Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

Diabetes Mellitus Clinical Trial

— RAPCAPS  

Official title:

Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263393
• Other study ID #: GI-CA-RAP-A
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: September 2018
• Source: The George Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3712
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Cerebrovascular Accidents
• Diabetes Mellitus
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Drug:
• ASA, 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.

Behavioral:
• Health Promotion
The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.

Locations

Country	Name	City	State
India	Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts	Bhimavaram	Andhra Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
The George Institute	Byrraju Foundation, The Future Forum, UK

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of high-risk individuals that have been assessed for cardiovascular risk		12 months after intevention
Primary	The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease		12 months from intervention
Secondary	The proportion of high risk individuals treated with two or more of the recommended drug therapies		12 months
Secondary	The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease		12 months from intervention
Secondary	The risk factor levels of the population identified as high risk.		12 months

External Links

•   A community-based cluster randomised trial for the prevention of cardiovascular disease based on (1) opportunistic screening of high-risk individuals, (2) management with proven therapies following a clinical algorithm, and (3) health promotion campaign