Symptom Monitoring in Hemodialysis
Recruiting now · Not applicable
Conditions studied: End Stage Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT05738330
- Run by
- University of Pennsylvania
- People needed
- 2400
- Starts
- 2023-06-24
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-11-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- Treatment with hemodialysis at a participating dialysis clinic
- English or Spanish speaking
You may not qualify if…
- Not willing to report their symptoms using the SMaRRT-HD platform
- Not willing to share clinically acquired data with the research team
- Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
- Incarceration
Where it is running
- Fresenius Medical Care — Waltham, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.