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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: Recruiting NA study of End-Stage Kidney Disease, sponsored by University of Pennsylvania.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome will be assessed as change in the Dialysis Symptom Index-Severity Score over 12 months (primary endpoint). Participants are asked whether or not they experienced symptoms during the past week. If the response is yes, the participant is asked to indicate "How much did it bother you?". Lowest score - 0; Highest score - 150. A higher score indicates a worse outcome.
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
| Field | Value |
|---|---|
| Enrollment Target | 2,400 participants |
| Start Date | 2023-06-24 |
| Est. Completion | 2027-09 |
| Phase | NA |
What NCT05738330 shows while recruiting
NCT05738330 is an interventional study that assigns participants to a tested intervention. Its 2,400 participants enrollment target places it among the larger protocols in the corpus, above the 346-participant average among 20 other End-Stage Kidney Disease trials with a reported enrollment target (594% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05738330's enrollment target sits among peer trials
2,400 2nd of 20 the highest of 20 other End-Stage Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End-Stage Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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