Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis.
Jennifer E Flythe, Cassandra B Picataggio, Leah Bernardo...
https://pubmed.ncbi.nlm.nih.gov/40889553Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05738330
Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
Led by University of Pennsylvania · Updated on 2025-11-24
2400
Participants Needed
1
Research Sites
26 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
This research aims to compare two methods of symptom monitoring in adults with End Stage Kidney Disease undergoing hemodialysis. The study evaluates whether using the SMaRRT-HD electronic patient-reported outcome measure system with supported clinician follow-up can reduce symptoms and improve communication between patients and care teams. Approximately 2400 patients from up to 36 diverse dialysis clinics in the US will participate, with clinics randomly assigned to either SMaRRT-HD or Usual Care. Participants in clinics using the SMaRRT-HD system will report symptoms on tablets through an electronic patient-reported outcome measure, and clinicians will receive alerts, guidance, and symptom reports to support follow-up care. This system is used alongside the usual symptom monitoring. Clinics assigned to Usual Care will continue their standard symptom monitoring through clinical interactions and a mandated health-related quality of life survey. The study period for the SMaRRT-HD system lasts 12 months. During the study, researchers will assess symptom severity, quality of life, fatigue, pain interference, anxiety, depression, healthcare engagement, hospitalizations, mortality, and dialysis session attendance at baseline, 6 months, and 12 months. Implementation outcomes such as adherence to symptom reporting, clinician follow-up, and acceptability of the system will also be evaluated. Hospitalizations and mortality will be tracked for 18 months total. Participants will be monitored throughout the active study period to understand the impact of symptom monitoring methods on their care.
CONDITIONS
Brief Title
Symptom Monitoring in Hemodialysis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Receiving hemodialysis treatment at a participating dialysis clinic
- Able to speak English or Spanish
You will not qualify if you...
- Not willing to report symptoms using the SMaRRT-HD platform
- Not willing to share clinical data with the research team
- Having a condition like dementia that prevents understanding of study information
- Being incarcerated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 12 months
Participants receive symptom monitoring while undergoing routine hemodialysis care at their clinics. Those in the SMaRRT-HD group use a tablet-based symptom reporting system with clinician follow-up support, while others receive usual care symptom monitoring through clinical interactions and standard surveys.
Ongoing symptom reporting during dialysis sessions and periodic assessments at baseline, 6 months, and 12 months
Follow-up
Duration - 6 months
Participants are observed for additional health outcomes such as hospitalizations and mortality for up to 6 months after the 12-month treatment period.
Periodic health status assessments during the follow-up period
Trial Site Locations
Total: 1 location
1
Fresenius Medical Care
Waltham, Massachusetts, United States, 02451
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here