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Symptom Monitoring in Hemodialysis
Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Age ≥ 18 years * Treatment with hemodialysis at a participating dialysis clinic * English or Spanish speaking Exclusion Criteria: * 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
About the study
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.
What is being tested
- Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) (behavioral)
- Usual Care (behavioral)
Sponsor: University of Pennsylvania · Participants: 2,400 · Started: Jun 24, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT05738330
Locations in the U.S.
| Massachusetts | Fresenius Medical Care, Waltham |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.