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同伴支持降低 2 型糖尿病患者糖尿病相关困扰的随机对照试验设计。

Peer support to decrease diabetes-related distress in patients with type 2 diabetes mellitus: design of a randomised controlled trial.

机构信息

Department of General Practice and Elderly Care Medicine, VU University Medical Center, Amsterdam, The Netherlands.

出版信息

BMC Endocr Disord. 2014 Mar 4;14:21. doi: 10.1186/1472-6823-14-21.

Abstract

BACKGROUND

Many type 2 diabetes mellitus patients face difficulties self-managing their illness, which can lead to high levels of diabetes-related distress. Diabetes distress may be decreased by peer support, as peers understand and have dealt with similar problems, and can help motivate each other. A recent systematic review concluded that evidence of benefits of peer support in patients with type 2 diabetes mellitus is too inconsistent due to weak theoretical foundation of the interventions. This study describes the design of a trial evaluating the effectiveness of a group-based, peer support programme with a strong theoretical foundation on diabetes-related distress in type 2 diabetes patients.

METHODS

This is a parallel group randomised controlled trial of a six session group-based peer support intervention, delivered by peer leaders and group psychotherapists, compared with one educational meeting on diabetes. At least 152 patients with a type 2 diabetes duration of three years or more and between 50 and 70 years of age, recruited via their general practitioner, will be randomised to receive the peer support intervention or one educational meeting. The intervention is developed in line with three key stages of research development of the Medical Research Council framework. The primary outcome measure for this study is diabetes-related distress. Secondary outcomes include self-management behaviour, well-being and health-related quality of life. Perceived social support is a process measure. Outcomes will be measured one month before, and 6, and 12 months after the intervention by means of self-reported questionnaires. Analysis will be on an intention-to-treat basis.

DISCUSSION

This article contains a description of the design of a study that will investigate the effect of a group-based, peer support intervention on diabetes-related distress in type 2 diabetes patients. The intervention was developed in recognition of the limited evidence, and the importance of a theoretical foundation and its implementation. Findings will contribute to knowledge in the field of peer support and patient-important outcomes in type 2 diabetes patients.

TRIAL REGISTRATION

Dutch Trial Registry: NTR3474.

摘要

背景

许多 2 型糖尿病患者在自我管理疾病方面存在困难,这可能导致糖尿病相关困扰程度较高。同伴支持可以减轻糖尿病困扰,因为同伴理解并处理过类似的问题,可以互相激励。最近的一项系统评价得出结论,由于干预措施的理论基础薄弱,2 型糖尿病患者同伴支持的益处证据不够一致。本研究描述了一项试验的设计,该试验评估了基于群体的、有坚实理论基础的同伴支持计划对 2 型糖尿病患者糖尿病相关困扰的有效性。

方法

这是一项平行组随机对照试验,比较了由同伴领导人和团体心理治疗师提供的六节基于群体的同伴支持干预与一次糖尿病教育会议,试验对象为至少有三年以上 2 型糖尿病病史、年龄在 50 至 70 岁之间的患者。通过他们的全科医生招募患者,将他们随机分配接受同伴支持干预或一次教育会议。该干预措施是根据医疗研究委员会框架的三个关键研究发展阶段制定的。本研究的主要结局测量指标是糖尿病相关困扰。次要结局指标包括自我管理行为、幸福感和健康相关生活质量。感知社会支持是一个过程测量指标。通过自我报告问卷在干预前一个月、干预后 6 个月和 12 个月进行评估。分析将基于意向治疗原则进行。

讨论

本文包含了一项研究的设计描述,该研究将调查基于群体的同伴支持干预对 2 型糖尿病患者糖尿病相关困扰的影响。该干预措施是在认识到证据有限以及理论基础及其实施的重要性的情况下制定的。研究结果将有助于同伴支持领域的知识以及 2 型糖尿病患者的患者重要结局。

试验注册

荷兰试验注册处:NTR3474。

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