ePROMs + Information Hub for Chronic Kidney Failure

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

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a parallel arm, pilot study used to examine the feasibility of electronic patient reported outcome measures (ePROMs) for symptom assessment and monitoring as well as a linked self-management support and decision support information hub (https://symptomcare.org) to facilitate symptom management for patients on maintenance hemodialysis. Two dialysis centers will be included in the study, with one center receiving SUPPORT-Dialysis (intervention arm) and the other receiving standard care (control arm).

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 data supports the effectiveness of the treatment SUPPORT-DIALYSIS for chronic kidney failure?

Research suggests that using electronic patient-reported outcome measures (ePROMs) can help improve communication about symptoms and potentially enhance care for patients with chronic kidney disease. This approach has been shown to be feasible and may improve patient-centered care by allowing real-time symptom monitoring. ^{1 2 3 4 5}

Is the ePROMs + Information Hub for Chronic Kidney Failure treatment safe for humans?

The research highlights that patients with chronic kidney disease (CKD) are at high risk for safety events due to the complexity of their care, with common issues like medication errors and infections. However, specific safety data for the ePROMs + Information Hub treatment itself is not provided in the available research. ^{6 7 8 9 10}

How is the SUPPORT-DIALYSIS treatment different from other treatments for chronic kidney failure?

SUPPORT-DIALYSIS is unique because it incorporates electronic patient-reported outcome measures (ePROMs) to monitor symptoms and quality of life in real-time, allowing for more personalized and responsive management of chronic kidney disease compared to traditional treatments. ^{1 4 5 11 12}

Research Team

Istvan Mucsi

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcome Measures (PROMs) to promote quality of care and safety in the management of patients with Advanced Chronic Kidney disease (PRO-trACK project): a mixed-methods project protocol. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Using patient-reported outcome measures during the management of patients with end-stage kidney disease requiring treatment with haemodialysis (PROM-HD): a qualitative study. [2023]

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

Feasibility of Tablet-Based Patient-Reported Symptom Data Collection Among Hemodialysis Patients. [2022]

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

Patient and Clinician Perspectives on Electronic Patient-Reported Outcome Measures in the Management of Advanced CKD: A Qualitative Study. [2021]

5. England 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. [2022]

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

CKD as an underrecognized threat to patient safety. [2023]

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

Patient-reported and actionable safety events in CKD. [2021]

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

Adverse drug events in hospitalized patients with chronic kidney disease. [2022]

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

Maintaining safety in the dialysis facility. [2019]

10. England pubmed.ncbi.nlm.nih.gov

"I just have to take it" - patient safety in acute care: perspectives and experiences of patients with chronic kidney disease. [2020]

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

Use of Electronic Patient-Reported Outcomes in the Care of Patients with Kidney Failure. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in hemodialysis patients: results of the first multicenter cross-sectional ePROMs study in France. [2022]