Chronic Kidney Diseases Clinical Trial
— ODYSSEE-KHOfficial title:
Open Access Digital CommunitY Promoting Self-Care, Peer Support, and HEalth LitEracy (ODYSSEE) for Kidney Health (KH) Trial
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 RRT education improves Home RRT, RRT preparation, annual hospitalization rate, engagement with CKD self-care resources at months 6 and 12 and trial completion and scores on outcome measures. RECRUITMENT Patients diagnosed with CKD who are 18 years of age or older were recruited from University Health Network (UHN), Sunnybrook Hospital, Scarborough Health Network, and The Ottawa Hospital. DESIGN ODYSSEE-KH is a double-arm, parallel-group, randomized controlled trial that has assessments at baseline, months 6 and 12, and trial completion (median = 19 months; range: 12 to 27 months). This is a single-blind design with research personnel masked. ODYSSEE-KH combines automated digital counselling of CKD self-care with renal replacement therapy (RRT) education. UC enhances the standard of usual care by providing patients with conventional digital CKD education. Over 27 months, patients will be emailed on a weekly basis with a digital link to log on to their respective program using a password-protected, personal account. ANALYSIS Separate GLMs will evaluate if Digital Counselling versus UC is independently associated with outcomes at months 6 and 12 and trial completion (median = 19; range: 12 to 27 months). Dependent variables include the KDQOL-SF, SF-36, EUROIA, PHQ-9, GAD-7, MIDLS, ESSI, PWB, BMPN, AI, as well as a modified SEMCD-6. Multivariable models will adjust for baseline assessments of each outcome and potential baseline covariates (noted above). In all GLMs, significant interactions will be followed by subgroup analyses with Bonferroni post hoc tests.
Status | Recruiting |
Enrollment | 344 |
Est. completion date | April 13, 2026 |
Est. primary completion date | April 13, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Scarborough General Hospital, Sunnybrook Health Sciences Centre, The Ottawa Hospital |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of home RRT | The primary objective is to determine whether an automated digital counselling program for CKD self-care and RRT education improves RRT or preemptive renal transplant over a median of 19 months. As in our previous research,45-47 assessment of RRT includes documentation of incident home dialysis (HPD or HHD) or preemptive kidney transplant (before dialysis) in a composite index, using data from the Canadian Institute for Health Information (CIHI).48 | Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Improvement of Home RRT | The secondary objective is to determine whether an automated digital counselling program for CKD self-care and RRT education improves home RRT (measured by a composite index of documented HHD, HPD, or pre-emptive kidney transplantation) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Improvement of RRT preparation with planned dialysis access | RRT preparation with planned dialysis access, based on the incidence of arteriovenous fistula (AVF), arteriovenous graft (AVG), or peritoneal dialysis (PD) catheter | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Incidence of annual hospitalization rate | Obtained using CIHI databases,48 assessed as the rate, per patient, per year, and defined from date of randomization to the earliest of death, start of dialysis | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Engagement with RRT education and CKD self-care counselling resources | Measured by the sum of logons, sum of logon hours, and number of logon days prior to a logon lapse of equal to or greater than 1 month (data is obtained using backend analytic tools of ODYSSEE, as in CHF-CePPORT49-52 and the previous pilot study)53-55 | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported engagement in activities for living well | Evaluation of Goal-Directed Activities to Promote Well-Being and Health (EUROIA), developed by the principal investigator | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported assessment for health-related quality of life due to kidney disease | 36-Item Kidney Disease Quality of Life - Short Form (KDQOL-SF) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported assessment of people's aspirations and goals | Aspirations Index (AI) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning) | 36-Item Short Form (SF-36) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported depression | 9-Item Patient Health Questionnaire (PHQ-9) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported perceived social support | ENRICHD Social Support Instrument (ESSI) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported psychological wellbeing | Flourishing Scale (FS) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported anxiety | 7-Item Generalized Anxiety Disorder instrument (GAD-7) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported feeling of value to self and others | 9-Item Mattering in Domains of Life Scale (MIDLS) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported measure of psychological wellbeing and happiness | 18-Item Psychological Wellbeing Scale (PWB) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported measure of overall life experience | 18-Item Balanced Measure of Psychological Needs (BMPN) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported measure of well-being | WHO-5 Item Well-Being Index | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported readiness for change (motivation) | Patient-reported readiness to initiate renal replacement therapy | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) | |
Secondary | Self-reported confidence in doing life activities | Self-Efficacy for Managing Chronic Diseases 6-item Scale (SEMCD-6) | Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months) |
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