Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

Phase 4

Completed

• Conditions: Cerebrovascular Accidents; Diabetes Mellitus; Myocardial Infarction; Angina Pectoris
• Interventions: Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin; Behavioral: Health Promotion

• Registration Number: NCT00263393
• Lead Sponsor: The George Institute

Brief Summary

This study will evaluate the effectiveness of a novel cardiovascular disease prevention program designed for delivery through existing primary health care services in rural villages in Andhra Pradesh.

The primary aim is to increase the number of high-risk individuals in the population that are appropriately managed with proven, low-cost preventive interventions. The corresponding null hypothesis is therefore that the prevention program will result in no change in the proportion of high-risk individuals identified and treated in villages assigned to intervention compared with those villages assigned to control.

Detailed Description

STUDY TYPE This project is a community intervention study that will use a large-scale, cluster-randomised design to compare the management of individuals at high cardiovascular risk in villages assigned to receive the cardiovascular prevention program (intervention) and villages assigned to continue usual practices (control). The definition of high-risk for treatment is based on an established history of previous vascular disease -heart attack or stroke- known hypertension or systolic blood pressure \> 160mmHg, or the presence of other risk factors such as smoking, high blood pressure, obesity, older age and family history which combined would result in a very high level of risk.

INTERVENTION PROGRAM TO BE EVALUATED The program to be evaluated comprises: (1) simple strategies designed to facilitate the opportunistic identification of high-risk individuals, (2) clinical algorithms for the implementation of proven preventive interventions based on World Health Organisation recommendations (3) a health promotion campaign designed to aid self-identification and self-referral of high-risk people and (4) simple, structured education programs to assist patients to comply with their treatment.

DATA COLLECTION Data to be collected will comprise an interviewer administered questionnaire with demographic details, basic medical history, cardiovascular risk factors, previous cardiovascular disease and any current treatments. This will be followed by a brief physical examination including measurement of blood pressure, heart rate, weight, height, waist and hip circumferences. Urine will be tested using a dipstick in all and all will have a fasting blood glucose assay. Fasting venous blood samples will be collected for assay of cholesterol, glucose and creatinine from a sample of 1,000.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-06
• Study First Submitted QC: 2005-12-06
• Study First Posted: 2005-12-08
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3712

Inclusion Criteria

• Age 30 years and above
• Personal history of heart attack or stroke
• Presence of other cardiovascular risk factors such as smoking, overweight, diabetes

Exclusion Criteria

• Mental disability
• Not living in the Study area

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Algorithm-based care	ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin	An algorithm based approach to increase the identification of high-risk individuals in the community through encouraging opportunistic screening, and to increase the use of appropriate evidence based prevention strategies.
Health-promotion	Health Promotion	The health promotion arm has been designed to increase knowledge of the causes of cardiovascular disease and enhance use of preventive behaviours in the general population

Primary Outcome Measures

Name	Time	Method
The proportion of high-risk individuals that have been assessed for cardiovascular risk	12 months after intevention
The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease	12 months from intervention

Secondary Outcome Measures

Name	Time	Method
The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease	12 months from intervention
The proportion of high risk individuals treated with two or more of the recommended drug therapies	12 months
The risk factor levels of the population identified as high risk.	12 months

Trial Locations

Locations (1)

Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts; 🇮🇳 Bhimavaram, Andhra Pradesh, India