Comparing Two Ways to Monitor Symptoms for Adults on Hemodialysis Using the SMaRRT-HD System Versus Usual Care
Led by University of Pennsylvania · Updated on 2025-11-24
2400
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
SMaRRT‑HD system + usual care
Usual Care
Structured PROM‑based symptom screening
What it is
A digital system for symptom monitoring in dialysis combining patient‑reported ePROM surveys, clinician alerts, guidance, symptom reports and a dashboard alongside usual clinical care
Routine symptom monitoring through clinical interactions plus a CMS‑mandated HRQOL symptom survey
Routine use of structured patient‑reported outcome measures (PROMs) for symptom tracking
Primary purpose
To improve dialysis symptom identification and management via systematic digital patient‑reporting
To monitor symptoms through usual clinical interactions and a standard HRQOL survey
To capture patients’ symptom burden using validated questionnaires regularly
How it is implemented
ePROM surveys on tablets, real‑time clinician alerts, guidance access and symptom report dashboards used by clinic personnel
Symptoms assessed during routine clinical interactions and via periodic HRQOL survey
Validated instruments like the Dialysis Symptom Index administered regularly in clinical practice
Evidence maturity
Under investigation; trial will assess impact on symptom severity and quality of life over 12-month participation
Established as standard current practice but lacks trial evaluation of symptom associations across care
Emerging best practice based on expert guidance though evidence on impact of routine PROMs in dialysis remains developing
Key limitations
Requires training, hardware and integration in clinic workflows; effect depends on uptake by staff and patients
Relies on passive reporting during clinical encounters and infrequent surveys, potentially under‑detecting symptoms
May be time‑consuming to administer and requires systematic adoption of validated tools
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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