Diabetes Mellitus Clinical Trial
Official title:
Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
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.
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.
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