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Clinical Trials in France / NCT07680270
Enrolling by invitation Observational

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 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Clermont-Ferrand
Phase
Observational
Started
2026-06-19
Last updated
2026-07-02

Condition(s) studied

Quality of LifeCardiology

Investigational drug(s) / intervention(s)

quality of life questionnaire

quality of life questionnaire: quality of life questionnaire (EQ5D) and shaphora job questionnaire

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: 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.

Primary outcome measure(s)

  • Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months — Baseline (pre-intervention) and 3 months after intervention
    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
  • Healthcare professionals' job satisfaction measured by the Satisfaction des Professionnels Hospitaliers au Travail (SAPHORA-Job) questionnaire — Baseline (and 12 months, when applicable)
    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.

Trial sites (1)

FacilityCityRegionStatus
CHU Clermont-Ferrand Clermont-Ferrand France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07680270 on ClinicalTrials.gov ↗ ← All trials in France