- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07651501
Barriers and Facilitators to Psychosocial Management in Cardiac Rehabilitation at the South Francilien Hospital Center (CHSF) (PSYRCV)
The goal of this observational study is to describe the barriers to psychosocial management in cardiac rehabilitation patients at the south francilien hospital center (CHSF) and understand how to improve it, in order to facilitate their return to work.
The main questions it aims to answer are :
- What are the perceived barriers to psychosocial management among the male and female cardiac rehabilitation patients at the CHSF ?
- What are the perceived barriers to psychosocial management among the medical, paramedical and administrative staff members of the cardiac rehabilitation service at the CHSF ?
Study Overview
Status
Conditions
Detailed Description
Cardiac rehabilitation is recommended for patients with acute or chronic cardiovascular disease in accordance with national and international guidelines.
The World Health Organization (WHO) defines cardiac rehabilitation as "the sum of activity and interventions required to ensure the best possible physical, mental, and social conditions so that patients with chronic or post-acute cardiovascular disease may, by their own efforts, preserve or resume their proper place in society and lead an active life".
In France, the clinical practice guidelines issued by the French National Authority for Health (HAS) and the French Society of Cardiology emphasize the need for a multidisciplinary approach to cardiac rehabilitation, integrating psychosocial support and preparation for return to work, in addition to exercise training, cardiovascular risk factor management, optimization of pharmacological treatment, screening for comorbidities, therapeutic and dietary education.
According to experts, improving patients' working conditions and preparing their return to work before actual work resumption constitute major components of psychosocial care.
Such interventions can be facilitated through occupational health services, including workplace assessments and adjustments to job tasks or working hours.
Although psychosocial care is recognized as an essential component of both cardiac rehabilitation and successful return to work, its implementation within rehabilitation programs remains insufficient in practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: François KOUKOUI, MD
- Phone Number: 33 1 01 61 69 80 86
- Email: francois.koukoui@chsf.fr
Study Contact Backup
- Name: Caroline TOURTE
- Phone Number: 33 1 01 61 69 31 50
- Email: caroline.tourte@chsf.fr
Study Locations
-
-
France
-
Corbeil-Essonnes, France, France, 91100
- Centre Hospitalier Sud Francilien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female, legally adult patients, participating in a cardiac rehabilitation program in day hospital at the CHSF
- Active in the workforce
- Planning to return to work
- Patients informed of the study and who did not object to it
Exclusion Criteria:
- Patient under legal guardianship
- Presence of cognitive impairments
- Patients who do not speak nor understand French.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Patients with cardiovascular disease participating in a cardiac rehabilitation program at the CHSF
|
The staff members will be asked about :
|
|
Cardiac rehabilitation staff members
medical, paramedical and administrative staff members of the cardiac rehabilitation service at the CHSF
|
Intervention Description : The patients will be asked about :
|
|
Occupational health physicians
A group of ccupational health physicians practicing in the Ile-de-France region, and members of an email distribution list.
|
Occupational health physicians will be asked about their practices concerning employees returning to work after cardiac rehabilitation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived barriers to psychosocial management
Time Frame: at day 0
|
likert scale
|
at day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety (GAD-7 score scale)
Time Frame: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Depression (PHQ9 score scale)
Time Frame: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Practices concerning employees returning to work after cardiac rehabilitation
Time Frame: at day 0
|
likert scale
|
at day 0
|
Collaborators and Investigators
Investigators
- Principal Investigator: François KOUKOUI, MD, Centre Hospitalier Sud Francilien
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-A01210-51
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Rehabilitation
-
Pakistan Institute of Medical SciencesNot yet recruiting
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States
-
I.R.C.C.S. Fondazione Santa LuciaUniversity of Roma La SapienzaCompleted
-
Defactum, Central Denmark RegionCompleted
-
Ivy susanne Modrau, MDAalborg University HospitalEnrolling by invitationCardiac RehabilitationDenmark
-
University of Central LancashireUniversity of Hull; Sheffield Hallam University; Leeds Beckett UniversityWithdrawnCardiac RehabilitationUnited Kingdom
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH)CompletedCardiac RehabilitationUnited States
-
Shanghai Zhongshan HospitalNot yet recruiting
-
University of ValenciaActive, not recruitingCardiac RehabilitationSpain
-
Texas A&M UniversityAscension HealthActive, not recruiting
Clinical Trials on Self administered questionnaire of cardiac rehabilitation patients
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Pr Joel COSTE, Hôpital Hôtel Dieu -...CompletedCOPD (With - Without Rehabilitation) | Diffuse Interstitial Lung Diseases | Pulmonary Arterial Hypertension Primary or Secondary (Post Embolic .....) | Cystic Fibrosis of the AdultFrance
-
University Hospital, LilleFondation Santé RoquetteCompleted
-
Alaa Mohammed YehiaCompletedMolar Incisor Hypomineralization | Dental Enamel HypoplasiaEgypt
-
Centre Hospitalier Intercommunal CreteilNot yet recruitingSquamous Cell Carcinoma of the Anal Canal | HPV-induced Cancer
-
Central Hospital, Nancy, FranceCompletedAtopic DermatitisFrance
-
University Hospital, BordeauxRecruitingSpinal Stenosis | Vertebral Osteomyelitis | SPINAL Fracture | Vertebral MetastasisFrance
-
Sohag UniversityNot yet recruitingQuality of Life | Health Anxiety
-
Sohag UniversityNot yet recruiting
-
University Hospital, BordeauxRecruitingInflammatory Bowel Diseases | Crohn Disease | Ulcerative ColitisFrance
-
Centre Hospitalier Charles Perrens, BordeauxRégion Nouvelle Aquitaine; Regional Health Agency New AquitaineNot yet recruitingCovid19 | Work-Related Condition | Work-Related Stress Disorder | Personnel, Hospital