在全科医疗中对2型糖尿病成人患者基于网络的自主导向干预措施的评估：一项研究方案。
Assessment of a web-based Guided Self-Determination intervention for adults with type 2 diabetes in general practice: a study protocol.
作者信息
Karlsen Bjørg, Oftedal Bjørg, Stangeland Lie Silje, Rokne Berit, Peyrot Mark, Zoffmann Vibeke, Graue Marit
机构信息
Department of Health Studies, University of Stavanger, Stavanger, Norway.
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
出版信息
BMJ Open. 2016 Dec 13;6(12):e013026. doi: 10.1136/bmjopen-2016-013026.
INTRODUCTION
Self-management is deemed the cornerstone in overall diabetes management. Web-based self-management interventions have potential to support adults with type 2 diabetes (T2DM) in managing their disease. Owing to somewhat ambiguous results of such interventions, interventions should be theory-based and incorporate well-defined counselling methods and techniques for behavioural change. This study is designed to assess the effectiveness of a theory-driven web-based Guided Self-Determination (GSD) intervention among adults with T2DM in general practice to improve diabetes self-management behaviours and glycosylated haemoglobin (HbA1c).
METHODS AND ANALYSIS
A complex intervention design based on the framework of the UK Medical Research Council is employed as a guide for developing the intervention, assessing its feasibility and evaluating its effectiveness. The study consists of three phases: (1) the modelling phase adapting the original GSD programme for adults with T2DM, using a qualitative design, (2) feasibility assessment of the adapted intervention on the web, employing qualitative and quantitative methods and (3) evaluating the effectiveness of the intervention on diabetes self-management behaviours and HbA1c, using a quasi-experimental design. The first phase, which is completed, and the second phase, which is underway, will provide important information about the development of the intervention and its acceptability, whereas the third phase will assess the effectiveness of this systematically developed intervention.
ETHICS AND DISSEMINATION
The Norwegian Regional Committee for Medical and Health Research Ethics (REK west number 2015/60) has approved the study design. Patients recruited in the different phases will fill out an informed consent form prior to inclusion and will be guaranteed anonymity and the right to withdraw from the study at any time. The results of the study will be published in peer-reviewed journals, electronically and in print, and presented at research conferences.
TRIAL REGISTRATION NUMBER
NCT02575599.
引言
自我管理被视为糖尿病综合管理的基石。基于网络的自我管理干预措施有潜力支持2型糖尿病（T2DM）成年人管理其疾病。由于此类干预措施的结果有些模糊，干预措施应以理论为基础，并纳入明确的行为改变咨询方法和技巧。本研究旨在评估一项基于理论驱动的网络引导式自我决定（GSD）干预措施对全科医疗中T2DM成年人改善糖尿病自我管理行为和糖化血红蛋白（HbA1c）的有效性。
方法与分析
采用基于英国医学研究委员会框架的复杂干预设计作为开发干预措施、评估其可行性和评价其有效性的指南。该研究包括三个阶段：（1）建模阶段，采用定性设计，将原始GSD计划改编用于T2DM成年人；（2）在网络上对改编后的干预措施进行可行性评估，采用定性和定量方法；（3）采用准实验设计评估干预措施对糖尿病自我管理行为和HbA1c的有效性。已完成的第一阶段和正在进行的第二阶段将提供有关干预措施开发及其可接受性的重要信息，而第三阶段将评估这种系统开发的干预措施的有效性。
伦理与传播
挪威医学和健康研究伦理区域委员会（REK west编号2015/60）已批准该研究设计。在不同阶段招募的患者将在纳入前填写知情同意书，并将被保证匿名以及随时退出研究的权利。该研究结果将在同行评审期刊上以电子和印刷形式发表，并在研究会议上展示。
试验注册号
NCT02575599。
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