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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263393
Recruitment Status : Completed
First Posted : December 8, 2005
Last Update Posted : September 12, 2018
Byrraju Foundation
The Future Forum, UK
Information provided by (Responsible Party):
Dr Rohina Joshi, 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3712 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Study Start Date : December 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00263393

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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
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Principal Investigator: Bruce C Neal The George Institute

Publications of Results:
Other Publications:
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Responsible Party: Dr Rohina Joshi, Research Fellow, The George Institute Identifier: NCT00263393     History of Changes
Other Study ID Numbers: GI-CA-RAP-A
First Posted: December 8, 2005    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Keywords provided by Dr Rohina Joshi, 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:
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Myocardial Infarction
Angina Pectoris
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs