Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263393
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2005-12-06
Brief Title:
Rural Andhra Pradesh Cardiovascular Prevention Study RAPCAPS
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPCAPS
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
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 1000
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 1000
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None