2,293
Participants
Start Date
March 15, 2024
Primary Completion Date
September 15, 2026
Study Completion Date
September 15, 2026
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.
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."
Ostermann, Vandœuvre-lès-Nancy
Agence de La Biomédecine
OTHER_GOV
University of Bordeaux
OTHER
University Hospital, Bordeaux
OTHER
University of Sydney
OTHER
Centre Hospitalier Régional Universitaire de Tours
OTHER_GOV
Association France REIN
UNKNOWN
Association AFIDTN (French Association of Dialysis, Transplant and Nephrology Nurses)
UNKNOWN
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Central Hospital, Nancy, France
OTHER