Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
SPREAD
A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
1 other identifier
interventional
806
1 country
13
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2010
CompletedFirst Posted
Study publicly available on registry
September 23, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 2, 2014
November 1, 2014
1.9 years
September 22, 2010
November 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
CHW based intervention post ACS
EXPERIMENTALCHW trained and supervised for intervening upon post ACS patients to improve adherence to evidence based care
Standard Care
NO INTERVENTIONPatients will be followed upto 12 months without a community health worker intervention as per standard practices of the hospital
Interventions
CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
Eligibility Criteria
You may qualify if:
- Consenting patients being discharged after an acute coronary event such as unstable angina, acute myocardial infarction, or after coronary intervention (CABG surgery or PCI).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. John's Research Institutelead
- National Heart and Lung Institutecollaborator
Study Sites (13)
Krishna Institute of Medical Science Ltd
Secunderabad, Aandhra Pradesh, 500003, India
Mahavir Hospital & Research Centre
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
Related Publications (1)
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.
PMID: 26857999DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Rajeev Gupta, MD, PHD
Fortis Escorts Hospital, Jaipur
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 22, 2010
First Posted
September 23, 2010
Study Start
August 1, 2011
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
December 2, 2014
Record last verified: 2014-11