Myocardial InfarctionPhase 4RAPCAPSNCT00263393
Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
A Phase 4 study testing ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin and Health Promotion in people with Myocardial Infarction and Angina Pectoris, run by The George Institute at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Myocardial Infarction, Angina Pectoris, Cerebrovascular Accidents
- What is being tested?
- ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,712 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2005to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 years and above
- Personal history of heart attack or stroke
- Presence of other cardiovascular risk factors such as smoking, overweight, diabetes
Who cannot join
- Mental disability
- Not living in the Study area
Trial locations and contacts
1 site in 1 country.
India1 site
Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts
Bhimavaram, Andhra Pradesh
About this study
Official title: Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
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.
Read the 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.
- Being tested
- ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin, Health Promotion
- Keywords
- Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Diabetes Mellitus, Cluster randomized design, Community-based intervention trial, Primary Healthcare intervention, Lifestyle advice
- Medical subject headings
- Myocardial Infarction, Angina Pectoris, Stroke, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, StatinDrug
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.
Health PromotionBehavioural
The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of high-risk individuals that have been assessed for cardiovascular risk
Measured: 12 months after intevention
The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease
Measured: 12 months from intervention
Secondary outcomes (3)
The proportion of high risk individuals treated with two or more of the recommended drug therapies
Measured: 12 months
The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease
Measured: 12 months from intervention
The risk factor levels of the population identified as high risk.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,712 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Byrraju Foundation, The Future Forum, UK
- Responsible party
- Principal investigator, Dr Rohina Joshi, The George Institute
- Investigators
- Bruce C Neal, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263393
- Sponsor's protocol ID
- GI-CA-RAP-A
- Acronym
- RAPCAPS
- Status last verified
- Sep 2018
- First submitted
- 6 Dec 2005
- Last updated
- 12 Sep 2018
- Results posted
- No
Publications
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.
PubMed 19699856Joshi 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.
PubMed 22440219
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh
- ClinicalTrials.gov ID
- NCT00263393
- Acronym / sponsor ID
- RAPCAPS / GI-CA-RAP-A
- Keywords
- Myocardial Infarction, Angina Pectoris, Cerebrovascular Accident, Diabetes Mellitus, Cluster randomized design, Community-based intervention trial, Primary Healthcare intervention, Lifestyle advice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,712 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- Byrraju Foundation, The Future Forum, UK
- Study start
- Dec 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 8 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm-based care | Other | Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, StatinAn 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-promotion | Other | Behavioral: Health PromotionThe 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 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30 years and above
- Personal history of heart attack or stroke
- Presence of other cardiovascular risk factors such as smoking, overweight, diabetes
Key exclusion criteria (2 listed)
- Mental disability
- Not living in the Study area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, StatinThe 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. | Drug | Algorithm-based care |
| Health PromotionThe second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices. | Behavioural | Health-promotion |
Primary outcome
The proportion of high-risk individuals that have been assessed for cardiovascular risk
Time frame: 12 months after intevention
The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease
Time frame: 12 months from intervention
3 secondary outcomes
The proportion of high risk individuals treated with two or more of the recommended drug therapies
Time frame: 12 months
The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease
Time frame: 12 months from intervention
The risk factor levels of the population identified as high risk.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Background: PubMed 19699856Chow 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.
- Results publication: PubMed 22440219Joshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce C Neal principal investigator
The George Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin and Health Promotion in people with Myocardial Infarction and Angina Pectoris, run by The George Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of high-risk individuals that have been assessed for cardiovascular risk (time frame: 12 months after intevention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263393, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.