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研究方案:应用程序与同伴支持助力健康未来及糖尿病良好生活(APHLID-M)。

Study protocol: Apps and peer support for a healthy future and living well with diabetes (APHLID-M).

作者信息

Mathews K O, MacMillan F, Wong V, Craig M, Greenfield J R, Hicks R, Jones T, Poynten A, Wong T, Reyes M, Tannous K, Wilson C, Hay P, Abdo S, Piya M K, Lai J, Venigalla M, Thomson R, Simmons D

机构信息

School of Medicine, Western Sydney University, Campbelltown, NSW, Australia.

Office of the Senior Deputy Vice-Chancellor and Vice-President (Research, Enterprise and Global), Western Sydney University, Penrith, Australia.

出版信息

Contemp Clin Trials Commun. 2025 Apr 14;45:101484. doi: 10.1016/j.conctc.2025.101484. eCollection 2025 Jun.

Abstract

BACKGROUND

Mental health conditions are common among non-pregnant young people with any form of diabetes, affecting diabetes self-management and increasing complications risk. Limited evidence exists on whether smartphone applications "apps" combining diabetes and mental health (MH) support can improve self-management and MH in these young people. The Apps and Peer support for a Healthy future and Living Well with Diabetes (APHLID-M) multicentre study includes two randomised controlled trials (RCTs) testing such an app, aimed at reducing distress among young adults with diabetes with and without a mental health condition (MHC).

METHODS AND ANALYSIS

An app containing diabetes and MH resources was configured onto a pre-existing, digital health platform. Young adults aged 16-30 years with diabetes will be recruited from eight Australian outpatient clinics, screened using the Kessler Psychological Distress Scale (K10) and the Problem Areas in Diabetes (PAID) questionnaires. Based on MH status, participants will be allocated to the primary RCT (MHC group) or a nested-exploratory RCT (No-MHC group) and randomised by site to the "app" (Intervention) or "no app" (control). All participants will have access to peer support and will continue to receive standard diabetes care through their clinic. Recruitment will end once 142 participants are enrolled in the primary RCT. The primary outcome is change in psychological distress (K10), and the secondary outcome change in HbA1c, assessed at baseline and 6 months.

DISCUSSION

APHLID-M will offer valuable insights into effects of digital technology in enhancing MH (particularly distress) physical health and well-being in young people with diabetes.

摘要

背景

心理健康问题在患有任何形式糖尿病的非妊娠青年中很常见,会影响糖尿病自我管理并增加并发症风险。关于结合糖尿病和心理健康(MH)支持的智能手机应用程序(“应用程序”)是否能改善这些年轻人的自我管理和心理健康,现有证据有限。“应用程序与同伴支持促进健康未来及糖尿病健康生活”(APHLID-M)多中心研究包括两项随机对照试验(RCT),测试此类应用程序,旨在减轻患有和未患有心理健康状况(MHC)的糖尿病青年的痛苦。

方法与分析

一个包含糖尿病和心理健康资源的应用程序被配置到一个现有的数字健康平台上。将从澳大利亚的八家门诊诊所招募16至30岁患有糖尿病的青年,使用凯斯勒心理困扰量表(K10)和糖尿病问题领域(PAID)问卷进行筛查。根据心理健康状况,参与者将被分配到主要随机对照试验(MHC组)或嵌套探索性随机对照试验(无MHC组),并按地点随机分为“应用程序”(干预组)或“无应用程序”(对照组)。所有参与者都将获得同伴支持,并将继续通过其诊所接受标准糖尿病护理。一旦142名参与者被纳入主要随机对照试验,招募工作将结束。主要结局是心理困扰(K10)的变化,次要结局是糖化血红蛋白(HbA1c)的变化,在基线和6个月时进行评估。

讨论

APHLID-M将为数字技术对增强患有糖尿病的年轻人的心理健康(尤其是困扰)、身体健康和幸福感的影响提供有价值的见解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7528/12052685/edfca39f7539/gr1.jpg

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