Open Access Digital CommunitY Promoting Self-Care, Peer Support, and HEalth LitEracy (ODYSSEE) for Kidney Health (KH) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 344
- 试验地点
- 2
- 主要终点
- Incidence of home RRT
研究概览
简要总结
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.
详细描述
BACKGROUND
In Canada, severe CKD prevalence is 14.9 per 1000 persons. The mortality risk is greatest for pre-dialysis patients with stage 4 or 5 CKD (182 deaths per 1000). The annual cost of medical services for Canadians with CKD is $32 billion, with an annual cost per patient of $20 124 and $23 303 at stages 4 and 5, respectively. Persons with stage 4 or 5 CKD also report a lower quality of life and experience the greatest decrement in quality-adjusted life years projected over time.
Kidney transplantation is recognized as the gold standard for RRT due to its benefit for improving clinical outcomes and quality of life. However, the median wait time in Canada for kidney transplantation is 4 years. Approximately 80% of patients with severe CKD are suitable to receive dialysis. Most CKD patients (76%) receive in-center hemodialysis (ICHD), while only 17% receive home hemodialysis (HHD) and 2.5% receive home peritoneal dialysis (HPD). When considering the systemic and patient burden of CKD, it is important to note that ICHD does not offer added survival benefits, and patients who receive home dialysis report greater quality of life. There is also a lower cost for providing HHD and HPD versus ICHD.
Task force statements and reviews advocate for informed patient choice about HHD and HPD, and patients who receive RRT education are more likely to select home dialysis. However, 38% of CKD patients on dialysis report that they were not informed or involved in the decision to select their dialysis modality, and 64% report that education on managing CKD was inadequate or not provided. During the SARS-CoV-2 pandemic, in-hospital dialysis was associated with a 3- to 4-fold increased risk of virus infection and a high mortality rate of 21-34%, which further supports HHD and HPD.
Task force committees concede that patients with severe CKD require specialized nephrology services that include (i) education to promote informed decision-making about RRT and (ii) counselling to improve quality of life and CKD self-care (i.e., attending medical appointments and adhering to medications, dialysis, fluid and dietary guidelines, monitoring symptoms, engaging in an active lifestyle, and refraining from smoking). A Cochrane review of 40 longitudinal cohort studies (pooled N = 63 887) reported that early access to specialized services predicted shorter hospitalization for initial admission [-9.1 days; 95% confidence interval (CI): -11 to -7], and reduced mortality at 12 months (RR =0.65; 95% CI: 0.62 to 0.69) and 5 years (RR = 0.66; 95% CI: 0.60 to 0.71). Corroborating findings from a meta-analysis (pooled N = 648) and a recent randomized trial (N = 130) show that CKD self-care education with telehealth services is associated with reduced hospital admissions and emergency department visits. A further meta-analysis (pooled N = 1647) reported improved quality of life with CKD self-care education or counselling. It is, therefore, vital to commence a CKD self-care and RRT initiative that is evidence-based, scalable, and patient-centred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
ODYSSEE-KH
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.
干预措施: ODYSSEE-KH (Behavioral)
Usual care (UC)
UC is the standard of usual care which provides patients with conventional digital CKD education
结局指标
主要结局
Incidence of home RRT
时间窗: Trial completion (median = 19 months, range = 12-27 months)
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
次要结局
- Self-reported psychological wellbeing(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported assessment of people's aspirations and goals(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported measure of overall health (e.g. pain, mental health, physical, role and social functioning)(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported measure of psychological wellbeing and happiness(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported measure of well-being(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Improvement of Home RRT(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Incidence of annual hospitalization rate(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Engagement with RRT education and CKD self-care counselling resources(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported engagement in activities for living well(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported anxiety(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported perceived social support(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported confidence in doing life activities(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Improvement of RRT preparation with planned dialysis access(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported assessment for health-related quality of life due to kidney disease(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported depression(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported feeling of value to self and others(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported measure of overall life experience(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))
- Self-reported readiness for change (motivation)(Month 6, month 12, Trial completion (median = 19 months, range = 12-27 months))