The complexity of chronic kidney disease (CKD) and its treatments have made self-management behaviors inevitably challenging. However, supplementing education with self-management skills may improve numerous health outcomes in people with nondialysis CKD. This study protocol describes a randomized controlled trial (RCT) aimed to evaluate the effects of a nurse-led self-management support program as an intervention for kidney disease knowledge and CKD self-management behaviors among people with pre-dialysis CKD. In Phase 1, people with CKD stage 3–4 and their family members are involved in co-designing, development and pilot testing of a theory-based self-management intervention. In Phase 2, we perform a cross-cultural adaptation of the Kidney Disease Knowledge Survey, CKD Self-Management and Self-efficacy for Managing Chronic Disease questionnaires. In Phase 3, a parallel RCT will be conducted to evaluate the intervention where 154 participants with CKD stage 3–4 will be randomly assigned to either the intervention (n = 77) or control group (n = 77). The intervention group will receive 6-week self-management program from a nurse-coach in addition to standard usual care, while the control group will receive only standard usual care. Outcome measures include kidney disease knowledge, CKD self-management behavior, self-efficacy, quality of life, blood pressure control and adherence to CKD diet as indicated by 24-h urine urea nitrogen, 24-h urine sodium and net endogenous acid production. Data will be collected at baseline and 12-week post-baseline. The between- and within-group intervention effects will be estimated using the Generalized Estimating Equations. The self-management intervention offers strategies to delay CKD progression and to encourage motivation to better self-manage at home. This study integrates self-management education and psychosocial support with culturally relevant scenarios, and evaluates important self-reported and objective outcomes.

Clinical Trials Registration: www.ClinicalTrials.gov, identifier: NCT03974646.

慢性肾脏病（CKD）及其治疗的复杂性使得自我管理行为不可避免地面临挑战。然而，通过自我管理技能补充教育可能会改善非透析 CKD 患者的许多健康结果。本研究方案描述了一项随机对照试验 (RCT)，旨在评估护士主导的自我管理支持计划作为透析前 CKD 患者肾脏疾病知识和 CKD 自我管理行为干预措施的效果。在第一阶段，慢性肾病 3-4 期患者及其家人参与基于理论的自我管理干预措施的共同设计、开发和试点测试。在第二阶段，我们对肾脏疾病知识调查、慢性肾病自我管理和慢性病管理自我效能问卷进行了跨文化调整。在第 3 阶段，将进行平行随机对照试验来评估干预措施，其中 154 名 CKD 3-4 期参与者将被随机分配到干预组 ( n  = 77) 或对照组 ( n  = 77)。除了标准的常规护理外，干预组还将接受护士教练为期 6 周的自我管理计划，而对照组将仅接受标准的常规护理。结果指标包括肾脏疾病知识、CKD 自我管理行为、自我效能、生活质量、血压控制和对 CKD 饮食的依从性（以 24 小时尿素氮、24 小时尿钠和净内源酸生成量为指标）。将在基线和基线后 12 周收集数据。将使用广义估计方程来估计组间和组内干预效果。自我管理干预提供了延缓 CKD 进展并鼓励更好在家自我管理的动力的策略。这项研究将自我管理教育和社会心理支持与文化相关场景相结合，并评估重要的自我报告和客观结果。

临床试验注册：www.ClinicalTrials.gov，标识符：NCT03974646。