Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-02-26 @ 12:22 AM
Study NCT ID:
NCT00263393
Status:
COMPLETED
Last Update Posted:
2018-09-12
First Post:
2005-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001262', 'term': 'Atenolol'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}, {'id': 'D006293', 'term': 'Health Promotion'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3712}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of high-risk individuals that have been assessed for cardiovascular risk', 'timeFrame': '12 months after intevention'}, {'measure': 'The proportion of individuals with correct knowledge about the effects of behavioural determinants of the risk of cardiovascular disease', 'timeFrame': '12 months from intervention'}], 'secondaryOutcomes': [{'measure': 'The proportion of high risk individuals treated with two or more of the recommended drug therapies', 'timeFrame': '12 months'}, {'measure': 'The knowledge, attitudes and practices of the population about preventable conditions and actions taken to prevent non-communicable disease', 'timeFrame': '12 months from intervention'}, {'measure': 'The risk factor levels of the population identified as high risk.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Myocardial Infarction', 'Angina Pectoris', 'Cerebrovascular Accident', 'Diabetes Mellitus', 'Cluster randomized design', 'Community-based intervention trial', 'Primary Healthcare intervention', 'Lifestyle advice'], 'conditions': ['Myocardial Infarction', 'Angina Pectoris', 'Cerebrovascular Accidents', 'Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '19699856', 'type': 'BACKGROUND', 'citation': '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': '22440219', 'type': 'RESULT', '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. doi: 10.1016/j.jacc.2011.10.901. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nINTERVENTION 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.\n\nDATA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30 years and above\n* Personal history of heart attack or stroke\n* Presence of other cardiovascular risk factors such as smoking, overweight, diabetes\n\nExclusion Criteria:\n\n* Mental disability\n* Not living in the Study area'}, 'identificationModule': {'nctId': 'NCT00263393', 'acronym': 'RAPCAPS', 'briefTitle': 'Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS)', 'organization': {'class': 'OTHER', 'fullName': 'The George Institute'}, 'officialTitle': 'Evaluation of a Primary Health Care Intervention for the Prevention of Cardiovascular Disease in Rural Andhra Pradesh', 'orgStudyIdInfo': {'id': 'GI-CA-RAP-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', '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.', 'interventionNames': ['Drug: ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin']}, {'type': 'OTHER', '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', 'interventionNames': ['Behavioral: Health Promotion']}], 'interventions': [{'name': 'ASA, Atenolol, hydrochlorothiazide, ACE inhibitor, Statin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Algorithm-based care']}, {'name': 'Health Promotion', 'type': 'BEHAVIORAL', 'description': 'The second intervention was a health promotion program designed to increase knowledge of cardiovascular risk factors compared to continued usual practices.', 'armGroupLabels': ['Health-promotion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bhimavaram', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Byrraju Foundation Primary Healthcare Centres in rural West Godavari and East Godavari Dstricts', 'geoPoint': {'lat': 16.54078, 'lon': 81.52322}}], 'overallOfficials': [{'name': 'Bruce C Neal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The George Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The George Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Byrraju Foundation', 'class': 'OTHER'}, {'name': 'The Future Forum, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Fellow', 'investigatorFullName': 'Dr Rohina Joshi', 'investigatorAffiliation': 'The George Institute'}}}}