Symptom Monitoring in Hemodialysis

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
University of Pennsylvania
Study ID
NCT05738330
Status
Recruiting
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Conditions

  • End Stage Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 24, 2023
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
2,400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Fresenius Medical CareWalthamMassachusetts02451
Cassandra Bowman, MHA
[email protected]
919-445-6790

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