Symptom Monitoring for Kidney Failure

(SMaRRT-HD Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

2400 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{3 4 11 12 13}

Research Team

Jennifer Flythe, MD

Principal Investigator

University of North Carolina, Chapel Hill

Laura M. Dember, MD

Principal Investigator

University of Pennsylvania

Eligibility 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 am receiving hemodialysis at a clinic involved in the study.

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.

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

Treatment Details

Interventions

• Symptom Monitoring on Renal Replacement Therapy - Hemodialysis (SMaRRT-HD)
• Usual Care

Trial Overview 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.

Participant Groups

Group I: Usual Care Active Control 1 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 Control 1 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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

Fresenius Medical Care North America

Industry Sponsor

Trials

40

Recruited

78,400+

Findings from Research

In a study involving 14 nocturnal hemodialysis patients monitored over 4,096 patient-nights, the average number of alarms per night decreased significantly from 1.98 to 0.74 as patients became more experienced, indicating improved stability and compliance over time.

Monitoring during the first three months of nocturnal hemodialysis is crucial for ensuring patient safety, but may be reduced thereafter if patients demonstrate stability, as no emergency calls were needed during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient monitoring in the London Daily/Nocturnal Hemodialysis Study. Heidenheim, AP., Leitch, R., Kortas, C., et al.[2019]

A study of 336 maintenance hemodialysis patients revealed that the most common symptoms they experience include tiredness (80%), sexual dysfunction (72%), and sleep disturbances (65-64%), indicating a significant burden of symptoms affecting their quality of life.

The study found that major depression is consistently linked to higher overall symptom burden and severity, suggesting that addressing mental health is crucial for improving the well-being of patients undergoing long-term dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in maintenance hemodialysis: a cross-sectional, multicenter study. Fleishman, TT., Dreiher, J., Shvartzman, P.[2020]

In a study of 92 patients with end-stage kidney disease undergoing hemodialysis, it was found that higher dialysis adequacy, measured by the spKt/V ratio, is associated with lower symptom burden as indicated by the Dialysis Symptom Index (DSI).

The study revealed that female patients and those with lower economic status reported higher DSI scores, highlighting the importance of ensuring adequate dialysis to improve the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between symptom burden and dialysis adequacy in patients with chronic kidney disease undergoing hemodialysis. Karaaslan, T., Pembegul, I.[2023]

Healthcare providers (HCPs) often underestimate the significant symptom burden experienced by hemodialysis (HD) patients, leading to inadequate symptom management.

Barriers to effective symptom control include provider unawareness, uncertainty about responsibility for treatment, and the perception that some symptoms are untreatable, highlighting the need for improved education and communication among HCPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving symptom management in hemodialysis patients: identifying barriers and future directions. Feldman, R., Berman, N., Reid, MC., et al.[2021]

A study of 354 dialysis patients identified three distinct symptom experience subgroups: low symptoms, moderate physical-low psychological symptoms, and moderate physical-high psychological symptoms, highlighting the diversity in patient experiences.

The subgroup with moderate physical-high psychological symptoms had the worst quality of life, the highest symptom burden, and a shorter survival time, suggesting the need for personalized symptom management strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distinct Symptom Experience Among Subgroups of Patients With ESRD Receiving Maintenance Dialysis. Ng, MSN., Miaskowski, C., Cooper, B., et al.[2021]

The Home Dialysis Virtual Ward (HDVW) Pilot Study aims to improve follow-up care for home dialysis patients, particularly after hospital discharge or other significant medical events, by providing weekly clinician-led telephone interviews for two weeks.

This initiative is designed to minimize gaps in care and assess patient outcomes, including re-hospitalization rates, which will be compared to a matched cohort, ultimately enhancing the quality of life and clinical management for patients undergoing home-based renal replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale for a home dialysis virtual ward: design and implementation. Schachter, ME., Bargman, JM., Copland, M., et al.[2022]

A survey of 508 outpatients undergoing hemodialysis revealed that common symptoms include fatigue (82%), intradialytic hypotension (76%), and cramps (74%), indicating a significant burden during treatment.

Recovery time from dialysis varied widely, with 23% of patients recovering within minutes, while others took until the next session, suggesting that tailored approaches to dialysis may be needed, especially for women and those with longer treatment durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perspective of haemodialysis-associated symptoms. Caplin, B., Kumar, S., Davenport, A.[2021]

The pediatric haemodialysis trigger tool (pHTT) effectively identified adverse events during dialysis sessions, leading to a significant reduction in harm rates from 1.03 to 0.32 per session after implementing interventions based on the tool's findings.

No adverse events caused permanent harm, highlighting the pHTT's role in enhancing patient safety and suggesting its integration into standard care practices for children undergoing haemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a trigger tool to monitor adverse events during haemodialysis in children: a pilot project. Balasubramanian, R., Folwell, R., Wheatley, A., et al.[2023]

In a review of home hemodialysis (HD) programs involving 190 patients over approximately 500 patient-years, there was a low incidence of life-threatening adverse events, with a rate of 0.060 events per 1,000 dialysis treatments.

Most adverse events were linked to human error and protocol lapses, highlighting the importance of thorough patient training and safety monitoring to enhance the safety of home HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective. Wong, B., Zimmerman, D., Reintjes, F., et al.[2014]

In a study involving 16 patients on maintenance hemodialysis, both online hemodiafiltration (olHDF) and high-retention-onset hemodialysis (HRO-HD) were found to significantly improve the clearance of beta-2 microglobulin (β2M) compared to high-flux hemodialysis (HF-HD).

Patients undergoing olHDF and HRO-HD had lower post-dialysis β2M levels, indicating these newer dialysis methods may provide better management of uremic toxins without affecting serum albumin or other solute levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flux versus High-Retention-Onset Membranes: In vivo Small and Middle Molecules Kinetics in Convective Dialysis Modalities. Cordeiro, ISF., Cordeiro, L., Wagner, CS., et al.[2020]

Patients undergoing thrice-weekly hemodialysis (HD) experienced significantly shorter total sleep times (TST) and lower sleep efficiency compared to patients with chronic kidney disease (CKD) stages 4 to 5, indicating that HD may negatively impact sleep quality.

An early-morning HD shift was linked to a 62-minute reduction in TST, suggesting that the timing of dialysis sessions can influence sleep patterns and contribute to daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of sleep/wake behavior in CKD stages 4 to 5 and hemodialysis populations using wrist actigraphy. Barmar, B., Dang, Q., Isquith, D., et al.[2022]

A best practice implementation project successfully introduced evidence-based strategies to prevent, assess, and manage post-dialysis fatigue in hemodialysis patients, significantly improving compliance with best practices from only 18% to over 75% in most criteria.

The project highlighted the importance of education for both nursing staff and patients, addressing a previously unrecognized issue in the HD population, which may lead to better management of fatigue and overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention, assessment and management of post-dialysis fatigue in patients attending in-center hemodialysis: a best practice implementation project. Oliver, V., Stephenson, M.[2018]

In a study of 79 end-stage renal disease patients undergoing hemodialysis, age was found to correlate with both the perception of disease severity and non-adherence to treatment, indicating that older patients may have different experiences and challenges with their therapy.

The study did not find a direct correlation between patients' perceptions of their illness and their adherence behaviors, suggesting that factors influencing non-adherence may be more complex than just how patients perceive their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-adherence to hemodialysis, perception of the illness, and severity of advanced nephropathy. Dantas, LG., Rocha, MS., Cruz, CMS.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient monitoring in the London Daily/Nocturnal Hemodialysis Study. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in maintenance hemodialysis: a cross-sectional, multicenter study. [2020]

3. Turkey pubmed.ncbi.nlm.nih.gov

Relationship between symptom burden and dialysis adequacy in patients with chronic kidney disease undergoing hemodialysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Improving symptom management in hemodialysis patients: identifying barriers and future directions. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Distinct Symptom Experience Among Subgroups of Patients With ESRD Receiving Maintenance Dialysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Rationale for a home dialysis virtual ward: design and implementation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Patients' perspective of haemodialysis-associated symptoms. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Developing a trigger tool to monitor adverse events during haemodialysis in children: a pilot project. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Procedure-related serious adverse events among home hemodialysis patients: a quality assurance perspective. [2014]

10. Switzerland pubmed.ncbi.nlm.nih.gov

High-Flux versus High-Retention-Onset Membranes: In vivo Small and Middle Molecules Kinetics in Convective Dialysis Modalities. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of sleep/wake behavior in CKD stages 4 to 5 and hemodialysis populations using wrist actigraphy. [2022]

12. Australia pubmed.ncbi.nlm.nih.gov

Prevention, assessment and management of post-dialysis fatigue in patients attending in-center hemodialysis: a best practice implementation project. [2018]

13. Brazil pubmed.ncbi.nlm.nih.gov

Non-adherence to hemodialysis, perception of the illness, and severity of advanced nephropathy. [2021]