Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

Study Overview
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Brief Summary
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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.

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

Conditions
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Myocardial Infarction, Acute

Intervention / Treatment
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* Behavioral: Motivational interview
* Behavioral: Active Comparator: Standard care group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational interview<br>Motivation Interview program with standard care | Behavioral: Motivational interview<br>* 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<br>|
| Active Comparator: Standard care group<br>Standard care | Behavioral: Active Comparator: Standard care group<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of secondary prevention | 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 | 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 | 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 | Measured with the Psychological General Well-Being Index (PGWBI) | 6th month | 
| Perceived quality of life | 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 | 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 | Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12). | 3rd month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Cardiac Rehabilitation, Rehabilitation Nursing, Primary Health Care, Motivational Interviewing