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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of active 12 month study participation plus 6 months; 18 months total
Awards & highlights
SMaRRT-HD Trial 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.Check my eligibility
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.See study design
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.
SMaRRT-HD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving hemodialysis at a clinic involved in the study.
Select...
I am 18 years old or older.
SMaRRT-HD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of active 12 month study participation plus 6 months; 18 months total
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of active 12 month study participation plus 6 months; 18 months total
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severity of dialysis-associated symptoms (Effectiveness)
Secondary outcome measures
Acceptability (Implementation); Interviews; All Clinics
Acceptability (Implementation); Interviews; SMaRRT-HD Clinics
Acceptability (Implementation); Surveys; All Clinics
+28 moreOther outcome measures
Quality of patient-clinician communication (Effectiveness)
SMaRRT-HD 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.
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Who is running the clinical trial?
Patient-Centered Outcomes Research InstituteOTHER
551 Previous Clinical Trials
29,995,058 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,188,642 Total Patients Enrolled
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,418,116 Total Patients Enrolled
4 Trials studying Kidney Failure
1,595 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I speak English or Spanish.I am not willing to share my medical data with the research team.I am not willing to use the SMaRRT-HD platform to report my symptoms.I am receiving hemodialysis at a clinic involved in the study.I am 18 years old or older.Currently in prison.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: SMaRRT-HD (Symptom Monitoring on Renal Replacement Therapy - Hemodialysis)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of new participants ongoing for this clinical trial?
"As noted on clinicaltrials.gov, this trial is no longer recruiting new participants; the initial posting date was June 1st 2023 and the listing has not been updated since February 10th 2023. However, 599 other studies are currently welcoming patients to take part in their trials."
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