Clinical trial NCT01207700: Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)
Official title: A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: post discharge intervention
adherence
compliance
community health worker
Lead sponsor: St. John's Research Institute
Sponsor class: OTHER
Collaborators: name: National Heart and Lung Institute
First posted: 2010-09-23
Enrollment: 806
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

Detailed description: 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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events
timeFrame: 12 months
measure: To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice
timeFrame: 12 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Krishna Institute of Medical Science Ltd
state: Aandhra Pradesh
city: Hyderabad
country: India
facility: Mahavir Hospital & Research Centre
state: Andhra Pradesh
city: Shimoga
country: India
facility: Nanjappa Hospital
state: Karnataka
city: Kottayam
country: India
facility: Caritas Hospital
state: Kerala
city: Bhopal
country: India
facility: Bhopal Memorial Hospital
state: Madhya Pradesh
city: Nagpur
country: India
facility: Avanti Institute of Cardiology
state: Maharastra
city: Pune
country: India
facility: Poona Hospital
state: Maharastra
city: Wardha
country: India
facility: Mahatma Gandhi Institute of Medical Science Sevagram
state: Maharastra
city: Jaipur
country: India
facility: Fortis Escorts Hospital
state: Rajasthan
city: Annamalai
country: India
facility: Rajamuthiah Medical College & Hospital
state: Tamil Nadu
city: Coimbatore
country: India
facility: PSG Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: Sahara Hospital
state: Uttar Pradesh
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
Study officials:
affiliation: Fortis Escorts Hospital, Jaipur
name: Dr. Rajeev Gupta, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.