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

What this Trial Is About

This research aims to evaluate whether regular monitoring and feedback of symptoms can improve the quality of life for patients undergoing dialysis for end-stage renal disease ESRD. The study focuses on addressing the often overlooked symptoms that affect the physical and mental health quality of life in dialysis patients. It also assesses the feasibility and cost-effectiveness of electronically capturing patient-reported outcomes within a national dialysis registry. Participants are randomly assigned to either an experimental group or a control group. The experimental group completes symptom questionnaires every three months via a digital tablet during dialysis sessions, with severe symptoms automatically reported to healthcare teams for management. The control group receives usual care without systematic symptom monitoring. Both groups complete quality of life assessments every six months over 18 months. Half of the dialysis units have a clinical research nurse supporting data collection for 12 months, followed by local teams managing data collection for the remaining six months. During the study, patients provide symptom and quality of life data through digital questionnaires completed at regular intervals during dialysis. Researchers analyze these patient-reported outcomes, clinical data from the national registry, and healthcare usage from administrative databases. Interviews with patients and healthcare professionals explore the implementation process and perceptions of the intervention. The primary outcome is the physical health score from a validated kidney disease quality of life questionnaire after 12 months. The total participation and observation period lasts 18 months, with ongoing safety and data monitoring.

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