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Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

C

Consorci d'Atenció Primària de Salut de l'Eixample

Status

Enrolling

Conditions

Myocardial Infarction, Acute

Treatments

Behavioral: Motivational interview
Behavioral: Active Comparator: Standard care group

Study type

Interventional

Funder types

Other

Identifiers

NCT05285969
HCB/2019/0727

Details and patient eligibility

About

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.

Enrollment

284 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

284 participants in 2 patient groups

Motivational interview
Experimental group
Description:
Motivation Interview program with standard care
Treatment:
Behavioral: Motivational interview
Standard care group
Active Comparator group
Description:
Standard care
Treatment:
Behavioral: Active Comparator: Standard care group

Trial contacts and locations

4

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Central trial contact

Luis González de Paz, PhD; Rocío Rodríguez Romero, RN

Data sourced from clinicaltrials.gov

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