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  Behavior: self-identification and self-referral for CVD risk  Behavior: Health care worker screening of high risk through algorithm  Behavior: Lifestyle change: theatre, talks, cooking class, walking	Phase IV

Further study details as provided by The George Institute:

Primary Outcomes: differences in; (1) the proportion of high-risk individuals identified and; (2) the proportions managed with appropriate treatment of lifestyle modification advice and recommended pharmacological agents.; These outcomes will be assessed via ongoing population surveys of randomly selected individuals and clinical record reviews.
Secondary Outcomes: 1) the knowledge, attitudes and practices of non-physician health care workers and physicians relating to cardiovascular prevention.; 2) the knowledge attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease; 3) the risk factor levels of the population identified as high risk.
Expected Total Enrollment:  4000

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.

Ages Eligible for Study:  30 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00263393

Clara K Chow, MBBS, FRACP      + 61 2 9993 4566    cchow@thegeorgeinstitute.org
Bruce C Neal, MBChB, PhD      +61 2 9993 4558    bneal@thegeorgeinstitute.org

India, Andhra Pradesh
      Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts, Bhimavaram,  Andhra Pradesh,  India

Study chairs or principal investigators

Bruce C Neal,  Principal Investigator,  The George Institute   

Study ID Numbers:  GI-CA-RAP-A
Last Updated:  December 8, 2005
Record first received:  December 6, 2005
ClinicalTrials.gov Identifier:  NCT00263393
Health Authority: Australia: Therapeutic Goods Administration
ClinicalTrials.gov processed this record on 2006-01-10