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Recruiting NCT05738330

Symptom Monitoring in Hemodialysis

No phase Interventional End Stage Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD), Usual Care.
Who it may be relevant to
Registry conditions: End Stage Kidney Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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 measures

  • Severity of dialysis-associated symptoms (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (12)
  • Health-related quality of life (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Post-dialysis recovery time (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Fatigue (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Pain interference (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Anxiety (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Depression (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Healthcare Engagement (Effectiveness) [Time frame: Baseline, 6 months, 12 months]
  • Hospitalizations (Effectiveness) [Time frame: Duration of active 12 month study participation plus 6 months; 18 months total]
  • Mortality (Effectiveness) [Time frame: Duration of active 12 month study participation plus 6 months; 18 months total]
  • Missed dialysis sessions (Effectiveness) [Time frame: Duration of active 12 month study participation]
  • Shortened dialysis sessions (Effectiveness) [Time frame: Duration of active 12 month study participation]
  • Penetration (Implementation) [Time frame: Duration of active 12 month study participation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fresenius Medical Care — Waltham

Publications

  • Flythe JE, Picataggio CB, Bernardo L, Dalrymple LS, Kossmann RJ, DeWalt DA, Hanson LC, Wang V, Unruh ML, Hsu JY, Dember LM. Design and rationale of the SMaRRT-HD study: A pragmatic, randomized trial of symptom monitoring for individuals receiving maintenance hemodialysis. Contemp Clin Trials. 2025 Oct;157:108058. doi: 10.1016/j.cct.2025.108058. Epub 2025 Aug 30. PMID 40889553

Identifiers

NCT: NCT05738330 · 852661

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗