- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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 ?
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: François KOUKOUI, MD
- Numéro de téléphone: 33 1 01 61 69 80 86
- E-mail: francois.koukoui@chsf.fr
Sauvegarde des contacts de l'étude
- Nom: Caroline TOURTE
- Numéro de téléphone: 33 1 01 61 69 31 50
- E-mail: caroline.tourte@chsf.fr
Lieux d'étude
-
-
France
-
Corbeil-Essonnes, France, France, 91100
- Centre Hospitalier Sud Francilien
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Perceived barriers to psychosocial management
Délai: at day 0
|
likert scale
|
at day 0
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety (GAD-7 score scale)
Délai: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Depression (PHQ9 score scale)
Délai: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Practices concerning employees returning to work after cardiac rehabilitation
Délai: at day 0
|
likert scale
|
at day 0
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François KOUKOUI, MD, Centre Hospitalier Sud Francilien
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026-A01210-51
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .