Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-27 @ 9:37 PM
Study NCT ID:
NCT06836661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Level 1: Patient\n\n1. Rational FDCs\n2. NPHWs and PMs mediated therapeutic lifestyle changes\n3. Texts/ WhatsApp reminders Level 2: Physician\n\n1\\. Reinforcing task sharing 2. Providing evidence on FDCs 3. Theory based behavior modification Level 3: Health administrators\n\n1. Pharmacy - Update drug formulary FDCs\n2. CV health days\n3. Facility strengthening'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-02-01', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of death, myocardial infarction, stroke and CVD-related hospitalisations at three years', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP', 'timeFrame': '3 years', 'description': 'b) The Cost-Effectiveness (incremental cost- effectiveness ratio, ICER) of the IP c) Key Fidelity Metrics - utilisation rates of fixed-dose combinations, adherence to drug therapy at 12 months, proportion monitoring BP at home, adherence to different components of TLC and optimal referral.\n\nd) Key Implementation Metrics using the Reach Effectiveness-Adoption Implementation and Maintenance (RE-AIM) framework (Implementation research metric/ framework)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CVD', 'Low cost intervention', 'task sharing', 'fixed dose combination pills'], 'conditions': ['ST Elevation (STEMI) Myocardial Infarction of Anterior Wall', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "The ICRAG-2 project aims to assess the impact, cost-effectiveness, and sustainability of a low-cost, multipronged intervention package to reduce cardiovascular disease (CVD) burden in India. Given the high CVD mortality rate in India, this study addresses the urgent need for scalable, evidence-based solutions. The project will unfold in three steps: first, formative research including systematic reviews, cross-sectional studies, and qualitative studies will identify key barriers, facilitators, and refine interventions. Next, a matched-pair cluster randomized controlled trial (CRCT) across 26 clusters will evaluate the intervention's impact on CVD outcomes over three years, focusing on therapeutic lifestyle changes, fixed-dose medications, and task-sharing with non-physician health workers. Finally, the project will engage stakeholders through policy dialogues to support potential national-scale implementation. This trial offers a promising model to reduce CVD incidence through customized, sustainable interventions targeting patients, providers, and the health system.", 'detailedDescription': "Cardiovascular diseases (CVD) are the leading cause of death worldwide, responsible for approximately 17.9 million deaths each year, which accounts for 31% of all global deaths. The majority of these deaths-about 85%-are due to heart attacks and strokes. In India, CVD has contributed to 28·1% of the total deaths and 14·1% of the total DALYs. There is a remarkably high burden of CVD in India, with an age-standardised death rate of 282 deaths/100,000 (264-293) compared with global levels (233 deaths per 100,000 (229-236). Ischemic heart disease and stroke have been identified as the top two causes of mortality in the country, highlighting the urgent need for effective interventions.\n\nEvidence supports the effectiveness of fixed dose combination treatments and the use of Non-Physician Health Workers (NPHWs) in primary and secondary prevention of CVD. India's healthcare system faces the dual challenge of rising CVD mortality and a lack of integrated preventive and management strategies for CVD at both the primary and secondary care levels. NPHWs play a major role in reducing CVD risk factors.\n\nDespite the growing burden of CVD, there is a notable lack of evidence in India that evaluate comprehensive CVD management strategies across multiple levels, particularly focusing on hard clinical endpoints such as mortality, myocardial infarction (MI), stroke, and cardiovascular hospitalisations. To fill these gaps, we need a robust implementation trial that evaluates the effectiveness of multiple proven interventions in diverse settings on hard clinical endpoints. Such a trial, likely the first of its kind, would provide key evidence to guide policy decisions to improve CVD management strategies in India."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1. High-risk primary prevention A. Patients aged more than 40years of any gender without a CVD event (MI, Stroke) with at least two of the following risk factors, A to E with a 10 year documented evidence OF (a to d) a. Diabetes Mellitus b. Hypertension c. Dyslipidaemia d. Microalbuminuria e. Family history of premature CVD event (MI, stroke or CVD-related death under 55 years) B. Patients aged above 50years of any gender without a CVD event (MI, Stroke) with at least one year of documented disease, at least two A to D (Above) 2. High-risk secondary prevention Patients aged above 40 years or above, with a CVD event with any one of the following: options a. MI or stroke less than three months, \\<br/\\> b. MI or stroke, more than three months, but less than one year with at least one comorbid condition, that is A to E (Above).\n\nc. Patients aged above 60 years or above with MI or stroke greater than three months BUT less than one year, without any comorbid condition. These patients are expected to have a moderate to high risk of a CVD event or death in the next three years.\n\nExclusion Criteria:\n\n* We will exclude patients with any ONE of the following:\n\n 1. Severe cognitive impairment of any aetiology and have no reliable caregivers.\n 2. Medical conditions with a survival prognosis of less than 12 months.\n 3. Unable to follow-up for the study period'}, 'identificationModule': {'nctId': 'NCT06836661', 'acronym': 'ENABLE', 'briefTitle': 'Impact, Cost, and Sustainability of a Customized, Low-Cost Intervention to Reduce Cardiovascular Disease Burden in India: A Cluster Randomized Trial', 'organization': {'class': 'OTHER', 'fullName': "St. John's Research Institute"}, 'officialTitle': 'Effect, Cost, and sustaiNability of a Synergistic, Multipronged, Customized, Low-cost Intervention Package to Reduce cArdiovascular Burden Across India: a cLustEr RCT', 'orgStudyIdInfo': {'id': '293/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm - FDC and TLC and medication adherance', 'description': 'NPHW enabled education and counseliing along with prescribing combination therapies and TLC and availability of low cost rational FDC at hospital pharmacy', 'interventionNames': ['Behavioral: FDC and TLC and medication adherance']}, {'type': 'EXPERIMENTAL', 'label': 'Control arm - Patients will Enhanced Usual Care (EUC)', 'description': 'Enhanced Usual Care (EUC) with periodic follow ups.', 'interventionNames': ['Behavioral: Patients will Enhanced Usual Care (EUC)']}], 'interventions': [{'name': 'FDC and TLC and medication adherance', 'type': 'BEHAVIORAL', 'description': 'Level 1: Patient 1. Rational FDCs 2. NPHWs and PMs mediated therapeutic lifestyle changes 3. Texts/ WhatsApp reminders Level 2:Physician 1. Reinforcing task sharing 2. Providing evidence on FDCs 3. Theory based behavior modification Level 3: Health administrators 1. Pharmacy - Update drug formulary FDCs 2. CV health days 3. Facility strengthening', 'armGroupLabels': ['Intervention arm - FDC and TLC and medication adherance']}, {'name': 'Patients will Enhanced Usual Care (EUC)', 'type': 'BEHAVIORAL', 'description': 'Patients will Enhanced Usual Care (EUC) with periodic follow ups', 'armGroupLabels': ['Control arm - Patients will Enhanced Usual Care (EUC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560034', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'contacts': [{'name': 'Denis Xavier, Dr.', 'role': 'CONTACT', 'email': 'denis.xavier@stjohns.in', 'phone': '49466141', 'phoneExt': '91-80'}, {'name': 'Deepa S, Dr.', 'role': 'CONTACT', 'email': 'deepa.sn@sjri.res.in', 'phone': '49467081', 'phoneExt': '91-80'}], 'facility': "Division of Clinical Research and training St. John's Research Institute Koramangala , - , India", 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'Denis Xavier, Dr.', 'role': 'CONTACT', 'email': 'denis.xavier@stjohns.in', 'phone': '49466141', 'phoneExt': '91-80'}, {'name': 'Deepa S, Dr.', 'role': 'CONTACT', 'email': 'deepa.sn@sjri.res.in', 'phone': '49467081', 'phoneExt': '91-80'}], 'overallOfficials': [{'name': 'Denis Xavier, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. John's Medical College and research Institute"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in specific publication arising out of the trial, after de-identification (text, tables, figures, and appendices).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. John's Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Assam Medical College, Dibrugarh, India', 'class': 'UNKNOWN'}, {'name': 'SRM Medical College Hospital & Research Centre', 'class': 'UNKNOWN'}, {'name': 'Jawaharlal Institute of Postgraduate Medical Education & Research', 'class': 'OTHER_GOV'}, {'name': 'Indian Council of Medical Research', 'class': 'OTHER_GOV'}, {'name': 'All India Institute of Medical Sciences, Bhopal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}