Symptom Monitoring in Hemodialysis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Treatment with hemodialysis at a participating dialysis clinic

English or Spanish speaking

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
  • Usual Care

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Pennsylvania

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator

Duke University

Collaborator

University of New Mexico

Collaborator

Fresenius Medical Care North America

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator