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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Clermont-Ferrand、フランス
- CHU Clermont-Ferrand
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Romain ESCHALIER、University Hospital, Clermont-Ferrand
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RNI 2026 ESCHALIER
- 2026-A00487-44 (その他の識別子:ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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