Symptom Monitoring in Hemodialysis
Recruiting · NCT05738330 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pennsylvania
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Fresenius Medical Care - Waltham, Massachusetts, United States