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

NCT ID: NCT04007887

Last Updated: 2019-07-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-15

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Adult education program

Intervention Type OTHER

A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment

Controls

Usual care for post-MI patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adult education program

A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Spyridon Deftereos

Associate Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Athens University Hospital Attikon

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Spyridon Deftereos, MD

Role: CONTACT

00302105832352

Facility Contacts

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Spyridon Deftereos

Role: primary

References

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Giannopoulos G, Karageorgiou S, Vrachatis D, Anagnostopoulos I, Kousta MS, Lakka E, Giotaki S, Raisakis K, Sianos G, Toutouzas K, Cleman M, Deftereos S. A stand-alone structured educational programme after myocardial infarction: a randomised study. Heart. 2021 Jun 11;107(13):1047-1053. doi: 10.1136/heartjnl-2020-318414.

Reference Type DERIVED
PMID: 33483355 (View on PubMed)

Other Identifiers

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CARD EBD2369/12-05-2017

Identifier Type: -

Identifier Source: org_study_id

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