Implementation of a System to Measure the Quality of Life of Patients and Caregivers: a First Experiment in Cardiology at the Clermont-Ferrand University Hospital

NCT07680270 | Enrolling By Invitation

• 2 other identifiers: RNI 2026 ESCHALIER2026-A00487-44
• Study Type: observational
• Target: 1,124
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Measure the quality of life score in the post-interventional care pathway for patients with cardiology, using the EQ-5D-5L; measure caregivers' feelings about their work using the SAPHORA-Job; testing the feasibility and understanding of the two questionnaires among patients and caregivers; building a quality of life database that can be used for clinical, organizational, and medico-economic purposes; producing initial medical resultseconomic exploratory on the relationship between quality of life and care arrangements; and develop a deployment model that can be generalized to other CHU services.

Conditions

Quality of Life; Cardiology

Keywords

quality of life; Hospital work satisfaction

Outcome Measures

Primary Outcomes (2)

• Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months

  Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L). Utility index values are calculated using the validated French value set. Scores generally range from values below 0 (health states worse than death) to 1 (full health), with higher scores indicating better health-related quality of life. Unit of Measure EQ-5D-5L utility index

  Baseline (pre-intervention) and 3 months after intervention

• Healthcare professionals' job satisfaction measured by the Satisfaction des Professionnels Hospitaliers au Travail (SAPHORA-Job) questionnaire

  Healthcare professionals' job satisfaction will be assessed using the Satisfaction des Professionnels Hospitaliers au Travail (SAPHORA-Job) questionnaire. The overall SAPHORA-Job score will be calculated as the mean of completed questionnaire items and ranges from 1 to 6, with higher scores indicating greater job satisfaction. If organizational improvement actions are implemented, the questionnaire will be administered again 12 months later to assess changes over time.

  Baseline (and 12 months, when applicable)

Study Arms (1)

patients and caregivers are their own witnesses

patients and caregivers are their own witnesses

Other: quality of life questionnaire

Interventions

quality of life questionnaire OTHER

quality of life questionnaire (EQ5D) and shaphora job questionnaire

patients and caregivers are their own witnesses

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in cardiology units A, B1 and B2 who have undergone the following procedures: pacemaker insertion (PM), defibrillator insertion (DEF), coronary angiography (FAG) or percutaneous aortic valve implantation (TAVI).

You may qualify if:

• For patients:
• Patients treated in cardiology units A, B1 and B2 who have undergone the following procedures: pacemaker insertion (PM), defibrillator insertion (DEF), coronary angiography (FAG) or percutaneous aortic valve implantation (TAVI).
• Patient aged 18 or over. Patients able to complete the questionnaire on their own.
• For caregivers:
• \- Working in the Cardiological Intensive Care Unit (USIC), the CB1 unit or the Cardio A unit at the Clermont-Ferrand University Hospital

You may not qualify if:

• For patients:
• Patients who do not master or cannot read French.
• Patients transferred to Follow-up and Rehabilitation Care (SSR)
• Patient under judicial protection (guardianship, curatorship) or deprived of liberty.
• For caregivers:
• Not proficient or unable to read French.
• The administrative agents, the stretcher-bearers, the ASH.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Study Officials

• Romain ESCHALIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 2, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

FR (1)