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ODYSSEE Kidney Health Trial

RecruitingNAAges 18 Years - anyAllUniversity Health Network, Toronto
NCT06274710 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

INTRODUCTION Severe CKD is defined as a risk of greater than 10% for progressing to RRT \[home hemodialysis (HHD), home peritoneal dialysis (HPD), and transplantation\] within 2 years. There is a need to improve access to CKD self-care counselling and RRT education for patients with severe CKD. Trials of CKD self-care education have achieved therapeutic benefits with moderate to high patient-provider contact. There is high potential for a trial of digital counselling for CKD self-care and RRT education to enhance patient health and quality of life. HYPOTHESES The primary hypothesis is that ODYSSEE-KH versus usual care (UC) will significantly increase the incidence of home RRT, measured by a composite index of HHD, HPD, and preemptive kidney transplant at trial completion (median = 19 months; range: 12 to 27 months). The secondary hypothesis is that ODYSSEE-KH for CKD self-care and RR

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📋 Eligibility rules (as published)
Inclusion Criteria: * CKD patients who are at least 18 years old, that have a greater than a 10% risk of requiring dialysis within 2 years, using the 4-variable 2-year Kidney Failure Risk Equation,1,2 and are registered in a nephrology clinic (including an in-center dialysis clinic) at a participating hospital * Confirmation from a referring nephrologist that the CKD has been stable for at least 1 month at the time of enrollment * Oral and written comprehension of English or French * Informed written consent * At least a basic level of self-reported computer literacy * Access to the internet and a computer Exclusion Criteria: * Previous kidney transplant or waitlisted for organ transplant at the time of enrollment * Severe co-morbidities that prohibit full participation (e.g., dementia, clinically severe depression) * Diagnosis of a medical condition for which the life expectancy is less than 2 years.
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What it tests

  • ODYSSEE-KH
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Where

1 site
University Health Network
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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