- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07680270
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)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Clermont-Ferrand, Francia
- CHU Clermont-Ferrand
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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patients and caregivers are their own witnesses
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quality of life questionnaire (EQ5D) and shaphora job questionnaire
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months
Periodo de tiempo: Baseline (pre-intervention) and 3 months after intervention
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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
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Healthcare professionals' job satisfaction measured by the Satisfaction des Professionnels Hospitaliers au Travail (SAPHORA-Job) questionnaire
Periodo de tiempo: Baseline (and 12 months, when applicable)
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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.
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Baseline (and 12 months, when applicable)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Romain ESCHALIER, University Hospital, Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RNI 2026 ESCHALIER
- 2026-A00487-44 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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