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Behavioural Intervention
ODYSSEE-KH for Chronic Kidney Disease (ODYSSEE-KH Trial)
N/A
Recruiting
Led By Robert Nolan, PhD
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
Oral and written comprehension of English or French
Confirmation from a referring nephrologist that the CKD has been stable for at least 1 month at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12, trial completion (median = 19 months, range = 12-27 months)
Awards & highlights
ODYSSEE-KH Trial Summary
"This trial aims to improve access to self-care counseling and education for patients with severe chronic kidney disease (CKD) through digital counseling. The main goal is to increase the number of patients opting for home
Who is the study for?
The ODYSSEE Kidney Health Trial is for adults diagnosed with severe chronic kidney disease (CKD) who are at high risk of needing renal replacement therapy like dialysis or a kidney transplant within the next two years. Participants are recruited from specific hospitals and must be willing to engage in digital counseling and education about CKD self-care.Check my eligibility
What is being tested?
This trial tests a digital counseling program called ODYSSEE-KH against usual care over 27 months. It aims to see if this program increases home-based renal replacement therapies and improves patient engagement, hospitalization rates, and quality of life through regular online educational content.See study design
What are the potential side effects?
Since the intervention involves digital counseling rather than medication, traditional side effects aren't expected. However, participants may experience varying levels of stress or anxiety related to managing their condition digitally.
ODYSSEE-KH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and communicate in English or French.
Select...
My kidney disease has been stable for at least a month, confirmed by my kidney doctor.
ODYSSEE-KH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 12, trial completion (median = 19 months, range = 12-27 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 12, trial completion (median = 19 months, range = 12-27 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of home RRT
Secondary outcome measures
Engagement with RRT education and CKD self-care counselling resources
Improvement of Home RRT
Improvement of RRT preparation with planned dialysis access
+15 moreODYSSEE-KH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ODYSSEE-KHExperimental Treatment1 Intervention
Participants in the intervention arm of the trial will have full access to digital counselling materials for CKD self-care and RRT education. Program engagement is dynamic with videos, digital handouts, animated charts, infographics, interactive digital trackers, and self-assessment forms. Patients will receive weekly email links to digital sessions (Supplements 1 and 2). Initial sessions will build motivation for therapeutic change. Subsequent sessions follow CBT guidelines. Finally, a monthly video posted on ODYSSEE will address common challenges and patient comments or queries.
Group II: Usual care (UC)Active Control1 Intervention
UC is the standard of usual care which provides patients with conventional digital CKD education
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
484,836 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,550,963 Total Patients Enrolled
The Ottawa HospitalOTHER
93 Previous Clinical Trials
62,574 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit in terms of patient enrollment for this medical study?
"Indeed, data on clinicaltrials.gov highlights the ongoing recruitment of participants for this particular medical trial. The study was first posted on December 13th, 2023 and last modified on February 20th, 2024. A total of 344 individuals are sought from a single facility."
Answered by AI
Are prospective patients still eligible to participate in this ongoing medical study?
"Indeed, data from clinicaltrials.gov confirms the ongoing recruitment for this trial. Initially posted on December 13, 2023, and most recently revised on February 20, 2024, the study aims to enroll a total of 344 participants across a single site."
Answered by AI
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