Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)

NCT00263393 | Completed Phase 4

• 1 other identifier: GI-CA-RAP-A
• Study Type: interventional
• Target: 3,712
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Algorithm-based care

OTHER

An algorithm based approach to increase the identification of high-risk individuals in the community through encouraging opportunistic screening, and to increase the use of appropriate evidence based prevention strategies.

Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin

Health-promotion

OTHER

The health promotion arm has been designed to increase knowledge of the causes of cardiovascular disease and enhance use of preventive behaviours in the general population

Behavioral: Health Promotion

Interventions

ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin DRUG

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.

Algorithm-based care

Health Promotion BEHAVIORAL

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

Health-promotion

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 years and above
• Personal history of heart attack or stroke
• Presence of other cardiovascular risk factors such as smoking, overweight, diabetes

You may not qualify if:

• Mental disability
• Not living in the Study area

Sponsors & Collaborators

• The George Institute: lead
• Byrraju Foundation: collaborator
• The Future Forum, UK: collaborator

Study Sites (1)

Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts

Bhimavaram, Andhra Pradesh, India

Location

Related 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.

  PMID: 19699856 BACKGROUND

• 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.

  PMID: 22440219 RESULT

MeSH Terms

Conditions

Myocardial Infarction; Angina Pectoris; Stroke; Diabetes Mellitus

Interventions

Atenolol; Hydrochlorothiazide; Angiotensin-Converting Enzyme Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Health Promotion

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Lipid Regulating Agents; Therapeutic Uses; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bruce C Neal

  The George Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 8, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

IN (1)