减少1型糖尿病自我管理障碍的干预：糖尿病之旅研究设计和参与者特征。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-20 DOI:10.1016/j.cct.2025.107849

Kimberly A. Driscoll , Paige J. Trojanowski , Desireé N. Williford , Holly K. O'Donnell , Erin Flynn , Constance A. Mara , Sara E. Wetter , Alexandra C. Himelhoch , Hannah Manis , Alicia Pardon , Cheyenne M. Reynolds , Emily R. Shaffer , Bailey Tanner , Jessica Kichler , Laura Smith , Sarah Westen , Anastasia Albanese-O'Neill , Sarah D. Corathers , Laura M. Jacobsen , Amy Poetker , Avani C. Modi

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引用次数: 0

摘要

大多数患有1型糖尿病（T1D）的青少年在达到最佳血糖水平时遇到障碍，包括有效的计划和监测他们的T1D和解决问题，以及跟进T1D治疗决策。因此，糖尿病之旅是一项随机对照临床试验，其总体目标是评估一种新颖的、游乐园主题的、基于网络的移动健康（mHealth）干预措施的可行性、可接受性和初步疗效，该干预措施专为经历T1D自我管理障碍的青少年量身定制。次要目的包括检查干预后T1D健康相关生活质量、T1D自我管理行为和血红蛋白A1c （HbA1c）的变化。本文描述了研究的基本原理、招募、设计和青少年（12-17 岁）的基线特征，这些青少年被随机分为两组：糖尿病之旅组或强化标准护理组。糖尿病之旅专注于减少与压力、倦怠、时间压力和计划相关的挑战，通过使用解决问题的框架提供5-8次干预会议。通过T1D工具包©网站（关于T1D的教育内容和简短视频），参与“提高护理标准”的参与者参加了4次以类似主题为重点的教育会议。青少年(N = 195)招募了163 N = 随机(法师 =  14.8±1.6  年;50 %女性，88 %白人；糖化血红蛋白% = 8.2 ± 1.8;86% %胰岛素泵)。糖尿病之旅受到COVID-19的影响，有必要修改研究设计。接下来的重要步骤将包括研究糖尿病之旅对主要和次要结果的影响，同时考虑到COVID-19的影响。

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Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics

Most adolescents with type 1 diabetes (T1D) encounter barriers to achieving optimal glycemia, including effective planning and monitoring their T1D and problem-solving, and following through with T1D treatment decisions. Thus, the overall aim of Diabetes Journey, a randomized controlled clinical trial, was to assess the feasibility, acceptability, and preliminary efficacy of a novel, amusement park-themed, web-based mobile health (mHealth) intervention tailored for adolescents who experienced barriers to T1D self-management. Secondary aims included examining post-intervention changes in T1D health-related quality of life, T1D self-management behaviors, and hemoglobin A1c (HbA1c). This article describes the study rationale, recruitment, design, and baseline characteristics of the adolescents (aged 12–17 years) who were randomized to one of two groups: Diabetes Journey or Enhanced Standard of Care. Diabetes Journey focused on reducing challenges related to stress, burnout, time pressure, and planning through the delivery of 5–8 intervention sessions using a problem-solving framework. Enhanced Standard of Care participants attended 4 education sessions focused on similar topics through the T1D Toolkit© website (educational content and brief videos about T1D). Adolescents (N = 195) were recruited with n = 162 randomized (M_age = 14.8 ± 1.6 years; 50 % female, 88 % White; HbA1c% = 8.2 ± 1.8; 86 % on insulin pumps). Diabetes Journey was impacted by COVID-19 and modifications to the study design were warranted. Future directions include examining the impact of Diabetes Journey on primary and secondary outcomes, while accounting for the impact of COVID-19.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts 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 disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.