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Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05285969
Enrollment
284
Registered
2022-03-18
Start date
2022-04-01
Completion date
2025-12-01
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Acute

Keywords

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

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.

Interventions

BEHAVIORALMotivational 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

BEHAVIORALActive 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).

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Physical functional capacity1st monthImprovement in aerobic capacity and resistance, measured by a physical effort test

Secondary

MeasureTime frameDescription
Effectiveness of secondary prevention1st monthEffectiveness 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.
Psychological status6th monthMeasured with the Psychological General Well-Being Index (PGWBI)
Perceived quality of life1st monthPhysical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).

Countries

Spain

Contacts

Primary ContactLuis González de Paz, PhD
lgonzale@clinic.cat0034 932275683
Backup ContactRocío Rodríguez Romero, RN
rorodri@clinic.cat0034932279800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026