Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 284
- Locations
- 8
- Primary Endpoint
- Physical functional capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Physical functional capacity
Time Frame: 6th month
Improvement in aerobic capacity and resistance, measured by a physical effort test
Secondary Outcomes
- Effectiveness of secondary prevention(6th month)
- Psychological status(6th month)
- Perceived quality of life(3rd month)
Investigators
Luis Gonzalez de Paz
Researcher
Consorci d'Atenció Primària de Salut de l'Eixample