Quality of LifeQALY-SATISNCT07680270
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
An observational study of Quality of Life and Cardiology, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life, Cardiology
- What is being tested?
- quality of life questionnaire
- How many people
- 1,124 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2026to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Cardiology
- Being tested
- quality of life questionnaire
- Keywords
- quality of life, Hospital work satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnaireOther
quality of life questionnaire (EQ5D) and shaphora job questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patients and caregivers are their own witnesses | patients and caregivers are their own witnesses Receives: Other: quality of life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (and 12 months, when applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start19 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain ESCHALIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680270
- Sponsor's protocol ID
- RNI 2026 ESCHALIER
- Other IDs
- 2026-A00487-44
- Acronym
- QALY-SATIS
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: it is a decision that can be taken and discussed in case of specific requests
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07680270
- Acronym / sponsor ID
- QALY-SATIS / RNI 2026 ESCHALIER
- Conditions
- Quality of Life, Cardiology
- Keywords
- quality of life, Hospital work satisfaction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,124 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients and caregivers are their own witnesses | – | Other: quality of life questionnairepatients and caregivers are their own witnesses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
- Working in the Cardiological Intensive Care Unit (USIC), the CB1 unit or the Cardio A unit at the Clermont-Ferrand University Hospital
Key exclusion criteria (7 listed)
- 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.
- Not proficient or unable to read French.
- The administrative agents, the stretcher-bearers, the ASH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life questionnairequality of life questionnaire (EQ5D) and shaphora job questionnaire | Other | patients and caregivers are their own witnesses |
Primary outcome
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. it is a decision that can be taken and discussed in case of specific requests
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romain ESCHALIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Cardiology, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Utility Index from baseline to 3 months (time frame: Baseline (pre-intervention) and 3 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.