Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS) (RAPCAPS)

This study has been completed.
Byrraju Foundation
The Future Forum, UK
Information provided by (Responsible Party):
Dr Rohina Joshi, The George Institute Identifier:
First received: December 6, 2005
Last updated: June 21, 2012
Last verified: June 2012

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.

Condition Intervention Phase
* Myocardial Infarction
Angina Pectoris
Cerebrovascular Accidents
Diabetes Mellitus
Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin
Behavioral: Health Promotion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh

Further study details as provided by The George Institute:

Primary Outcome Measures:
  • The proportion of high-risk individuals that have been assessed for cardiovascular risk [ Time Frame: 12 months after intevention ]
  • 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 Outcome Measures:
  • The proportion of high risk individuals treated with two or more of the recommended drug therapies [ Time Frame: 12 months ]
  • 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 ]
  • The risk factor levels of the population identified as high risk. [ Time Frame: 12 months ]

Enrollment: 3712
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Algorithm-based care
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.
Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin
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.
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
Behavioral: Health Promotion
The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.

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.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00263393

Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts
Bhimavaram, Andhra Pradesh, India
Sponsors and Collaborators
The George Institute
Byrraju Foundation
The Future Forum, UK
Principal Investigator: Bruce C Neal The George Institute
  More Information

Additional Information:
Responsible Party: Dr Rohina Joshi, Research Fellow, The George Institute Identifier: NCT00263393     History of Changes
Other Study ID Numbers: GI-CA-RAP-A
Study First Received: December 6, 2005
Last Updated: June 21, 2012

Keywords provided by The George Institute:
Myocardial Infarction
Angina Pectoris
Cerebrovascular Accident
Diabetes Mellitus
Cluster randomized design
Community-based intervention trial
Primary Healthcare intervention
Lifestyle advice

Additional relevant MeSH terms:
Diabetes Mellitus
Myocardial Infarction
Angina Pectoris
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents processed this record on April 27, 2017