Department of Psychology, National University of Singapore, 9 Arts Link AS402/28, Singapore.
BMC Nephrol. 2011 Jan 28;12:4. doi: 10.1186/1471-2369-12-4.
Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.
METHODS/DESIGN: This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change.
The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes. This program, if found to be effective, has the potential to be implemented within the existing renal services delivery model in Singapore, particularly as this is being delivered by health care professionals already working with hemodialysis patients in these settings who are specifically trained in facilitating self management in renal patients.
血液透析患者的治疗依从性差较为常见，这可能会增加临床结局不良和死亡的风险。自我管理干预已被证明可有效提高其他慢性患者的依从性。本试验旨在评估一种新开发的基于小组的血液透析患者自我管理干预措施与标准护理相比的有效性。
方法/设计：这是一项多中心平行臂分组随机对照试验（RCT），比较了由医疗保健专业人员提供的四节小组自我管理干预措施与标准护理对血液透析患者的影响。共有 176 名同意接受至少 6 个月血液透析的成年人被随机分配接受自我管理干预或标准护理。主要结局是临床状态和依从性的生化标志物。次要结局包括一般健康相关生活质量、疾病特异性生活质量、情绪、自我效能和自我报告的依从性。由独立评估者在基线、干预后即刻以及干预后 3 个月和 9 个月进行评估，并通过线性混合效应模型在所有时间点进行意向治疗原则分析。定性部分将检查方案参与者发现特别有用的方面以及任何改变的障碍。
NKF-NUS 干预措施建立在之前强调赋权患者控制自身治疗管理的重要性的研究基础上。该试验设计通过使用足够大的样本量来检测生化标志物的临床显著变化、招募足够大的代表性样本、基于理论的干预措施以及在各个随访点仔细评估临床和心理结局，解决了之前研究的弱点。纳入多个因变量可以评估干预措施的更广泛影响，包括硬性终点和患者报告的结局。如果该方案被证明有效，它有可能在新加坡现有的肾脏服务提供模式中实施，特别是因为该方案是由已经在这些环境中与血液透析患者合作的医疗保健专业人员提供的，他们专门接受过培训，以促进肾脏患者的自我管理。
