Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS) "RAPCAPS"

Completed

Phase 4 Results

Trial Description

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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Atenolol (Tenormin)Drug
    Other Names: tenormin
    Intervention Desc: Beta-adrenergic receptor antagonist (beta-blocker); anti-hypertensive
  • Statin Drug
    Other Names: Pre-existing statin regimen
    Intervention Desc: The statins (or HMG-CoA reductase inhibitors) form a class of hypolipidemic drugs used to lower cholesterol levels in people with or at risk of cardiovascular disease.
  • ACE inhibitor Drug
    Intervention Desc: ACE inhibitors, or inhibitors of Angiotensin-Converting Enzyme, are a group of pharmaceuticals that are used primarily in treatment of hypertension and congestive heart failure, in some cases as the drugs of first choice.
  • hydrochlorathiazide Drug
    Intervention Desc: Hydrochlorothiazide, sometimes abbreviated HCT, HCTZ, or HZT is a popular diuretic drug of the thiazide class that acts by inhibiting the kidneys' ability to retain water.
  • Health Promotion Behavioral
    Intervention Desc: The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
    ARM 1: Kind: Experimental
    Label: Health-promotion
    Description: 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
  • ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Algorithm-based care
    Description: 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.
  • Self-identification and self-referral for CVD risk Behavioral
    ARM 1: Kind: Experimental
    Label: Algorithm-based care
    Description: 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.
  • Health care worker screening of high risk through algorithm Behavioral
    ARM 1: Kind: Experimental
    Label: Algorithm-based care
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Patient Involvement

Subjects will have 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Differences in, the proportion of high-risk individuals identified, and 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 tTe knowledge, attitudes and practices of non-physician health care workers and physicians relating to cardiovascular prevention; the knowledge attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease; the risk factor levels of the population identified as high risk.
Primary The proportion of high-risk individuals that have been assessed for cardiovascular risk 12 months after intevention No
Primary The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease 12 months from intervention No
Secondary The proportion of high risk individuals treated with two or more of the recommended drug therapies 12 months No
Secondary The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease 12 months from intervention No
Secondary The risk factor levels of the population identified as high risk. 12 months No

Sponsors