Symptom Monitoring for Kidney Failure
(SMaRRT-HD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Pennsylvania
Disqualifiers: Dementia, Incarceration, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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 30 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on symptom monitoring rather than medication changes.
What data supports the effectiveness of the treatment Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)?
Research shows that hemodialysis patients often have many symptoms that are not well-managed, and monitoring can help ensure patient safety and treatment compliance. This suggests that symptom monitoring, like SMaRRT-HD, could improve symptom management by providing real-time oversight and data collection.
12345Is symptom monitoring during hemodialysis safe for humans?
Research indicates that home hemodialysis has an excellent safety record, although there is a potential for adverse events when performed without supervision.
678910How is the SMaRRT-HD treatment different from other treatments for kidney failure?
SMaRRT-HD is unique because it focuses on monitoring and managing symptoms specifically for patients undergoing hemodialysis, addressing issues like sleep disturbances and post-dialysis fatigue, which are often overlooked in standard treatments.
34111213Eligibility Criteria
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.Inclusion Criteria
I speak English or Spanish.
I am receiving hemodialysis at a clinic involved in the study.
I am 18 years old or older.
Exclusion Criteria
Underlying condition such as dementia that is anticipated to prevent comprehension of the trial information document (fact sheet)
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.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Implementation of the SMaRRT-HD system for symptom monitoring and supported clinician follow-up
12 months
Regular visits for dialysis sessions with symptom monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
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.
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.
Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD) is already approved in United States for the following indications:
🇺🇸 Approved in United States as SMaRRT-HD for:
- Symptom monitoring in hemodialysis patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Fresenius Medical CareWaltham, MA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
University of North Carolina, Chapel HillCollaborator
Duke UniversityCollaborator
University of New MexicoCollaborator
Fresenius Medical Care North AmericaIndustry Sponsor
References
Patient monitoring in the London Daily/Nocturnal Hemodialysis Study. [2019]Patient monitoring involves real-time surveillance of patients while they dialyze at home by a staff member ("monitor") at a centralized location. Monitoring is designed to ensure patient safety, patient compliance with treatment, and automatic collection of treatment data.
Patient-reported outcomes in maintenance hemodialysis: a cross-sectional, multicenter study. [2020]The aim of this study is to assess patient-reported outcome measures (PROMs) related to symptoms among maintenance hemodialysis patients (MHDp).
Relationship between symptom burden and dialysis adequacy in patients with chronic kidney disease undergoing hemodialysis. [2023]The aim of this study was to reveal the relationship between hemodialysis (HD) adequacy and dialysis symptom index (DSI) in patients with end-stage kidney disease (ESKD).
Improving symptom management in hemodialysis patients: identifying barriers and future directions. [2021]Hemodialysis (HD) patients experience significant symptom burden that is often undertreated.
Distinct Symptom Experience Among Subgroups of Patients With ESRD Receiving Maintenance Dialysis. [2021]Patients with end-stage renal disease receiving dialysis experience multiple concurrent symptoms. A person-centered understanding of patients' symptom experiences may offer insights into individualized management.
Rationale for a home dialysis virtual ward: design and implementation. [2022]Home-based renal replacement therapy (RRT) [peritoneal dialysis (PD) and home hemodialysis (HHD)] offers independent quality of life and clinical advantages compared to conventional in-center hemodialysis. However, follow-up may be less complete for home dialysis patients following a change in care settings such as post hospitalization. We aim to implement a Home Dialysis Virtual Ward (HDVW) strategy, which is targeted to minimize gaps of care.
Patients' perspective of haemodialysis-associated symptoms. [2021]Introduction. Patients often report symptoms during haemodialysis (HD). To better understand patients' experience, we surveyed routine HD outpatients, to quantify the burden and duration of dialysis-associated symptoms.
Developing a trigger tool to monitor adverse events during haemodialysis in children: a pilot project. [2023]We developed a paediatric haemodialysis trigger tool (pHTT) for application per haemodialysis (HD) session in children receiving intermittent in-centre HD and systematically monitored adverse events.
Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective. [2014]There has been resurgent interest in home hemodialysis (HD) in recent years because of the reported benefits and its excellent safety record. However, the potential for adverse events, including potentially catastrophic ones, exists when patients are performing HD in their homes without supervision. There is a lack of literature on this important topic.
High-Flux versus High-Retention-Onset Membranes: In vivo Small and Middle Molecules Kinetics in Convective Dialysis Modalities. [2020]Patients undergoing maintenance hemodialysis (HD) exhibit increased levels of uremic toxins, which are associated with poor outcomes. Recently, new dialysis membranes have allowed clearance of solutes with higher molecular weight, without significant albumin losses high-retention-onset-HD (HRO-HD).
Comparison of sleep/wake behavior in CKD stages 4 to 5 and hemodialysis populations using wrist actigraphy. [2022]Patients with kidney failure have more sleep symptoms than the general population, but the contribution to sleep symptoms of kidney failure versus its treatment with thrice-weekly hemodialysis has been unclear. We assessed the influence of hemodialysis on sleep/wake behavior by using wrist actigraphy and self-reported sleep quality compared with patients with chronic kidney disease (CKD) stages 4 to 5.
Prevention, assessment and management of post-dialysis fatigue in patients attending in-center hemodialysis: a best practice implementation project. [2018]The hemodialysis (HD) population experiences a myriad of disease-related symptoms that are often not recognized and/or not treated. Post-dialysis fatigue is a frequent complaint of HD patients following a dialysis session, and there is currently no evidence-based approach to alleviate this problem.
Non-adherence to hemodialysis, perception of the illness, and severity of advanced nephropathy. [2021]Hemodialysis (HD) is a complex therapy that imposes several changes in the patient's life. Failure to follow therapy recommendations is called non-adherence (NA). The patient's illness perception, severity of chronic kidney disease, and individual strategies for coping with HD can have an impact on NA to the demands of therapy.