Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT05738330

Conditions

End Stage Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Usual Care

Study Details

Brief summary:

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

End Stage Kidney Disease

Study ID

NCT05738330

Start date

Jun 24, 2023

Status verified date

Nov, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)

Dialysis clinics randomized to SMaRRT-HD will implement the SMaRRT-HD symptom monitoring system. SMaRRT-HD consists of 1) tablet-based symptom reporting using a patient reported outcome measure (PROM) and 2) supported clinician follow-up consisting of symptom alerts, guidances for symptom management, and symptom tracking reports that are shared with patients. For trial participants in SMaRRT-HD clinics, the SMaRRT-HD system will be implemented in addition to the Usual Care approach to symptom monitoring.

active comparator: Usual Care

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 CMS-mandated Health-Related Quality of Life (HRQOL) survey that includes questions about symptoms.

Interventions

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

Dialysis clinics randomized to the SMaRRT-HD group will use the SMaRRT-HD system to capture patient-reported symptoms and support clinician follow-up. The online system includes the patient symptom ePROM surveys, clinician real-time email alerts, clinician guidances for symptom management, and patient-facing symptom reports as well as an administrative dashboard supporting management of trial participants at clinics using SMaRRT-HD. Designated clinic personnel (i.e., patient care technicians and nurses) will receive training on how to use the system to administer the symptom ePROM surveys to patients on tablet computers. Designated clinic nurses and medical providers will receive training on how to access guidances for symptom management and patient-facing symptom reports in the SMaRRT-HD system. For trial participants in SMaRRT-HD clinics, the SMaRRT-HD system will be implemented in addition to the Usual Care approach to symptom monitoring.

Usual Care

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 CMS-mandated Health-Related Quality of Life (HRQOL) survey that includes questions about symptoms.

Primary outcome measure

  • Severity of dialysis-associated symptoms (Effectiveness) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Locations

Fresenius Medical Care

Recruiting

Waltham, Massachusetts, United States, 02451

Contacts

Cassandra Bowman, MHA

919-445-6790Cassandra_Bowman@unc.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-11-24.