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| 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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| India, Andhra Pradesh | |
| Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts | |
| Bhimavaram, Andhra Pradesh, India | |
| Principal Investigator: | Bruce C Neal | The George Institute |
More Information
| 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 |
|
Myocardial Infarction Angina Pectoris Cerebrovascular Accident Diabetes Mellitus |
Cluster randomized design Community-based intervention trial Primary Healthcare intervention Lifestyle advice |
|
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 |