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Symptom Monitoring for Kidney Failure (SMaRRT-HD Trial)

N/A
Recruiting
Led By Jennifer Flythe, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treatment with hemodialysis at a participating dialysis clinic
Age ≥ 18 years
Must not have
Not willing to share clinically acquired data with the research team
Not willing to report their symptoms using the SMaRRT-HD platform
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of active 12 month study participation plus 6 months; 18 months total
Awards & highlights

Summary

This trial will test whether monitoring symptoms in dialysis patients using SMaRRT-HD and supported clinician follow-up will reduce suffering and improve outcomes.

Who is the study for?
This trial is for adults over 18 who are undergoing hemodialysis at a participating clinic and can communicate in English or Spanish. It's not suitable for those unwilling to use the SMaRRT-HD symptom reporting system, share clinical data with researchers, have conditions like dementia affecting comprehension, or are incarcerated.
What is being tested?
The study compares a new electronic symptom monitoring system (SMaRRT-HD) that prompts treatment of symptoms and improves communication between patients and care teams against usual care without this technology. About 2400 patients across diverse US clinics will participate for 12 months.
What are the potential side effects?
Since this trial involves monitoring systems rather than medications, there aren't direct side effects from interventions. However, participants may experience discomfort or inconvenience while using the tablet-based reporting tool.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving hemodialysis at a clinic involved in the study.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not willing to share my medical data with the research team.
Select...
I am not willing to use the SMaRRT-HD platform to report my symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of active 12 month study participation plus 6 months; 18 months total
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of active 12 month study participation plus 6 months; 18 months total for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Severity of dialysis-associated symptoms (Effectiveness)
Secondary study objectives
Acceptability (Implementation); Interviews; All Clinics
Acceptability (Implementation); Interviews; SMaRRT-HD Clinics
Acceptability (Implementation); Surveys; All Clinics
+28 more
Other study objectives
Quality of patient-clinician communication (Effectiveness)

Trial Design

2Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
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.
Group II: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
568 Previous Clinical Trials
27,247,009 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,543 Previous Clinical Trials
4,246,642 Total Patients Enrolled
Duke UniversityOTHER
2,424 Previous Clinical Trials
3,063,684 Total Patients Enrolled
4 Trials studying Kidney Failure
1,595 Patients Enrolled for Kidney Failure

Media Library

Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) Clinical Trial Eligibility Overview. Trial Name: NCT05738330 — N/A
Kidney Failure Research Study Groups: Usual Care, SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)
Kidney Failure Clinical Trial 2023: Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) Highlights & Side Effects. Trial Name: NCT05738330 — N/A
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738330 — N/A
~1582 spots leftby Mar 2027
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