NCT06257134: F-SWIFT

Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients.

Recruiting now NA Last updated 13 February 2026

What this trial tests

NA trial testing No systematic monitoring of symptoms in End Stage Renal Disease in 2,293 participants. Currently enrolling.

Timeline

6 February 2026

Primary endpoint
15 September 2026

15 December 2026

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	2,293
Start date	6 February 2026
Primary completion	15 September 2026
Estimated completion	15 December 2026
Sites	3 locations across France

Drugs / interventions tested

• No systematic monitoring of symptoms
• Systematic monitoring of symptoms

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.