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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

No Placebo-Only Group

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:

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I am not willing to share my medical data with the research team.

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I am not willing to use the SMaRRT-HD platform to report my symptoms.

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

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met