ePROMs + Information Hub for Chronic Kidney Failure

Not currently recruiting at 2 trial locations

Overseen By Istvan Mucsi, MD PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Severe acute illness, Dementia, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with chronic kidney failure undergoing regular hemodialysis. The researchers aim to determine if electronic surveys (ePROMs) can help patients track symptoms and manage care more effectively. One group will use a special online tool called SUPPORT-DIALYSIS, while another group will receive usual care. This trial suits individuals who have been on hemodialysis for over three months and are comfortable using English. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance symptom management for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this protocol is safe for patients on maintenance hemodialysis?

Research continues to assess the safety of SUPPORT-DIALYSIS for patients. This tool helps individuals on dialysis manage their treatment more effectively. Few studies focus specifically on patient safety during the transition from chronic kidney disease to end-stage kidney disease (ESKD), when more intensive treatments like dialysis begin.

Patients starting dialysis often encounter various health challenges and require continuous care to manage symptoms and complications. SUPPORT-DIALYSIS aims to improve symptom management and decision-making. However, without specific safety data, researchers are still investigating to ensure the tool does not introduce new risks to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SUPPORT-DIALYSIS trial because it introduces a digital approach to managing chronic kidney failure. Unlike traditional treatments that focus solely on medical interventions like dialysis or medication, SUPPORT-DIALYSIS integrates electronic Patient-Reported Outcome Measures (ePROMs) with an Information Hub. This digital platform allows patients to actively participate in their care by providing real-time feedback and accessing personalized educational resources. By empowering patients and enhancing communication between them and their healthcare providers, this approach aims to improve treatment adherence and outcomes in a way that traditional methods have not fully achieved.

What evidence suggests that this trial's treatments could be effective for chronic kidney failure?

Research has shown that social support can greatly improve the lives of people on dialysis. Studies have found that patients with better social support experience greater satisfaction and an enhanced quality of life. This support can also reduce hospital visits and extend survival. Additionally, about one-third of dialysis patients experience mild to moderate stress, highlighting the need for improved support systems to manage symptoms and enhance overall well-being. In this trial, SUPPORT-DIALYSIS aims to address these issues by providing tools and resources to help patients manage their symptoms more effectively. Participants in one arm will receive SUPPORT-DIALYSIS with access to an output report and information hub, while those in another arm will receive SUPPORT-DIALYSIS only. ^{1 3 5 6 7}

Who Is on the Research Team?

Istvan Mucsi

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for patients who have been on maintenance hemodialysis for over 3 months due to kidney disease. It's not suitable for those with severe acute illnesses, non-English speakers, a life expectancy under 6 months, dementia, or an inability to consent.

Inclusion Criteria

I have been on hemodialysis for over 3 months.

Exclusion Criteria

Patients with severe acute illness or condition that hampers questionnaire completion assessed by clinical team

Unable to understand English - as assessed by clinical team

Your doctor believes you have less than 6 months to live.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessment and recruitment of participants, including consent and baseline measurements

3 months

Treatment

Participants complete ePROMs surveys every four weeks during dialysis treatment

6 months

Every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Every 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SUPPORT-DIALYSIS

Trial Overview The study tests SUPPORT-DIALYSIS with access to a symptom management website against standard care without this tool. Patients at two dialysis centers will be randomly assigned to either use the ePROMs and information hub or receive the usual treatment.

How Is the Trial Designed?

Group I: SUPPORT-DIALYSIS with Access to Output Report and Information Hub Experimental Treatment 1 Intervention

Feasibility of SUPPORT-Dialysis at Toronto General Hospital

Group II: SUPPORT-DIALYSIS Only Experimental Treatment 1 Intervention

Usual Treatment at Humber River Hospital

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Humber River Hospital

Collaborator

Trials

7

Recruited

4,500+

Published Research Related to This Trial

Chronic kidney disease (CKD) is often underrecognized in healthcare, making it a high-risk condition for safety events that can worsen kidney function and lead to end-stage renal disease.

Improving recognition of CKD and implementing disease-specific safety indicators could help reduce adverse safety events and slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CKD as an underrecognized threat to patient safety. Fink, JC., Brown, J., Hsu, VD., et al.[2023]

A pilot trial involving 52 patients with advanced chronic kidney disease (CKD) tested the feasibility of using online electronic patient-reported outcome measures (ePROMs) for real-time symptom monitoring, showing high retention (96%) and adherence (74% at 180 days).

The ePROM intervention was well-accepted by patients, indicating potential for improving patient engagement in managing CKD, although strategies are needed to maintain long-term participation beyond 270 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a pilot feasibility randomised controlled trial exploring the use of an electronic patient-reported outcome measure in the management of UK patients with advanced chronic kidney disease. Kyte, D., Anderson, N., Bishop, J., et al.[2022]

In a study of 267 predialysis patients with chronic kidney disease (CKD), 69.3% experienced at least one adverse safety event, highlighting the high risk of complications in this population.

The most common adverse events reported were hypoglycemia in diabetic patients and hyperkalemia (high potassium levels), with significant co-occurrences of these events, indicating a need for better safety monitoring in CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported and actionable safety events in CKD. Ginsberg, JS., Zhan, M., Diamantidis, CJ., et al.[2021]

In a study of 300 adult patients with chronic kidney disease (CKD), 40.7% experienced adverse drug events (ADEs), highlighting the high prevalence of medication-related complications in this population.

Out of the 159 reported ADEs, 30.2% were deemed preventable, suggesting that the involvement of clinical pharmacists in monitoring medication use could significantly reduce these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in hospitalized patients with chronic kidney disease. Hassan, Y., Al-Ramahi, RJ., Aziz, NA., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2924404/

Association of Social Support with Outcomes in Incident ... Outcomes included 1-year patient satisfaction and quality of life (QOL), dialysis modality switching, and hospitalizations and mortality (through December 2004) ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499861/

End-Stage Renal Disease - StatPearls - NCBI Bookshelf - NIH The 5-year survival rate for a patient undergoing long-term dialysis in the US is approximately 35% and about 25% in patients with diabetes. Go ...

3. nature.com nature.com/articles/s41581-024-00820-6

Chronic kidney disease and the global public health agenda Even in HICs, 15–20% of patients die within 12 months of starting dialysis. Millions more develop kidney failure and require KRT but lack access ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790040

Long-term Outcomes Among Patients With Advanced ... Younger cohorts aged 70 to 79 years (9 studies; 607 patients) had a median survival of 7 to 41 months, and cohorts 80 years or older (25 studies ...

5. evidence.nihr.ac.uk evidence.nihr.ac.uk/collection/dialysis-for-kidney-failure-evidence-to-improve-care/

Dialysis for kidney failure: evidence to improve care Overall, 1 in 3 (33%) people with kidney failure had mild to moderate distress. This was most likely in patients on dialysis for 2 years or more ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5839985/

Medical Safety in the Care of the Person with End Stage ... Few studies have evaluated patient safety in the context of ESKD, particularly after the complex transition from chronic kidney disease (CKD) to ESKD. Many ...

7. ajkd.org ajkd.org/article/S0272-6386(24)00048-9/fulltext

US Renal Data System 2023 Annual Data Report The United States Renal Data System 2023 Annual Data Report (ADR) contains updated information about the chronic kidney disease (CKD) and end-stage renal ...