Actively Recruiting
Symptom Monitoring in Hemodialysis
Led by University of Pennsylvania · Updated on 2025-11-24
2400
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
U
University of North Carolina, Chapel Hill
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Symptom Monitoring in Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 18 years
- Receiving hemodialysis treatment at a participating dialysis clinic
- Able to speak English or Spanish
You will not qualify if you...
- Unwilling to report symptoms using the SMaRRT-HD platform
- Unwilling to share clinical data with the research team
- Having a condition like dementia that may prevent understanding the trial information
- Being incarcerated
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fresenius Medical Care
Waltham, Massachusetts, United States, 02451
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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