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Impact on Physical Activity of Coronary Patients in Phase 3 of a Therapeutic Consolidation Educational Program Involving a "Patient Partner" Associated With a Healthcare Professional. (P-HEARTNER)

C

Centre Hospitalier Universitaire de Nīmes

Status

Completed

Conditions

Myocardial Infarction

Treatments

Diagnostic Test: Biological check-up
Diagnostic Test: 6-minute walk test and administers the modified Borg scale at its conclusion.
Other: Teleconsultation at 2 months
Other: Teleconsultation at 4 months
Device: Accelerometer
Other: Remote group education workshop
Other: Administration of a logbook
Other: Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership
Other: Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.

Study type

Interventional

Funder types

Other

Identifiers

NCT05927363
APIRES-NIMAO/2022/VV-01

Details and patient eligibility

About

Following myocardial infarction, cardiac rehabilitation has undeniable benefits on criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:

  1. immediate post-acute, in a cardiology department,
  2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
  3. Resumption of active life by the patient. Indeed, one of the major aims of secondary prevention is long-term adherence to physical activity.However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, and the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after Phase 2 of CR is a major objective.

Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. This study aims to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on moderate-to-sustained physical activity (> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

Full description

Following myocardial infarction, cardiac rehabilitation has shown undeniable benefits on strong criteria such as cardiovascular mortality and coronary recurrence. Cardiac rehabilitation consists of 3 phases:

  1. immediate post-acute, in a cardiology department,
  2. active cardiac rehabilitation for several weeks under medical supervision as an inpatient or outpatient,
  3. Resumption of active life by the patient: one of the major aims of secondary prevention is long-term adherence to physical activity.

The importance of phase 2 of cardiac rehabilitation is particularly emphasized and is the subject of recommendations by learned societies. The aim is to re-train the patient under paramedical and medical supervision, and to induce behavioral changes through specific therapeutic education. Exercise re-training aims to increase the patient's cardiorespiratory functional capacity and their ability to do physical activity of moderate-to-sustained intensity. One of the most commonly used units to calculate the intensity of physical activity is the Metabolic Equivalent of Task (MET). The higher the intensity of the activity, the higher the number of METs. Physical activity of at least moderate intensity, as recommended in the long-term care of coronary patients corresponds to 3 METs. The therapeutic objective by international recommendations, and explained to patients during phase 2 CR, is to achieve 150 minutes a week of moderate-to-sustained physical activity (3 METs or more). However, only 20% to 40% of coronary patients remain physically active at 6 months or 1 year, which means that the effects of Phase 2 cardiac rehabilitation are not maintained. Managing to maintain at least a moderate level of physical activity after phase 2 of CR, is a major objective.

Various interventions (booklets, applications, activity programs, motivational talks led by healthcare professionals have been tested and compared with the usual care in Phase 3 cardiac rehabilitation. An effect seems to exist on the level of physical activity reported, but with a significant evaluation bias. Objective, validated measures of physical activity such as accelerometry have not proved their long-term efficacy (6 months being the classically explored endpoint). An intervention establishing a patient-centered relationship and cognitive-behavioral elements would seem to be a perspective of choice to be explored, therapeutic education having been little explored in phase 3 of cardiac rehabilitation and in the long term. To address some of the barriers identified in qualitative studies, the joint participation of a "patient partner" would seem to of interest. The PP is a patient who has acquired knowledge of their disease over time, through experience and experience and therapeutic education. They encourage dialogue between care teams and patients, facilitating patients' self-expression, and contributes to a better understanding of the discourse.

The hypothesis is that a therapeutic educational consolidation program, involving a "patient partner" associated with a health professional, will increase the level of physical activity of coronary patients in Phase 3 of cardiac rehabilitation.

The main objective of this study is to use accelerometry to evaluate the 6-month efficacy of the therapeutic education program for consolidation in phase 3 of Cardiovascular Rehabilitation involving a patient partner and a caregiver on the level of moderate to sustained physical activity (> 3 METs) in coronary patients on Phase 3 of cardiac rehabilitation compared with usual rehabilitation management.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient of legal age (≥ 18 years).
  • Patient having undergone phase 2 treatment in the cardiovascular rehabilitation department of the CHU for myocardial infarction.
  • Patient with a means of communication that allows easy internet connection (i.e. a smartphone).
  • Patient fluent in French.
  • Patient who has given free informed consent.
  • Patient affiliated or beneficiary of a health insurance scheme.

Exclusion criteria

  • Patient with severe or unstable comorbidity (respiratory insufficiency renal failure, decompensated heart failure). heart failure).
  • Patient with unstable angina.
  • Patient with contraindications to physical activity following physical activity following cardiovascular rehabilitation (according to medical discussion, based on the recommendations of the French Society of Cardiology).
  • Patient with no suitable means of communication.
  • Patient under court protection, guardianship or curatorship.
  • Pregnant, parturient or breast-feeding patients.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Controls
No Intervention group
Description:
Patients in Phase 3 of cardiac rehabilitation, undergoing the usual care provided.
Experimental Group
Experimental group
Description:
Patients in Phase 3 of cardiovascular rehabilitation, following a therapeutic educational program for consolidation ("patient partner" and a caregiver) as well as the usual care provided.
Treatment:
Other: Administration of self-questionnaires: IPAQ, EMAPS, the Exercise Confidence Survey, EQ-5D-5L and the Mediterranean diet adherence score.
Other: Therapeutic educational consolidation program in Phase 3 of cardiac rehabilitation associating a patient & caregiver partnership
Other: Administration of a logbook
Other: Remote group education workshop
Device: Accelerometer
Other: Teleconsultation at 4 months
Other: Teleconsultation at 2 months
Diagnostic Test: Biological check-up
Diagnostic Test: 6-minute walk test and administers the modified Borg scale at its conclusion.

Trial contacts and locations

1

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Central trial contact

Anissa MEGZARI; Alexis HOMS, Dr.

Data sourced from clinicaltrials.gov

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