- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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 ?
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: François KOUKOUI, MD
- Telefonnummer: 33 1 01 61 69 80 86
- E-mail: francois.koukoui@chsf.fr
Undersøgelse Kontakt Backup
- Navn: Caroline TOURTE
- Telefonnummer: 33 1 01 61 69 31 50
- E-mail: caroline.tourte@chsf.fr
Studiesteder
-
-
France
-
Corbeil-Essonnes, France, Frankrig, 91100
- Centre Hospitalier Sud Francilien
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived barriers to psychosocial management
Tidsramme: at day 0
|
likert scale
|
at day 0
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety (GAD-7 score scale)
Tidsramme: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Depression (PHQ9 score scale)
Tidsramme: at day 0
|
Minimal, mild, moderate, severe
|
at day 0
|
|
Practices concerning employees returning to work after cardiac rehabilitation
Tidsramme: at day 0
|
likert scale
|
at day 0
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: François KOUKOUI, MD, Centre Hospitalier Sud Francilien
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-A01210-51
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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