protocolSection identificationModule nctId: NCT06274710, orgStudyIdInfo id: 23-5554, briefTitle: ODYSSEE Kidney Health Trial, acronym: ODYSSEE-KH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2026-04-13, completionDateStruct date: 2026-04-13, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: Scarborough General Hospital, collaborators name: The Ottawa Hospital, descriptionModule briefSummary: INTRODUCTIONSevere 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.HYPOTHESESThe 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.RECRUITMENTPatients 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.DESIGNODYSSEE-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.ANALYSISSeparate 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., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: ODYSSEE-KH, outcomesModule primaryOutcomes measure: Incidence of home RRT, secondaryOutcomes measure: Improvement of Home RRT, secondaryOutcomes measure: Improvement of RRT preparation with planned dialysis access, secondaryOutcomes measure: Incidence of annual hospitalization rate, secondaryOutcomes measure: Engagement with RRT education and CKD self-care counselling resources, secondaryOutcomes measure: Self-reported engagement in activities for living well, secondaryOutcomes measure: Self-reported assessment for health-related quality of life due to kidney disease, secondaryOutcomes measure: Self-reported assessment of people's aspirations and goals, secondaryOutcomes measure: Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning), secondaryOutcomes measure: Self-reported depression, secondaryOutcomes measure: Self-reported perceived social support, secondaryOutcomes measure: Self-reported psychological wellbeing, secondaryOutcomes measure: Self-reported anxiety, secondaryOutcomes measure: Self-reported feeling of value to self and others, secondaryOutcomes measure: Self-reported measure of psychological wellbeing and happiness, secondaryOutcomes measure: Self-reported measure of overall life experience, secondaryOutcomes measure: Self-reported measure of well-being, secondaryOutcomes measure: Self-reported readiness for change (motivation), secondaryOutcomes measure: Self-reported confidence in doing life activities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M2N 7A2, country: Canada, contacts name: Robert P Nolan, PhD, role: CONTACT, phone: (416) 340-4800, phoneExt: 6400, email: rob.nolan@uhnresearch.ca, contacts name: Karly Gunson, HBA, BHSc, role: CONTACT, phone: (416) 340-4800, phoneExt: 6400, email: karly.gunson2@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False