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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{"title":"Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics","authors":"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","doi":"10.1016/j.cct.2025.107849","DOIUrl":null,"url":null,"abstract":"<div><div>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 (<em>N</em> = 195) were recruited with <em>n</em> = 162 randomized (M<sub>age</sub> = 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.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107849"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000436","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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Abstract
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 (Mage = 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.