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Secondary Prevention of coRonary Events After Discharge From Hospital (SPREAD)

A Randomized, Open Trial Comparing Post Discharge Interventions to Standard Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01207700
Acronym
SPREAD
Enrollment
806
Registered
2010-09-23
Start date
2011-08-31
Completion date
2013-08-31
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

post discharge intervention, adherence, compliance, community health worker

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.

Interventions

BEHAVIORALCHW based intervention post ACS

CHW is trained and supervised to provide interventions that could improved adherence to post ACS care

Sponsors

National Heart and Lung Institute
CollaboratorOTHER
St. John's Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To obtain estimates of rates of adherence to pharmacotherapy and lifestyle modification interventions and the incidence of major cardiovascular events12 monthsEvaluate the rates of adherence to pharmacotherapy and lifestyle modifications using the community health worker
To determine the feasibility of conducting a secondary prevention trial using CDCHWs on adherence to medications and lifestyle advice12 MONTHSA 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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026