研究方案：应用程序和同伴支持糖尿病患者的健康未来和生活（APHLID-M）

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-14 DOI:10.1016/j.conctc.2025.101484

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

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引用次数: 0

摘要

心理健康状况在患有任何形式糖尿病的未怀孕青年中都很常见，影响糖尿病的自我管理并增加并发症的风险。关于智能手机应用程序结合糖尿病和心理健康（MH）支持是否能改善这些年轻人的自我管理和MH的证据有限。app和同伴支持健康未来和糖尿病患者生活（aphid - m）多中心研究包括两个随机对照试验（rct）测试这样一个应用程序，旨在减少有或没有精神健康状况（MHC）的年轻糖尿病患者的痛苦。方法和分析一个包含糖尿病和MH资源的应用程序被配置到一个已有的数字健康平台上。年龄在16-30岁的年轻糖尿病患者将从8个澳大利亚门诊诊所招募，使用Kessler心理困扰量表（K10）和糖尿病问题领域（PAID）问卷进行筛选。根据MHC状态，参与者将被分配到主要RCT （MHC组）或嵌套探索性RCT（无MHC组），并按地点随机分配到“应用程序”（干预）或“无应用程序”（对照组）。所有参与者都将获得同伴支持，并将继续通过他们的诊所接受标准的糖尿病治疗。一旦142名参与者被纳入主要随机对照试验，招募将结束。主要结局是心理困扰（K10）的改变，次要结局是糖化血红蛋白（HbA1c）的改变，在基线和6个月时进行评估。讨论aphlid - m将为数字技术在提高年轻糖尿病患者的身体健康和福祉方面的影响提供有价值的见解。

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

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.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.