MedTrace Logo

Impact of the Routine Collection of Symptoms on Quality of Life in Dialysis Patients

NCT05154708 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2025-02-27

No results posted yet for this study

Summary

Chronic kidney disease (CKD) affects 85,000 people in France. Medical care for this disease represents 2% of the Health Insurance budget.

Patients on dialysis frequently experience severe or overwhelming symptoms which contributes to poor health related quality of life (HRQoL). However, taking into account the measurement of the patients' symptoms by the patients themselves would allow to improve their HRQoL by putting more emphasis on the results that matter the most to the patients. It would also improve information and decision-making between nephrology care team and patients.

Systematic use of patients reported outcomes measures (PROMs) is not widely used due to a number of barriers including logistics and feasibility.

How will the F-SWIFT Pilot project address the barriers associated with PROMs? By choosing short questionnaires to complete By providing feedback on the severity of symptoms to the dialysis team and to patients By making links to good practice recommendations included in the feedback Allowing electronic collection of PROMs The research question therefore asks whether regular symptom monitoring with feedback to dialysis staff improves dialysis patient's outcomes? To do this, a pilot study must be carried out with the following main objectives Test the feasibility of integrating electronic measurements of PROMs with feedback to the dialysis team.

Three centers are participating in this pilot study:

* The nephrology department of the Nancy CHRU
* The Lorraine Association for the Treatment of Renal Insufficiency (ALTIR)
* The nephrology department of the Nîmes University Hospital

The project will take place in 2 phases :

Phase 1 To identify the needs and expectations of patients and health professionals in relation to a systematic electronic measurement of symptoms made by the patients themselves.

Focus groups (interviews) will be conducted with patients (n=15) and healthcare professionals (n=15).

Phase 2 (n=50-60 patients) To develop and test an electronic PROMs system allowing

* Collect patients' symptoms
* Identify patients with severe symptoms
* Alert the dialysis team in case of severe symptoms
* Suggest appropriate management strategies

Conditions

  • Patients Reported Outcomes

Sponsors & Collaborators

  • Agence de La Biomédecine

    collaborator OTHER_GOV

  • Association France REIN

    collaborator UNKNOWN

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Luc FRIMAT · CHRU de Nancy

  • Olivier Moranne · Centre Hospitalier Universitaire de Nīmes

  • Nelly CASTIN · ALTIR

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2023-11-13
Completion
2024-02-22

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05154708 on ClinicalTrials.gov