Clinical trial NCT00263393: Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
Official title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Angina Pectoris
Cerebrovascular Accidents
Diabetes Mellitus
Keywords: Myocardial Infarction
Angina Pectoris
Cerebrovascular Accident
Diabetes Mellitus
Cluster randomized design
Community-based intervention trial
Primary Healthcare intervention
Lifestyle advice
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: Byrraju Foundation
name: The Future Forum, UK
First posted: 2005-12-08
Enrollment: 3712
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: The proportion of high-risk individuals that have been assessed for cardiovascular risk
timeFrame: 12 months after intevention
measure: The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease
timeFrame: 12 months from intervention
Secondary outcomes:
measure: The proportion of high risk individuals treated with two or more of the recommended drug therapies
timeFrame: 12 months
measure: The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease
timeFrame: 12 months from intervention
measure: The risk factor levels of the population identified as high risk.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bhimavaram
country: India
facility: Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts
state: Andhra Pradesh
Study officials:
affiliation: The George Institute
name: Bruce C Neal
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow CK, Joshi R, Gottumukkala AK, Raju K, Raju R, Reddy S, Macmahon S, Neal B. Rationale and design of the Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a factorial, cluster-randomized trial of 2 practical cardiovascular disease prevention strategies developed for rural Andhra Pradesh, India. Am Heart J. 2009 Sep;158(3):349-55. doi: 10.1016/j.ahj.2009.05.034. Epub 2009 Jul 15.
citation: Joshi R, Chow CK, Raju PK, Raju KR, Gottumukkala AK, Reddy KS, Macmahon S, Heritier S, Li Q, Dandona R, Neal B. The Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS): a cluster randomized trial. J Am Coll Cardiol. 2012 Mar 27;59(13):1188-96. doi: 10.1016/j.jacc.2011.10.901. No abstract available.