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

Primary Purpose

Myocardial Infarction, Angina Pectoris, Cerebrovascular Accidents

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin
Health Promotion
Sponsored by
The George Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Diabetes Mellitus, Cluster randomized design, Community-based intervention trial, Primary Healthcare intervention, Lifestyle advice

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Algorithm-based care

Health-promotion

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The proportion of high-risk individuals that have been assessed for cardiovascular risk
The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2005
Last Updated
September 10, 2018
Sponsor
The George Institute
Collaborators
Byrraju Foundation, The Future Forum, UK
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1. Study Identification

Unique Protocol Identification Number
NCT00263393
Brief Title
Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
Acronym
RAPCAPS
Official Title
Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The George Institute
Collaborators
Byrraju Foundation, The Future Forum, UK

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Angina Pectoris, Cerebrovascular Accidents, Diabetes Mellitus
Keywords
Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Diabetes Mellitus, Cluster randomized design, Community-based intervention trial, Primary Healthcare intervention, Lifestyle advice

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3712 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Algorithm-based care
Arm Type
Other
Arm Description
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.
Arm Title
Health-promotion
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Promotion
Intervention Description
The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
Primary Outcome Measure Information:
Title
The proportion of high-risk individuals that have been assessed for cardiovascular risk
Time Frame
12 months after intevention
Title
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 Measure Information:
Title
The proportion of high risk individuals treated with two or more of the recommended drug therapies
Time Frame
12 months
Title
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
Title
The risk factor levels of the population identified as high risk.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce C Neal
Organizational Affiliation
The George Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts
City
Bhimavaram
State/Province
Andhra Pradesh
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
19699856
Citation
Chow CK, Joshi R, Gottumukkala AK, Raju K, Raju R, Reddy S, Macmahon S, Neal B. Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. Am Heart J. 2009 Sep;158(3):349-55. doi: 10.1016/j.ahj.2009.05.034. Epub 2009 Jul 15.
Results Reference
background
PubMed Identifier
22440219
Citation
Joshi R, Chow CK, Raju PK, Raju KR, Gottumukkala AK, Reddy KS, Macmahon S, Heritier S, Li Q, Dandona R, Neal B. The Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a cluster randomized trial. J Am Coll Cardiol. 2012 Mar 27;59(13):1188-96. doi: 10.1016/j.jacc.2011.10.901. No abstract available.
Results Reference
result

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Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

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