ClinicalTrials.gg
WithdrawnNCT07651501PSYRCVUpdated Nov 10, 2026

Barriers and Facilitators to Psychosocial Management in Cardiac Rehabilitation at the South Francilien Hospital Center (CHSF)

An observational study in Cardiac Rehabilitation, sponsored by Centre Hospitalier Sud Francilien. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Centre Hospitalier Sud Francilien · Observational

Why this study was withdrawn
The study did not obtain regulatory approval.
Updated Nov 10, 2026Now WithdrawnEnrollment updatedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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 ?
Read the 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.

02

Conditions studied

  • Cardiac Rehabilitation

Keywords

  • cardiac rehabilitation
  • Psychosocial intervention
  • Occupational health
  • Return to work
03

In context

Lead sponsor

Centre Hospitalier Sud Francilien is the lead sponsor of 58 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the cardiac rehabilitation service at the south francilien hospital center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patient under legal guardianship
  • Presence of cognitive impairments
  • Patients who do not speak nor understand French.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

    Patients with cardiovascular disease participating in a cardiac rehabilitation program at the CHSF

    Other: Self administered questionnaire of cardiac rehabilitation patients

  • Cardiac rehabilitation staff members

    medical, paramedical and administrative staff members of the cardiac rehabilitation service at the CHSF

    Other: Self administered questionnaire of cardiac rehabilitation staff members

  • Occupational health physicians

    A group of ccupational health physicians practicing in the Ile-de-France region, and members of an email distribution list.

    Other: Self administered questionnaire of occupational health physicians

Interventions

  • OtherSelf administered questionnaire of cardiac rehabilitation staff members

    Intervention Description : The patients will be asked about : * Their sociodemographic profile (age, gender, family status) * Their professional profile * Their current hospitalisation (reason for hospitalisation, and screening for symptoms of anxiety and depression) * Perceived barriers to psychological support * Perceived barriers to using occupational health services

  • OtherSelf administered questionnaire of cardiac rehabilitation patients

    The staff members will be asked about : * Their sociodemographic profile * Their professional profile * Perceived barriers to psychological support * Perceived barriers to referral to occupational health services.

  • OtherSelf administered questionnaire of occupational health physicians

    Occupational health physicians will be asked about their practices concerning employees returning to work after cardiac rehabilitation

06

What researchers measure

Primary outcomes

  1. Perceived barriers to psychosocial management

    likert scale

    Time frame: at day 0

Secondary outcomes

  1. Anxiety (GAD-7 score scale)

    Minimal, mild, moderate, severe

    Time frame: at day 0

  2. Depression (PHQ9 score scale)

    Minimal, mild, moderate, severe

    Time frame: at day 0

  3. Practices concerning employees returning to work after cardiac rehabilitation

    likert scale

    Time frame: at day 0

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Withdrawn The study did not obtain regulatory approval.
changed Nov 10, 2026
Enrollment
20 (estimated)→0 (actual)
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Withdrawn
    Why stopped The study did not obtain regulatory approval.
    Enrollment 20 (estimated)→0 (actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07651501
Lead sponsor
Centre Hospitalier Sud Francilien
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 10, 2026

Study contacts

François KOUKOUI, MD
principal investigator · Centre Hospitalier Sud Francilien

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion