Clinical trial NCT06257134: Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients.
Official title: 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 (French Symptom Monitoring WIth Feedback Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Symptoms
Quality of life
IPOS-Renal
Dialysis units
ePROMS
Tablets
RedCAP
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
name: University of Bordeaux
name: University Hospital, Bordeaux
name: University of Sydney
name: Centre Hospitalier Régional Universitaire de Tours
name: Association France REIN
name: Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-02-13
Enrollment: 2293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: F-SWIFT is a large-scale, multi-center, randomized controlled trial (qualitative and quantitative) nested in a national registry.

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, KDQoL-36 and SONG-Fatigue questionnaires.

Control group

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

The F-SWIFT project includes a process analysis to underpin the transferability of F-SWIFT in the event of proven effectiveness with a view to large-scale deployment.
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Respondents' perceptions of the impact of the system's implementation and changes in practices
timeFrame: 3 months
measure: 12-month survival measured using REIN registry data
timeFrame: 12 months
measure: Questionnaire completion rates for different arms and periods.
timeFrame: 12 months
measure: Severity of symptoms measured using the IPOS Renal (Integrated Palliative Outcome Score Renal) questionnaires
timeFrame: 18 months
measure: Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires
timeFrame: 18 months
measure: Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires
timeFrame: 18 months
measure: 12-month survival measured using REIN data
timeFrame: 18 months
measure: Numbers of care consumption, including hospitalizations, drugs, prescriptions for biological and imaging tests, based on SNDS data.
timeFrame: 18 months
measure: Incremental cost between intervention and no-intervention groups related to the quality-adjusted life-year differential assessed by the evolution of utility at 12 months measured by the EQD5D-5L questionnaire.
timeFrame: 18 months
measure: Duration of dialysis measured using REIN registry data.
timeFrame: 18 months
measure: Frequency of dialysis measured using REIN registry data.
timeFrame: 18 months
measure: Number of dialysis stops measured using REIN registry data.
timeFrame: 18 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Ostermann
Study officials:
affiliation: Centre d'Investigation Clinique - Epidémiologie Clinique 1433
name: Francis GUILLEMIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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