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.

Background: There is growing evidence that self‐management behaviour can improve outcomes for patients with chronic kidney disease (CKD). However, there are no measures available in Malay to effectively assess self-management of CKD. The aim of this study was to translate, culturally adapt, and validate the Malay Chronic Kidney Disease Self-Management (MCKD-SM) for Malay-speaking health professionals and patients. Methods: This study was carried out in two phases: translation and cultural adaptation, and validation. Instruments were translated from English to Malay then adapted and validated in a sample of 337 patients with CKD stages 3-4 attending a nephrology clinic in a tertiary hospital in Malaysia. Construct validity was evaluated by exploratory factor analysis. Reliability of the instrument was assessed by internal consistency and test‐retest reliability. The correlations between MCKD-SM and kidney disease knowledge, MCKD-SM and self-efficacy were hypothesised a priori and investigated. Results: The Malay version of the Chronic Kidney Disease Self-Management instrument has 29 items grouped into three factors: “Understanding and Managing my CKD”, “Seeking Support” and “Adherence to Recommended Regimen”. The three factors accounted for 56.3 % of the total variance. Each factor showed acceptable internal reliability with Cronbach’s α from 0.885-0.960. 2-week intra-rater test-retest reliability intraclass correlation coefficient values for all items ranged between 0.938 to 1.000. MCKD-SM scores significantly correlates with kidney disease knowledge (r = 0.366, p < 0.01) and self-efficacy (r = 0.212, p < 0.01).Conclusion: The Malay version of the CKD-SM was found to be a valid and reliable patient‐reported outcome measure of pre-dialysis CKD self-management behaviour in the Malay-speaking population.