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Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
This study is ongoing, but not recruiting participants.
First Received: December 6, 2005   Last Updated: February 11, 2009   History of Changes
Sponsor: The George Institute
Collaborators: Byrraju Foundation
The Future Forum, UK
Information provided by: The George Institute
ClinicalTrials.gov Identifier: NCT00263393
  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: self-identification and self-referral for CVD risk
Behavioral: Health care worker screening of high risk through algorithm
Behavioral: Health Promotion
Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
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 ]

Estimated Enrollment: 4000
Study Start Date: December 2005
Estimated Study Completion Date: November 2008
Primary Completion Date: July 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 Behavioral: self-identification and self-referral for CVD risk Behavioral: Health care worker screening of high risk through algorithm
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
Lifestyle change: theatre, talks, cooking class, walking

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263393

Locations
India, Andhra Pradesh
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:
No publications provided by The George Institute

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: The George Institute for International Health ( Rohina Joshi )
Study ID Numbers: GI-CA-RAP-A
Study First Received: December 6, 2005
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00263393     History of Changes
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:
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Myocardial Ischemia
Sodium Chloride Symporter Inhibitors
Physiological Effects of Drugs
Diuretics
Angina Pectoris
Pain
Brain Diseases
Cerebrovascular Disorders
Membrane Transport Modulators
Signs and Symptoms
Necrosis
Pathologic Processes
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Brain Ischemia
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases
Metabolic Diseases
Stroke
Nervous System Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Ischemia

ClinicalTrials.gov processed this record on February 08, 2010