RECRUITING

Symptom Monitoring in Hemodialysis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Quick Facts

Study Start:2023-06-24
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05738330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Treatment with hemodialysis at a participating dialysis clinic
  3. * English or Spanish speaking
  1. * Not willing to report their symptoms using the SMaRRT-HD platform
  2. * Not willing to share clinically acquired data with the research team
  3. * Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
  4. * Incarceration

Contacts and Locations

Principal Investigator

Jennifer Flythe, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Laura Dember, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Fresenius Medical Care
Waltham, Massachusetts, 02451
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Jennifer Flythe, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill
  • Laura Dember, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-24
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-06-24
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • End stage kidney disease
  • Kidney
  • Hemodialysis
  • Dialysis
  • Symptom monitoring
  • Electronic Patient-Reported Outcome Measure (ePROM)

Additional Relevant MeSH Terms

  • End Stage Kidney Disease