A PROgramme of Lifestyle Intervention in Families for Cardiovascular risk reduction (PROLIFIC Study): design and rationale of a family based randomized controlled trial in individuals with family history of premature coronary heart disease

BMC Public Health

Study Protocol

Nikhil Tandon¹  Sandosh Padmanabhan²  Dorairaj Prabhakaran³  T. R. Lekha³  Panniyammakal Jeemon³  G. Sanjay⁴  S. Harikrishnan⁴  Sivasankaran Sivasubramonian⁴ 

[1] All India Institute of Medical Sciences, New Delhi, India;Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK;Public Health Foundation of India, New Delhi, India;Sree Chitra Tirunal Institute of Medical Sciences and Technology, Trivandrum, India;

关键词: Coronary Heart Disease;    Generalize Estimate Equation;    Quality Adjusted Life Year;    Tobacco Cessation;    Coronary Heart Disease Risk Factor;   

DOI  :  10.1186/s12889-016-3928-6

 received in 2016-11-15, accepted in 2016-12-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundRecognizing patterns of coronary heart disease (CHD) risk in families helps to identify and target individuals who may have the most to gain from preventive interventions. The overall goal of the study is to test the effectiveness and sustainability of an integrated care model for managing cardiovascular risk in high risk families. The proposed care model targets the structural and environmental conditions that predispose high risk families to development of CHD through the following interventions: 1) screening for cardiovascular risk factors, 2) providing lifestyle interventions 3) providing a framework for linkage to appropriate primary health care facility, and 4) active follow-up of intervention adherence.MethodsInitially, a formative qualitative research component will gather information on understanding of diseases, barriers to care, specific components of the intervention package and feedback on the intervention. Then a cluster randomized controlled trial involving 740 families comprising 1480 participants will be conducted to determine whether the package of interventions (integrated care model) is effective in reducing or preventing the progression of CHD risk factors and risk factor clustering in families. The sustainability and scalability of this intervention will be assessed through economic (cost-effectiveness analyses) and qualitative evaluation (process outcomes) to estimate value and acceptability. Scalability is informed by cost-effectiveness and acceptability of the integrated cardiovascular risk reduction approach.DiscussionKnowledge generated from this trial has the potential to significantly affect new programmatic policy and clinical guidelines that will lead to improvements in cardiovascular health in India.Trial registration numberNCT02771873, registered in May 2016 (https://clinicaltrials.gov/ct2/show/results/NCT02771873)

【 授权许可】

CC BY   
© The Author(s). 2017