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Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

Primary Purpose

Myocardial Infarction, Acute

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Motivational interview

Active Comparator: Standard care group

About this trial

This is an interventional treatment trial for Myocardial Infarction, Acute focused on measuring Myocardial Infarction, Cardiac Rehabilitation, Rehabilitation Nursing, Primary Health Care, Motivational Interviewing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Centre Atenció Primària de Les CortsRecruiting
CAP Compte Borrell
Centre Atenció Primària MontengreRecruiting
Centre Atenció Primària CasanovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational interview

Standard care group

Arm Description

Motivation Interview program with standard care

Standard care

Outcomes

Primary Outcome Measures

Physical functional capacity

Improvement in aerobic capacity and resistance, measured by a physical effort test

Physical functional capacity

Improvement in aerobic capacity and resistance, measured by a physical effort test

Secondary Outcome Measures

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.

Effectiveness of secondary prevention

Psychological status

Measured with the Psychological General Well-Being Index (PGWBI)

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).

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).

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).

Full Information

NCT ID

NCT05285969

First Posted

February 28, 2022

Last Updated

March 28, 2023

Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

Instituto de Salud Carlos III, Institut Català de la Salut, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT05285969

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

October 1, 2025 (Anticipated)

Study Completion Date

December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Consorci d'Atenció Primària de Salut de l'Eixample

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Acute

Keywords

Myocardial Infarction, Cardiac Rehabilitation, Rehabilitation Nursing, Primary Health Care, Motivational Interviewing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Motivational interview

Arm Type

Experimental

Arm Description

Motivation Interview program with standard care

Arm Title

Standard care group

Arm Type

Active Comparator

Arm Description

Standard care

Intervention Type

Behavioral

Intervention Name(s)

Motivational interview

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Active Comparator: Standard care group

Intervention Description

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).

Primary Outcome Measure Information:

Title

Physical functional capacity

Description

Improvement in aerobic capacity and resistance, measured by a physical effort test

Time Frame

1st month

Title

Physical functional capacity

Description

Improvement in aerobic capacity and resistance, measured by a physical effort test

Time Frame

6th month

Secondary Outcome Measure Information:

Title

Effectiveness of secondary prevention

Description

Time Frame

1st month

Title

Effectiveness of secondary prevention

Description

Time Frame

3rd month

Title

Effectiveness of secondary prevention

Description

Time Frame

6th month

Title

Psychological status

Description

Measured with the Psychological General Well-Being Index (PGWBI)

Time Frame

6th month

Title

Perceived quality of life

Description

Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).

Time Frame

1st month

Title

Perceived quality of life

Description

Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).

Time Frame

2nd month

Title

Perceived quality of life

Description

Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).

Time Frame

3rd month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luis González de Paz, PhD

Phone

0034 932275683

lgonzale@clinic.cat

First Name & Middle Initial & Last Name or Official Title & Degree

Rocío Rodríguez Romero, RN

Phone

0034932279800

Ext

381179

rorodri@clinic.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis González de Paz, PhD

Organizational Affiliation

Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rocío Rodríguez Romero, RN

Organizational Affiliation

Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Carles Falces Salvador, PhD

Organizational Affiliation

Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.

Official's Role

Study Chair

Facility Information:

Facility Name

Centre Atenció Primària de Les Corts

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis González de Paz, PhD

Facility Name

CAP Compte Borrell

City

Barcelona

ZIP/Postal Code

08029

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noemí García-Planes, R.N.

Facility Name

Centre Atenció Primària Montengre

City

Barcelona

ZIP/Postal Code

08029

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juan J. Zamora, RN

Facility Name

Centre Atenció Primària Casanova

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rocio Rodríguez Romero, BSN

12. IPD Sharing Statement

Plan to Share IPD

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Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

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