NCT05738330Recruiting
Symptom Monitoring in Hemodialysis
Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2400 (estimated)
- First submitted
- 31 Jan 2023
- Start date
- 24 Jun 2023
- Primary completion date
- Mar 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Chronic kidney disease
- NCT number
- NCT05738330
What you commit to
- Study type: Interventional
- Planned participants: 2400
- From 24 Jun 2023 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
Other
- Not willing to report their symptoms using the SMaRRT-HD platform
- Not willing to share clinically acquired data with the research team
- Incarceration
Who the study is looking for
- Age ≥ 18 years
- Treatment with hemodialysis at a participating dialysis clinic
- English or Spanish speaking
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fresenius Medical Care Coordinator of this site? Confirm its status | Waltham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.