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在初级保健中使用闲聊产生重大影响干预措施与2型糖尿病患者讨论体重管理:一项随机对照试验的方案

Discussing Weight Management With Type 2 Diabetes Patients in Primary Care Using the Small Talk Big Difference Intervention: Protocol for a Randomized Controlled Trial.

作者信息

Brooksbank Katriona, O'Donnell Joanne, Corbett Vicky, Shield Sarah, Ainsworth Rachel, Shearer Ross, Montgomery Susan, Gallagher Andrew, Duncan Hannah, Hamilton Lorna, Laszlo Valerie, Noone Rhonda, Baxendale Anna, Blane David, Logue Jennifer

机构信息

Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.

Merck Sharpe & Dohme, Hoddesdon, United Kingdom.

出版信息

JMIR Res Protoc. 2019 Feb 15;8(2):e12162. doi: 10.2196/12162.

Abstract

BACKGROUND

Guidelines for the management of type 2 diabetes universally recommend that adults with type 2 diabetes and obesity be offered individualized interventions to encourage weight loss. Yet despite the existing recommendations, provision of weight management services is currently patchy around the United Kingdom and where services are available, high attrition rates are often reported. In addition, individuals often fail to take up services, that is, after discussion with a general practitioner or practice nurse, individuals are referred to the service but do not attend for an appointment. Qualitative research has identified that the initial discussion raising the issue of weight, motivating the patient, and referring to services is crucial to a successful outcome from weight management.

OBJECTIVE

Our aim was to evaluate the effectiveness of an Internet-based training program and practice implementation toolkit with or without face-to-face training for primary care staff. The primary outcome is the change in referral rate of patients with type 2 diabetes to National Health Service adult weight management programs, 3 months pre- and postintervention.

METHODS

We used the Behavior Change Wheel to develop an intervention for staff in primary care consisting of a 1-hour Internet-based eLearning package covering the links between obesity, type 2 diabetes, and the benefits of weight management, the treatment of diabetes in patients with obesity, specific training in raising the issue of weight, local services and referral pathways, overview of weight management components/ evidence base, and the role of the referrer. The package also includes a patient pamphlet, a discussion tool, a practice implementation checklist, and an optional 2.5-hour face-to-face training session. We have randomly assigned 100 practices in a 1:1 ratio to either have immediate access to all the resources or have access delayed for 4 months. An intention-to-treat statistical analysis will be performed.

RESULTS

Recruitment to the study is now complete. We will finalize follow-up in 2018 and publish in early 2019.

CONCLUSIONS

This protocol describes the development and randomized evaluation of the effectiveness of an intervention to improve referral and uptake rates of weight management programs for adults with type 2 diabetes. At a time when many new dietary and pharmacological weight management interventions are showing large clinical benefits for people with type 2 diabetes, it is vital that primary care practitioners are willing, skilled, and able to discuss weight and make appropriate referrals to services.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03360058; https://clinicaltrials.gov/ct2/show/NCT03360058 (Archived by WebCite at http://www.webcitation.org/74HI8ULfn).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12162.

摘要

背景

2型糖尿病管理指南普遍建议,应为患有2型糖尿病和肥胖症的成年人提供个性化干预措施以促进体重减轻。然而,尽管有现有建议,但目前英国各地提供体重管理服务的情况并不均衡,而且在有服务的地方,经常报告有高流失率。此外,个体往往不接受服务,也就是说,在与全科医生或执业护士讨论后,个体被转介到该服务,但并未预约就诊。定性研究表明,最初讨论体重问题、激励患者并转介到服务对于体重管理的成功结果至关重要。

目的

我们的目的是评估基于互联网的培训项目和实践实施工具包(有或没有面对面培训)对基层医疗人员的有效性。主要结局是干预前3个月和干预后2型糖尿病患者转介到国民健康服务体系成人体重管理项目的转介率变化。

方法

我们使用行为改变轮为基层医疗人员开发了一种干预措施,包括一个1小时的基于互联网的电子学习包,内容涵盖肥胖、2型糖尿病之间的联系以及体重管理的益处、肥胖患者的糖尿病治疗、提出体重问题的具体培训、当地服务和转介途径、体重管理组成部分/证据基础概述以及转介者的作用。该包还包括一份患者手册、一个讨论工具、一份实践实施清单以及一个可选的2.5小时面对面培训课程。我们已将100个诊所按1:1的比例随机分配,一组可立即获取所有资源,另一组延迟4个月获取。将进行意向性分析。

结果

该研究的招募工作现已完成。我们将在2018年完成随访,并于2019年初发表。

结论

本方案描述了一项干预措施的开发及对其有效性的随机评估,该干预措施旨在提高2型糖尿病成年人体重管理项目的转介率和接受率。在许多新的饮食和药物体重管理干预措施对2型糖尿病患者显示出巨大临床益处的当下,基层医疗从业者愿意、有技能且能够讨论体重问题并进行适当的服务转介至关重要。

试验注册

ClinicalTrials.gov NCT03360058;https://clinicaltrials.gov/ct2/show/NCT03360058(由WebCite存档于http://www.webcitation.org/74HI8ULfn)。

国际注册报告识别号(IRRID):DERR1-10.2196/12162。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4ee9/6396071/8da9cf0602e7/resprot_v8i2e12162_fig1.jpg

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