一项基于护士主导的咨询干预的解释性随机对照试验，旨在支持 2 型糖尿病患者服用降血糖药物的依从性。
An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.
机构信息
Department of Primary Health Care Sciences, University of Oxford, Oxford, UK.
出版信息
BMC Fam Pract. 2012 Apr 5;13:30. doi: 10.1186/1471-2296-13-30.
BACKGROUND
Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes.
METHODS
This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c ≥ 7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat.
RESULTS
211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction.
CONCLUSIONS
This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice.
背景
不按时服药会降低治疗效果，导致发病率和死亡率上升。我们评估了一种基于咨询的干预措施的效果，该措施旨在支持 2 型糖尿病患者客观评估的口服降血糖药物（OGLM）的依从性，与常规护理相比。
方法
这是一项平行组随机试验，纳入了成人 2 型糖尿病患者，HbA1c≥7.5%（58mmol/mol），至少服用一种 OGLM。参与者被分配到由诊所护士提供的创新的基于咨询的干预措施，以加强患者定期服用 OGLM 的动机，并通过行动计划支持药物服用，或接受常规护理。主要结局是在 12 周内使用电子药物监测设备（TrackCap，Aardex，瑞士）客观测量的规定剂量药物的服用天数百分比。主要分析是意向治疗。
结果
2006 年 7 月 1 日至 2008 年 11 月 30 日期间，在 13 家英国普通诊所（初级保健诊所）随机分配了 211 名患者。共有 194 名参与者（91.9%）获得了主要结局数据。干预组的平均（标准差）依从天数为 77.4%（26.3），标准护理组为 69.0%（30.8）（组间平均差异 8.4%，95%置信区间 0.2%至 16.7%，p=0.044）。干预对功能状态或治疗满意度没有显著的不利影响。
结论
这种在初级保健中单次 30 分钟的特定、基于理论的干预措施，显著提高了客观测量的药物依从性，且对治疗满意度没有不良影响。这些发现证明了在更长时间内采用这种方法提高药物依从性的有效性，同时需要进行临床和成本效益结果的试验，以指导临床实践。
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