anderson, Angelika; Venkatesh, Svetha; Duong, Thi; Vellanki, Pratibha; Richdale, Amanda; Trembath, David; Cairns, Darin; Marshall, Wendy; Rodwell, Tania; Rayner, Madeleine; Whitehouse, Andrew J O

    2016-10-19

    Evidence for early intensive behavioural interventions (EIBI) by therapists as an effective treatment for children with an Autism Spectrum Disorder (ASD) is growing. High-intensity and sustained delivery of quality EIBI is expensive. The TOBY (Therapy Outcomes by You) Playpad is an App-based platform delivering EIBI to facilitate learning for young children with ASD, while enabling parents to become co-therapists. Intervention targets include increasing joint attention, imitation and communication of children with ASD. The primary aim of the study presented in this protocol is to determine the effectiveness of the TOBY App in reducing ASD symptoms when used as a complement to conventional EIBI. The secondary aim is to examine parental attributes as a result of TOBY App use. Children aged less than 4;3 years diagnosed with ASD and parents will be recruited into this single-blind, randomised controlled trial using a pragmatic approach. Eligible participants will be randomised to the treatment group 'TOBY therapy + therapy as usual' or, the control group 'therapy as usual' for six months. The treatment will be provided by the TOBY App and parent where a combination of learning environments such as on-iPad child only (solo), partner (with parent) and off-iPad - Natural Environment (with parent) Tasks will be implemented. Parents in the treatment group will participate in a TOBY training workshop. Treatment fidelity will be monitored via an App-based reporting system and parent diaries. The primary outcome measure is the Autism Treatment Evaluation Checklist. The secondary outcome measures involve diagnostics, functional and developmental assessments, including parent questionnaires at baseline (T0), three months (T1) and six months (T2). This trial will determine the effectiveness of the TOBY App as a therapeutic complement to other early interventions children with ASD receive. The trial will also determine the feasibility of a parent delivered early intervention

  17. Preview of the Mission Assurance Analysis Protocol (MAAP): Assessing Risk and Opportunity in Complex Environments

    National Research Council Canada - National Science Library

    Alberts, Christopher; Dorofee, Audrey; Marino, Lisa

    2008-01-01

    .... A MAAP assessment provides a systematic, in-depth analysis of the potential for success in distributed, complex, and uncertain environments and can be applied across the life cycle and throughout the supply chain...

  18. Interventions targeted at primary care practitioners to improve the identification and referral of patients with co-morbid obesity: a realist review protocol.

    Science.gov (United States)

    Blane, David N; Macdonald, Sara; Morrison, David; O'Donnell, Catherine A

    2015-05-01

    Obesity is one of the most significant public health challenges in the developed world. Recent policy has suggested that more can be done in primary care to support adults with obesity. In particular, general practitioners (GPs) and practice nurses (PNs) could improve the identification and referral of adults with obesity to appropriate weight management services. Previous interventions targeted at primary care practitioners in this area have had mixed results, suggesting a more complex interplay between patients, practitioners, and systems. The objectives of this review are (i) to identify the underlying 'programme theory' of interventions targeted at primary care practitioners to improve the identification and referral of adults with obesity and (ii) to explore how and why GPs and PNs identify and refer individuals with obesity, particularly in the context of weight-related co-morbidity. This protocol will explain the rationale for using a realist review approach and outline the key steps in this process. Realist review is a theory-led approach to knowledge synthesis that provides an explanatory analysis aimed at discerning what works, for whom, in what circumstances, how, and why. In this review, scoping interviews with key stakeholders involved in the planning and delivery of adult weight management services in Scotland helped to inform the identification of formal theories - from psychology, sociology, and implementation science - that will be tested as the review progresses. A comprehensive search strategy is described, including scope for iterative searching. Data analysis is outlined in three stages (describing context-mechanism-outcome configurations, exploring patterns in these configurations, and developing and testing middle-range theories, informed by the formal theories previously identified), culminating in the production of explanatory programme theory that considers individual, interpersonal, and institutional/systems-level components. This is the

  19. Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

    Science.gov (United States)

    Shih, Sophy T F; Davis-Lameloise, Nathalie; Janus, Edward D; Wildey, Carol; Versace, Vincent L; Hagger, Virginia; Asproloupos, Dino; O'Reilly, Sharleen L; Phillips, Paddy A; Ackland, Michael; Skinner, Timothy; Oats, Jeremy; Carter, Rob; Best, James D; Dunbar, James A

    2014-06-30

    The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

  20. Pressure and pain In Systemic sclerosis/Scleroderma - an evaluation of a simple intervention (PISCES: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Alcacer-Pitarch Begonya

    2012-02-01

    Full Text Available Abstract Background Foot problems associated with Systemic Sclerosis (SSc/Scleroderma have been reported to be both common and disabling. There are only limited data describing specifically, the mechanical changes occurring in the foot in SSc. A pilot project conducted in preparation for this trial confirmed the previous reports of foot related impairment and reduced foot function in people with SSc and demonstrated a link to mechanical etiologies. To-date there have been no formal studies of interventions directed at the foot problems experienced by people with Systemic Sclerosis. The primary aim of this trial is to evaluate whether foot pain and foot-related health status in people with Systemic Sclerosis can be improved through the provision of a simple pressure-relieving insole. Methods The proposed trial is a pragmatic, multicenter, randomised controlled clinical trial following a completed pilot study. In four participating centres, 140 consenting patients with SSc and plantar foot pain will be randomised to receive either a commercially available pressure relieving and thermally insulating insole, or a sham insole with no cushioning or thermal properties. The primary end point is a reduction in pain measured using the Foot Function Index Pain subscale, 12 weeks after the start of intervention. Participants will complete the primary outcome measure (Foot Function Index pain sub-scale prior to randomisation and at 12 weeks post randomisation. Secondary outcomes include participant reported pain and disability as derived from the Manchester Foot Pain and Disability Questionnaire and plantar pressures with and without the insoles in situ. Discussion This trial protocol proposes a rigorous and potentially significant evaluation of a simple and readily provided therapeutic approach which, if effective, could be of a great benefit for this group of patients. Trial registration number ISRCTN: ISRCTN02824122

  1. The effects of interventions targeting multiple health behaviors on smoking cessation outcomes: a rapid realist review protocol.

    Science.gov (United States)

    Minian, Nadia; deRuiter, Wayne K; Lingam, Mathangee; Corrin, Tricia; Dragonetti, Rosa; Manson, Heather; Taylor, Valerie H; Zawertailo, Laurie; Ebnahmady, Arezoo; Melamed, Osnat C; Rodak, Terri; Hahn, Margaret; Selby, Peter

    2018-03-01

    Health behaviors directly impact the health of individuals, and populations. Since individuals tend to engage in multiple unhealthy behaviors such as smoking, excessive alcohol use, physical inactivity, and eating an unhealthy diet simultaneously, many large community-based interventions have been implemented to reduce the burden of disease through the modification of multiple health behaviors. Smoking cessation can be particularly challenging as the odds of becoming dependent on nicotine increase with every unhealthy behavior a smoker exhibits. This paper presents a protocol for a rapid realist review which aims to identify factors associated with effectively changing tobacco use and target two or more additional unhealthy behaviors. An electronic literature search will be conducted using the following bibliographic databases: MEDLINE, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), The Cochrane Library, Social Science Abstracts, Social Work Abstracts, and Web of Science. Two reviewers will screen titles and abstracts for relevant research, and the selected full papers will be used to extract data and assess the quality of evidence. Throughout this process, the rapid realist approach proposed by Saul et al., 2013 will be used to refine our initial program theory and identify contextual factors and mechanisms that are associated with successful multiple health behavior change. This review will provide evidence-based research on the context and mechanisms that may drive the success or failure of interventions designed to support multiple health behavior change. This information will be used to guide curriculum and program development for a government funded project on improving smoking cessation by addressing multiple health behaviors in people in Canada. PROSPERO CRD42017064430.

  2. Development and validation of a generic questionnaire for the implementation of complex medical interventions

    Directory of Open Access Journals (Sweden)

    Kramer, Lena

    2014-04-01

    Full Text Available [english] Introduction: The implementation of complex medical interventions in daily practice is often fraught with difficulties. According to the iterative phase model proposed by the British Medical Research Council (MRC, the development, implementation and evaluation of complex interventions should be theory-driven. A conceptual model that seems to be a promising framework is the Theory of planned behaviour (TPB. In our study we aimed to develop and validate a generic and multifaceted questionnaire based on the TPB to detect physicians’ willingness to implement complex medical interventions and the factors influencing this willingness.Methods: The questionnaire was developed according to the literature and was informed by previous qualitative research of our department. It was validated on the example of an electronic library of decision aids, arriba-lib. The sample consisted of 181 General Practitioners (GPs who received a training regarding arriba-lib and subsequently filled in the questionnaire, assessing the TPB variables attitude, subjective norm, perceived behaviour control and intention. Follow-up assessments were conducted after two (assessing retest reliability and eight weeks (assessing target behaviour. We performed a confirmatory factor analysis investigating the factorial structure of our questionnaire according to the TPB. Beside the calculation of the questionnaire’s psychometric properties we conducted a structural equation model and an ordinal regression to predict actual behaviour regarding the installation and application of arriba-lib.Results: The postulated three factorial model (attitude, subjective norm, perceived behaviour control of our questionnaire based on the TPB was rejected. A two factorial model with a combined factor subjective norm/perceived behaviour control was accepted. The explained variance in the ordinal regression was low (Nagelkerke’s R=.12. Neither attitude nor intention were able to predict

  3. Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care

    Science.gov (United States)

    2012-01-01

    Background Communication impairment is a frequent consequence of stroke. Patients who cannot articulate their needs respond with frustration and agitation, resulting in poor optimization of post-stroke functions. A key component of patient-centred care is the ability of staff to communicate in a way that allows them to understand the patient’s needs. We developed a patient-centred communication intervention targeting registered and unregulated nursing staff caring for complex continuing care patients with communication impairments post stroke. Research objectives include 1) examining the effects of the intervention on patients’ quality of life, depression, satisfaction with care, and agitation; and (2) examining the extent to which the intervention improves staff’s attitudes and knowledge in caring for patients with communication impairments. The intervention builds on a previous pilot study. Methods/design A quasi-experimental repeated measures non-equivalent control group design in a complex continuing care facility is being used. Patients with a communication impairment post-stroke admitted to the facility are eligible to participate. All staff nurses are eligible. Baseline data are collected from staff and patients. Follow-up will occur at 1 and 3 months post-intervention. Subject recruitment and data collection from 60 patients and 30 staff will take approximately 36 months. The Patient-Centred Communication Intervention consists of three components: (1) development of an individualized patient communication care plan; (2) a one-day workshop focused on communication and behavioural management strategies for nursing staff; and (3) a staff support system. The intervention takes comprehensive patient assessments into account to inform the development of communication and behavioural strategies specifically tailored to each patient. Discussion The Patient-Centred Communication Intervention will provide staff with strategies to facilitate interactions with

  4. Patient-centred communication intervention study to evaluate nurse-patient interactions in complex continuing care

    Directory of Open Access Journals (Sweden)

    McGilton Katherine S

    2012-10-01

    Full Text Available Abstract Background Communication impairment is a frequent consequence of stroke. Patients who cannot articulate their needs respond with frustration and agitation, resulting in poor optimization of post-stroke functions. A key component of patient-centred care is the ability of staff to communicate in a way that allows them to understand the patient’s needs. We developed a patient-centred communication intervention targeting registered and unregulated nursing staff caring for complex continuing care patients with communication impairments post stroke. Research objectives include 1 examining the effects of the intervention on patients’ quality of life, depression, satisfaction with care, and agitation; and (2 examining the extent to which the intervention improves staff’s attitudes and knowledge in caring for patients with communication impairments. The intervention builds on a previous pilot study. Methods/design A quasi-experimental repeated measures non-equivalent control group design in a complex continuing care facility is being used. Patients with a communication impairment post-stroke admitted to the facility are eligible to participate. All staff nurses are eligible. Baseline data are collected from staff and patients. Follow-up will occur at 1 and 3 months post-intervention. Subject recruitment and data collection from 60 patients and 30 staff will take approximately 36 months. The Patient-Centred Communication Intervention consists of three components: (1 development of an individualized patient communication care plan; (2 a one-day workshop focused on communication and behavioural management strategies for nursing staff; and (3 a staff support system. The intervention takes comprehensive patient assessments into account to inform the development of communication and behavioural strategies specifically tailored to each patient. Discussion The Patient-Centred Communication Intervention will provide staff with strategies to

  5. Lesion complexity drives the cost of superficial femoral artery endovascular interventions

    Science.gov (United States)

    Walker, Karen L.; Nolan, Brian W.; Columbo, Jesse A.; Rzucidlo, Eva M.; Goodney, Philip P.; Walsh, Daniel B.; Atkinson, Benjamin J.; Powell, Richard J.

    2017-01-01

    Objective Patients who undergo endovascular treatment of superficial femoral artery (SFA) disease vary greatly in lesion complexity and treatment options. This study examined the association of lesion severity and cost of SFA stenting and to determine if procedure cost affects primary patency at 1 year. Methods A retrospective record review identified patients undergoing initial SFA stenting between January 1, 2010, and February 1, 2012. Medical records were reviewed to collect data on demographics, comorbidities, indication for the procedure, TransAtlantic Inter-Society Consensus (TASC) II severity, and primary patency. The interventional radiology database and hospital accounting database were queried to determine cost drivers of SFA stenting. Procedure supply cost included any item with a bar code used for the procedure. Associations between cost drivers and lesion characteristics were explored. Primary patency was determined using Kaplan-Meier survival curves and a log-rank test. Results During the study period, 95 patients underwent stenting in 98 extremities; of these, 61% of SFA stents were performed for claudication, with 80% of lesions classified as TASC II A or B. Primary patency at 1 year was 79% for the entire cohort. The mean total cost per case was $10,333. Increased procedure supply cost was associated with adjunct device use, the number of stents, and TASC II severity. Despite higher costs of treating more complex lesions, primary patency at 1 year was similar at 80% for high-cost (supply cost >$4000) vs 78% for low-cost (supply cost <$4000) interventions. Conclusions SFA lesion complexity, as defined by TASC II severity, drives the cost of endovascular interventions but does not appear to disadvantage patency at 1 year. Reimbursement agencies should consider incorporating disease severity into reimbursement algorithms for lower extremity endovascular interventions. PMID:26206581

  6. Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Radford, Kathryn A; Phillips, Julie; Jones, Trevor; Gibson, Ali; Sutton, Chris; Watkins, Caroline; Sach, Tracey; Duley, Lelia; Walker, Marion; Drummond, Avril; Hoffman, Karen; O'Connor, Rory; Forshaw, Denise; Shakespeare, David

    2015-01-01

    Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a

  7. Depression Screening and Education: Options to Reduce Barriers to Treatment (DESEO): protocol for an educational intervention study.

    Science.gov (United States)

    Sanchez, Katherine; Eghaneyan, Brittany H; Trivedi, Madhukar H

    2016-07-29

    Barriers to depression treatment among Hispanic populations include persistent stigma, inadequate doctor patient communication (DPC) and resultant sub-optimal use of anti-depressant medications. Stigma is primarily perpetuated due to inadequate disease literacy and cultural factors. Common concerns about depression treatments among Hispanics include fears about the addictive and harmful properties of antidepressants, worries about taking too many pills, and the stigma attached to taking psychotropic medications. The current manuscript presents the study protocol for the Depression Screening and Education: Options to Reduce Barriers to Treatment (DESEO) study funded by the Center for Medicare and Medicaid Services (CMS) Grants to Support the Hispanic Health Services Research Grant Program. DESEO will implement universal screening with a self-report depression screening tool (the 9-item Patient Health Questionnaire (PHQ-9)) that is presented through a customized web application and a Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement. This project will be conducted at one community health center whose patient population is majority Hispanic. The target enrollment for recruitment is 350 patients over the 24-month study period. A one-group, pretest-posttest design will be used to asses knowledge of depression and its treatment and related stigma before, immediately after, and one month post intervention. Primary care settings often are the gateway to identifying undiagnosed mental health disorders, particularly for people with comorbid physical health conditions. This study is unique in that it aims to examine the specific role of patient education as an intervention to increase engagement in depression treatment. By participating in the DEI, it is expected that patients will have time to understand treatment

  8. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

    2016-06-24

    Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

  9. AHRQ series on complex intervention systematic reviews-paper 6: PRISMA-CI extension statement and checklist.

    Science.gov (United States)

    Guise, Jeanne-Marie; Butler, Mary E; Chang, Christine; Viswanathan, Meera; Pigott, Terri; Tugwell, Peter

    2017-10-01

    Complex interventions are widely used in health systems, public health, education, and communities and are increasingly the subject of systematic reviews. Oversimplification and inconsistencies in reporting about complex interventions can limit the usability of review findings. Although guidance exists to ensure that reports of individual studies and systematic reviews adhere to accepted scientific standards, their design-specific focus leaves important reporting gaps relative to complex interventions in health care. This paper provides a stand-alone extension to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting tool for complex interventions-PRISMA-CI-to help authors, publishers, and readers understand and apply to systematic reviews of complex interventions. PRISMA-CI development followed the Enhancing the QUAlity and Transparency Of health Research Network guidance for extensions and focused on adding or modifying only essential items that are truly unique to complex interventions and are not covered by broader interpretation of current PRISMA guidance. PRISMA-CI provides an important structure and guidance for systematic reviews and meta-analyses for the highly prevalent and dynamic field of complex interventions. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  10. Circular instead of hierarchical: methodological principles for the evaluation of complex interventions

    Directory of Open Access Journals (Sweden)

    Fønnebø Vinjar

    2006-06-01

    Full Text Available Abstract Background The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs, and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery. Discussion The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM. This has to do with the essential tension between internal validity (rigor and the removal of bias and external validity (generalizability. Summary Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.

  11. [Intervention priorities in the acute stage of complex emergencies drafted by nine humanitarian aid agencies].

    Science.gov (United States)

    Carrillo Jaimes, Carmen Sofía; Arcos González, Pedro Ignacio

    2004-01-01

    Complex Emergencies are an international Public Health problem currently becoming increasingly more frequent and of growing proportions which lead to major death and disease rates, especially during the acute stage thereof. This study is aimed at identifying and analyzing the top-priority areas of intervention in the acute stage of a complex emergency drafted in the operating manuals of the main aid agencies, as well as the degree of development and structuring of the activities proposed in each area on which priority has been placed. The intervention manuals drafted by nine major aid agencies were used as study material. A quantitative analysis was then made of the 16 intervention priorities set out, as well as of the degree to which each priority was defined based on the development of 73 variables of aspects of the proposals set out in the manuals. The ACNUR manual includes 90% of the 73 variables for further expansion upon the priorities, the UN Humanitarian Affaire Coordination Office manual including 35% of the 73 variables. ACNUR better expands upon the non-healthcare variables, followed by MSF and USAID. Doctors without borders shows a 97.3% degree of expansion of the healthcare variables) followed by ACNUR (94.7%), USAID (92.1%). ACNUR has been found to have the most integral proposal, the UN Humanitarian Affairs Coordination Office having the most discreet. There is a general trend towad further expanding upon and unifying the health indicators, whilst other aspects are not further expanded upon.

  12. Mediation and moderation of treatment effects in randomised controlled trials of complex interventions.

    Science.gov (United States)

    Emsley, Richard; Dunn, Graham; White, Ian R

    2010-06-01

    Complex intervention trials should be able to answer both pragmatic and explanatory questions in order to test the theories motivating the intervention and help understand the underlying nature of the clinical problem being tested. Key to this is the estimation of direct effects of treatment and indirect effects acting through intermediate variables which are measured post-randomisation. Using psychological treatment trials as an example of complex interventions, we review statistical methods which crucially evaluate both direct and indirect effects in the presence of hidden confounding between mediator and outcome. We review the historical literature on mediation and moderation of treatment effects. We introduce two methods from within the existing causal inference literature, principal stratification and structural mean models, and demonstrate how these can be applied in a mediation context before discussing approaches and assumptions necessary for attaining identifiability of key parameters of the basic causal model. Assuming that there is modification by baseline covariates of the effect of treatment (i.e. randomisation) on the mediator (i.e. covariate by treatment interactions), but no direct effect on the outcome of these treatment by covariate interactions leads to the use of instrumental variable methods. We describe how moderation can occur through post-randomisation variables, and extend the principal stratification approach to multiple group methods with explanatory models nested within the principal strata. We illustrate the new methodology with motivating examples of randomised trials from the mental health literature.

  13. A novel combined interventional radiologic and hepatobiliary surgical approach to a complex traumatic hilar biliary stricture

    Directory of Open Access Journals (Sweden)

    Rachel E. NeMoyer

    Full Text Available Introduction: Benign strictures of the biliary system are challenging and uncommon conditions requiring a multidisciplinary team for appropriate management. Presentation of case: The patient is a 32-year-old male that developed a hilar stricture as sequelae of a gunshot wound. Due to the complex nature of the stricture and scarring at the porta hepatis a combined interventional radiologic and surgical approach was carried out to approach the hilum of the right and left hepatic ducts. The location of this stricture was found by ultrasound guidance intraoperatively using a balloon tipped catheter placed under fluoroscopy in the interventional radiology suite prior to surgery. This allowed the surgeons to select the line of parenchymal transection for best visualization of the stricture. A left hepatectomy was performed, the internal stent located and the right hepatic duct opened tangentially to allow a side-to-side Roux-en-Y hepaticojejunostomy (a Puestow-like anastomosis. Discussion: Injury to the intrahepatic biliary ductal confluence is rarely fatal, however, the associated injuries lead to severe morbidity as seen in this example. Management of these injuries poses a considerable challenge to the surgeon and treating physicians. Conclusion: Here we describe an innovative multi-disciplinary approach to the repair of this rare injury. Keywords: Combined approach, Interventional radiology, Hepatobiliary surgery, Complex traumatic hilar biliary stricture, Case report

  14. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions.

    Science.gov (United States)

    De Silva, Mary J; Breuer, Erica; Lee, Lucy; Asher, Laura; Chowdhary, Neerja; Lund, Crick; Patel, Vikram

    2014-07-05

    The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex

  15. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

    Science.gov (United States)

    2014-01-01

    Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for

  16. Study protocol: pragmatic randomized control trial of an internet-based intervention (My tools 4 care) for family carers.

    Science.gov (United States)

    Duggleby, Wendy; Ploeg, Jenny; McAiney, Carrie; Fisher, Kathryn; Swindle, Jenny; Chambers, Tracey; Ghosh, Sunita; Peacock, Shelley; Markle-Reid, Maureen; Triscott, Jean; Williams, Allison; Forbes, Dorothy; Pollard, Lori

    2017-08-14

    Family carers of older persons with Alzheimer's' disease and related dementia (ADRD) and multiple chronic conditions (MCC) experience significant, complex, and distressing transitions such as changes to their environment, roles and relationships, physical health, and mental health. An online intervention (My Tools 4 Care) was developed for family carers of persons with ADRD and MCC living at home, with the aim of supporting these carers through transitions and increasing their self-efficacy, hope, and health related quality of life (HRQoL). This study will evaluate My Tools 4 Care (MT4C) by asking the following research questions: 1. Does use of MT4C result in a 3 month (immediately post intervention) and 6-month (3 months after intervention) increase in HRQoL, self-efficacy, and hope, in carers of persons with ADRD and MCC compared to an educational control group? 2. Does use of MT4C help carers of community-dwelling older adults with ADRD and MCC deal with significant changes they experience as carers? and 3. Are the effects/benefits of the MT4C intervention achieved at no additional cost compared to an educational control group? Using a pragmatic mixed methods randomized controlled trial design, 180 family carers of community dwelling older persons (65 years of age and older) with ADRD and MCC will participate in the study. Data will be collected from the intervention and an educational control group at four time points: baseline, 1 month, 3 and 6 months. We expect to find that family carers using MT4C will show greater improvement in hope, self-efficacy and HRQoL, at no additional cost from a societal perspective, compared to those in the educational control group. General estimating equations will be used to determine differences between groups and over time. Data collection began in Ontario and Alberta Canada in June 2015 and is expected to be completed in June 2017. The results will inform policy and practice as MT4C can be easily revised for local

  17. A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation.

    Science.gov (United States)

    Setuain, Igor; Gonzalez-Izal, Miriam; Paularena, Ainara; Luque, Jose Luis; Andersen, Lars L; Izquierdo, Mikel

    2017-02-07

    Work-related injuries of the shoulder complex represent a challenge for clinicians because of the large variety of clinical entities involved and the broad anatomic structures that can be affected. Furthermore, commonly performed orthopedic tests have demonstrated limited accuracy for diagnosing the injury despite considerable research efforts. The aim of this study protocol is therefore to describe a comprehensive approach integrating both a clinical- and functional status-based pathology and an adapted rehabilitation prescription. A longitudinal cohort study will be performed at the Department of Rehabilitation and Medical Assistance of a mutual insurance society for work-related injury management in Spain (Mutua Navarra, Pamplona, Navarra Spain). Patients will be attended by an occupational physician who specializes in work-related injuries and is part of the project team that will systematically visit all the participants. After the medical diagnosis and any requested supplementary evaluations (i.e., radiological examinations), the patients will be referred to the rehabilitation service. Before the physiotherapeutic rehabilitation program is initiated, the patients will undergo a comprehensive functional screening at the biomechanics laboratory. Using a decision-making scheme, the identified functional deficits will be used to customize the individual rehabilitation plan. The proposed objective criteria-based shoulder diagnosis and rehabilitation model could be a new effective strategy for minimizing the time required to regain functional capacity and recover from symptoms among patients with work-related shoulder injuries. The study protocol has been registered on Clinical Trials.gov as NCT02732002 (April 10 th 2016).

  18. Development of Motivate4Change Using the Intervention Mapping Protocol: An Interactive Technology Physical Activity and Medication Adherence Promotion Program for Hospitalized Heart Failure Patients.

    Science.gov (United States)

    Oosterom-Calo, Rony; Te Velde, Saskia J; Stut, Wim; Brug, Johannes

    2015-07-20

    It is important that heart failure (HF) patients adhere to their medication regimen and engage in physical activity. Evidence shows that adherence to these HF self-management behaviors can be improved with appropriate interventions. To further promote medication adherence and physical activity among HF patients, we developed an intervention for hospitalized HF patients. The intervention mapping protocol was applied in the development of the intervention. This entailed performing a needs assessment, defining change objectives, selecting determinants and strategies, and developing the materials. The resulting intervention, Motivate4Change, makes use of interactive technology and provides HF patients with personalized feedback and advice. Specific change objectives were defined. The relevant behavioral determinants for the physical activity program were practical knowledge on physical activity performance and self-efficacy for, and perceived benefits of, physical activity. For medication-taking, the selected determinants were practical knowledge on medication-taking, perceived barriers to medication-taking, beliefs about the necessity and harm regarding the medication prescribed, and beliefs about overprescribing and harm of medication in general. The change objectives and behavior change determinants were translated in feedback and advice strategies in an interactive technology program that included tailored feedback and advice, and role models in videos in which the behaviors and overcoming barriers were demonstrated. Relevant stakeholders were involved in the interventions development process. The intervention was pretested among HF patients and adjustments were made accordingly. The interactive technology physical activity and medication adherence promotion program for hospitalized HF patients was systematically developed using the intervention mapping protocol and was based on the available theory and evidence regarding HF self-management behavior change. The

  19. Optimized IMAC-IMAC protocol for phosphopeptide recovery from complex biological samples

    DEFF Research Database (Denmark)

    Ye, Juanying; Zhang, Xumin; Young, Clifford

    2010-01-01

    using Fe(III)-NTA IMAC resin and it proved to be highly selective in the phosphopeptide enrichment of a highly diluted standard sample (1:1000) prior to MALDI MS analysis. We also observed that a higher iron purity led to an increased IMAC enrichment efficiency. The optimized method was then adapted...... to phosphoproteome analyses of cell lysates of high protein complexity. From either 20 microg of mouse sample or 50 microg of Drosophila melanogaster sample, more than 1000 phosphorylation sites were identified in each study using IMAC-IMAC and LC-MS/MS. We demonstrate efficient separation of multiply phosphorylated...... characterization of phosphoproteins in functional phosphoproteomics research projects....

  20. Study protocol: evaluation of an online, father-inclusive, universal parenting intervention to reduce child externalising behaviours and improve parenting practices.

    Science.gov (United States)

    Tully, Lucy A; Piotrowska, Patrycja J; Collins, Daniel A J; Mairet, Kathleen S; Hawes, David J; Kimonis, Eva R; Lenroot, Rhoshel K; Moul, Caroline; Anderson, Vicki; Frick, Paul J; Dadds, Mark R

    2017-06-19

    Parenting interventions that focus on enhancing the quality and consistency of parenting are effective for preventing and reducing externalising problems in children. There has been a recent shift towards online delivery of parenting interventions in order to increase their reach and impact on the population prevalence of child externalising problems. Parenting interventions have low rates of father participation yet research suggests that father involvement may be critical to the success of the intervention. Despite this, no online parenting interventions have been specifically developed to meet the needs and preferences of fathers, as well as mothers. This paper describes the protocol of a study examining the effectiveness of an online, father-inclusive parenting intervention called 'ParentWorks', which will be delivered as a universal intervention to Australian families. A single group clinical trial will be conducted to examine the effectiveness of ParentWorks for reducing child externalising problems and improving parenting, as well as to explore the impact of father engagement (in two-parent families) on child outcomes. Australian parents/caregivers with a child aged 2-16 years will be recruited. Participants will provide informed consent, complete pre-intervention measures and will then complete the intervention, which consists of five compulsory video modules and three optional modules. The primary outcomes for this study are changes in child externalising behaviour, positive and dysfunctional parenting practices and parental conflict, and the secondary outcome is changes in parental mental health. Demographic information, satisfaction with the intervention, and measures of parental engagement will also be collected. Questionnaire data will be collected at pre-intervention, post-intervention and three-month follow-up, as well as throughout the program. This paper describes the study protocol of a single group clinical trial of a national, online, father

  1. Developing adaptive interventions for adolescent substance use treatment settings: protocol of an observational, mixed-methods project.

    Science.gov (United States)

    Grant, Sean; Agniel, Denis; Almirall, Daniel; Burkhart, Q; Hunter, Sarah B; McCaffrey, Daniel F; Pedersen, Eric R; Ramchand, Rajeev; Griffin, Beth Ann

    2017-12-19

    Over 1.6 million adolescents in the United States meet criteria for substance use disorders (SUDs). While there are promising treatments for SUDs, adolescents respond to these treatments differentially in part based on the setting in which treatments are delivered. One way to address such individualized response to treatment is through the development of adaptive interventions (AIs): sequences of decision rules for altering treatment based on an individual's needs. This protocol describes a project with the overarching goal of beginning the development of AIs that provide recommendations for altering the setting of an adolescent's substance use treatment. This project has three discrete aims: (1) explore the views of various stakeholders (parents, providers, policymakers, and researchers) on deciding the setting of substance use treatment for an adolescent based on individualized need, (2) generate hypotheses concerning candidate AIs, and (3) compare the relative effectiveness among candidate AIs and non-adaptive interventions commonly used in everyday practice. This project uses a mixed-methods approach. First, we will conduct an iterative stakeholder engagement process, using RAND's ExpertLens online system, to assess the importance of considering specific individual needs and clinical outcomes when deciding the setting for an adolescent's substance use treatment. Second, we will use results from the stakeholder engagement process to analyze an observational longitudinal data set of 15,656 adolescents in substance use treatment, supported by the Substance Abuse and Mental Health Services Administration, using the Global Appraisal of Individual Needs questionnaire. We will utilize methods based on Q-learning regression to generate hypotheses about candidate AIs. Third, we will use robust statistical methods that aim to appropriately handle casemix adjustment on a large number of covariates (marginal structural modeling and inverse probability of treatment weights

  2. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Kate M. O’Brien

    Full Text Available ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to.

  3. Effectiveness of a healthy lifestyle intervention for low back pain and osteoarthritis of the knee: protocol and statistical analysis plan for two randomised controlled trials

    Science.gov (United States)

    O’Brien, Kate M.; Williams, Amanda; Wiggers, John; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Kamper, Steven J.; McAuley, James; Attia, John; Oldmeadow, Chris; Williams, Christopher M.

    2016-01-01

    ABSTRACT Background These trials are the first randomised controlled trials of telephone-based weight management and healthy lifestyle interventions for low back pain and knee osteoarthritis. This article describes the protocol and statistical analysis plan. Method These trials are parallel randomised controlled trials that investigate and compare the effect of a telephone-based weight management and healthy lifestyle intervention for improving pain intensity in overweight or obese patients with low back pain or knee osteoarthritis. The analysis plan was finalised prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described. Conclusions A protocol for standard analyses was developed for the results of two randomised controlled trials. This protocol describes the data, and the pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori protocol will be followed to ensure rigorous standards of data analysis are strictly adhered to. PMID:27683839

  4. Protocol for the CHEST Australia Trial: a phase II randomised controlled trial of an intervention to reduce time-to-consult with symptoms of lung cancer

    OpenAIRE

    Murray, Sonya R; Murchie, Peter; Campbell, Neil; Walter, Fiona M; Mazza, Danielle; Habgood, Emily; Kutzer, Yvonne; Martin, Andrew; Goodall, Stephen; Barnes, David J; Emery, Jon D

    2015-01-01

    Introduction Lung cancer is the most common cancer worldwide, with 1.3 million new cases diagnosed every year. It has one of the lowest survival outcomes of any cancer because over two-thirds of patients are diagnosed when curative treatment is not possible. International research has focused on screening and community interventions to promote earlier presentation to a healthcare provider to improve early lung cancer detection. This paper describes the protocol for a phase II, multisite, rand...

  5. Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers

    OpenAIRE

    Col?n-Emeric, Cathleen; Toles, Mark; Cary, Michael P.; Batchelor-Murphy, Melissa; Yap, Tracey; Song, Yuting; Hall, Rasheeda; Anderson, Amber; Burd, Andrew; Anderson, Ruth A.

    2016-01-01

    Background Little is known about the sustainability of behavioral change interventions in long-term care (LTC). Following a cluster randomized trial of an intervention to improve staff communication (CONNECT), we conducted focus groups of direct care staff and managers to elicit their perceptions of factors that enhance or reduce sustainability in the LTC setting. The overall aim was to generate hypotheses about how to sustain complex interventions in LTC. Methods In eight facilities, we cond...

  6. Knowledge Transfer on Complex Social Interventions in Public Health: A Scoping Study

    Science.gov (United States)

    Dagenais, Christian; Malo, Marie; Robert, Émilie; Ouimet, Mathieu; Berthelette, Diane; Ridde, Valéry

    2013-01-01

    Objectives Scientific knowledge can help develop interventions that improve public health. The objectives of this review are (1) to describe the status of research on knowledge transfer strategies in the field of complex social interventions in public health and (2) to identify priorities for future research in this field. Method A scoping study is an exploratory study. After searching databases of bibliographic references and specialized periodicals, we summarized the relevant studies using a predetermined assessment framework. In-depth analysis focused on the following items: types of knowledge transfer strategies, fields of public health, types of publics, types of utilization, and types of research specifications. Results From the 1,374 references identified, we selected 26 studies. The strategies targeted mostly administrators of organizations and practitioners. The articles generally dealt with instrumental utilization and most often used qualitative methods. In general, the bias risk for the studies is high. Conclusion Researchers need to consider the methodological challenges in this field of research in order to improve assessment of more complex knowledge transfer strategies (when they exist), not just diffusion/dissemination strategies and conceptual and persuasive utilization. PMID:24324593

  7. A Framework for the Study of Complex mHealth Interventions in Diverse Cultural Settings.

    Science.gov (United States)

    Maar, Marion A; Yeates, Karen; Perkins, Nancy; Boesch, Lisa; Hua-Stewart, Diane; Liu, Peter; Sleeth, Jessica; Tobe, Sheldon W

    2017-04-20

    To facilitate decision-making capacity between options of care under real-life service conditions, clinical trials must be pragmatic to evaluate mobile health (mHealth) interventions under the variable conditions of health care settings with a wide range of participants. The mHealth interventions require changes in the behavior of patients and providers, creating considerable complexity and ambiguity related to causal chains. Process evaluations of the implementation are necessary to shed light on the range of unanticipated effects an intervention may have, what the active ingredients in everyday practice are, how they exert their effect, and how these may vary among recipients or between sites. Building on the CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth) statement and participatory evaluation theory, we present a framework for the process evaluations for mHealth interventions in multiple cultural settings. We also describe the application of this evaluation framework to the implementation of DREAM-GLOBAL (Diagnosing hypertension-Engaging Action and Management in Getting Lower BP in Indigenous and LMIC [low- and middle-income countries]), a pragmatic randomized controlled trial (RCT), and mHealth intervention designed to improve hypertension management in low-resource environments. We describe the evaluation questions and the data collection processes developed by us. Our literature review revealed that there is a significant knowledge gap related to the development of a process evaluation framework for mHealth interventions. We used community-based participatory research (CBPR) methods and formative research data to develop a process evaluation framework nested within a pragmatic RCT. Four human organizational levels of participants impacted by the mHealth intervention were identified that included patients, providers, community and organizations actors, and health systems and

  8. Interventional catheter methods for complex tetralogy of fallot and 'Critical' PS/pulmonary atresia with intact interventional septum

    International Nuclear Information System (INIS)

    Issenberg, H.J.

    2005-01-01

    TOF is generally accepted as the index lesion used for evaluating the overall quality of a congenital cardiac program. To achieve good results , the evaluation and management of TOF requires an intimate collaboration between all members of the cardiac team involved in the care of these children, especially the interventional catheterizer and the surgeon. Each program has to develop its own approach, relying on the collective strengths of their staff. Any weak link in this chain will often have a profoundly negative effect upon the patient , which may be difficult to correct later. Whereas the cathlab was the sole source of the anatomic and physiologic data for surgical planning, much of the information, especially intracardiac anatomy and physiology, can now be acquired with echocardiography, and if necessary, enhanced with MRI and CT. The role of diagnostic angiography is reserved for the elucidation of complex and small vascular structures beyond the resolution and specificity of less invasive methods, such as pulmonary artery branches, coronary arteries and arterial collaterals. This anatomy becomes particularly important when staging procedures for TOF in the infant with small pulmonary arteries or atresia, when is the greatest potential for enhancing arterial size and vascular bed growth. Our approach is to perform early correction which will insure antegrade flow into the small pulmonary arteries, by opening the outflow tract (patch or conduit), and when feasible, closing the VSD. Aortic to pulmonary arterial shunts are avoided. Direct access into the pulmonary arteries allows additional catheter-based interventions. Which may include balloon dilation and stenting, which avoiding any deformity from peripheral shunts. Aortic collaterals perfusing lung segments competing with antegrade flow into the branch pulmonary arteries may need Giannturco coil occlusion. Those with small pulmonary arteries may require multiple ballooning/stenting interventions to increase

  9. Planned development and evaluation protocol of two versions of a web-based computer-tailored nutrition education intervention aimed at adults, including cognitive and environmental feedback.

    Science.gov (United States)

    Springvloet, Linda; Lechner, Lilian; Oenema, Anke

    2014-01-17

    Despite decades of nutrition education, the prevalence of unhealthy dietary patterns is still high and inequalities in intake between high and low socioeconomic groups still exist. Therefore, it is important to innovate and improve existing nutrition education interventions. This paper describes the development, design and evaluation protocol of a web-based computer-tailored nutrition education intervention for adults targeting fruit, vegetable, high-energy snack and fat intake. This intervention innovates existing computer-tailored interventions by not only targeting motivational factors, but also volitional and self-regulation processes and environmental-level factors. The intervention development was guided by the Intervention Mapping protocol, ensuring a theory-informed and evidence-based intervention. Two versions of the intervention were developed: a basic version targeting knowledge, awareness, attitude, self-efficacy and volitional and self-regulation processes, and a plus version additionally addressing the home environment arrangement and the availability and price of healthy food products in supermarkets. Both versions consist of four modules: one for each dietary behavior, i.e. fruit, vegetables, high-energy snacks and fat. Based on the self-regulation phases, each module is divided into three sessions. In the first session, feedback on dietary behavior is provided to increase awareness, feedback on attitude and self-efficacy is provided and goals and action plans are stated. In the second session goal achievement is evaluated, reasons for failure are explored, coping plans are stated and goals can be adapted. In the third session, participants can again evaluate their behavioral change and tips for maintenance are provided. Both versions will be evaluated in a three-group randomized controlled trial with measurements at baseline, 1-month, 4-months and 9-months post-intervention, using online questionnaires. Both versions will be compared with a generic

  10. A randomized controlled trial examining the effectiveness of a STOMA psychosocial intervention programme on the outcomes of colorectal patients with a stoma: study protocol.

    Science.gov (United States)

    Lim, Siew Hoon; Chan, Sally Wai-Chi; Lai, Jiunn Herng; He, Hong-Gu

    2015-06-01

    To report a study protocol that evaluates the effects of a psychosocial intervention on patients with a newly formed stoma. With the loss of a significant body function and distorted body image, stoma patients experience physical, psychological and social challenges. Nurses have an important role in helping patients' make a smooth transition to living with their stoma. Limited studies have examined the effects of psychosocial interventions on improving stoma-related health outcomes. A randomized controlled trial is planned. Eighty-four patients with newly formed stoma in a tertiary hospital in Singapore (Research Ethics Committee approval obtained in January 2013) will be recruited. Participants will be randomly assigned to either a control group who receive routine care or an intervention group who receive STOMA psychosocial intervention besides routine care. Outcome variables include stoma care self-efficacy, days to stoma proficiency, length of hospital stay, acceptance of stoma, anxiety and depression and quality of life. Data will be collected at four time points: before randomization and intervention (baseline), on the day of discharge (mid-intervention), at 4 weeks after discharge (postintervention 1) and at 4 months after discharge (postintervention 2). This study will develop a psychosocial intervention programme, which may improve patients' stoma-related outcomes. The findings will provide direction to health professionals about education and the type of support that could be offered to patients concerning stoma care in the hospital setting, which will eventually improve their quality of life. © 2014 John Wiley & Sons Ltd.

  11. Complex Coronary Interventions with the Novel Mozec™ CTO Balloon: The MOZART Registry.

    Science.gov (United States)

    Lupi, Alessandro; Rognoni, Andrea; Schaffer, Alon; Secco, Gioel G; Bongo, Angelo S

    2015-01-01

    Mozec™ CTO is a novel semicompliant rapid-exchange PTCA balloon catheter with specific features dedicated to treat complex coronary lesions like chronic total occlusions (CTOs). However, no data have been reported about the performance of this device in an all-comers population with complex coronary lesions. We evaluated the safety and success rate of Mozec™ CTO balloon in 41 consecutive patients with chronic stable angina and complex coronary lesions (15 severe calcified coronary stenoses, 15 bifurcation lesions with planned two-stent intervention, and 11 CTOs). Safety was assessed reporting the balloon burst rate after inflation exceeding the rated burst pressure (RBP) according to the manufacturer's reference table. Success was defined as the possibility to advance the device further the target lesion. The Mozec™ CTO balloon showed an excellent performance with a 93.3% success in crossing tight and severely calcified lesions (14/15 pts), a 93.3% success in engaging jailed side branches after stent deployment across bifurcations (14/15 pts), and a 90.9% success in crossing CTO lesions (10/11 pts). The burst rate at RBP of the Mozec™ CTO balloon was 6.7% (1/15 balloons) in the tight and severely calcified lesions, 6.7% (1/15 balloons) when dilating jailed vessels, and 9.1% (1/11 balloons) in CTOs. The novel Mozec™ CTO balloon dilatation catheter showed promising results when employed to treat complex lesions in an all-comers population. Further studies should clarify if this kind of balloon might reduce the need of more costly devices like over-the-wire balloons and microcatheters for complex lesions treatment.

  12. Reviewing evidence on complex social interventions: appraising implementation in systematic reviews of the health effects of organisational-level workplace interventions

    Science.gov (United States)

    Egan, M; Bambra, C; Petticrew, M; Whitehead, M

    2009-01-01

    Background: The reporting of intervention implementation in studies included in systematic reviews of organisational-level workplace interventions was appraised. Implementation is taken to include such factors as intervention setting, resources, planning, collaborations, delivery and macro-level socioeconomic contexts. Understanding how implementation affects intervention outcomes may help prevent erroneous conclusions and misleading assumptions about generalisability, but implementation must be adequately reported if it is to be taken into account. Methods: Data on implementation were obtained from four systematic reviews of complex interventions in workplace settings. Implementation was appraised using a specially developed checklist and by means of an unstructured reading of the text. Results: 103 studies were identified and appraised, evaluating four types of organisational-level workplace intervention (employee participation, changing job tasks, shift changes and compressed working weeks). Many studies referred to implementation, but reporting was generally poor and anecdotal in form. This poor quality of reporting did not vary greatly by type or date of publication. A minority of studies described how implementation may have influenced outcomes. These descriptions were more usefully explored through an unstructured reading of the text, rather than by means of the checklist. Conclusions: Evaluations of complex interventions should include more detailed reporting of implementation and consider how to measure quality of implementation. The checklist helped us explore the poor reporting of implementation in a more systematic fashion. In terms of interpreting study findings and their transferability, however, the more qualitative appraisals appeared to offer greater potential for exploring how implementation may influence the findings of specific evaluations. Implementation appraisal techniques for systematic reviews of complex interventions require further

  13. Agency for Healthcare Research and Quality Evidence-based Practice Center methods for systematically reviewing complex multicomponent health care interventions.

    Science.gov (United States)

    Guise, Jeanne-Marie; Chang, Christine; Viswanathan, Meera; Glick, Susan; Treadwell, Jonathan; Umscheid, Craig A; Whitlock, Evelyn; Fu, Rongwei; Berliner, Elise; Paynter, Robin; Anderson, Johanna; Motu'apuaka, Pua; Trikalinos, Tom

    2014-11-01

    The purpose of this Agency for Healthcare Research and Quality Evidence-based Practice Center methods white paper was to outline approaches to conducting systematic reviews of complex multicomponent health care interventions. We performed a literature scan and conducted semistructured interviews with international experts who conduct research or systematic reviews of complex multicomponent interventions (CMCIs) or organizational leaders who implement CMCIs in health care. Challenges identified include lack of consistent terminology for such interventions (eg, complex, multicomponent, multidimensional, multifactorial); a wide range of approaches used to frame the review, from grouping interventions by common features to using more theoretical approaches; decisions regarding whether and how to quantitatively analyze the interventions, from holistic to individual component analytic approaches; and incomplete and inconsistent reporting of elements critical to understanding the success and impact of multicomponent interventions, such as methods used for implementation the context in which interventions are implemented. We provide a framework for the spectrum of conceptual and analytic approaches to synthesizing studies of multicomponent interventions and an initial list of critical reporting elements for such studies. This information is intended to help systematic reviewers understand the options and tradeoffs available for such reviews. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. The evaluation of complex interventions in palliative care: an exploration of the potential of case study research strategies.

    Science.gov (United States)

    Walshe, Catherine

    2011-12-01

    Complex, incrementally changing, context dependent and variable palliative care services are difficult to evaluate. Case study research strategies may have potential to contribute to evaluating such complex interventions, and to develop this field of evaluation research. This paper explores definitions of case study (as a unit of study, a process, and a product) and examines the features of case study research strategies which are thought to confer benefits for the evaluation of complex interventions in palliative care settings. Ten features of case study that are thought to be beneficial in evaluating complex interventions in palliative care are discussed, drawing from exemplars of research in this field. Important features are related to a longitudinal approach, triangulation, purposive instance selection, comprehensive approach, multiple data sources, flexibility, concurrent data collection and analysis, search for proving-disproving evidence, pattern matching techniques and an engaging narrative. The limitations of case study approaches are discussed including the potential for subjectivity and their complex, time consuming and potentially expensive nature. Case study research strategies have great potential in evaluating complex interventions in palliative care settings. Three key features need to be exploited to develop this field: case selection, longitudinal designs, and the use of rival hypotheses. In particular, case study should be used in situations where there is interplay and interdependency between the intervention and its context, such that it is difficult to define or find relevant comparisons.

  15. The effectiveness of health literacy interventions on the informed consent process of health care users: a systematic review protocol.

    Science.gov (United States)

    Perrenoud, Beatrice; Velonaki, Venetia-Sofia; Bodenmann, Patrick; Ramelet, Anne-Sylvie

    2015-10-01

    most tasks required to function in the health care setting.Low or inadequate health literacy has been found to have several adverse effects on health and health care use: reduced ability to take medications properly and to interpret labels and health messages, poorer overall health status and higher risk of mortality in seniors, increased emergency department and hospital use, and decreased use of preventive interventions.Most studies examining the relationship between health literacy and informed consent conclude that patients with low health literacy are less likely to participate in decision making concerning their health care. According to a recent literature review, health care users' literacy, together with other factors, were found to be important determinants of a patient's capacity to provide fully informed consent. According to this review, 21 to 86% of the patients were able to recall the potential risks and complications of their medical procedure. This percentage may be even lower because most of the included studies referred to self-reported recall, which may be a flawed measure. According to the literature, much of the written material related to the informed consent is too difficult for health care users to understand. In addition, in their study, McCarthy et al. observed that during consultations, physicians spoke and used significantly more complex language than their patients, which may result in inappropriate communication for the patients, mainly for those with limited literacy. The situations described above may raise a number of critical legal and ethical problems. Health professionals, who shape the conditions of interactions with the patient, are responsible for adapting appropriate interventions, such as communication approaches that take into account patients' health literacy. These interventions could have a major contribution to the improvement of the informed consent process.Sheridan et al. conducted a systematic review on interventions

  16. Everything should be as simple as possible, but no simpler: towards a protocol for accumulating evidence regarding the active content of health behaviour change interventions.

    Science.gov (United States)

    Peters, Gjalt-Jorn Ygram; de Bruin, Marijn; Crutzen, Rik

    2015-01-01

    There is a need to consolidate the evidence base underlying our toolbox of methods of behaviour change. Recent efforts to this effect have conducted meta-regressions on evaluations of behaviour change interventions, deriving each method's effectiveness from its association to intervention effect size. However, there are a range of issues that raise concern about whether this approach is actually furthering or instead obstructing the advancement of health psychology theories and the quality of health behaviour change interventions. Using examples from theory, the literature and data from previous meta-analyses, these concerns and their implications are explained and illustrated. An iterative protocol for evidence base accumulation is proposed that integrates evidence derived from both experimental and applied behaviour change research, and combines theory development in experimental settings with theory testing in applied real-life settings. As evidence gathered in this manner accumulates, a cumulative science of behaviour change can develop.

  17. Implementation of a school-based social and emotional learning intervention: understanding diffusion processes within complex systems.

    Science.gov (United States)

    Evans, Rhiannon; Murphy, Simon; Scourfield, Jonathan

    2015-07-01

    Sporadic and inconsistent implementation remains a significant challenge for social and emotional learning (SEL) interventions. This may be partly explained by the dearth of flexible, causative models that capture the multifarious determinants of implementation practices within complex systems. This paper draws upon Rogers (2003) Diffusion of Innovations Theory to explain the adoption, implementation and discontinuance of a SEL intervention. A pragmatic, formative process evaluation was conducted in alignment with phase 1 of the UK Medical Research Council's framework for Developing and Evaluating Complex Interventions. Employing case-study methodology, qualitative data were generated with four socio-economically and academically contrasting secondary schools in Wales implementing the Student Assistance Programme. Semi-structured interviews were conducted with 15 programme stakeholders. Data suggested that variation in implementation activity could be largely attributed to four key intervention reinvention points, which contributed to the transformation of the programme as it interacted with contextual features and individual needs. These reinvention points comprise the following: intervention training, which captures the process through which adopters acquire knowledge about a programme and delivery expertise; intervention assessment, which reflects adopters' evaluation of an intervention in relation to contextual needs; intervention clarification, which comprises the cascading of knowledge through an organisation in order to secure support in delivery; and intervention responsibility, which refers to the process of assigning accountability for sustainable delivery. Taken together, these points identify opportunities to predict and intervene with potential implementation problems. Further research would benefit from exploring additional reinvention activity.

  18. Sustaining complex interventions in long-term care: a qualitative study of direct care staff and managers.

    Science.gov (United States)

    Colón-Emeric, Cathleen; Toles, Mark; Cary, Michael P; Batchelor-Murphy, Melissa; Yap, Tracey; Song, Yuting; Hall, Rasheeda; Anderson, Amber; Burd, Andrew; Anderson, Ruth A

    2016-07-16

    Little is known about the sustainability of behavioral change interventions in long-term care (LTC). Following a cluster randomized trial of an intervention to improve staff communication (CONNECT), we conducted focus groups of direct care staff and managers to elicit their perceptions of factors that enhance or reduce sustainability in the LTC setting. The overall aim was to generate hypotheses about how to sustain complex interventions in LTC. In eight facilities, we conducted 15 focus groups with 83 staff who had participated in at least one intervention session. Where possible, separate groups were conducted with direct care staff and managers. An interview guide probed for staff perceptions of intervention salience and sustainability. Framework analysis of coded transcripts was used to distill insights about sustainability related to intervention features, organizational context, and external supports. Staff described important factors for intervention sustainability that are particularly challenging in LTC. Because of the tremendous diversity in staff roles and education level, interventions should balance complexity and simplicity, use a variety of delivery methods and venues (e.g., group and individual sessions, role-play/storytelling), and be inclusive of many work positions. Intervention customizability and flexibility was particularly prized in this unpredictable and resource-strapped environment. Contextual features noted to be important include addressing the frequent lack of trust between direct care staff and managers and ensuring that direct care staff directly observe manager participation and support for the program. External supports suggested to be useful for sustainability include formalization of changes into facility routines, using "train the trainer" approaches and refresher sessions. High staff turnover is common in LTC, and providing materials for new staff orientation was reported to be important for sustainability. When designing or

  19. Framework to Define Structure and Boundaries of Complex Health Intervention Systems: The ALERT Project

    Directory of Open Access Journals (Sweden)

    Elena Boriani

    2017-07-01

    Full Text Available Health intervention systems are complex and subject to multiple variables in different phases of implementation. This constitutes a concrete challenge for the application of translational science in real life. Complex systems as health-oriented interventions call for interdisciplinary approaches with carefully defined system boundaries. Exploring individual components of such systems from different viewpoints gives a wide overview and helps to understand the elements and the relationships that drive actions and consequences within the system. In this study, we present an application and assessment of a framework with focus on systems and system boundaries of interdisciplinary projects. As an example on how to apply our framework, we analyzed ALERT [an integrated sensors and biosensors’ system (BEST aimed at monitoring the quality, health, and traceability of the chain of the bovine milk], a multidisciplinary and interdisciplinary project based on the application of measurable biomarkers at strategic points of the milk chain for improved food security (including safety, human, and ecosystem health (1. In fact, the European food safety framework calls for science-based support to the primary producers’ mandate for legal, scientific, and ethical responsibility in food supply. Because of its multidisciplinary and interdisciplinary approach involving human, animal, and ecosystem health, ALERT can be considered as a One Health project. Within the ALERT context, we identified the need to take into account the main actors, interactions, and relationships of stakeholders to depict a simplified skeleton of the system. The framework can provide elements to highlight how and where to improve the project development when project evaluations are required.

  20. Implementation of an efficacious intervention for high risk women in Mexico: protocol for a multi-site randomized trial with a parallel study of organizational factors

    Directory of Open Access Journals (Sweden)

    Patterson Thomas L

    2012-10-01

    Full Text Available Abstract Background Studies of implementation of efficacious human immunodeficiency virus (HIV prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs among female sex workers (FSWs in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman intervention into community-based organizations (CBOs. Methods We have partnered with Mexican Foundation for Family Planning (Mexfam, a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs. Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia; they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura

  1. A novel combined interventional radiologic and hepatobiliary surgical approach to a complex traumatic hilar biliary stricture.

    Science.gov (United States)

    NeMoyer, Rachel E; Shah, Mihir M; Hasan, Omar; Nosher, John L; Carpizo, Darren R

    2018-01-01

    Benign strictures of the biliary system are challenging and uncommon conditions requiring a multidisciplinary team for appropriate management. The patient is a 32-year-old male that developed a hilar stricture as sequelae of a gunshot wound. Due to the complex nature of the stricture and scarring at the porta hepatis a combined interventional radiologic and surgical approach was carried out to approach the hilum of the right and left hepatic ducts. The location of this stricture was found by ultrasound guidance intraoperatively using a balloon tipped catheter placed under fluoroscopy in the interventional radiology suite prior to surgery. This allowed the surgeons to select the line of parenchymal transection for best visualization of the stricture. A left hepatectomy was performed, the internal stent located and the right hepatic duct opened tangentially to allow a side-to-side Roux-en-Y hepaticojejunostomy (a Puestow-like anastomosis). Injury to the intrahepatic biliary ductal confluence is rarely fatal, however, the associated injuries lead to severe morbidity as seen in this example. Management of these injuries poses a considerable challenge to the surgeon and treating physicians. Here we describe an innovative multi-disciplinary approach to the repair of this rare injury. Copyright © 2018. Published by Elsevier Ltd.

  2. The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS – A randomised control trial protocol

    Directory of Open Access Journals (Sweden)

    Morton Veronica

    2008-06-01

    -effectiveness of the interventions. Discussion The paper presents a protocol for the first pragmatic randomised controlled trial evaluating the effectiveness and cost-effectiveness of stepped care interventions for older hazardous alcohol users in primary care. Trial registration ISRCTN52557360

  3. The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

    Science.gov (United States)

    van de Glind, I; Bunn, C; Gray, C M; Hunt, K; Andersen, E; Jelsma, J; Morgan, H; Pereira, H; Roberts, G; Rooksby, J; Røynesdal, Ø; Silva, M; Sorensen, M; Treweek, S; van Achterberg, T; van der Ploeg, H; van Nassau, F; Nijhuis-van der Sanden, M; Wyke, S

    2017-07-27

    EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. The process evaluation will

  4. Effect evaluation of a two-year complex intervention to reduce loneliness in non-institutionalised elderly Dutch people.

    Science.gov (United States)

    Honigh-de Vlaming, Rianne; Haveman-Nies, Annemien; Heinrich, Judith; van't Veer, Pieter; de Groot, Lisette C P G M

    2013-10-21

    Public health policy calls for intervention programmes to reduce loneliness in the ageing population. So far, numerous loneliness interventions have been developed, with effectiveness demonstrated for few of these interventions. The loneliness intervention described in this manuscript distinguishes itself from others by including multiple intervention components and targeting individuals and their environment. Intervention components included a mass media campaign, information meetings, psychosocial group courses, social activities organised by neighbours, and training of intermediaries. The aim of this manuscript is to study the effects of this integrated approach on initial and long-term outcomes. A quasi-experimental pre-test post-test intervention study was conducted among non-institutionalised elderly people aged 65 years and over to evaluate the effectiveness of the intervention by comparing the intervention community and the control community. Data on outputs, initial and long-term outcomes, and the overall goal were collected by self-administered questionnaires. Data of 858 elderly people were available for the analyses. To assess the effect linear regression analyses with adjustments for age, gender, church attendance, and mental health were used. In addition, the process evaluation provided information about the reach of the intervention components. After two years, 39% of the elderly people were familiar with the intervention programme. The intervention group scored more favourably than the control group on three subscales of the initial outcome, motivation (-4.4%, 95% CI-8.3--0.7), perceived social support (-8.2%, 95% CI-13.6--2.4), and subjective norm (-11.5%, 95% CI-17.4--5.4). However, no overall effects were observed for the long-term outcome, social support, and overall goal, loneliness. Two years after its initiation the reach of the intervention programme was modest. Though no effect of the complex intervention was found on social support and

  5. The safety and feasibility of guidezilla catheter in complex coronary interventions and an observational study.

    Science.gov (United States)

    Ma, Jianying; Hou, Lei; Qian, Juying; Ge, Lei; Zhang, Feng; Chang, Shufu; Xu, Rende; Qin, Qing; Ge, Junbo

    2017-10-01

    The monorail Guidezilla guide extension catheter was designed to provide additional backup and facilitate device delivery in percutaneous coronary intervention (PCI) for complex coronary anatomy such as chronic total occlusion (CTO), extreme vessel tortuosity, diseased bypass grafts, and anomalous coronary arteries, among others.The present retrospective, single-center study included 188 consecutive patients who underwent PCI using the Guidezilla catheter from March 2015 to August 2016. Study outcomes were rates of target lesion crossing success, procedural success, and complications.The Guidezilla catheter was used most commonly in PCI of CTOs (45%) and heavy proximal calcification (37%), followed by tortuosity (10%), previously deployed proximal stents (4%), and coronary artery anomaly (4%). The right coronary artery (48%) was most commonly intervened followed by the left ascending (35%) and left circumflex (17%) arteries. Rates of target lesion crossing success and procedural success were both 99%, with one device-related periprocedural complication, namely proximal vessel dissection secondary to deep insertion which was successfully treated with stent implantation. Ninety percent of PCI were performed and completed successfully by radial access.In a single center with experienced operators, the use of the Guidezilla guide extension catheter in PCI of complex coronary anatomy performed mostly via radial artery access appeared safe and efficacious, and greatly facilitated device delivery.

  6. Developing, delivering and evaluating primary mental health care: the co-production of a new complex intervention.

    Science.gov (United States)

    Reeve, Joanne; Cooper, Lucy; Harrington, Sean; Rosbottom, Peter; Watkins, Jane

    2016-09-06

    Health services face the challenges created by complex problems, and so need complex intervention solutions. However they also experience ongoing difficulties in translating findings from research in this area in to quality improvement changes on the ground. BounceBack was a service development innovation project which sought to examine this issue through the implementation and evaluation in a primary care setting of a novel complex intervention. The project was a collaboration between a local mental health charity, an academic unit, and GP practices. The aim was to translate the charity's model of care into practice-based evidence describing delivery and impact. Normalisation Process Theory (NPT) was used to support the implementation of the new model of primary mental health care into six GP practices. An integrated process evaluation evaluated the process and impact of care. Implementation quickly stalled as we identified problems with the described model of care when applied in a changing and variable primary care context. The team therefore switched to using the NPT framework to support the systematic identification and modification of the components of the complex intervention: including the core components that made it distinct (the consultation approach) and the variable components (organisational issues) that made it work in practice. The extra work significantly reduced the time available for outcome evaluation. However findings demonstrated moderately successful implementation of the model and a suggestion of hypothesised changes in outcomes. The BounceBack project demonstrates the development of a complex intervention from practice. It highlights the use of Normalisation Process Theory to support development, and not just implementation, of a complex intervention; and describes the use of the research process in the generation of practice-based evidence. Implications for future translational complex intervention research supporting practice change

  7. Development and evaluation of two web-based interventions for the promotion of physical activity in older adults: study protocol for a community-based controlled intervention trial.

    Science.gov (United States)

    Muellmann, Saskia; Bragina, Inna; Voelcker-Rehage, Claudia; Rost, Eric; Lippke, Sonia; Meyer, Jochen; Schnauber, Jochen; Wasmann, Merlin; Toborg, Merle; Koppelin, Frauke; Brand, Tilman; Zeeb, Hajo; Pischke, Claudia R

    2017-05-25

    Regular physical activity (PA) is a key contributor to healthy ageing. However, despite known health benefits, only one third of older adults in Germany reach the PA levels recommended for persons aged 65 years and above by the World Health Organization. The aim of the current study is to evaluate the effectiveness of two web-based interventions for the initiation and maintenance of regular PA (i.e., intervention groups 1 and 2) compared to a delayed intervention control group of older adults aged 65 to 75 years. Study participants will be randomly assigned to one of three study arms in five communities in the Bremen-Oldenburg metropolitan region: a) Participants in the first arm will receive access to a web-based intervention for 10 weeks allowing them to track their weekly PA (subjective self-monitoring, intervention group 1); b) participants in the second arm will receive access to the web-based intervention for 10 weeks and, in addition, track PA using Fitbit Zips (objective self-monitoring, intervention group 2); c) participants in the delayed intervention control group will receive access to the intervention implemented in the first study arm after completion of the 12-week follow-up in the other two groups within each community. In addition, weekly group meetings in the communities will be offered to study participants in the intervention groups providing the opportunity to address questions related to the use of the website and to practice PA in groups (e.g., neighborhood walks, strength and balance exercises). To evaluate short-term effects of the intervention on physical and psychological health, PA, physical fitness, and cognitive and psychological variables will be assessed at baseline and 12-week follow-up. This study will provide answers regarding acceptance and effectiveness of web-based interventions promoting uptake and maintenance of regular PA in persons aged 65-75 years. Study findings will contribute to a growing body of evidence in

  8. Recent advances in hopanoids analysis: Quantification protocols overview, main research targets and selected problems of complex data exploration.

    Science.gov (United States)

    Zarzycki, Paweł K; Portka, Joanna K

    2015-09-01

    Pentacyclic triterpenoids, particularly hopanoids, are organism-specific compounds and are generally considered as useful biomarkers that allow fingerprinting and classification of biological, environmental and geological samples. Simultaneous quantification of various hopanoids together with battery of related non-polar and low-molecular mass compounds may provide principal information for geochemical and environmental research focusing on both modern and ancient investigations. Target compounds can be derived from microbial biomass, water columns, sediments, coals, crude fossils or rocks. This create number of analytical problems due to different composition of the analytical matrix and interfering compounds and therefore, proper optimization of quantification protocols for such biomarkers is still the challenge. In this work we summarizing typical analytical protocols that were recently applied for quantification of hopanoids like compounds from different samples. Main steps including components of interest extraction, pre-purification, fractionation, derivatization and quantification involving gas (1D and 2D) as well as liquid separation techniques (liquid-liquid extraction, solid-phase extraction, planar and low resolution column chromatography, high-performance liquid chromatography) are described and discussed from practical point of view, mainly based on the experimental papers that were published within last two years, where significant increase in hopanoids research was noticed. The second aim of this review is to describe the latest research trends concerning determination of hopanoids and related low-molecular mass lipids analyzed in various samples including sediments, rocks, coals, crude oils and plant fossils as well as stromatolites and microbial biomass cultivated under different conditions. It has been found that majority of the most recent papers are based on uni- or bivariate approach for complex data analysis. Data interpretation involves

  9. Efficacy of the RADPAD protective drape during real world complex percutaneous coronary intervention procedures.

    Science.gov (United States)

    Murphy, John C; Darragh, Karen; Walsh, Simon J; Hanratty, Colm G

    2011-11-15

    The RADPAD is a lead-free surgical drape containing bismuth and barium that has been demonstrated to reduce scatter radiation exposure to primary operators during fluoroscopic procedures. It is not known to what degree the RADPAD reduces radiation exposure in operators who perform highly complex percutaneous coronary intervention (PCI) requiring prolonged fluoroscopic screening times. Sixty consecutive patients due to undergo elective complex PCI involving rotational atherectomy, multivessel PCI, or chronic total occlusions were randomized in a 1:1 pattern to have their procedures performed with and without the RADPAD drape in situ. Dosimetry was performed on the left arm of the primary operator. There were 40 cases of chronic total occlusion, including 28 with contralateral injections; 15 cases involving rotational atherectomy; and 5 cases of multivessel PCI. There was no significant difference in screening times or dose-area products between the 2 patient groups. Primary operator radiation dose relative to screening time (RADPAD: slope = 1.44, R² = 0.25; no RADPAD: slope = 4.60, R² = 0.26; analysis of covariance F = 4.81, p = 0.032) and dose-area product (RADPAD: slope = 0.003, R² = 0.26; no RADPAD: slope = 0.011, R² = 0.52; analysis of covariance F = 12.54, p = 0.008) was significantly smaller in the RADPAD cohort compared to the no-RADPAD group. In conclusion, the RADPAD significantly reduces radiation exposure to primary operators during prolonged, complex PCI cases. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Koo, H C; Poh, B K; Ruzita, Abd Talib

    2016-01-01

    The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

  11. Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

    Science.gov (United States)

    2013-01-01

    Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

  12. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol.

    Science.gov (United States)

    Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-04-29

    Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis

  13. A school-based physical activity promotion intervention in children: rationale and study protocol for the PREVIENE Project

    Directory of Open Access Journals (Sweden)

    Pablo Tercedor

    2017-09-01

    Full Text Available Abstract Background The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost, easy-toimplement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions (active commuting to/from school, active Physical Education lessons, active school recess, sleep health promotion, and an integrated program incorporating all 4 interventions to improve physical activity, fitness, anthropometry, sleep health, academic achievement, and health-related quality of life in primary school children. Methods A total of 300 children (grade 3; 8-9 years of age from six schools in Granada (Spain will be enrolled in one of the 8-week interventions (one intervention per school; 50 children per school or a control group (no intervention school; 50 children. Outcomes will include physical activity (measured by accelerometry, physical fitness (assessed using the ALPHA fitness battery, and anthropometry (height, weight and waist circumference. Furthermore, they will include sleep health (measured by accelerometers, a sleep diary, and sleep health questionnaires, academic achievement (grades from the official school’s records, and health-related quality of life (child and parental questionnaires. To assess the effectiveness of the different interventions on objectively measured PA and the other outcomes, the generalized linear model will be used. Discussion The PREVIENE Project will provide the information about the effectiveness and implementation of different school-based interventions for physical activity promotion in primary school children.

  14. A school-based physical activity promotion intervention in children: rationale and study protocol for the PREVIENE Project.

    Science.gov (United States)

    Tercedor, Pablo; Villa-González, Emilio; Ávila-García, Manuel; Díaz-Piedra, Carolina; Martínez-Baena, Alejandro; Soriano-Maldonado, Alberto; Pérez-López, Isaac José; García-Rodríguez, Inmaculada; Mandic, Sandra; Palomares-Cuadros, Juan; Segura-Jiménez, Víctor; Huertas-Delgado, Francisco Javier

    2017-09-26

    The lack of physical activity and increasing time spent in sedentary behaviours during childhood place importance on developing low cost, easy-toimplement school-based interventions to increase physical activity among children. The PREVIENE Project will evaluate the effectiveness of five innovative, simple, and feasible interventions (active commuting to/from school, active Physical Education lessons, active school recess, sleep health promotion, and an integrated program incorporating all 4 interventions) to improve physical activity, fitness, anthropometry, sleep health, academic achievement, and health-related quality of life in primary school children. A total of 300 children (grade 3; 8-9 years of age) from six schools in Granada (Spain) will be enrolled in one of the 8-week interventions (one intervention per school; 50 children per school) or a control group (no intervention school; 50 children). Outcomes will include physical activity (measured by accelerometry), physical fitness (assessed using the ALPHA fitness battery), and anthropometry (height, weight and waist circumference). Furthermore, they will include sleep health (measured by accelerometers, a sleep diary, and sleep health questionnaires), academic achievement (grades from the official school's records), and health-related quality of life (child and parental questionnaires). To assess the effectiveness of the different interventions on objectively measured PA and the other outcomes, the generalized linear model will be used. The PREVIENE Project will provide the information about the effectiveness and implementation of different school-based interventions for physical activity promotion in primary school children.

  15. An internet-based intervention for people with psychosis (EviBaS): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Rüegg, Nina; Moritz, Steffen; Berger, Thomas; Lüdtke, Thies; Westermann, Stefan

    2018-04-13

    Evidence shows that internet-based self-help interventions are effective in reducing symptoms for a wide range of mental disorders. To date, online interventions treating psychotic disorders have been scarce, even though psychosis is among the most burdensome disorders worldwide. Furthermore, the implementation of cognitive-behavioral therapy (CBT) for psychosis in routine health care is challenging. Internet-based interventions could narrow this treatment gap. Thus, a comprehensive CBT-based online self-help intervention for people with psychosis has been developed. The aim of this study is the evaluation of the feasibility and efficacy of the intervention compared with a waiting list control group. The intervention includes modules on delusion, voice hearing, social competence, mindfulness, and seven other domains. Participants are guided through the program by a personal moderator. Usage can be amended by an optional smartphone app. In this randomized controlled trial, participants are allocated to a waiting list or an intervention of eight weeks. Change in positive psychotic symptoms of both groups will be compared (primary outcome) and predictors of treatment effects will be assessed. To our knowledge, this project is one of the first large-scale investigations of an internet-based intervention for people with psychosis. It may thus be a further step to broaden treatment options for people suffering from this disorder. NCT02974400 (clinicaltrials.gov), date of registration: November 28th 2016.

  16. Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.

    Science.gov (United States)

    Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K

    2014-01-01

    We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  17. Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

    Directory of Open Access Journals (Sweden)

    Rajalakshmi Lakshman

    2014-01-01

    Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  18. A Pragmatic Approach to Guide Implementation Evaluation Research: Strategy Mapping for Complex Interventions

    Directory of Open Access Journals (Sweden)

    Alexis K. Huynh

    2018-05-01

    Full Text Available IntroductionGreater specification of implementation strategies is a challenge for implementation science, but there is little guidance for delineating the use of multiple strategies involved in complex interventions. The Cardiovascular (CV Toolkit project entails implementation of a toolkit designed to reduce CV risk by increasing women’s engagement in appropriate services. The CV Toolkit project follows an enhanced version of Replicating Effective Programs (REP, an evidence-based implementation strategy, to implement the CV Toolkit across four phases: pre-conditions, pre-implementation, implementation, and maintenance and evolution. Our current objective is to describe a method for mapping implementation strategies used in real time as part of the CV Toolkit project. This method supports description of the timing and content of bundled strategies and provides a structured process for developing a plan for implementation evaluation.MethodsWe conducted a process of strategy mapping to apply Proctor and colleagues’ rubric for specification of implementation strategies, constructing a matrix in which we identified each implementation strategy, its conceptual group, and the corresponding REP phase(s in which it occurs. For each strategy, we also specified the actors involved, actions undertaken, action targets, dose of the implementation strategy, and anticipated outcome addressed. We iteratively refined the matrix with the implementation team, including use of simulation to provide initial validation.ResultsMapping revealed patterns in the timing of implementation strategies within REP phases. Most implementation strategies involving the development of stakeholder interrelationships and training and educating stakeholders were introduced during the pre-conditions or pre-implementation phases. Strategies introduced in the maintenance and evolution phase emphasized communication, re-examination, and audit and feedback. In addition to its value

  19. Development and feasibility testing of an intervention to support active lifestyles in youths with type 1 diabetes-the ActivPals programme: a study protocol.

    Science.gov (United States)

    Mitchell, Fiona; Kirk, Alison; Robertson, Kenneth; Reilly, John J

    2016-01-01

    The global incidence of type 1 diabetes is rising, and youths with type 1 diabetes continue to suffer poorer health than peers without diabetes. Evidence suggests youths with type 1 diabetes have physical activity (PA) levels well below the recommendations for health and have high levels of sedentary behaviour. An active lifestyle is therefore recommended to improve health. There is limited research showing effective lifestyle behaviour change in this population; therefore, an evidence gap exists between the need to promote physical activity in type 1 diabetes care and lack of understanding on how to do this. This protocol paper describes a feasibility and pilot study of the ActivPals programme-an intervention to support active lifestyles in youths with type 1 diabetes. Key intervention components have been identified from preliminary work (individual and family focus, peer mentoring, technology integration and improved communication and understanding) and are being developed into a pragmatic randomised controlled trial (RCT) supported by recruitment pathways. A steering group of health care professionals and managers will refine the intervention to patient needs. A pilot trial is providing data on intervention implementation, acceptability and feasibility. Twenty youths with type 1 diabetes are being recruited and randomised into an intervention or control group. Physical activity is being measured objectively using the Actigraph GT3X+ monitor at baseline and 1-month follow-up. Contextual factors associated with intervention delivery are being explored. This study will contribute to the development of evidence-based, user-informed and pragmatic interventions leading to healthier lifestyles in youths with type 1 diabetes.

  20. Bounce Back Now! Protocol of a population-based randomized controlled trial to examine the efficacy of a Web-based intervention with disaster-affected families.

    Science.gov (United States)

    Ruggiero, Kenneth J; Davidson, Tatiana M; McCauley, Jenna; Gros, Kirstin Stauffacher; Welsh, Kyleen; Price, Matthew; Resnick, Heidi S; Danielson, Carla Kmett; Soltis, Kathryn; Galea, Sandro; Kilpatrick, Dean G; Saunders, Benjamin E; Nissenboim, Josh; Muzzy, Wendy; Fleeman, Anna; Amstadter, Ananda B

    2015-01-01

    Disasters have far-reaching and potentially long-lasting effects on youth and families. Research has consistently shown a clear increase in the prevalence of several mental health disorders after disasters, including depression and posttraumatic stress disorder. Widely accessible evidence-based interventions are needed to address this unmet need for youth and families, who are underrepresented in disaster research. Rapid growth in Internet and Smartphone access, as well as several Web based evaluation studies with various adult populations has shown that Web-based interventions are likely to be feasible in this context and can improve clinical outcomes. Such interventions also are generally cost-effective, can be targeted or personalized, and can easily be integrated in a stepped care approach to screening and intervention delivery. This is a protocol paper that describes an innovative study design in which we evaluate a self-help Web-based resource, Bounce Back Now, with a population-based sample of disaster affected adolescents and families. The paper includes description and justification for sampling selection and procedures, selection of assessment measures and methods, design of the intervention, and statistical evaluation of critical outcomes. Unique features of this study design include the use of address-based sampling to recruit a population-based sample of disaster-affected adolescents and parents, telephone and Web-based assessments, and development and evaluation of a highly individualized Web intervention for adolescents. Challenges related to large-scale evaluation of technology-delivered interventions with high-risk samples in time-sensitive research are discussed, as well as implications for future research and practice. Published by Elsevier Inc.

  1. Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

    Science.gov (United States)

    Nasstasia, Yasmina; Baker, Amanda L; Halpin, Sean A; Hides, Leanne; Lewin, Terry J; Kelly, Brian J; Callister, Robin

    2018-03-01

    Recent meta-analytic reviews suggest exercise can reduce depression severity among adults with major depressive disorder (MDD); however, efficacy studies with depressed youth are limited. Few studies have investigated the efficacy of multi-modal exercise interventions in this population, addressed treatment engagement, or explored the differential effects of exercise on depressive symptom profiles. This paper describes the study protocol and recruitment pattern for an assessor blinded, two-arm randomised controlled trial investigating the efficacy of an integrated motivational interviewing (MI) and multi-modal exercise intervention in youth diagnosed with MDD. Associations between depressive symptom profiles (cognitive, somatic and affective) and psychological, physiological (fitness), and biological (blood biomarker) outcomes will also be examined. Participants aged 15-25 years with current MDD were recruited. Eligible participants were randomised and stratified according to gender and depression severity to either an immediate or delayed (control) group. The immediate group received a brief MI intervention followed by a 12-week small group exercise intervention (3 times per week for 1 h), all delivered by personal trainers. The delayed control group received the same intervention 12-weeks later. Both groups were reassessed at mid-treatment or mid-control, post-treatment or post-control, and follow-up (12 weeks post-treatment). 68 participants were recruited and randomly allocated to an intervention group. This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.

  2. A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

    Science.gov (United States)

    Lindenberg, Katajun; Halasy, Katharina; Schoenmaekers, Sophie

    2017-06-01

    The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention programs. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT group intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies. Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, are randomly assigned to a) PROTECT preventive intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms as well as the promotion of problem solving, cognitive restructuring and emotion regulation skills. The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention, i.e., it is theory- and evidence-based and addresses both risk-reduction and strength-promotion, it considers current research and epidemiology and ethical standards such as professional secrecy and is designed as a systemic intervention at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate). ClinicalTrials.gov: NCT02907658.

  3. Effectiveness of a multicomponent school based intervention to reduce bullying among adolescents in Chandigarh, North India: A quasi-experimental study protocol

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    Monica Rana

    2018-04-01

    Full Text Available Background: Bullying perpetration and victimization is associated with significant academic, psychosocial and health related problems among adolescents. There is a need to develop effective interventions to prevent bullying among adolescents, especially in low and middle income countries. This paper presents the study protocol to develop, and evaluate the effect of multi-component school based prevention program for bullying in India. Design: Quasi-experimental study. Methods: The study will be conducted among 846 students of grade 7th and 8th in the intervention and control schools in Chandigarh, Union Territory, North India. A government and a private school will be selected purposively in each of the intervention and control arm. The intervention is based on socio-ecological model, and will be administered at individual, relationship (parents and teachers and school level. The primary study outcome will be the proportion of students experiencing any kind of bullying (bullying, victimization, or both, in each study arm. The effectiveness of the intervention will be measured by performing difference in difference analysis and generalized estimating equations. Expected impact for public health: Bullying is an aggressive behaviour with significant morbidities, including psychological or physical trauma, affecting individuals not only in their adolescence, but also later in their adulthood. This quasi-experimental study is expected to provide evidence on whether multi-component bullying prevention intervention program, can reduce the burden of bullying perpetration and victimization among school adolescents in India. The results of the study will add in the exiting literature on bullying intervention program, especially, from the low middle-income countries, as there are limited studies available on this topic in these countries.

  4. A randomised controlled trial of a theory-based intervention to improve sun protective behaviour in adolescents ('you can still be HOT in the shade': study protocol

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    Hawkes Anna L

    2012-01-01

    Full Text Available Abstract Background Most skin cancers are preventable by encouraging consistent use of sun protective behaviour. In Australia, adolescents have high levels of knowledge and awareness of the risks of skin cancer but exhibit significantly lower sun protection behaviours than adults. There is limited research aimed at understanding why people do or do not engage in sun protective behaviour, and an associated absence of theory-based interventions to improve sun safe behaviour. This paper presents the study protocol for a school-based intervention which aims to improve the sun safe behaviour of adolescents. Methods/design Approximately 400 adolescents (aged 12-17 years will be recruited through Queensland, Australia public and private schools and randomized to the intervention (n = 200 or 'wait-list' control group (n = 200. The intervention focuses on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. It will be delivered during three × one hour sessions over a three week period from a trained facilitator during class time. Data will be collected one week pre-intervention (Time 1, and at one week (Time 2 and four weeks (Time 3 post-intervention. Primary outcomes are intentions to sun protect and sun protection behaviour. Secondary outcomes include attitudes toward performing sun protective behaviours (i.e., attitudes, perceptions of normative support to sun protect (i.e., subjective norms, group norms, and image norms, and perceived control over performing sun protective behaviours (i.e., perceived behavioural control. Discussion The study will provide valuable information about the effectiveness of the intervention in improving the sun protective behaviour of adolescents.

  5. 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

  6. The Classroom Communication Resource (CCR) intervention to change peer's attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Mallick, Rizwana; Kathard, Harsha; Thabane, Lehana; Pillay, Mershen

    2018-01-17

    schools will lead to positive shift in attitudes about stuttering at 6-months post-intervention among grade 7 participants. The trial number is NCT03111524 . It was registered with clinical trials.gov Protocol registration and results system (PRS) retrospectively on 9 March 2017.

  7. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Directory of Open Access Journals (Sweden)

    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  8. 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

  9. Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bell, Imogen H; Fielding-Smith, Sarah F; Hayward, Mark; Rossell, Susan L; Lim, Michelle H; Farhall, John; Thomas, Neil

    2018-05-02

    Smartphone-based ecological momentary assessment and intervention (EMA/I) show promise for enhancing psychological treatments for psychosis. EMA has the potential to improve assessment and formulation of experiences which fluctuate day-to-day, and EMI may be used to prompt use of therapeutic strategies in daily life. The current study is an examination of these capabilities in the context of a brief, coping-focused intervention for distressing voice hearing experiences. This is a rater-blinded, pilot randomised controlled trial comparing a four-session intervention in conjunction with use of smartphone EMA/I between sessions, versus treatment-as-usual. The recruitment target is 34 participants with persisting and distressing voice hearing experiences, recruited through a Voices Clinic based in Melbourne, Australia, and via wider advertising. Allocation will be made using minimisation procedure, balancing of the frequency of voices between groups. Assessments are completed at baseline and 8 weeks post-baseline. The primary outcomes of this trial will focus on feasibility and acceptability of the intervention and trial methodology, with secondary outcomes examining preliminary clinical effects related to overall voice severity, the emotional and functional impact of the voices, and emotional distress. This study offers a highly novel examination of specific smartphone capabilities and their integration with traditional psychological treatment for distressing voices. Such technology has potential to enhance psychological interventions and promote adaptation to distressing experiences. Australian New Zealand Clinical Trial Registry, ACTRN12617000348358 . Registered on 7 March 2017.

  10. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    John A. Cunningham

    2016-07-01

    Full Text Available Abstract Background Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention in addition to an Internet intervention for problem gambling (G-only intervention in participants with gambling problems who do or do not have co-occurring mental health symptoms. Methods Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280 to take part in the study will be randomized to one of two versions of an online intervention for gamblers – an intervention that just targets gambling issues (G-only versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH. It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website. Discussion The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms. Trial registration ClinicalTrials.gov NCT02800096 ; Registration date: June 14, 2016.

  11. Protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Tomkinson, Keeley; Garfield, Kirsty; Lyons, Ronan A; Simon, Joanne; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer-supporters. Approximately 15 % of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer-supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer-supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully-powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a

  12. Effectiveness of eHealth interventions for the promotion of physical activity in older adults: a systematic review protocol.

    Science.gov (United States)

    Muellmann, Saskia; Forberger, Sarah; Möllers, Tobias; Zeeb, Hajo; Pischke, Claudia R

    2016-03-16

    It is known that regular physical activity (PA) is associated with improvements in physical, psychological, cognitive, and functional health outcomes. The World Health Organization recommends 150 min of moderate exercise per week for older adults to achieve these health benefits. However, only 20-60 % of adults aged 60 years and above currently meet these recommendations for exercise. The widespread use of the internet and mobile phones among older adults may open new opportunities to promote PA in this population. Findings of previous reviews suggest that eHealth interventions are effective in promoting PA in adults of various ages. However, to date, none of these reviews have provided a differentiated picture of engagement in such interventions and effects on PA among older adults. Also, we are unaware of any studies comparing effects of participation in eHealth vs. traditional paper-and-pencil interventions on PA in this population. The aim of this systematic review and meta-analysis is to compare the effectiveness of eHealth interventions promoting PA in older adults aged 55 years and above with either a non-eHealth PA intervention or a group that is not exposed to any intervention. Eight electronic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, PEI, PsycINFO, Web of Science, and OpenGrey) will be searched to identify experimental and quasi-experimental studies examining the effectiveness of eHealth interventions for PA promotion in adults aged 55 years and above. Two authors will independently select and review references, extract data, and assess the quality of the included studies by using the Cochrane Collaboration's risk of bias tool. Disagreements between authors will be resolved by discussion involving a third author. If feasible, a meta-analysis will be conducted. Narrative synthesis using harvest plots will be performed, should a meta-analysis not be feasible. The proposed systematic review will be the first review that compares the effectiveness of e

  13. Biplane interventional pediatric system with cone‐beam CT: dose and image quality characterization for the default protocols

    Science.gov (United States)

    Vañó, Eliseo; Alejo, Luis; Ubeda, Carlos; Gutiérrez‐Larraya, Federico; Garayoa, Julia

    2016-01-01

    The aim of this study was to assess image quality and radiation dose of a biplane angiographic system with cone‐beam CT (CBCT) capability tuned for pediatric cardiac procedures. The results of this study can be used to explore dose reduction techniques. For pulsed fluoroscopy and cine modes, polymethyl methacrylate phantoms of various thicknesses and a Leeds TOR 18‐FG test object were employed. Various fields of view (FOV) were selected. For CBCT, the study employed head and body dose phantoms, Catphan 504, and an anthropomorphic cardiology phantom. The study also compared two 3D rotational angiography protocols. The entrance surface air kerma per frame increases by a factor of 3–12 when comparing cine and fluoroscopy frames. The biggest difference in the signal‐to‐noise ratio between fluoroscopy and cine modes occurs at FOV 32 cm because fluoroscopy is acquired at a 1440×1440 pixel matrix size and in unbinned mode, whereas cine is acquired at 720×720 pixels and in binned mode. The high‐contrast spatial resolution of cine is better than that of fluoroscopy, except for FOV 32 cm, because fluoroscopy mode with 32 cm FOV is unbinned. Acquiring CBCT series with a 16 cm head phantom using the standard dose protocol results in a threefold dose increase compared with the low‐dose protocol. Although the amount of noise present in the images acquired with the low‐dose protocol is much higher than that obtained with the standard mode, the images present better spatial resolution. A 1 mm diameter rod with 250 Hounsfield units can be distinguished in reconstructed images with an 8 mm slice width. Pediatric‐specific protocols provide lower doses while maintaining sufficient image quality. The system offers a novel 3D imaging mode. The acquisition of CBCT images results in increased doses administered to the patients, but also provides further diagnostic information contained in the volumetric images. The assessed CBCT protocols provide images that are noisy

  14. Biplane interventional pediatric system with cone-beam CT: dose and image quality characterization for the default protocols.

    Science.gov (United States)

    Corredoira, Eva; Vañó, Eliseo; Alejo, Luis; Ubeda, Carlos; Gutiérrez-Larraya, Federico; Garayoa, Julia

    2016-07-08

    The aim of this study was to assess image quality and radiation dose of a biplane angiographic system with cone-beam CT (CBCT) capability tuned for pediatric cardiac procedures. The results of this study can be used to explore dose reduction techniques. For pulsed fluoroscopy and cine modes, polymethyl methacrylate phantoms of various thicknesses and a Leeds TOR 18-FG test object were employed. Various fields of view (FOV) were selected. For CBCT, the study employed head and body dose phantoms, Catphan 504, and an anthropomorphic cardiology phantom. The study also compared two 3D rotational angiography protocols. The entrance surface air kerma per frame increases by a factor of 3-12 when comparing cine and fluoroscopy frames. The biggest difference in the signal-to- noise ratio between fluoroscopy and cine modes occurs at FOV 32 cm because fluoroscopy is acquired at a 1440 × 1440 pixel matrix size and in unbinned mode, whereas cine is acquired at 720 × 720 pixels and in binned mode. The high-contrast spatial resolution of cine is better than that of fluoroscopy, except for FOV 32 cm, because fluoroscopy mode with 32 cm FOV is unbinned. Acquiring CBCT series with a 16 cm head phantom using the standard dose protocol results in a threefold dose increase compared with the low-dose protocol. Although the amount of noise present in the images acquired with the low-dose protocol is much higher than that obtained with the standard mode, the images present better spatial resolution. A 1 mm diameter rod with 250 Hounsfield units can be distinguished in reconstructed images with an 8 mm slice width. Pediatric-specific protocols provide lower doses while maintaining sufficient image quality. The system offers a novel 3D imaging mode. The acquisition of CBCT images results in increased doses administered to the patients, but also provides further diagnostic information contained in the volumetric images. The assessed CBCT protocols provide images that are noisy, but with

  15. A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol.

    Science.gov (United States)

    Kestler, Edgar; Walker, Dilys; Bonvecchio, Anabelle; de Tejada, Sandra Sáenz; Donner, Allan

    2013-03-21

    design. Our main outcome measures will be the change in perinatal mortality and in the proportion of institution-based deliveries. A unique feature of this protocol is that we are not proposing an individual intervention, but rather a package of interventions, which is designed to address the complexities and realities of maternal and perinatal mortality in developing countries. To date, many other countries, has focused its efforts to decrease maternal mortality indirectly by improving infrastructure and data collection systems rather than on implementing specific interventions to directly improve outcomes. ClinicalTrial.gov,http://NCT01653626.

  16. The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Schakel, L.; Veldhuijzen, D.S.; Middendorp, H. van; Prins, C.; Joosten, S.A.; Ottenhoff, T.H.; Visser, L.G.; Evers, A.W.M.

    2017-01-01

    BACKGROUND: Previous research has provided evidence for the link between psychological processes and psychophysiological health outcomes. Psychological interventions, such as face-to-face or online cognitive behavioral therapy (CBT) and serious games aimed at improving health, have shown promising

  17. Family-based interventions to increase physical activity in children: a meta-analysis and realist synthesis protocol

    NARCIS (Netherlands)

    Brown, H.E.; Atkin, A.J.; Panter, J.; Corder, K.; Wong, G.; Chin A Paw, M.J.M.; van Sluijs, E.

    2014-01-01

    Introduction: Despite the established relationship between physical activity and health, data suggest that many children are insufficiently active, and that levels decline into adolescence. Engaging the family in interventions may increase and maintain children's physical activity levels at the

  18. The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: Protocol of the EFIGRO study

    OpenAIRE

    Medrano, M.; Maiz, E.; Maldonado-Martin, Sara; Arenaza, L.; Rodríguez-Vigil, B.; Ortega, F.B.; Ruiz, J.R.; Larrarte, E.; Diez-López, I.; Sarasúa-Miranda, A.; Tobalina, I.; Barrenechea, L.; Pérez-Asenjo, J.; Kannengiesser, S.; Manhães-Savio, A.

    2015-01-01

    Background: Non-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance. Objectives: (i) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and (ii) to examine the effect of the intervention on cardiometabolic risk factors, self-esteem and well-being. Methods: A total of 160 chi...

  19. A Self-Paced, Web-Based, Positive Emotion Skills Intervention for Reducing Symptoms of Depression: Protocol for Development and Pilot Testing of MARIGOLD.

    Science.gov (United States)

    Cheung, Elaine O; Addington, Elizabeth L; Bassett, Sarah M; Schuette, Stephanie A; Shiu, Eva W; Cohn, Michael A; Leykin, Yan; Saslow, Laura R; Moskowitz, Judith T

    2018-06-05

    Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. The project was funded in

  20. Spouses’ involvement in older patients’ fast-track programmes during total hip replacement using case management intervention. A study protocol of the SICAM-trial

    DEFF Research Database (Denmark)

    Berthelsen, Connie Bøttcher; Kristensson, Jimmie

    2015-01-01

    Aim To present the protocol of a two-group quasi-experimental study of spouses’ involvement through case management (The SICAM-trial) in older patients’ fast-track programmes during total hip replacement. Background Patients in fast-track programmes are required to take an active part in their tr......Aim To present the protocol of a two-group quasi-experimental study of spouses’ involvement through case management (The SICAM-trial) in older patients’ fast-track programmes during total hip replacement. Background Patients in fast-track programmes are required to take an active part...... in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay – yet they are seldom invited to participate in a supporting role. Design A two-group quasi-experimental design with pre-test and repeated post...... and subsequently include the intervention group to avoid contamination of the control group. A case manager will be recruited to perform the case management intervention. Data will be collected from both groups at baseline, 2 weeks and 3 months after surgery. Outcome measures for patients include: functional...

  1. Effects of a combined intervention with a lentil protein hydrolysate and a mixed training protocol on the lipid metabolism and hepatic markers of NAFLD in Zucker rats.

    Science.gov (United States)

    Martínez, Rosario; Kapravelou, Garyfallia; Donaire, Ana; Lopez-Chaves, Carlos; Arrebola, Francisco; Galisteo, Milagros; Cantarero, Samuel; Aranda, Pilar; Porres, Jesus M; López-Jurado, María

    2018-02-21

    Metabolic syndrome is a cluster of metabolic alterations characterized by central obesity, dyslipidemia, elevated plasma glucose, insulin resistance (IR) and non-alcoholic fatty liver disease (NAFLD). In this study, a combined intervention of a lentil protein hydrolysate and a mixed training protocol was assessed in an animal experimental model of genetic obesity and metabolic syndrome. Thirty-two male obese and 32 lean Zucker rats were divided into eight different experimental groups. Rats performed a mixed exercise protocol or had a sedentary lifestyle and were administered a lentil protein hydrolysate or placebo. Daily food intake, weekly body weight gain, plasma parameters of glucose and lipid metabolisms, body composition, hepatic weight, total fat content and fatty acid profile, as well as gene expression of lipogenic and lipolytic nuclear transcription factors and their target genes were measured. Obese Zucker rats exhibited higher body and liver weight and fat content than did their lean counterparts. Such alterations were related to modifications in aerobic capacity, plasma biochemical parameters of glucose and lipid metabolisms, hepatic fatty acid profile and gene expression of nuclear transcription factors SREBP1c, PPARα, LXR and associated lipogenic and lipolytic enzymes. The interventions tested did not affect body weight gain but improved aerobic capacity, reduced hepatomegalia and steatosis associated with NAFLD and relieved the adverse effects produced by this condition in glucose and lipid metabolisms through the modulation in the expression of different genes involved in diverse metabolic pathways.

  2. Project PANK: Rationale, study protocol and baseline results of a multidisciplinary school based intervention in children with cardiovascular and metabolic risk factors

    Directory of Open Access Journals (Sweden)

    Rui Batalau

    2017-05-01

    Full Text Available Abstract Aims: Cardiovascular disease risk factors occur more frequently in children with obesity. Project PANK is a multidisciplinary school-based intervention lasting 6 months to improve BMI z-score, waist circumference (WC, waist-to-height ratio (WHtR, blood pressure (BP, nutrition, physical activity (PA, sedentary behaviour (SB, cardiorespiratory fitness (CRF, glucose, cholesterol, and triglycerides (TG. Methods/DesignA total of 77 children (7-10 years were recruited from an urban school. The protocol includes PA and SB individual meetings for children/parents; increasing school exercise; PA and SB lessons for children; A goal in the number of steps/day to accomplish in and after school. In nutrition, the protocol includes three individual meetings for children/parents and six lessons for children. ResultsPositive associations were found between the BMI Z-score, WC, and WHtR with TG; the BMI Z-score and WHtR with glucose; the light PA time and HDL-C; the vigorous and moderate-to-vigorous PA with CRF; the caloric intake and lipids with LDL-C, BMI z-score, WC, and WHtR. A negative association was found between CRF and TG. ConclusionBaseline results stress the importance of multidisciplinary school-based interventions. We hypothesized that PANK will improve blood variables, anthropometric measures, and BP, by changing food intake, enhancing PA and CRF, and decreasing SB.

  3. Community Engagement in a complex intervention to improve access to primary mental health care for hard-to-reach groups.

    Science.gov (United States)

    Lamb, Jonathan; Dowrick, Christopher; Burroughs, Heather; Beatty, Susan; Edwards, Suzanne; Bristow, Kate; Clarke, Pam; Hammond, Jonathan; Waheed, Waquas; Gabbay, Mark; Gask, Linda

    2015-12-01

    Despite the availability of effective evidence-based treatments for depression and anxiety, many 'harder-to-reach' social and patient groups experience difficulties accessing treatment. We developed a complex intervention, the AMP (Improving Access to Mental Health in Primary Care) programme, which combined community engagement (CE), tailored (individual and group) psychosocial interventions and primary care involvement. To develop and evaluate a model for community engagement component of the complex intervention. This paper focuses on the development of relationships between stakeholders, their engagement with the issue of access to mental health and with the programme through the CE model. Our evaluation draws on process data, qualitative interviews and focus groups, brought together through framework analysis to evaluate the issues and challenges encountered. A case study of the South Asian community project carried out in Longsight in Greater Manchester, United Kingdom. Complex problems require multiple local stakeholders to work in concert. Assets based approaches implicitly make demands on scarce time and resources. Community development approaches have many benefits, but perceptions of open-ended investment are a barrier. The time-limited nature of a CE intervention provides an impetus to 'do it now', allowing stakeholders to negotiate their investment over time and accommodating their wider commitments. Both tangible outcomes and recognition of process benefits were vital in maintaining involvement. CE interventions can play a key role in improving accessibility and acceptability by engaging patients, the public and practitioners in research and in the local service ecology. © 2014 John Wiley & Sons Ltd.

  4. Tailoring Healthy Workplace Interventions to Local Healthcare Settings: A Complexity Theory-Informed Workplace of Well-Being Framework.

    Science.gov (United States)

    Brand, Sarah L; Fleming, Lora E; Wyatt, Katrina M

    2015-01-01

    Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains (system characteristics) that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW) framework is responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace, a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy workplace interventions that create workplaces conducive to healthy behaviour change.

  5. Tailoring Healthy Workplace Interventions to Local Healthcare Settings: A Complexity Theory-Informed Workplace of Well-Being Framework

    Directory of Open Access Journals (Sweden)

    Sarah L. Brand

    2015-01-01

    Full Text Available Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains (system characteristics that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW framework is responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace, a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy workplace interventions that create workplaces conducive to healthy behaviour change.

  6. Tailoring Healthy Workplace Interventions to Local Healthcare Settings: A Complexity Theory-Informed Workplace of Well-Being Framework

    Science.gov (United States)

    Brand, Sarah L.; Fleming, Lora E.; Wyatt, Katrina M.

    2015-01-01

    Many healthy workplace interventions have been developed for healthcare settings to address the consistently low scores of healthcare professionals on assessments of mental and physical well-being. Complex healthcare settings present challenges for the scale-up and spread of successful interventions from one setting to another. Despite general agreement regarding the importance of the local setting in affecting intervention success across different settings, there is no consensus on what it is about a local setting that needs to be taken into account to design healthy workplace interventions appropriate for different local settings. Complexity theory principles were used to understand a workplace as a complex adaptive system and to create a framework of eight domains (system characteristics) that affect the emergence of system-level behaviour. This Workplace of Well-being (WoW) framework is responsive and adaptive to local settings and allows a shared understanding of the enablers and barriers to behaviour change by capturing local information for each of the eight domains. We use the results of applying the WoW framework to one workplace, a UK National Health Service ward, to describe the utility of this approach in informing design of setting-appropriate healthy workplace interventions that create workplaces conducive to healthy behaviour change. PMID:26380358

  7. Efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline in Twin Families (VIPP-Twins): Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Euser, Saskia; Bakermans-Kranenburg, Marian J; van den Bulk, Bianca G; Linting, Mariëlle; Damsteegt, Rani C; Vrijhof, Claudia I; van Wijk, Ilse C; Crone, Eveline A; van IJzendoorn, Marinus H

    2016-06-06

    Intervention programs with the aim of enhancing parenting quality have been found to be differentially effective in decreasing negative child outcomes such as externalizing behavioral problems, resulting in modest overall effect sizes. Here we present the protocol for a randomized controlled trial to examine the efficacy of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline for Twin Families (VIPP-Twins) on parenting quality and children's behavioral control and social competence. In addition, we aim to test the differential susceptibility theory; we examine differential efficacy of the intervention based on genetic make-up or temperament for both parents and children. Lastly, we explore neurobiological mechanisms underlying intervention effects on children's developmental outcomes. The original VIPP-SD was adapted for use in families with twins. The VIPP-Twins consists of five biweekly sessions in which the families are visited at home, parent-child interactions are videotaped and parents receive positive feedback on selected video fragments. Families (N = 225) with a same sex twin (mean age = 3.6 years) were recruited to participate in the study. The study consists of four assessments. After two baseline assessments in year 1 and year 2, a random 40 % of the sample will receive the VIPP-Twins program. The first post-test assessment will be carried out one month after the intervention and there will be a long term follow-up assessment two years after the intervention. Measures include observational assessments of parenting and children's social competence and behavioral control, and neurobiological assessments (i.e., hormonal functioning and neural (re-)activity). Results of the study will provide insights in the efficacy of the VIPP-Twins and reveal moderators and mediators of program efficacy. Overall the randomized controlled trial is an experimental test of the differential susceptibility theory. Dutch Trial

  8. The development of an intervention programme to reduce whole-body vibration exposure at work induced by a change in behaviour: a study protocol

    Science.gov (United States)

    Tiemessen, Ivo JH; Hulshof, Carel TJ; Frings-Dresen, Monique HW

    2007-01-01

    Background Whole body vibration (WBV) exposure at work is common and studies found evidence that this exposure might cause low back pain (LBP). A recent review concluded there is a lack of evidence of effective strategies to reduce WBV exposure. Most research in this field is focussed on the technical implications, although changing behaviour towards WBV exposure might be promising as well. Therefore, we developed an intervention programme to reduce WBV exposure in a population of drivers with the emphasis on a change in behaviour of driver and employer. The hypothesis is that an effective reduction in WBV exposure, in time, will lead to a reduction in LBP as WBV exposure is a proxy for an increased risk of LBP. Methods/Design The intervention programme was developed specifically for the drivers of vibrating vehicles and their employers. The intervention programme will be based on the most important determinants of WBV exposure as track conditions, driving speed, quality of the seat, etc. By increasing knowledge and skills towards changing these determinants, the attitude, social influence and self-efficacy (ASE) of both drivers and employers will be affected having an effect on the level of exposure. We used the well-known ASE model to develop an intervention programme aiming at a change or the intention to change behaviour towards WBV exposure. The developed programme consists of: individual health surveillance, an information brochure, an informative presentation and a report of the performed field measurements. Discussion The study protocol described is advantageous as the intervention program actively tries to change behaviour towards WBV exposure. The near future will show if this intervention program is effective by showing a decrease in WBV exposure. PMID:18005400

  9. The development of an intervention programme to reduce whole-body vibration exposure at work induced by a change in behaviour: a study protocol

    Directory of Open Access Journals (Sweden)

    Frings-Dresen Monique HW

    2007-11-01

    Full Text Available Abstract Background Whole body vibration (WBV exposure at work is common and studies found evidence that this exposure might cause low back pain (LBP. A recent review concluded there is a lack of evidence of effective strategies to reduce WBV exposure. Most research in this field is focussed on the technical implications, although changing behaviour towards WBV exposure might be promising as well. Therefore, we developed an intervention programme to reduce WBV exposure in a population of drivers with the emphasis on a change in behaviour of driver and employer. The hypothesis is that an effective reduction in WBV exposure, in time, will lead to a reduction in LBP as WBV exposure is a proxy for an increased risk of LBP. Methods/Design The intervention programme was developed specifically for the drivers of vibrating vehicles and their employers. The intervention programme will be based on the most important determinants of WBV exposure as track conditions, driving speed, quality of the seat, etc. By increasing knowledge and skills towards changing these determinants, the attitude, social influence and self-efficacy (ASE of both drivers and employers will be affected having an effect on the level of exposure. We used the well-known ASE model to develop an intervention programme aiming at a change or the intention to change behaviour towards WBV exposure. The developed programme consists of: individual health surveillance, an information brochure, an informative presentation and a report of the performed field measurements. Discussion The study protocol described is advantageous as the intervention program actively tries to change behaviour towards WBV exposure. The near future will show if this intervention program is effective by showing a decrease in WBV exposure.

  10. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS – a randomized controlled trial protocol for a stationary cycling intervention

    Directory of Open Access Journals (Sweden)

    Simms Victoria

    2007-03-01

    Full Text Available Abstract Background In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. Methods/design The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling or a control (no cycling group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR range (70 – 80% maximum HR. Thirty sessions will take place over a 10–12 week period. All children will be evaluated before (baseline and after (follow-up the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM; the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT. Discussion This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS; a Phase I randomized controlled trial

  11. Interventions for the prevention of cardiovascular diseases: a protocol for a systematic review of economic evaluations in low-income and middle-income countries.

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    Aminde, Leopold Ndemnge; Veerman, Lennert

    2016-12-21

    Low-income and middle-income countries (LMICs) are experiencing a growing disease burden due to cardiovascular and other chronic non-communicable diseases. Interventions for the control of these diseases are paramount; however, these countries are faced with competing health and financial needs. There is an urgent need for quality evidence on cost-effective strategies to address these chronic diseases. We aim to synthesise the current literature on economic evaluations of interventions for primary and secondary cardiovascular disease prevention in LMICs. A systematic review of studies (published and unpublished) in LMICs up to 30 October 2016 will be conducted. The following databases will be searched: PubMed/MEDLINE, EMBASE, SCOPUS, CINAHL, Web of Science, EconLit, NHS Economic Evaluations Database (NHS EED). Data sources specific to African literature, such as the WHO AFROLIB, Africa Index Medicus and African Journals online (AJOL) as well as grey literature, will also be searched. 2 reviewers shall independently screen potential articles for inclusion and disagreements shall be resolved by consensus. Quality appraisal of studies shall be done using Drummond's checklist for economic evaluation of studies. A descriptive synthesis of the evidence obtained is planned. The primary outcomes will be costs per life years gained or unit of clinical outcome, cost per quality-adjusted life years or disability-adjusted life years. This systematic review protocol has been prepared according to the Preferred Reporting Items for Systematic reviews and Meta-analyses for Protocols (PRISMA-P) 2015 statement. Ethics approval is not required considering that this is a protocol for a systematic review of published studies. Results from this review will be disseminated via conference presentations and peer-reviewed journal publications. CRD42016043510. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

    Science.gov (United States)

    Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

    2015-09-11

    Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

  13. Study protocol for Enhancing Parenting In Cancer (EPIC): development and evaluation of a brief psycho-educational intervention to support parents with cancer who have young children.

    Science.gov (United States)

    Stafford, Lesley; Sinclair, Michelle; Turner, Jane; Newman, Louise; Wakefield, Claire; Krishnasamy, Mei; Mann, G Bruce; Gilham, Leslie; Mason, Kylie; Rauch, Paula; Cannell, Julia; Schofield, Penelope

    2017-01-01

    Parents with cancer have high rates of psychological morbidity, and their children are at risk of poor psychosocial outcomes, particularly in the context of parental distress and poor family communication. Parents express concerns about the impact of cancer on their children and report a lack of professional guidance in meeting their children's needs. Few parenting interventions exist and current interventions have extensive infrastructure demands making them unsuitable for routine use in most health settings. The aims of this study are to develop and establish the feasibility and acceptability of a novel and accessible psycho-educational intervention to improve parenting efficacy and decrease parental stress among adults with cancer who have children aged 3-12 years. The intervention will be suitable for parents with cancer who are receiving treatment with a view to longer term survival, irrespective of cancer diagnosis, and their respective co-parents. This study comprises two phases using the UK Medical Research Council framework for developing complex interventions. In the development phase, intervention content will be iteratively developed and evaluated in consultation with consumers, and in the piloting phase, feasibility will be tested in a clinical sample of 20 parents with cancer and their co-parents using a single arm, pre-test post-test design. The intervention will comprise an audiovisual resource (DVD), a question prompt list, and a telephone call with a clinical psychologist. Questionnaires administered pre- and 1 month post-intervention will assess parental stress, psychological morbidity, quality of life, self-efficacy and perceptions of child adjustment, and family functioning. Intervention feasibility will be determined by mixed-method participant evaluation of perceived usefulness, benefits, and acceptability. This new initiative will translate existing descriptive evidence into an accessible intervention that supports parenting during cancer

  14. Effects of a complex intervention on fall risk in the general practitioner setting: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Freiberger E

    2013-08-01

    Full Text Available Ellen Freiberger,1 Wolfgang A Blank,2 Johannes Salb,1 Barbara Geilhof,3 Christian Hentschke,1 Peter Landendoerfer,2 Martin Halle,3 Monika Siegrist31Institute of Sport Science and Sport Universität Erlangen-Nürnberg, Nuremberg, Germany; 2Institute of General Practice, Technische Universität München, Munich, Germany; 3Department of Prevention, Rehabilitation and Sports Medicine, Technische Universität München, Munich, GermanyPurpose: To study the feasibility of first, reaching functionally declined, but still independent older persons at risk of falls through their general practitioner (GP and second, to reduce their physiological and psychological fall risk factors with a complex exercise intervention. We investigated the effects of a 16-week exercise intervention on physiological (function, strength, and balance and psychological (fear of falling outcomes in community-dwelling older persons in comparison with usual care. In addition, we obtained data on adherence of the participants to the exercise program.Methods: Tests on physical and psychological fall risk were conducted at study inclusion, and after the 16-week intervention period in the GP office setting. The 16-week intervention included progressive and challenging balance, gait, and strength exercise as well as changes to behavioral aspects. To account for the hierarchical structure in the chosen study design, with patients nested in GPs and measurements nested in patients, a three-level linear mixed effects model was determined for analysis.Results: In total, 33 GPs recruited 378 participants (75.4% females. The mean age of the participants was 78.1 years (standard deviation 5.9 years. Patients in the intervention group showed an improvement in the Timed-Up-and-Go-test (TUG that was 1.5 seconds greater than that showed by the control group, equivalent to a small to moderate effect. For balance, a relative improvement of 0.8 seconds was accomplished, and anxiety about falls was

  15. Evaluating the CARE4Carer Blended Care Intervention for Partners of Patients With Acquired Brain Injury: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Cox, Vincent Cm; Schepers, Vera Pm; Ketelaar, Marjolijn; van Heugten, Caroline M; Visser-Meily, Johanna Ma

    2018-02-16

    Support programs for partners of patients with acquired brain injury are necessary since these partners experience several unfavorable consequences of caregiving, such as a high burden, emotional distress, and poor quality of life. Evidence-based support strategies that can be included in these support programs are psychoeducation, skill building, problem solving, and improving feelings of mastery. A promising approach would seem to be to combine web-based support with face-to-face consultations, creating a blended care intervention. This paper outlines the protocol of a randomized controlled trial to evaluate the CARE4Carer blended care intervention for partners of patients with acquired brain injury. A multicenter two-arm randomized controlled trial will be conducted. A total of 120 partners of patients with acquired brain injury will be recruited from five rehabilitation centers in the Netherlands. The blended care intervention consists of a nine-session web-based support program and two face-to-face consultations with a social worker. Themes that will be addressed are: giving partners insight into their own situation, including possible pitfalls and strengths, learning how to cope with the situation, getting a grip on thoughts and feelings, finding a better balance in the care for the patient with acquired brain injury, thinking about other possible care options, taking care of oneself, and communication. The intervention lasts 20 weeks and the control group will receive usual care. The outcome measures will be assessed at baseline and at 24- and 40-week follow-up. The primary outcome is caregiver mastery. Secondary outcome measures are strain, burden, family functioning, emotional functioning, coping, quality of life, participation, and social network. The effect of the intervention on the primary and secondary outcome measures will be determined. Additional a process evaluation will be conducted. The findings of this study will be used to improve the care for

  16. Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

    Science.gov (United States)

    Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

    2017-01-01

    An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

  17. Impact of a ketogenic diet intervention during radiotherapy on body composition: II. Protocol of a randomised phase I study (KETOCOMP).

    Science.gov (United States)

    Klement, Rainer J; Sweeney, Reinhart A

    2016-04-01

    We have found that a ketogenic diet (KD) during the course of radiotherapy (RT) was feasible and led to a preservation or favorable changes of body composition. Based on these observations and theoretical considerations, we initiated a study to investigate the impact of a KD or a ketogenic breakfast intervention in patients undergoing RT. All patients presenting for curative RT with age between 18 and 75, body mass index between 18 and 34 kg/m 2 and a histologically confirmed cancer of the breast, colorectum or head and neck region are considered for inclusion. Exclusion criteria are Karnofsky index radiotherapy fraction after an overnight fast and subsequently ingest a ketogenic breakfast consisting of (i) 50-250 ml of a medium-chain triglyceride drink (betaquick ® , vitaflo, Bad Homburg, Germany) plus (ii) 5-15 g amino acids (MAP, dr. reinwald healthcare gmbh+co kg, Schwarzenbruck, Germany). If willing to undertake a complete KD for the duration of RT, patients are entered into intervention group 2. Intervention group 2 does not have to fast prior to RT fractions but will be supplemented with MAP analogous to intervention group 1. The control group will not receive dietary advice to follow a KD or reduce carbohydrate intake. The objective is twofold: (i) to test whether the ketogenic interventions are feasibly, as measured by the number of dropouts; (ii) to see whether intervention groups 1 and 2 attain a better preservation of BIA phase angle than the control group. Primary endpoints are the feasibility of the interventions (measured through dropout rates), and changes in body weight and composition (measured through BIA). Secondary endpoints are changes in quality of life (EORTC questionnaires) and blood parameters as well as the occurrence and grade of toxicities and grade of regression after surgery in case of colorectal carcinomas. Copyright © 2015 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  18. The GOOD life: Study protocol for a social norms intervention to reduce alcohol and other drug use among Danish adolescents

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    Christiane Stock

    2016-08-01

    Full Text Available Abstract Background It is currently unknown if school-based social norms interventions are effective in preventing harmful alcohol consumption and other drug use among adolescents in Denmark. This paper describes the social norms-based programme The GOOD life and the design of a cluster-randomized controlled trial to test its effectiveness. Methods/Design The intervention The GOOD life is composed of three social norms components representing three different communication channels, namely face-to-face communication (normative feedback session, print communication (posters and interactive media (web application. The intervention period of 8 weeks is preceded and followed by data collection, with the follow-up taking place 3 months after baseline. Public schools in the Region of Southern Denmark with grades 8 and 9 are invited to participate in the study and participating schools are randomly allocated to either intervention or control schools. The aim is to recruit a total of 39 schools and a sample of 1.400 pupils for the trial. An online questionnaire is conducted to examine the use of alcohol, tobacco and marijuana as well as the perceived frequency of use among peers of their own grade, which is measured before and after the intervention. Baseline data is used to develop social norms messages which are included in the three intervention components. Primary outcomes are binge drinking (more than 5 units at one occasion and perceived frequency of binge drinking among peers, while smoking, marijuana use and alcohol-related harm will be assessed as secondary outcomes. Discussion The GOOD life study will provide necessary insights on descriptive and injunctive norms regarding alcohol and other drug use among Danish adolescents. In addition, it will provide new knowledge and insight on the feasibility, implementation context and effectiveness of a newly developed social norms intervention in the Danish school context. Trial registration Date of

  19. Promoting community readiness for physical activity among older adults in Germany--protocol of the ready to change intervention trial.

    Science.gov (United States)

    Brand, Tilman; Gansefort, Dirk; Rothgang, Heinz; Röseler, Sabine; Meyer, Jochen; Zeeb, Hajo

    2016-02-01

    Healthy ageing is an important concern for many societies facing the challenge of an ageing population. Physical activity (PA) is a major contributor to healthy ageing; however insufficient PA levels are prevalent in old age in Germany. Community capacity building and community involvement are often recommended as key strategies to improve equitable access to prevention and health promotion. However, evidence for the effectiveness of these strategies is scarce. This study aims to assess the community readiness for PA promotion in local environments and to analyse the utility of strategies to increase community readiness for reaching vulnerable groups. We designed a mixed method intervention trial comprising three study modules. The first module includes an assessment of community readiness for PA interventions in older adults. The assessment is carried out in a sample of 24 municipalities in the Northwest of Germany using structured key informant interviews. In the second module, eight municipalities with the low community readiness are selected from the sample and randomly assigned to one of two study groups: active enhancement of community readiness (intervention) versus no enhancement (control). After enhancing community readiness in the active enhancement group, older adults in both study groups will be recruited for participation in a PA intervention. Participation rates are compared between the study groups to evaluate the effects of the intervention. In addition, a cost-effectiveness analysis is carried out calculating recruitment costs per person reached in the two study groups. In the third module, qualitative interviews are conducted with participants and non-participants of the PA intervention exploring reasons for participation or non-participation. This study offers the potential to contribute to the evidence base of reaching vulnerable older adults for PA interventions and provide ideas on how to reduce participation barriers. Its findings will inform

  20. Evaluating the sustainability, scalability, and replicability of an STH transmission interruption intervention: The DeWorm3 implementation science protocol

    Science.gov (United States)

    Ajjampur, Sitara S. R.; Bailey, Robin; Galactionova, Katya; Gwayi-Chore, Marie-Claire; Halliday, Katherine; Ibikounle, Moudachirou; Juvekar, Sanjay; Kalua, Khumbo; Kang, Gagandeep; Lele, Pallavi; Luty, Adrian J. F.; Pullan, Rachel; Sarkar, Rajiv; Schär, Fabian; Tediosi, Fabrizio; Weiner, Bryan J.; Yard, Elodie; Walson, Judd

    2018-01-01

    Hybrid trials that include both clinical and implementation science outcomes are increasingly relevant for public health researchers that aim to rapidly translate study findings into evidence-based practice. The DeWorm3 Project is a series of hybrid trials testing the feasibility of interrupting the transmission of soil transmitted helminths (STH), while conducting implementation science research that contextualizes clinical research findings and provides guidance on opportunities to optimize delivery of STH interventions. The purpose of DeWorm3 implementation science studies is to ensure rapid and efficient translation of evidence into practice. DeWorm3 will use stakeholder mapping to identify individuals who influence or are influenced by school-based or community-wide mass drug administration (MDA) for STH and to evaluate network dynamics that may affect study outcomes and future policy development. Individual interviews and focus groups will generate the qualitative data needed to identify factors that shape, contextualize, and explain DeWorm3 trial outputs and outcomes. Structural readiness surveys will be used to evaluate the factors that drive health system readiness to implement novel interventions, such as community-wide MDA for STH, in order to target change management activities and identify opportunities for sustaining or scaling the intervention. Process mapping will be used to understand what aspects of the intervention are adaptable across heterogeneous implementation settings and to identify contextually-relevant modifiable bottlenecks that may be addressed to improve the intervention delivery process and to achieve intervention outputs. Lastly, intervention costs and incremental cost-effectiveness will be evaluated to compare the efficiency of community-wide MDA to standard-of-care targeted MDA both over the duration of the trial and over a longer elimination time horizon. PMID:29346376

  1. PREVIEW behavior modification intervention toolbox (PREMIT: a study protocol for a psychological element of a multicenter project

    Directory of Open Access Journals (Sweden)

    Daniela Kahlert

    2016-08-01

    Full Text Available Background: Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. Objective: To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counselling approach. Methods: The program development took five progressive steps, in line with the Public Health Action Cycle: (1 Summing-up the intervention goal(s, target group and the setting, (2 uncovering the generative psychological mechanisms, (3 identifying behavior change techniques and tools, (4 preparing for evaluation and (5 implementing the intervention and assuring quality. Results: PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major ‘product’ of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participant’s behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and train-the-trainer workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre

  2. PREVIEW Behavior Modification Intervention Toolbox (PREMIT): A Study Protocol for a Psychological Element of a Multicenter Project.

    Science.gov (United States)

    Kahlert, Daniela; Unyi-Reicherz, Annelie; Stratton, Gareth; Meinert Larsen, Thomas; Fogelholm, Mikael; Raben, Anne; Schlicht, Wolfgang

    2016-01-01

    Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT) that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counseling approach. The program development took five progressive steps, in line with the Public Health Action Cycle: (1) Summing-up the intervention goal(s), target group and the setting, (2) uncovering the generative psychological mechanisms, (3) identifying behavior change techniques and tools, (4) preparing for evaluation and (5) implementing the intervention and assuring quality. PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major "product" of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participants' behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and "train-the-trainer" workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre-diabetic people.

  3. How lay health workers tailor in effective health behaviour change interventions: a protocol for a systematic review.

    Science.gov (United States)

    Hodgins, Faith; Gnich, Wendy; Ross, Alastair J; Sherriff, Andrea; Worlledge-Andrew, Heather

    2016-06-16

    Lay health workers (LHWs) are utilised as a channel of delivery in many health interventions. While they have no formal professional training related to their role, they utilise their connections with the target group or community in order to reach individuals who would not normally readily engage with health services. Lay health worker programmes are often based on psychological theories of behaviour change that point to 'tailoring to individuals' needs or characteristics' as key to success. Although lay health workers have been shown to be effective in many contexts, there is, as yet, little clarity when it comes to how LHWs assess individuals' needs in order to tailor their interventions. This study aims to develop a better understanding of the effective implementation of tailoring in lay health worker interventions by appraising evidence and synthesising studies that report evaluations of tailored interventions. Health and psychology electronic databases (EMBASE, CINAHL, MEDLINE and PsycINFO) will be searched. Reference lists of included studies will also be searched. For articles that are deemed to be potentially relevant, we will employ a 'cluster searching' technique in order to identify all published papers related to a relevant intervention. Cluster searching will be undertaken in an effort to maximise the breadth and depth of description of the intervention. Quantitative studies will be assessed using the Quality Assessment Tool for Quantitative Studies, developed by the Effective Public Health Practice Project, ON, Canada. Qualitative studies will be assessed using the Critical Appraisal Skills Programme (CASP) checklist for qualitative research. Sythesising the data will enable the development of a taxonomy of strategies for the criteria used for individual assessment of recipients' needs and the ways in which messages or actions are tailored to these individual criteria by LHWs. This systematic review focuses specifically on how health promotion and

  4. Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Bucci, Sandra; Barrowclough, Christine; Ainsworth, John; Morris, Rohan; Berry, Katherine; Machin, Matthew; Emsley, Richard; Lewis, Shon; Edge, Dawn; Buchan, Iain; Haddock, Gillian

    2015-09-10

    Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT. We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app. To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to

  5. Nutrition and Culinary in the Kitchen Program: a randomized controlled intervention to promote cooking skills and healthy eating in university students - study protocol.

    Science.gov (United States)

    Bernardo, Greyce Luci; Jomori, Manuela Mika; Fernandes, Ana Carolina; Colussi, Claudia Flemming; Condrasky, Margaret D; Proença, Rossana Pacheco da Costa

    2017-12-20

    Community-based intervention studies that aim at developing cooking skills have increased in the scientific literature and are related to healthier food practices. However, methodological limitations are observed and only a few studies have university students as the target. The university entrance period has been related to negative changes in eating habits among young people and it represents an important period for developing interventions for health promotion. This study describes the study protocol and the evaluation framework for the Nutrition and Culinary in the Kitchen program. This program aims to develop cooking skills in university students, and is based on the Cooking with a Chef program in the United States. This ongoing, randomized controlled intervention was designed with a six month follow-up study. The intervention consisted of three-hour weekly classes during a six week period with printed materials provided. Five of the classes were hands-on cooking and one was a tour to a popular food market. There were eight primary outcome measures: changes in relation to i) accessibility and availability of fruits and vegetables; ii) cooking attitudes; iii) cooking behaviors at home; iv) cooking behaviors away from home; v) produce consumption self-efficacy; vi) self-efficacy for using basic cooking techniques; vii) self-efficacy for using fruits, vegetables, and seasonings (while cooking); and viii) knowledge of cooking terms and techniques. Secondary outcomes included changes in body mass index and in personal characteristics related to cooking. Repeated measures were collected through the application of an online self-completed survey, at baseline, after intervention and six months after intervention. A sample of 80 university students (40: intervention group; 40: control group) was estimated to detect a mean change of 1.5 points in cooking knowledge, with study power of 80%, and 95% level of confidence, plus 20% for random losses and 10% for confounding

  6. A randomised control crossover trial of a theory based intervention to improve sun-safe and healthy behaviours in construction workers: study protocol.

    Science.gov (United States)

    Nioi, Amanda; Wendelboe-Nelson, Charlotte; Cowan, Sue; Cowie, Hilary; Rashid, Shahzad; Ritchie, Peter; Cherrie, Mark; Lansdown, Terry C; Cherrie, John W

    2018-02-15

    Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels. Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and

  7. An integrated intervention to reduce intimate partner violence and psychological distress with refugees in low-resource settings: study protocol for the Nguvu cluster randomized trial.

    Science.gov (United States)

    Tol, Wietse A; Greene, M Claire; Likindikoki, Samuel; Misinzo, Lusia; Ventevogel, Peter; Bonz, Ann G; Bass, Judith K; Mbwambo, Jessie K K

    2017-05-18

    Intimate partner violence (IPV) is a critical public health and human rights concern globally, including for refugee women in low-resource settings. Little is known about effective interventions for this population. IPV and psychological distress have a bi-directional relationship, indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships. This protocol describes a cluster randomized controlled trial aimed at evaluating an 8-session integrated psychological and advocacy intervention (Nguvu) with female adult survivors of past-year IPV displaying moderate to severe psychological distress. Outcomes are reductions in: recurrence of IPV; symptoms of anxiety, depression and post-traumatic stress (primary); and functional impairment (secondary). Hypothesized mediators of the intervention are improvements in social support, coping skills and support seeking. We will recruit 400 participants from existing women's support groups operating within villages in Nyarugusu refugee camp, Tanzania. Women's groups will be randomized to receive the intervention (Nguvu and usual care) or usual care alone. All eligible women will complete a baseline assessment (week 0) followed by a post-treatment (week 9) and a 3-month post-treatment assessment (week 20). The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models. Study procedures have been approved by Institutional Review Boards in the United States and Tanzania. This trial will provide evidence on the efficacy of a novel integrated group intervention aimed at secondary prevention of IPV that includes a structured psychological component to address psychological distress. The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in

  8. An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial.

    Science.gov (United States)

    Watson, Judith; Tober, Gillian; Raistrick, Duncan; Mdege, Noreen; Dale, Veronica; Crosby, Helen; Godfrey, Christine; Lloyd, Charlie; Toner, Paul; Parrott, Steve

    2013-04-30

    Alcohol misuse is a major cause of premature mortality and ill health. Although there is a high prevalence of alcohol problems among patients presenting to general hospital, many of these people are not help seekers and do not engage in specialist treatment. Hospital admission is an opportunity to steer people towards specialist treatment, which can reduce health-care utilization and costs to the public sector and produce substantial individual health and social benefits. Alcohol misuse is associated with other lifestyle problems, which are amenable to intervention. It has been suggested that the development of a healthy or balanced lifestyle is potentially beneficial for reducing or abstaining from alcohol use, and relapse prevention. The aim of the study is to test whether or not the offer of a choice of health-related lifestyle interventions is more acceptable, and therefore able to engage more problem drinkers in treatment, than an alcohol-focused intervention. This is a pragmatic, randomized, controlled, open pilot study in a UK general hospital setting with concurrent economic evaluation and a qualitative component. Potential participants are those admitted to hospital with a diagnosis likely to be responsive to addiction interventions who score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT). The main purpose of this pilot study is to evaluate the acceptability of two sorts of interventions (healthy living related versus alcohol focused) to the participants and to assess the components and processes of the design. Qualitative research will be undertaken to explore acceptability and the impact of the approach, assessment, recruitment and intervention on trial participants and non-participants. The effectiveness of the two treatments will be compared at 6 months using AUDIT scores as the primary outcome measure. There will be additional economic, qualitative and secondary outcome measurements. Development of the study was a

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

    Science.gov (United States)

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

    2016-06-02

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

  10. The HERrespect intervention to address violence against female garment workers in Bangladesh: study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Al Mamun, Mahfuz; Parvin, Kausar; Yu, Marat; Wan, Jessica; Willan, Samantha; Gibbs, Andrew; Jewkes, Rachel; Naved, Ruchira Tabassum

    2018-04-18

    Women in Bangladesh experience high rates of Intimate Partner Violence (IPV). IPV is more prevalent against income earning women compared to their non-earning counterparts, and Workplace Violence (WPV) is also common. Such violence is a violation of women's rights, and also constrains them from contributing to their personal growth, household, community and the economy at large. There is limited evidence on what works to prevent IPV and WPV amongst garment workers. This paper describes an evaluation of HERrespect, an intervention which aims to reduce IPV and WPV against female garment workers in and around Dhaka, Bangladesh. The trial employs a quasi-experimental design, with four intervention and four control factories. In the intervention factories a randomly selected cohort of married female line workers, a cohort of male line workers, and all middle management staff received the intervention. The intervention strategies involved (1) gender transformative group-based training for workers and management staff; (2) joint session between workers (15 female and male) and middle-management staff; (3) factory-wide activities; (4) awareness raising among top management; (5) factory policy review and development and 6) a community based campaign. For the evaluation, a cohort of randomly selected female workers and a cohort of selected management staff have been established. All workers (n = 800) and management staff (n = 395) from these cohorts were interviewed at baseline using two different questionnaires, and will be interviewed in the endline, 24 months post-baseline. Intention to treat analysis will be used for assessing the impact of HERrespect, comparing the intervention and control factories. To our knowledge this is the first study that seeks to evaluate the impact on IPV and WPV, of group sessions with female workers, male workers, and management; factory-wide campaigns and a community intervention among female garment workers in Bangladesh. Apart

  11. A cluster randomised trial testing an intervention to improve parents' recognition of their child's weight status: study protocol.

    Science.gov (United States)

    Parkinson, Kathryn N; Jones, Angela R; Tovee, Martin J; Ells, Louisa J; Pearce, Mark S; Araujo-Soares, Vera; Adamson, Ashley J

    2015-06-12

    Parents typically do not recognise their child's weight status accurately according to clinical criteria, and thus may not take appropriate action if their child is overweight. We developed a novel visual intervention designed t