NCT06257134 Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients.
| NCT ID | NCT06257134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | End Stage Renal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,293 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,293 participants in total. It began in 2026-02-06 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In France, end-stage renal disease (ESRD) affects almost 170 people per million inhabitants every year, and 92,500 people are treated by dialysis or kidney transplantation (0.14% of the French population). The treatment of chronic renal failure is extremely costly: 4 billion euros in 2021, i.e. 2% of health insurance expenditure, and an annual cost of 42,000 euros per patient. The health-related quality of life (HRQoL) of dialysis patients is low, with reports of patients at 40%-60% of full health. In France, there has been a significant decrease in physical (-15.4 points) and mental (-6.9 points) component scores compared with the general population. Dialysis patients often present severe or overwhelming symptoms, which contribute to this poor HRQoL. However, in nephrology, studies have focused on survival and laboratory biomarkers, and very few interventions have been aimed at improving what was a priority for patients, i.e. treating their symptoms and improving their HRQoL. Opportunities to intervene and improve symptom management and overall HRQoL may therefore have been missed. Ignoring patients' symptoms is an important omission. Of 28 randomized trials in primary care and oncology that measured the impact of communicating patient-reported outcomes to clinicians, 65% showed improved care processes and 47% improved health outcomes. The results of two recent randomized trials in oncology suggest that symptom monitoring can improve HRQoL and overall survival. There is no evidence for dialysis patients, although therapeutic solutions are available in most cases. Nephrology teams do not sufficiently recognize the prevalence, severity and negative effects of symptoms in their patients, and patients under-report their symptoms. With systematic symptom screening and automatic transmission of symptoms in the form of alerts, dialysis staff will be able to react and implement routine management to alleviate patients' symptoms. The F-SWIFT study evaluates the hypothesis that regular symptom monitoring and feedback to hemodialysis patients and their dialysis staff improves patient HRQoL at 18 months. In addition, the trial aims to determine whether electronic capture of patient-reported outcomes within a national dialysis patient registry is feasible and cost-effective, evaluated using consumption data from the Système National des données de Santé (SNDS) medico-administrative database. F-SWIFT is the French part of an international project (SWIFT) initiated in Australia in 2021: Australian New Zealand Clinical Trials Registry #ACTRN12620001061921. This French part is funded by Inserm's AAP MESSIDORE 2022. F-SWIFT is also the continuation of the pilot study n° 2021-A00776-35 accepted by the CPP EST II on 19/10/2021 and financed by the Agence de la Biomédecine (AOR 2021) in the RIPH3 category.
Eligibility Criteria
Inclusion Criteria: Symptom collection phase The inclusion criteria for patients are as follows: * Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data. * Adults aged 18 and over * Patients with end-stage renal disease treated by dialysis in participating dialysis units * Patients able to answer questionnaires Process evaluation phase The inclusion criteria for healthcare professionals are as follows: * Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data. * Patients with end-stage renal disease treated by dialysis in participating dialysis units. * Doctors and nurses working in the dialysis unit taking part in the study. Exclusion Criteria: The non-inclusion criteria for patients are as follows: * Minors * Patients under legal protection, guardianship or curatorship * Patient not communicating or unable to give consent * Patient not being treated in a dialysis unit participating in the study * Patients being treated temporarily in a participating dialysis unit (respite care, vacationers, etc.) * Patient with cognitive disorders * Patient unable or unwilling to answer questionnaires The non-inclusion criteria for healthcare professionals are as follows: * Non-voluntary healthcare professional * Healthcare professional not working in the participating facility
Contact & Investigator
Francis GUILLEMIN, MD, PhD
PRINCIPAL INVESTIGATOR
Centre d'Investigation Clinique - Epidémiologie Clinique 1433
Frequently Asked Questions
Who can join the NCT06257134 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06257134 currently recruiting?
Yes, NCT06257134 is actively recruiting participants. Contact the research team at n.juge@chru-nancy.fr for enrollment information.
Where is the NCT06257134 trial being conducted?
This trial is being conducted at Gradignan, France, Vandœuvre-lès-Nancy, France, Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT06257134 clinical trial?
NCT06257134 is sponsored by Central Hospital, Nancy, France. The principal investigator is Francis GUILLEMIN, MD, PhD at Centre d'Investigation Clinique - Epidémiologie Clinique 1433. The trial plans to enroll 2,293 participants.