Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

NCT05285969 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2023-03-29

No results posted yet for this study

Summary

Introduction: Secondary prevention after acute myocardial infarction may include cardiac rehabilitation and lifestyle changes. Cardiac rehabilitation has mainly taken place in hospitals without coordination with primary healthcare. Motivational interviews have been shown to be effective as a means for change in patients after acute myocardial infarction. The objective of this study is to evaluate the effectiveness of a cardiac rehabilitation program with motivational interviews in patients discharged from hospital after acute myocardial infarction.

Methods: Randomized clinical non-pharmacological trial. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction in six primary healthcare centers. Participants will be randomized to cardiac rehabilitation with motivational interviews or normal standard of care. All secondary results will be evaluated at 1,3 and 6 months.

Conditions

  • Myocardial Infarction, Acute

Interventions

BEHAVIORAL

Motivational interview

The new CR program with MI will be structured in 4 sessions and an optional fifth during the six months after discharge. The methodology of the MI sessions will follow the four phases logical sequence of MI proposed by Rollnick and Millner. 1) engage in a collaborative relationship, 2) focus on a particular change, 3) evoke intrinsic motivations for change, and 4) plan an immediate step for change

BEHAVIORAL

Active Comparator: Standard care group

All patients in the control group will receive a kit with informative material with the actions and procedures to follow (diet, physical activity, smoking cessation, and other recommendations about secondary prevention).

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV
  • Institut Català de la Salut

    collaborator OTHER
  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    collaborator OTHER
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer

    collaborator OTHER
  • Hospital Clinic of Barcelona

    collaborator OTHER
  • Consorci d'Atenció Primària de Salut de l'Eixample

    lead OTHER

Principal Investigators

  • Luis González de Paz, PhD · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  • Rocío Rodríguez Romero, RN · Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  • Carles Falces Salvador, PhD · Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2025-10-01
Completion
2025-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05285969 on ClinicalTrials.gov