Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

Condition(s) targeted: * Myocardial Infarction; Angina Pectoris; Cerebrovascular Accidents; Diabetes Mellitus

Intervention: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin (Drug); self-identification and self-referral for CVD risk (Behavioral); Health care worker screening of high risk through algorithm (Behavioral); Lifestyle change: theatre, talks, cooking class, walking (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: The George Institute

Official(s) and/or principal investigator(s):
Bruce C Neal, Principal Investigator, Affiliation: The George Institute

Overall contact:
Clara K Chow, MBBS, FRACP, Phone: + 61 2 9993 4566, Email: cchow@thegeorgeinstitute.org

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.

Official title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh

Study design: Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

Primary outcome:

differences in

the proportion of high-risk individuals identified and

the proportions managed with appropriate treatment of lifestyle modification advice and recommended pharmacological agents.

These outcomes will be assessed via ongoing population surveys of randomly selected individuals and clinical record reviews.

Secondary outcome:

the knowledge, attitudes and practices of non-physician health care workers and physicians relating to cardiovascular prevention.

the knowledge attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease

the risk factor levels of the population identified as high risk.

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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Clara K Chow, MBBS, FRACP, Phone: + 61 2 9993 4566, Email: cchow@thegeorgeinstitute.org

Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts, Bhimavaram, Andhra Pradesh, India; Recruiting
Akshay Mishra, MBBS, MD, Phone: * 91 9866550489, Email: Akshay@byrrajufoundation.org
Bruce C Neal, MBChB PhD, Principal Investigator
Stephen W MacMahon, BScMA PhD, Principal Investigator
Clara K Chow, MBBS FRACP, Principal Investigator
Magnolia Cardona, MBBS MPH, Principal Investigator
K Rama Raju, MBBS MS surg, Principal Investigator
P Krishnam Raju, MBBS MD, Principal Investigator

A community-based cluster randomised trial for the prevention of cardiovascular disease based on (1) opportunistic screening of high-risk individuals, (2) management with proven therapies following a clinical algorithm, and (3) health promotion campaign

Starting date: December 2005
Ending date: June 2007
Last updated: October 10, 2006