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.
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
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
Parallel
No systematic monitoring of symptoms
Other interventionNo 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.
Systematic monitoring of symptoms
Other interventiononce 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.
Health-related quality of life over 12 months, measured by the physical health score of the validated Kidney Disease and Quality of Life™ Short Form (KDQoL-36) questionnaire.
KDQoL-36 Short form assesses quality of life over the past 4 weeks. Physical health score ranges from 0=Worst quality of life to 100=Best quality of life
Respondents' perceptions of the impact of the system's implementation and changes in practices
semi-structured interviews analyzed by NVivo
12-month survival measured using REIN registry data
percentage (0 to 100%) of patients alive at 12 months
Questionnaire completion rates for different arms and periods.
Percentage (0 to 100%) of questionnaire completed
Severity of symptoms measured using the IPOS Renal (Integrated Palliative Outcome Score Renal) questionnaires
Describe the severity of symptoms and their relationship to comorbidities in dialysis patients in the intervention group.
Click on the lead sponsor to view all of their trials.
Central Hospital, Nancy, France
Lead sponsor
Agence de La Biomédecine
Collaborator
University of Bordeaux
Collaborator
University Hospital, Bordeaux
Collaborator
University of Sydney
Collaborator
Centre Hospitalier Régional Universitaire de Tours
Collaborator
Association France REIN
Collaborator
Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
