Angina Pectoris, Cerebrovascular Accidents, Diabetes Mellitus, Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Diabetes Mellitus, Cluster randomized design, Community-based intervention trial, Primary Healthcare intervention, Lifestyle advice
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.
Interventions
DRUGASA, 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.
BEHAVIORALHealth Promotion
The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
Sponsors
Byrraju Foundation
The Future Forum, UK
The George Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of high-risk individuals that have been assessed for cardiovascular risk | 12 months after intevention |
| The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease | 12 months from intervention |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of high risk individuals treated with two or more of the recommended drug therapies | 12 months |
| The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease | 12 months from intervention |
| The risk factor levels of the population identified as high risk. | 12 months |
Countries
India
Outcome results
None listed