Routine electronic symptom monitoring for adults on dialysis
Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients, With Results Notification to Teams. A Cluster Randomised Controlled Trial Nested in a National Registry F-SWIFT (French Symptom Monitoring WIth Feedback Trial)
This project tests whether regular electronic symptom questionnaires for adults on dialysis can improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2293 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 3 sites (Gradignan and 2 other locations) |
| Trial ID | NCT06257134 on ClinicalTrials.gov |
What this trial studies
F-SWIFT is a multicenter, randomized controlled trial nested in the French REIN dialysis registry that compares routine electronic symptom monitoring to usual care in adult dialysis patients. Participants in the intervention arm complete the IPOS‑Renal questionnaire every three months for 18 months with results systematically reported to treating clinicians, while HRQoL is measured every six months with EQ-5D-5L and KDQoL-36 in both groups. The trial includes quantitative outcome analysis and a qualitative process evaluation to support transferability and potential large-scale deployment. Data are drawn from registry records and analyzed by biostatisticians and human and social sciences researchers at CHRU Nancy.
Who should consider this trial
Good fit: Ideal candidates are adults with end-stage renal disease receiving dialysis at participating French dialysis units who can complete questionnaires and consent to the use of their data.
Not a fit: Patients who cannot complete questionnaires, are under legal protection (guardianship/curatorship), minors, or who receive care outside participating units are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lead to earlier recognition and management of symptoms and measurable improvements in patients' health-related quality of life.
How similar studies have performed: Routine electronic symptom monitoring has shown promise in other chronic conditions but is relatively untested in nephrology, so this trial addresses a novel application for dialysis patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gradignan and 2 other locations
- Maison du Rein AURAD Aquitaine — Gradignan, France (Not_yet_recruiting)
- Altir — Vandœuvre-lès-Nancy, France (Recruiting)
- CHRU Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Francis GUILLEMIN, MD, PhD — Centre d'Investigation Clinique - Epidémiologie Clinique 1433
- Study coordinator: Nadine JUGE
- Email: n.juge@chru-nancy.fr
- Phone: 03 83 15 35 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.