KH4L自我管理项目的随机临床试验

Background: Chronic kidney disease (CKD) imposes physical, psychological, and social burdens. While self-management is essential in CKD, many existing interventions lack theoretical grounding and patient co-design. The Kidney Health 4 Life (KH4L) program was developed to address these gaps via a modular, online, peer-supported self-management intervention. Methods: This open-label, single-blind, parallel group randomized controlled trial recruited Australian adults with CKD. Participants were randomized 1:1 to receive the KH4L intervention or standard care. The intervention consisted of six self-paced online modules, health coaching, and peer support. The primary outcome was self-management capability. Secondary outcomes included self-efficacy, knowledge, and psychological wellbeing. Outcomes were assessed at baseline, 6 weeks, and 18 weeks post baseline. Linear mixed models were utilized for quantitative outcomes and qualitative feedback was analysed using simple thematic analysis. Results: Of 394 enrolled, 383 were included in the analysis. There was no significant change in the primary outcome of total self-management scores. However, the intervention group showed significant improvements in problem solving (P = .009), self-efficacy (P = .048), and CKD-related knowledge (P = .017). Mixed results were seen with the psychological outcomes with depression scores improving more in the control group (P = .043) and no improvement in anxiety. Subgroup analyses indicated greater benefits for those accessing CKD-specific modules compared to dialysis-specific content, possibly due to smaller sample size. Conclusions: KH4L improved some self-management outcomes in people with CKD. The findings highlight the value of tailored, stage-specific digital interventions and suggest theory-informed programs can improve self-efficacy and knowledge. Further research is needed to optimize engagement and ascertain long-term impacts.