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NCT05738330 · ClinicalTrials.gov registry record · NA

Symptom Monitoring in Hemodialysis

A NA study of End-Stage Kidney Disease, sponsored by University of Pennsylvania.

Recruiting
Registry status
NA
Development phase
2,400
Enrollment target
1
Study location

NCT05738330 is a NA study of End-Stage Kidney Disease that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 2,400 participants, above the 346-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (594% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05738330, a NA study of End-Stage Kidney Disease, is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
NA
Development phase
2,400 participants
Enrollment target
1
Study location

Study 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 Studied

Interventions

  • BEHAVIORAL Usual Care
  • BEHAVIORAL Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)

Study Locations (1)

Massachusetts

  • Fresenius Medical Care - Waltham

Trial Details

FieldValue
Enrollment Target 2,400 participants
Start Date 2023-06-24
Est. Completion 2027-09
Phase NA

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT05738330

The ClinicalTrials.gov registry entry for NCT05738330 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 2,400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 346-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (594% higher). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with End-Stage Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.

NCT05738330 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05738330 about?

NCT05738330 is a clinical study titled "Symptom Monitoring in Hemodialysis". 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 cli...

What is the current status of trial NCT05738330?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,400 participants. The study started on 2023-06-24. Estimated completion is 2027-09.

What conditions does trial NCT05738330 study?

This clinical trial studies the following conditions: End-Stage Kidney Disease.

What interventions are being tested in trial NCT05738330?

The interventions under investigation include: Usual Care (BEHAVIORAL), Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05738330?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05738330 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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