Farmer Andrew J, Prevost A Toby, Hardeman Wendy, Craven Anthea, Sutton Stephen, Griffin Simon J, Kinmonth Ann-Louise
Department of Primary Health Care, University of Oxford, Oxford, OX3 7LF, UK.
BMC Fam Pract. 2008 Apr 11;9:20. doi: 10.1186/1471-2296-9-20.
Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design.
The SAMS (Supported Adherence to Medication Study) trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation is carried out independently of trial co-ordination and practices using minimisation to adjust for selected confounders.
The SAMS intervention and trial design address weaknesses of previous research by recruitment from a well-characterised population, definition of a feasible theory based intervention to support medication taking and careful measurement to estimate and interpret efficacy. The results will inform practice and the design of a cost-effectiveness trial [ISRCTN30522359].
尽管一些干预措施已被证明可提高糖尿病患者的药物依从性，但结果并不一致。我们开发了一种基于理论的干预措施，将在特征明确的人群中进行评估，以测试其疗效，并为未来的干预措施开发和试验设计提供指导。
SAMS（支持药物依从性研究）试验是一项基于初级保健的多中心随机对照试验，研究对象为200例2型糖尿病患者，糖化血红蛋白（HbA1c）水平在7.5%及以上。该试验旨在评估一种基于计划行为理论和意志行动规划的双组分动机干预措施与标准护理相比，在支持药物依从性方面的疗效。干预措施由执业护士实施。护士通过角色扮演的工作坊方式接受培训，并通过对录音咨询的评估进行监督。该试验采用两组平行设计，招募后8周进行不均衡的3:2个体随机分组，并进行12周的随访。主要结局是使用电子药物监测仪在12周内测量的药物依从性，以干预组和对照组正确服药天数的平均百分比差异表示。亚组分析将探讨基线时服用药物数量、年龄、HbA1c以及自我报告的依从性对结局的影响。该研究还将测量与传统药物包装相比，使用电子药物监测设备包装药物分发给试验参与者的效果。这将通过招募时一对一随机分组到这些条件下，并评估两组在自我报告的药物依从性以及从基线到8周糖化血红蛋白平均变化方面的差异来实现。收集无应答者的匿名人口统计学数据。中央随机分组独立于试验协调和医疗机构进行，采用最小化法调整选定的混杂因素。
SAMS干预措施和试验设计通过从特征明确的人群中招募、定义基于可行理论的支持服药干预措施以及进行仔细测量以估计和解释疗效，解决了以往研究的不足。研究结果将为实践和成本效益试验[ISRCTN30522359]的设计提供参考。
