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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)

1 juli 2026 uppdaterad av: University Hospital, Clermont-Ferrand
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.

Studieöversikt

Status

Anmälan via inbjudan

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

1124

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Clermont-Ferrand, Frankrike
        • CHU clermont-ferrand

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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).

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
patients and caregivers are their own witnesses
quality of life questionnaire (EQ5D) and shaphora job questionnaire

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months
Tidsram: 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

Baseline (pre-intervention) and 3 months after intervention
Healthcare professionals' job satisfaction measured by the Satisfaction des Professionnels Hospitaliers au Travail (SAPHORA-Job) questionnaire
Tidsram: 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.
Baseline (and 12 months, when applicable)

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Romain ESCHALIER, University Hospital, Clermont-Ferrand

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 juni 2026

Primärt slutförande (Beräknad)

30 december 2026

Avslutad studie (Beräknad)

30 maj 2028

Studieregistreringsdatum

Först inskickad

23 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juli 2026

Första postat (Faktisk)

2 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • RNI 2026 ESCHALIER
  • 2026-A00487-44 (Annan identifierare: ANSM)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

it is a decision that can be taken and discussed in case of specific requests

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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