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Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
The SMaRRT-HD trial is a cluster randomized trial of symptom monitoring with supported clinician follow-up using the SMaRRT-HD electronic patient reported outcome measure (ePROM) system versus Usual Care. Approximately 2400 patients at up to 36 geographically and racially diverse US hemodialysis clinics will be enrolled. The primary trial hypothesis is that regular symptom patient reported outcome measure (PROM) administration with supported clinician follow-up in dialysis care will reduce suffering and improve outcomes by prompting treatment of unrecognized symptoms, and enhancing patient-care team communication. Clinics randomized to the SMaRRT-HD group will adopt the use of SMaRRT-HD for 12 months. SMaRRT-HD is a symptom monitoring system that includes 1) tablet-based symptom reporting using a PROM and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. Dialysis clinics randomized to Usual Care will not adopt SMaRRT-HD or any other trial-driven procedures. Usual Care clinics will monitor symptoms through clinical care interactions with participants and by administering a Health Related Quality of Life survey that includes questions about symptoms.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fresenius Medical Care
Waltham, Massachusetts, United States
Start Date
June 24, 2023
Primary Completion Date
March 1, 2027
Completion Date
September 1, 2027
Last Updated
November 24, 2025
2,400
ESTIMATED participants
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
BEHAVIORAL
Usual Care
BEHAVIORAL
Lead Sponsor
University of Pennsylvania
Collaborators
NCT07271420
NCT05525507
Data Source & Attribution
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