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Completed

NCT Number: NCT00263393

Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

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.

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Key information

Conditions

Myocardial Infarction Angina Pectoris Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accidents Cerebrovascular Disorders Chest Pain Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts

Bhimavaram, Andhra Pradesh, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin

Drug

The first intervention was a clinical algorithm designed to enhance the identification and treatment of high-risk individuals compared to continued usual care. The algorithm was designed to be used by either physician or non-physician health care workers.

health promotion

Behavioral

The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.

Primary outcomes

  1. The proportion of high-risk individuals that have been assessed for cardiovascular risk

    Time frame: 12 months after intevention

  2. The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease

    Time frame: 12 months from intervention

Secondary outcomes

  1. The proportion of high risk individuals treated with two or more of the recommended drug therapies

    Time frame: 12 months

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

    Time frame: 12 months from intervention

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The George Institute

Other

Collaborators

  • Byrraju Foundation
  • The Future Forum, UK

Registry information

Official study title

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

Acronym: RAPCAPS

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Dec 8, 2005
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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