Monitoring symptoms in patients undergoing hemodialysis
Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis
NA · University of Pennsylvania · NCT05738330
This study is testing a new system that helps patients on hemodialysis report their symptoms more easily to see if it improves their care compared to regular check-ups.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT05738330 on ClinicalTrials.gov |
What this trial studies
The SMaRRT-HD trial is a cluster randomized trial that evaluates the effectiveness of a symptom monitoring system in hemodialysis patients compared to usual care. Approximately 2400 patients from 30 diverse hemodialysis clinics across the US will participate. The trial utilizes an electronic patient-reported outcome measure (ePROM) system to regularly assess symptoms and facilitate clinician follow-up, aiming to reduce unrecognized symptoms and improve communication between patients and care teams. Clinics assigned to the SMaRRT-HD group will implement this system for a duration of 12 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are currently receiving hemodialysis treatment and can communicate in English or Spanish.
Not a fit: Patients who are unable to report their symptoms using the SMaRRT-HD platform or have conditions that impair their comprehension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce patient suffering and improve health outcomes for individuals undergoing hemodialysis.
How similar studies have performed: Other studies have shown promise in using symptom monitoring systems in chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Waltham, Massachusetts
- Fresenius Medical Care — Waltham, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Flythe, MD — University of North Carolina, Chapel Hill
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Kidney Disease, End stage kidney disease, Kidney, Hemodialysis, Dialysis, Symptom monitoring, Electronic Patient-Reported Outcome Measure