- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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 ?
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: François KOUKOUI, MD
- Número de teléfono: 33 1 01 61 69 80 86
- Correo electrónico: francois.koukoui@chsf.fr
Copia de seguridad de contactos de estudio
- Nombre: Caroline TOURTE
- Número de teléfono: 33 1 01 61 69 31 50
- Correo electrónico: caroline.tourte@chsf.fr
Ubicaciones de estudio
-
-
France
-
Corbeil-Essonnes, France, Francia, 91100
- Centre Hospitalier Sud Francilien
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived barriers to psychosocial management
Periodo de tiempo: at day 0
|
likert scale
|
at day 0
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety (GAD-7 score scale)
Periodo de tiempo: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Depression (PHQ9 score scale)
Periodo de tiempo: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Practices concerning employees returning to work after cardiac rehabilitation
Periodo de tiempo: at day 0
|
likert scale
|
at day 0
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: François KOUKOUI, MD, Centre Hospitalier Sud Francilien
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2026-A01210-51
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .