Effect of an Adult EDUcation Program on CArdiovascular ouTcomEs in Post-myocardial-infarction Patients (EDUCATE)

July 27, 2019 updated by: Spyridon Deftereos, National and Kapodistrian University of Athens

Effect of an Adult Education Program on Cardiovascular Outcomes in Post-myocardial-infarction Patients

A non-MD-led adult education program consisting in 10 one-hour sessions designed to provide information and motivation will be offered to patients who have recently been hospitalized for acute myocardial infarction (STEMI and NSTEMI), regarding the management of their treatment and strategies to aggressively optimize control of cardiovascular risk factors..

The intervention arm will be compared to a control group of patients treated with usual care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Athens University Hospital Attikon
        • Contact:
          • Spyridon Deftereos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of acute ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI), Type Ι, according to the 3rd Universal Definition of MI, within the preceding 6 weeks
  • Absence of substantial cognitive dysfunction (Mini Mental State examination score ≥24)

Exclusion Criteria:

- Age >80 years or <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Post-MI patients attending an adult education program designed to inform and motivate them on how to best control cardiovascular risk factors as a means to offer optimized secondary prevention of cardiovascular events
Other: Adult education program
A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment
No Intervention: Controls
Usual care for post-MI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
Time Frame: 24 months
Time from randomization to the composite endpoint of death or myocardial infarction or cerebrovascular event or unplanned hospitalization for cardiovascular reasons
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE
Time Frame: 24 months
Major cardio-/cerebro-vascular events (cardiovascular death, myocardial infarction, cerebrovascular event)
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL-chol
Time Frame: 12 months
Change from baseline to 12 months in LDL-cholesterol concentration
12 months
Change in body-mass index
Time Frame: 12 months
Change from baseline to 12 months in the body-mass index
12 months
Change in arterial pressure
Time Frame: 12 months
Change from baseline to 12 months in systolic arterial pressure (the mean of 3 office measurements)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

June 30, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 27, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARD EBD2369/12-05-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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