基于网络的 2 型糖尿病患者自我管理支持（HeLP-Diabetes）：在英国初级保健中的随机对照试验。

Web-based self-management support for people with type 2 diabetes (HeLP-Diabetes): randomised controlled trial in English primary care.

机构信息

Research Department of Primary Care and Population Health, University College London, London, UK.

Department of Public Health and Primary Care, Cardiovascular Epidemiology Unit, University of Cambridge, Cambridge, UK.

出版信息

BMJ Open. 2017 Sep 27;7(9):e016009. doi: 10.1136/bmjopen-2017-016009.

OBJECTIVE

To determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.

METHODS AND DESIGN

Individually randomised two-arm controlled trial.

SETTING

21 general practices in England.

PARTICIPANTS

Adults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.

INTERVENTION AND COMPARATOR

Usual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.

OUTCOMES AND DATA COLLECTION

Joint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.

ANALYSIS

The analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.

RESULTS

Of the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.

CONCLUSIONS

Access to HeLP-Diabetes improved glycaemic control over 12 months.

TRIAL REGISTRATION NUMBER

ISRCTN02123133.

目的

确定基于网络的自我管理方案对 2 型糖尿病患者的有效性，以改善血糖控制并减少与糖尿病相关的痛苦。

方法和设计

个体随机对照双臂试验。

设置

英格兰的 21 家普通诊所。

参与者

年龄在 18 岁或以上，经参与普通诊所诊断患有 2 型糖尿病的成年人。

干预和对照组

常规护理加糖尿病患者的健康生活（Help-Diabetes），一种互动的，基于理论的，基于网络的自我管理方案，或仅包含基本信息的简单文本网站。

结果和数据收集

联合主要结果是糖化血红蛋白（HbA1c）和与糖尿病相关的困扰，通过糖尿病问题领域量表（PAID）进行测量，在随机分组后 3 个月和 12 个月收集，以 12 个月为主要终点。研究护士对分配情况进行盲法，收集临床数据；参与者在线完成自我报告问卷。

分析

使用线性混合效应模型比较组间随机分配（意向治疗），调整基线数据并进行缺失值的多重插补。

结果

在 2013 年 9 月至 2014 年 12 月之间随机分配的 374 名参与者中，185 名被分配到干预组，189 名被分配到对照组。最终（12 个月）随访的 HbA1c 数据可用于 318 名（85％）和 337 名（90％）参与者。其中，291 名（78％）和 321 名（86％）的应答在 10-14 个月的预定窗口内记录。与对照组相比，干预组的 HbA1c 较低（平均差异 -0.24％；95％CI-0.44 至-0.049；p=0.014）。两组之间的平均 PAID 评分没有显著差异（p=0.21），但对最近被诊断为糖尿病的参与者的预设亚组分析显示，该组干预具有有益影响（p=0.004）。没有报告任何不良事件。

结论

使用 HeLP-Diabetes 可在 12 个月内改善血糖控制。

试验注册号

ISRCTN02123133。