Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

Myocardial Infarction, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285969
• Other study ID #: HCB/2019/0727
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2023
• Source: Consorci d'Atenció Primària de Salut de l'Eixample
• Contact: Luis González de Paz, PhD
• Phone: 0034 932275683
• Email: lgonzale[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: December 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Behavioral:
• Motivational interview
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
• Active Comparator: Standard care group
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).

Locations

Country	Name	City	State
Spain	CAP Compte Borrell	Barcelona
Spain	Centre Atenció Primària Casanova	Barcelona
Spain	Centre Atenció Primària de Les Corts	Barcelona
Spain	Centre Atenció Primària Montengre	Barcelona

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical functional capacity	Improvement in aerobic capacity and resistance, measured by a physical effort test	1st month
Primary	Physical functional capacity	Improvement in aerobic capacity and resistance, measured by a physical effort test	6th month
Secondary	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
Secondary	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
Secondary	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
Secondary	Psychological status	Measured with the Psychological General Well-Being Index (PGWBI)	6th month
Secondary	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
Secondary	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
Secondary	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