Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients. (F-SWIFT)

February 5, 2024 updated by: GUILLEMIN Francis, MD, Central Hospital, Nancy, France

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2293

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Patients in the control group will complete three HRQoL questionnaires every six months via a digital tablet during their dialysis session.
Other: No systematic monitoring of symptoms
No 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.
Experimental: Experimental group
Every three months, patients in the experimental group will have their symptoms systematically recorded using the IPOS-Renal questionnaire via a digital tablet during their dialysis session.
Other: Systematic monitoring of symptoms

once 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respondents' perceptions of the impact of the system's implementation and changes in practices
Time Frame: 3 months
semi-structured interviews analyzed by NVivo
3 months
12-month survival measured using REIN registry data
Time Frame: 12 months
percentage (0 to 100%) of patients alive at 12 months
12 months
Questionnaire completion rates for different arms and periods.
Time Frame: 12 months
Percentage (0 to 100%) of questionnaire completed
12 months
Severity of symptoms measured using the IPOS Renal (Integrated Palliative Outcome Score Renal) questionnaires
Time Frame: 18 months
Describe the severity of symptoms and their relationship to comorbidities in dialysis patients in the intervention group.
18 months
Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires
Time Frame: 18 months

Describe the severity of symptoms and their relationship to comorbidities in dialysis patients in the intervention group.

Song Fatigue : Minimum value: not at all maximum value: extremely Maximum value means a worse result
18 months
Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires
Time Frame: 18 months

Evaluate the effectiveness of the intervention on the mental health score of the validated KDQoL-36 questionnaire.

Song Fatigue : Minimum value: not at all maximum value: extremely Maximum value means a worse result
18 months
12-month survival measured using REIN data
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months
Numbers of care consumption, including hospitalizations, drugs, prescriptions for biological and imaging tests, based on SNDS data.
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months
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.
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months
Duration of dialysis measured using REIN registry data.
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months
Frequency of dialysis measured using REIN registry data.
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months
Number of dialysis stops measured using REIN registry data.
Time Frame: 18 months
Evaluate the effectiveness of the intervention at 18 months and the sustainability of practices based on the indicators used in the main objective and secondary objectives 2, 3 and 6.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
University of Bordeaux
University Hospital, Bordeaux
University of Sydney
Agence de La Biomédecine
Association France REIN
Centre Hospitalier Régional Universitaire de Nancy
Centre Hospitalier Régional Universitaire de Tours
Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)

Investigators

  • Principal Investigator: Francis GUILLEMIN, MD, PhD, Centre d'Investigation Clinique - Epidémiologie Clinique 1433

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023PI052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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