Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05738330

Symptom Monitoring in Hemodialysis

Led by University of Pennsylvania · Updated on 2025-11-24

2400

Participants Needed

1

Research Sites

218 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

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.

CONDITIONS

Official Title

Symptom Monitoring in Hemodialysis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 18 years
  • Receiving hemodialysis treatment at a participating dialysis clinic
  • Able to speak English or Spanish
Not Eligible

You will not qualify if you...

  • Unwilling to report symptoms using the SMaRRT-HD platform
  • Unwilling to share clinical data with the research team
  • Having a condition like dementia that may prevent understanding the trial information
  • Being incarcerated

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fresenius Medical Care

Waltham, Massachusetts, United States, 02451

Actively Recruiting

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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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