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

NCT06257134 | Recruiting

• 1 other identifier: 2023PI052
• Study Type: interventional
• Target: 2,293
• Locations: 1 country
• Sites: 3

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.

Conditions

End Stage Renal Disease

Keywords

Symptoms; Quality of life; IPOS-Renal; Dialysis units; ePROMS; Tablets; RedCAP

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (12)

• Respondents' perceptions of the impact of the system's implementation and changes in practices

  3 months

• 12-month survival measured using REIN registry data

  12 months

• Questionnaire completion rates for different arms and periods.

  12 months

• Severity of symptoms measured using the IPOS Renal (Integrated Palliative Outcome Score Renal) questionnaires

  18 months

• Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires

  18 months

Study Arms (2)

Control group

OTHER

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

Experimental group

EXPERIMENTAL

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

Interventions

Systematic monitoring of symptoms OTHER

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.

Experimental group

No systematic monitoring of symptoms OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptom collection phase
• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (3)

Maison du Rein AURAD Aquitaine

Gradignan, 33171, France

NOT YET RECRUITING

ALTIR

Vandœuvre-lès-Nancy, 54 500, France

RECRUITING

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

Related Publications (17)

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• Viecelli AK, Duncanson E, Bennett PN, D'Antoine M, Dansie K, Handke W, Tong A, Palmer S, Jesudason S, McDonald S, Morton RL; Symptom Monitoring With Feedback Trial (SWIFT) Investigators. Perspectives of Patients, Nurses, and Nephrologists About Electronic Symptom Monitoring With Feedback in Hemodialysis Care. Am J Kidney Dis. 2022 Aug;80(2):215-226.e1. doi: 10.1053/j.ajkd.2021.12.007. Epub 2022 Jan 25.

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• Kalantar-Zadeh K, Li PK, Tantisattamo E, Kumaraswami L, Liakopoulos V, Lui SF, Ulasi I, Andreoli S, Balducci A, Dupuis S, Harris T, Hradsky A, Knight R, Kumar S, Ng M, Poidevin A, Saadi G, Tong A; World Kidney Day Steering Committee. Living well with kidney disease by patient and care-partner empowerment: Kidney health for everyone everywhere. Saudi J Kidney Dis Transpl. 2021 Mar-Apr;32(2):289-297. doi: 10.4103/1319-2442.335439.

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MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis GUILLEMIN, MD, PhD

  Centre d'Investigation Clinique - Epidémiologie Clinique 1433

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine JUGE

CONTACT

03 83 15 35 39; n.juge@chru-nancy.fr

Amandine OSTERMANN

CONTACT

03 83 15 35 30; a.ostermann@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: February 13, 2024
• Study Start: February 6, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)