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

NANot yet recruitingINTERVENTIONAL
Enrollment

2,293

Participants

Timeline

Start Date

March 15, 2024

Primary Completion Date

September 15, 2026

Study Completion Date

September 15, 2026

Conditions
End Stage Renal Disease
Interventions
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.

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."

Trial Locations (1)

54 500

Ostermann, Vandœuvre-lès-Nancy

All Listed Sponsors
collaborator

Agence de La Biomédecine

OTHER_GOV

collaborator

University of Bordeaux

OTHER

collaborator

University Hospital, Bordeaux

OTHER

collaborator

University of Sydney

OTHER

collaborator

Centre Hospitalier Régional Universitaire de Tours

OTHER_GOV

collaborator

Association France REIN

UNKNOWN

collaborator

Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)

UNKNOWN

collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

lead

Central Hospital, Nancy, France

OTHER

NCT06257134 - Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients. | Biotech Hunter | Biotech Hunter