Department of Psychology, National University of Singapore, Singapore; School of Health Sciences, City, University of London, London, United Kingdom.
National Kidney Foundation, Singapore.
Am J Kidney Dis. 2018 Mar;71(3):371-381. doi: 10.1053/j.ajkd.2017.09.014. Epub 2017 Dec 1.
Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear.
Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial.
SETTING & PARTICIPANTS: Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers.
Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions.
OUTCOMES & MEASUREMENTS: Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention.
235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (P<0.001) among patients randomly assigned to HED-SMART. In contrast, IDWG in controls showed no change except at 3 months, when it worsened significantly. Improvements in mineral markers were noted in the HED-SMART arm at 3 months (P<0.001) and in potassium concentrations (P<0.001) at 9 months. Phosphate concentrations improved in HED-SMART at 3 months (P=0.03), but these effects were not maintained at 9 months postintervention. Significant differences between the arms were found for the secondary outcomes of self-reported adherence, self-management skills, and self-efficacy at all time points.
Low proportion of patients with diabetes.
HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care.
Registered at ISRCTN with study number ISRCTN31434033.
血液透析患者普遍存在治疗依从性差的问题。然而，目前缺乏针对该人群的有效干预措施。一些小型的行为干预研究显示出了改善效果，但临床效果和长期效果尚不清楚。
多中心平行（1:1）设计，盲法聚类随机对照试验。
在 14 家透析中心接受维持性血液透析的患者。
符合条件的患者的透析班次被随机分配到互动式和有针对性的自我管理培训计划（HED-SMART；干预组；n=134）或常规护理（对照组；n=101）。HED-SMART 是根据问题解决和社会学习理论的原则开发的，由医疗保健专业人员在 4 个疗程中以小组形式提供。
共有 235 名患者参与了该研究（应答率为 44.2%），其中 82.1%完成了方案。与基线相比，所有 3 项评估的血清钾和磷酸盐浓度、透析间体重增加（IDWG）、自我报告的依从性和自我管理技能均显著降低（P<0.001）。相反，对照组的 IDWG 除了在 3 个月时明显恶化外，没有变化。在 HED-SMART 组中，3 个月时矿物质标志物改善（P<0.001），9 个月时钾浓度改善（P<0.001）。HED-SMART 组 3 个月时磷酸盐浓度改善（P=0.03），但在干预后 9 个月时这些效果没有维持。在所有时间点，自我报告的依从性、自我管理技能和自我效能的次要结局均显示出组间的显著差异。
患有糖尿病的患者比例较低。
HED-SMART 为改善血液透析患者的健康提供了一种有效且实用的模式。如果在更长的随访时间内保持临床指标和自我报告的依从性改善，这可能会显著减少与终末期肾脏疾病相关的并发症。鉴于这种方案的可行性，它具有补充常规护理的强大潜力。
在 ISRCTN 注册，研究编号 ISRCTN31434033。
