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Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

This study has been completed.
Sponsor:
Collaborators:
Byrraju Foundation
The Future Forum, UK
Information provided by (Responsible Party):
Dr Rohina Joshi, The George Institute
ClinicalTrials.gov Identifier:
NCT00263393
First received: December 6, 2005
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of high risk individuals treated with two or more of the recommended drug therapies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The risk factor levels of the population identified as high risk. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.
Health-promotion
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00263393

Locations
India
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
Investigators
Principal Investigator: Bruce C Neal The George Institute
  More Information

Additional Information:
Publications:
Joshi R, Chow CK, Raju PK, Raju KR, Gottumukkala AK, Reddy KS, MacMahon S, Heritier S, Li Q, Dandona R, and Neal B. The Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): A Cluster Randomized Trial J Am Coll Cardiol 2012 59: 1188-1196

Responsible Party: Dr Rohina Joshi, Research Fellow, The George Institute
ClinicalTrials.gov Identifier: NCT00263393     History of Changes
Other Study ID Numbers: GI-CA-RAP-A
Study First Received: December 6, 2005
Last Updated: June 21, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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:
Angina Pectoris
Cerebral Infarction
Diabetes Mellitus
Infarction
Myocardial Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Chest Pain
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Ischemia
Metabolic Diseases
Myocardial Ischemia
Necrosis
Nervous System Diseases
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Diuretics

ClinicalTrials.gov processed this record on November 20, 2014