NCT07651501

Brief 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 ?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 11, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

cardiac rehabilitationPsychosocial interventionOccupational healthReturn to work

Outcome Measures

Primary Outcomes (1)

  • Perceived barriers to psychosocial management

    likert scale

    at day 0

Secondary Outcomes (3)

  • Anxiety (GAD-7 score scale)

    at day 0

  • Depression (PHQ9 score scale)

    at day 0

  • Practices concerning employees returning to work after cardiac rehabilitation

    at day 0

Study Arms (3)

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

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

Cardiac rehabilitation staff members

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.

Patients

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

Occupational health physicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

Study Officials

  • François KOUKOUI, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François KOUKOUI, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2026

First Posted

June 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations