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| Name | Class |
|---|---|
| National Heart and Lung Institute | OTHER |
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This is a randomized, open trial comparing post discharge interventions by community health workers (CHW) to standard care in acute coronary syndrome (ACS) patients.
This trial will be conducted in 10 hospitals in India/different parts(both secondary and tertiary care). A total of 800 patients will be recruited, with equal allocation to SPREAD interventions and control groups (usual care)
Inclusion criteria:
Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
Exclusion criteria:
Patients with other terminal/ debilitating illness, (e.g., advanced cancer, disabling stroke) those not expected to survive for the study duration, those with dementia and psychiatric illness or patients unlikely to comply with study requirements, including regular follow up.
OUTCOME MEASURES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHW based intervention post ACS | Experimental | CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care |
|
| Standard Care | No Intervention | Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHW based intervention post ACS | Behavioral | CHW is trained and supervised to provide interventions that could improved adherence to post ACS care |
|
| Measure | Description | Time Frame |
|---|---|---|
| To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events | Evaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker | 12 months |
| To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice | A pilot study to look at feasibiility of using a trained community health worker to deliver health messages to patients who have had a coronary event | 12 MONTHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rajeev Gupta, MD, PHD | Fortis Escorts Hospital, Jaipur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krishna Institute of Medical Science Ltd | Secunderabad | Aandhra Pradesh | 500003 | India | ||
| Mahavir Hospital & Research Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26857999 | Derived | Xavier D, Gupta R, Kamath D, Sigamani A, Devereaux PJ, George N, Joshi R, Pogue J, Pais P, Yusuf S. Community health worker-based intervention for adherence to drugs and lifestyle change after acute coronary syndrome: a multicentre, open, randomised controlled trial. Lancet Diabetes Endocrinol. 2016 Mar;4(3):244-253. doi: 10.1016/S2213-8587(15)00480-5. Epub 2016 Feb 6. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Hyderabad |
| Andhra Pradesh |
| 500004 |
| India |
| Nanjappa Hospital | Shimoga | Karnataka | 577201 | India |
| Caritas Hospital | Kottayam | Kerala | India |
| Bhopal Memorial Hospital | Bhopal | Madhya Pradesh | 462038 | India |
| Avanti Institute of Cardiology | Nagpur | Maharashtra | 440012 | India |
| Poona Hospital | Pune | Maharashtra | India |
| Mahatma Gandhi Institute of Medical Science Sevagram | Wardha | Maharashtra | 442001 | India |
| Sir Ganga Ram Hospital | New Delhi | New Delhi | 110060 | India |
| Fortis Escorts Hospital | Jaipur | Rajasthan | 302017 | India |
| Rajamuthiah Medical College & Hospital | Annāmalainagar | Tamil Nadu | 608 002 | India |
| PSG Hospital | Coimbatore | Tamil Nadu | 641 004 | India |
| Sahara Hospital | Lucknow | Uttar Pradesh | 226010 | India |
| D010342 |
| Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |