Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

March 28, 2023 updated by: Luis Gonzalez de Paz, Consorci d'Atenció Primària de Salut de l'Eixample

Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

284

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

  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • Centre Atenció Primària de Les Corts
      • Barcelona, Spain, 08029
        • Not yet recruiting
        • CAP Compte Borrell
      • Barcelona, Spain, 08029
        • Recruiting
        • Centre Atenció Primària Montengre
      • Barcelona, Spain, 08036
        • Recruiting
        • Centre Atenció Primària Casanova

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years.
  • Hospital admission for acute coronary syndrome (diagnostic codes ICD-10: I20-I22).
  • Post unscheduled cardiac revascularization surgery (procedure code ICD-10: 021x).
  • Discharge to home with the area of the 7 PHCs.
  • Indication of RC indication.
  • Voluntary participation.

Exclusion Criteria:

  • Acute aortic disease,
  • Severe pulmonary hypertension.
  • Uncontrolled arrhythmias.
  • Decompensated Heart Failure or significant valvular or congenital heart disease.
  • Intervention in heart valves and/or interventricular septum.
  • Diseases that prevent exercise.
  • Osteoarticular disease that severely limits exercise.
  • Severe mental disorder.
  • Any severe psychiatric disorders.
  • Cognitive disability.
  • Verbal communication problems.
  • Participation in hospital Cardiac Rehabilitation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motivational interview
Motivation Interview program with standard care
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
Active Comparator: Standard care group
Standard care
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical functional capacity
Time Frame: 1st month
Improvement in aerobic capacity and resistance, measured by a physical effort test
1st month
Physical functional capacity
Time Frame: 6th month
Improvement in aerobic capacity and resistance, measured by a physical effort test
6th month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of secondary prevention
Time Frame: 1st month

Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):

Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
1st month
Effectiveness of secondary prevention
Time Frame: 3rd month

Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):

Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
3rd month
Effectiveness of secondary prevention
Time Frame: 6th month

Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):

Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
6th month
Psychological status
Time Frame: 6th month
Measured with the Psychological General Well-Being Index (PGWBI)
6th month
Perceived quality of life
Time Frame: 1st month
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
1st month
Perceived quality of life
Time Frame: 2nd month
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
2nd month
Perceived quality of life
Time Frame: 3rd month
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
3rd month

Collaborators and Investigators

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

Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Hospital Clinic of Barcelona
Institut Català de la Salut
Instituto de Salud Carlos III
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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)

April 1, 2022

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

March 9, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2019/0727

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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