Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients. - Trial NCT06257134

Timeline & Enrollment

Primary Outcome

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.

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.

ICD-10 Classifications