Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

NCT05285969 | Unknown

• 1 other identifier: HCB/2019/0727
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Myocardial Infarction; Cardiac Rehabilitation; Rehabilitation Nursing; Primary Health Care; Motivational Interviewing

Outcome Measures

Primary Outcomes (2)

• Physical functional capacity

  Improvement in aerobic capacity and resistance, measured by a physical effort test

  1st month

• Physical functional capacity

  Improvement in aerobic capacity and resistance, measured by a physical effort test

  6th month

Secondary Outcomes (7)

• Effectiveness of secondary prevention

  1st month

• Effectiveness of secondary prevention

  3rd month

• Effectiveness of secondary prevention

  6th month

• Psychological status

  6th month

• Perceived quality of life

  1st month

Study Arms (2)

Motivational interview

EXPERIMENTAL

Motivation Interview program with standard care

Behavioral: Motivational interview

Standard care group

ACTIVE COMPARATOR

Standard care

Behavioral: Active Comparator: Standard care group

Interventions

Motivational interview BEHAVIORAL

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

Motivational interview

Active Comparator: Standard care group BEHAVIORAL

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).

Standard care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci d'Atenció Primària de Salut de l'Eixample: lead
• Instituto de Salud Carlos III: collaborator
• Institut Català de la Salut: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Hospital Clinic of Barcelona: collaborator

Study Sites (4)

Centre Atenció Primària de Les Corts

Barcelona, 08028, Spain

RECRUITING

CAP Compte Borrell

Barcelona, 08029, Spain

NOT YET RECRUITING

Centre Atenció Primària Montengre

Barcelona, 08029, Spain

RECRUITING

Centre Atenció Primària Casanova

Barcelona, 08036, Spain

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Myocardial Infarction

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Luis González de Paz, PhD

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  PRINCIPAL INVESTIGATOR

• Rocío Rodríguez Romero, RN

  Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

  STUDY CHAIR

• Carles Falces Salvador, PhD

  Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.

  STUDY CHAIR

Central Study Contacts

Luis González de Paz, PhD

CONTACT

0034 932275683; lgonzale@clinic.cat

Rocío Rodríguez Romero, RN

CONTACT

0034932279800; rorodri@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)