跳至主要内容
临床试验/NCT07680270
NCT07680270Enrolling By Invitation不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 1,124 人开始时间: 2026年6月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,124
试验地点
1
主要终点
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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