Diabetes Mellitus Clinical Trial
— RAPCAPSOfficial title:
Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
NCT number | NCT00263393 |
Other study ID # | GI-CA-RAP-A |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2005 |
Est. completion date | June 2009 |
Verified date | September 2018 |
Source | The George Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
India | Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts | Bhimavaram | Andhra Pradesh |
Lead Sponsor | Collaborator |
---|---|
The George Institute | Byrraju Foundation, The Future Forum, UK |
India,
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
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 |
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