Trial DesignRationale and design of the Primary pREvention strategies at the community level to Promote Adherence of treatments to pREvent cardiovascular diseases trial number (CTRI/2012/09/002981)
Section snippets
Design
PrePAre is a multicenter, household-level, cluster-randomized trial with 1:1 allocation to intervention and control arms.
Ethics statement
We obtained approval from institutional ethics committees of the participating institutes in India (Rajah Muthaiah Medical College Annamalainagar, St John's Medical College Bengaluru, Mahatma Gandhi Institute of Medical Sciences, Sevagram); Population Health Research Institute, Hamilton, Canada; NHLBI Bethesda, USA; and Health Ministry Screening Committee, Government of
Acknowledgements
We acknowledge all community health workers, study supervisors, study physicians, database team members, and division of clinical trials staff who are currently helping with the conduct of this study. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents.
References (32)
- et al.
Reduction in pneumonia mortality and total childhood mortality by means of community-based intervention trial in Gadchiroli, India
Lancet
(1990) - et al.
Effect of community-based newborn-care intervention package implemented through two service-delivery strategies in Sylhet district, Bangladesh: a cluster-randomised controlled trial
Lancet
(2008) - et al.
Combating chronic disease in developing countries
Lancet
(2009) - et al.
Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I Follow-up Study cohort
Lancet
(2008) - et al.
The Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
J Am Coll Cardiol
(2012) - et al.
Impact of a worksite intervention program on cardiovascular risk factors: a demonstration project in an Indian industrial population
J Am Coll Cardio
(2009) - et al.
Cardiovascular disease
- et al.
Chronic diseases now a leading cause of death in rural India: mortality data from the Andhra Pradesh Rural Health Initiative
Int J Epidemiol
(2006) - et al.
Epidemiology and causation of coronary heart disease and stroke in India
Heart
(2008) - et al.
Risk factors for early myocardial infarction in South Asians compared with individuals in other countries
JAMA
(2007)
Effects of community-wide education on cardiovascular disease risk factors. The Stanford Five-City-Project
JAMA
Community education for cardiovascular disease prevention: risk factor changes in the Minnesota Heart Health Program
Am J Public Health
Community-based noncommunicable disease interventions: lessons from developed countries for developing ones
Bull World Health Organ
Change in risk factors for coronary heart disease during 10 years of a community intervention programme (North Karelia Project)
BMJ
Cited by (17)
Efficacy of IVRS-based mHealth intervention in reducing cardiovascular risk in metabolic syndrome: A cluster randomized trial
2021, Diabetes and Metabolic Syndrome: Clinical Research and ReviewsCitation Excerpt :Response for an individual item varied from daily, weekly, monthly, <1/month to never and were recorded. For defining healthy diet we used criteria of consumption of >5 servings/day of fruits and vegetables (Supplementary File 1), as used in a previous study [22,23]. We inquired regarding symptoms suggestive of cardiovascular, respiratory and other diseases, past history of diabetes, hypertension, chronic cardiovascular, respiratory or gastrointestinal diseases which were recorded.
Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial
2019, American Heart JournalLow quality cardiovascular care is important coronary risk factor in India
2018, Indian Heart JournalCardiovascular Diseases in India Compared With the United States
2018, Journal of the American College of CardiologyThe World Heart Federation Roadmap for Nonvalvular Atrial Fibrillation
2017, Global HeartCitation Excerpt :New research on the feasibility of a nonphysician health worker (NPHW)–led screening AF program in community health centers in China is planned and will offer valuable evidence of the effectiveness of such programs. In the meantime, experiences in successful training of NPHWs to screen for CVD [89,90] and cancer [91] in LMICs may provide useful insights for implementation of nonspecialist screening programs for AF. The field of telemedicine may also provide opportunities for addressing trained health care professional shortages in LMICs [92,93], with some findings suggesting that transmission of ECG results from remote, rural areas to urban facilities may improve detection of CVD generally [94].
The Effectiveness of Community Health Workers for CVD Prevention in LMIC
2017, Global Heart