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ePROMs + Information Hub for Chronic Kidney Failure
N/A
Waitlist Available
Led By Istvan Mucsi
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing maintenance hemodialysis for more than 3 months
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up (every 4 weeks, up to 6 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether or not electronic patient reported outcome measures (ePROMs) can help assess and monitor symptoms for patients on maintenance hemodialysis, as well as whether or not a self-management support and decision support information hub can help with symptom management.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves electronic monitoring and informational support rather than medication, traditional side effects are not expected. However, there may be indirect effects related to using technology such as stress or frustration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on hemodialysis for over 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ follow-up (every 4 weeks, up to 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up (every 4 weeks, up to 6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Eligible Patients who decline consent
Proportion of Enrolled Patients who Drop-Out From the Study
Proportion of Participants who miss or refuse ePROMs follow-ups
+1 moreSecondary study objectives
Clinical Team Acceptability
Patient Acceptability
Other study objectives
Incidence Rate of Healthcare Use
Disease
Mental Health Component Score
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SUPPORT-DIALYSIS with Access to Output Report and Information HubExperimental Treatment1 Intervention
Feasibility of SUPPORT-Dialysis at Toronto General Hospital
Group II: SUPPORT-DIALYSIS OnlyExperimental Treatment1 Intervention
Usual Treatment at Humber River Hospital
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,520 Previous Clinical Trials
503,208 Total Patients Enrolled
1 Trials studying Kidney Failure
50 Patients Enrolled for Kidney Failure
Humber River HospitalOTHER
5 Previous Clinical Trials
4,341 Total Patients Enrolled
Istvan MucsiPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
227 Total Patients Enrolled
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