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

F-SWIFT is a large-scale, multi-center, randomized controlled trial (qualitative and quantitative) nested in a national registry.

Indeed, this research project is nested in the REIN (Réseau Epidémiologique et Information en Nephrologie) registry, to which all dialysis units in France have been contributing for over 10 years. All information on the dialysis units and the patients included is taken directly from the register. The field presence of REIN's clinical research officers ensures the quality of the data routinely collected for the registry, and reused in this project.

The F-SWIFT project includes a process analysis to support the transferability of F-SWIFT in the event of proven effectiveness, with a view to large-scale deployment.

Data analysis will be carried out by a biostatistician and Human and Social Sciences engineers from CIC 1433 Epidémiologie Clinique at CHRU Nancy.

In accordance with the third paragraph of article 56 of the French Data Protection Act, the presentation of the results of data processing may under no circumstances allow direct or indirect identification of the persons involved in the research.

Experimental group

• Quarterly measurement for 18 months of patients' symptoms using the IPOS-Renal questionnaire, which will be systematically reported to professionals.
• Measurement every 6 months for 18 months of patients' health-related HRQoL using the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version), KDQoL-36 (Kidney Disease and Quality of Life™ Short Form) and SONG-Fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires.

Control group

• No systematic symptom monitoring will be organized, and patients will receive usual care.
• Measurement every 6 months for 18 months of health-related HRQoL using the EQ-5D-5L, KDQoL-36 and SONG-Fatigue questionnaires.

Process evaluation phase

Quantitative component

For all dialysis units included in the experimental arm:

The REIN registry will provide data on: legal status, volume of patients managed, treatment options offered. The REIN registry will also provide data on patients in these units: age, sex, comorbidity, length of time on dialysis and dialysis treatment modality.

For patients at inclusion, an ad hoc questionnaire will be added on electronic equipment at home, which includes the availability and use of a laptop, desktop, tablet, cell phone and broadband internet subscription.

Per unit, every 3 months, loyalty criteria (% of patients having completed the IPOS-Renal questionnaire) and dose criteria (cumulative number of completed IPOS-Renal questionnaires) will be collected.

Based on the reimbursement list provided by the health insurance (data extracted from the REIN register linked to the SNDS), changes in prescribing practices will be studied (prescription of drugs and supportive care, in particular dietary, psychological and sports care). The before-and-after trends will be analyzed one year after the end of the study in the unit (remote evaluation), since the data are only consolidated at that time.

Qualitative component:

Three months after the start of the study, from among the units in the experimental group meeting the condition without external assistance from the Clinical Research Nurse (CRN) to collect data, five units will be selected following an extreme case sampling (2 with the highest level, 1 with a standard level and 2 with the lowest level of intervention application) to conduct semi-structured interviews.

At this stage, the research team will focus on organizational and implementation factors to provide information for the scientific committee, which will be responsible for decisions to adapt the F-SWIFT intervention and improve its effectiveness. After three months of fine-tuning the intervention, the research team will carry out a second wave of qualitative process evaluation to (re)test the intervention in five other units.

Semi-structured individual interviews will therefore be conducted with patients and healthcare professionals (nurses and doctors) on the basis of a guide developed to gather perceptual data on how contextual characteristics affect the effective implementation and outcomes of the F-SWIFT intervention.

Participants in the individual semi-structured interview will receive an e-mail from an engineer in the humanities and social sciences, informing them of the date and time of the appointment, as well as the connection link if the interview takes place remotely.

Inclusion criteria

Symptom collection phase

The inclusion criteria for patients are as follows:

• 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

Process evaluation phase

The inclusion criteria for healthcare professionals are as follows:

• 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.
• Patients with end-stage renal disease treated by dialysis in participating dialysis units.
• Doctors and nurses working in the dialysis unit taking part in the study.

Exclusion criteria

The non-inclusion criteria for patients are as follows:

• 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
• Patients being treated temporarily in a participating dialysis unit (respite care, vacationers, etc.)
• Patient with cognitive disorders
• Patient unable or unwilling to answer questionnaires

The non-inclusion criteria for healthcare professionals are as follows:

• Non-voluntary healthcare professional
• Healthcare professional not working in the participating facility