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

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.

Conditions

• End Stage Renal Disease

Interventions

OTHER

No systematic monitoring of symptoms

No systematic monitoring of symptoms will be carried out, and patients will receive the usual care. Data collection will be carried out with the assistance of a clinical research nurse up to 12 months, then under the direction of local healthcare teams at 18 months.

OTHER

Systematic monitoring of symptoms

once a month, individual patient scores will be sent to dialysis staff. Any score of 3 (severe symptoms) or 4 (overwhelming) on a scale of 0 to 4, on the IPOS-Renal instrument, will be permanently reported to the referrer to trigger the patient's usual symptom management. Patients will complete 3 further HRQoL questionnaires at baseline, M6, M12 and M18: EQ-5D-5L, KDQoL-36, SONG Fatigue. A clinical research nurse will be present in half of the participating dialysis units to help patients and dialysis teams to include and follow up patients, up to 12 months. Between 12 and 18 months, data will be collected in "real life", under the guidance of local healthcare teams. In the other half of the dialysis units, data will be collected under the direction of the local healthcare teams, who will have to organize themselves to ensure data collection. These units will also be asked to conduct semi-structured interviews as part of the qualitative phase.

Sponsors & Collaborators

• Agence de La Biomédecine

  collaborator OTHER_GOV

• University of Bordeaux

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University of Sydney

  collaborator OTHER

• Centre Hospitalier Régional Universitaire de Tours

  collaborator OTHER_GOV

• Association France REIN

  collaborator UNKNOWN

• Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)

  collaborator UNKNOWN

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Central Hospital, Nancy, France

  lead OTHER

Principal Investigators

• Francis GUILLEMIN, MD, PhD · Centre d'Investigation Clinique - Epidémiologie Clinique 1433

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-06

Primary Completion

2026-09-15

Completion

2026-12-15

Countries

• France

Study Locations