Digital counseling for chronic kidney disease self-care and education
Open Access Digital CommunitY Promoting Self-Care, Peer Support, and HEalth LitEracy (ODYSSEE) for Kidney Health (KH) Trial
NA · University Health Network, Toronto · NCT06274710
This study is testing a digital counseling program to see if it can help people with severe chronic kidney disease take better care of themselves and choose home dialysis options compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06274710 on ClinicalTrials.gov |
What this trial studies
The ODYSSEE Kidney Health Trial aims to improve self-care behaviors and education regarding renal replacement therapy (RRT) for patients with severe chronic kidney disease (CKD) through a digital counseling intervention. This approach utilizes cognitive behavioral therapy and motivational interviewing techniques to enhance patient engagement and decision-making regarding home dialysis options. The trial will compare the effectiveness of this digital intervention against usual care in increasing the incidence of home RRT over a median follow-up period of 19 months. The study also seeks to assess improvements in hospitalization rates and overall quality of life for participants.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a greater than 10% risk of requiring dialysis within 2 years and who are registered in a nephrology clinic.
Not a fit: Patients who have previously undergone a kidney transplant or have severe co-morbidities that limit their participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly enhance the quality of life and treatment options for patients with severe CKD by promoting home dialysis.
How similar studies have performed: Previous studies have shown that educational interventions for CKD patients can lead to improved outcomes, suggesting potential success for this digital approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Robert Nolan, PhD — University Health Network, Toronto
- Study coordinator: Robert Nolan, PhD
- Email: rob.nolan@uhn.ca
- Phone: (416) 340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, Cognitive behavioural therapy, Motivational interviewing, eHealth, Self-care behaviours, Clinical Trial, Health-related quality of life, Digital health