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 (QALY-SATIS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Quality of Life; Cardiology
• Intervention / Treatment: Other: quality of life questionnaire

Detailed Description

Context: The post-clinical intervention quality of life has become a central clinical criterion for assessing the overall effect of management and is an essential indicator in medico-economic analyses. It allows, among other things, to include the QALYS (Quality-Adjusted Life Years), which combine life expectancy and quality of life in a single synthetic measure, facilitating comparisons between different therapeutic strategies. Health-related quality of life is often measured through the use of a validated questionnaire, completed by patients, which translates their perceived state of health into utility scores. In France, the EQ-5D questionnaire, which covers five dimensions of quality of life (mobility, autonomy, daily activities, pain/discomfort, anxiety/depression), is the main tool used for this measure. The answers are converted into a value of utility using a quotation system (or 'value set') specific to the French population, scientifically validated.

Despite the relevance of this information for improving patient well-being and for medico-economic studies, the collection of quality of life data is still too often absent from the healthcare pathway. To our knowledge, no clinical department of the CHU has a systematic, integrated and automated system for interviewing patients before and after an intervention, in order to document the evolution of their quality of life over time.

At the same time, the quality of life of medical staff is a growing issue, both for the quality of care and for the overall performance of health facilities. The professional well-being of caregivers, their mental load, their level of exhaustion or even their work/personal life balance directly influence their availability, their involvement and the quality of the caregiver-patient relationship.

• Study Type: Observational
• Enrollment (Estimated): 1124

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients and caregivers are their own witnesses	Other: quality of life questionnaire; quality of life questionnaire (EQ5D) and shaphora job questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Romain ESCHALIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; Hospital work satisfaction
• Other Study ID Numbers: RNI 2026 ESCHALIER; 2026-A00487-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: it is a decision that can be taken and discussed in case of specific requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No