Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

The George Institute

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus; Cerebrovascular Accidents; Angina Pectoris; Myocardial Infarction

Treatments: Behavioral: Health Promotion; Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT00263393

GI-CA-RAP-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,712 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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3,712 participants in 2 patient groups

Algorithm-based care

Other group

Description:

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.

Treatment:

Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin

Health-promotion

Other group

Description:

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

Treatment:

Behavioral: Health Promotion