Clinical trial NCT05285969: Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction
Official title: Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction, Acute
Keywords: Myocardial Infarction
Cardiac Rehabilitation
Rehabilitation Nursing
Primary Health Care
Motivational Interviewing
Lead sponsor: Consorci d'Atenció Primària de Salut de l'Eixample
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Institut Català de la Salut
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Institut d'Investigacions Biomèdiques August Pi i Sunyer
name: Hospital Clinic of Barcelona
First posted: 2022-03-18
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Physical functional capacity
timeFrame: 1st month
measure: Physical functional capacity
timeFrame: 6th month
Secondary outcomes:
measure: Effectiveness of secondary prevention
timeFrame: 1st month
measure: Effectiveness of secondary prevention
timeFrame: 3rd month
measure: Effectiveness of secondary prevention
timeFrame: 6th month
measure: Psychological status
timeFrame: 6th month
measure: Perceived quality of life
timeFrame: 1st month
measure: Perceived quality of life
timeFrame: 2nd month
measure: Perceived quality of life
timeFrame: 3rd month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centre Atenció Primària de Les Corts
city: Barcelona
country: Spain
facility: CAP Compte Borrell
city: Barcelona
country: Spain
facility: Centre Atenció Primària Montengre
city: Barcelona
country: Spain
facility: Centre Atenció Primària Casanova
Study officials:
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Luis González de Paz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
name: Rocío Rodríguez Romero, RN
role: STUDY_CHAIR
affiliation: Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.
name: Carles Falces Salvador, PhD
role: STUDY_CHAIR
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