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

Jeemon, P., Harikrishnan, S., Sanjay, G., Sivasubramonian, S., Lekha, T.R., Padmanabhan, S. , Tandon, N. and Prabhakaran, D. (2017) 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, 17, 10. (doi: 10.1186/s12889-016-3928-6) (PMID:28056897) (PMCID:PMC5217619)

Abstract

Background: Recognizing 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. Methods: Initially, 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. Discussion: Knowledge 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.

• Item Type: Articles
• Additional Information: Panniyammakal Jeemon is currently supported by a clinical and public health intermediate fellowship from the Wellcome Trust-Department of Biotechnology, India Alliance. This study is funded as part of this fellowship.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Padmanabhan, Professor Sandosh
• Authors: Jeemon, P., Harikrishnan, S., Sanjay, G., Sivasubramonian, S., Lekha, T.R., Padmanabhan, S., Tandon, N., and Prabhakaran, D.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: BMC Public Health
• Publisher: BioMed Central
• ISSN: 1471-2458
• ISSN (Online): 1471-2458
• Copyright Holders: Copyright © 2017 The Authors
• First Published: First published in BMC Public Health 17: 10
• Publisher Policy: Reproduced under a Creative Commons License