Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
NCT ID: NCT01207700
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
806 participants
INTERVENTIONAL
2011-08-31
2013-08-31
Brief Summary
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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)
Detailed Description
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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:
1. Feasibility
2. Difference in adherence to specific medications for secondary prevention of CAD (Coronary Artery Diseases) compared to the control group, at one year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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CHW based intervention post ACS
CHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care
CHW based intervention post ACS
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
Standard Care
Patients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
No interventions assigned to this group
Interventions
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CHW based intervention post ACS
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
ALL
No
Sponsors
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National Heart and Lung Institute
OTHER
St. John's Research Institute
OTHER
Responsible Party
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Dr Alben Sigamani
Associate Professor
Principal Investigators
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Dr. Rajeev Gupta, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Fortis Escorts Hospital, Jaipur
Locations
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Krishna Institute of Medical Science Ltd
Secunderabad, Aandhra Pradesh, India
Mahavir Hospital & Research Centre
Hyderabad, Andhra Pradesh, India
Nanjappa Hospital
Shimoga, Karnataka, India
Caritas Hospital
Kottayam, Kerala, India
Bhopal Memorial Hospital
Bhopal, Madhya Pradesh, India
Avanti Institute of Cardiology
Nagpur, Maharashtra, India
Poona Hospital
Pune, Maharashtra, India
Mahatma Gandhi Institute of Medical Science Sevagram
Wardha, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, New Delhi, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Rajamuthiah Medical College & Hospital
Annāmalainagar, Tamil Nadu, India
PSG Hospital
Coimbatore, Tamil Nadu, India
Sahara Hospital
Lucknow, Uttar Pradesh, India
Countries
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References
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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.
Other Identifiers
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NO1-HV-98215/SJRI - DCT/SPREAD
Identifier Type: -
Identifier Source: org_study_id