Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy.
Improving Diabetes Management in Emerging Adulthood: An Intervention Development Study Using the Multiphase Optimization Strategy.
复制标题
改善新兴成年中的糖尿病管理：使用多相优化策略的干预开发研究。
DOI：
10.2196/20191
复制
发表时间：
2020-10-20
影响因子：
1.7
通讯作者：
Ondersma SJ
中科院分区：
文献类型：
--
作者：
Idalski Carcone A;Ellis DA;Eggly S;MacDonell KE;Ghosh S;Buggs-Saxton C;Ondersma SJ
成年初期（18-25岁）的糖尿病自我管理不良与糖尿病健康状况较差和糖尿病并发症有关。新兴成年人对个性化和独立性的关注是他们糖尿病预后不良的基础，为行为改变提供了一个杠杆。自我决定理论（SDT）表明，干预措施，利用新兴的成年人的先天发展需要的自主性，可能会提供一个途径，以改善糖尿病的结果，增加的责任感和控制糖尿病自我管理活动。本研究项目将使用多阶段优化策略，在控制不佳的1型糖尿病（T1 D; HbA 1c ≥9.0%）老年青少年和新成人（16-25岁）中，检测三种支持性干预成分的疗效，以引起代谢控制的临床显著改善，通过血红蛋白A1 c（HbA 1c）改善0.5%进行评估。问题提示列表（QPL）是一种工具，通过提出问题和陈述担忧，使患者能够在医疗访问期间发挥更积极的作用。动机增强系统（MES）是一个简短的咨询干预，使用动机访谈沟通策略，以建立内在的动机和自我效能的自我管理。短信提醒完成糖尿病护理任务可能会增加糖尿病自我管理的自我效能。在为新生成年人完善这些干预成分后，我们将使用八臂全析因设计进行成分选择实验：2（QPL是或否）×2（MES是或否）×2（文本是或否）。参与者将完成3次研究访视：基线、2个月治疗结束和6个月随访。主要结局是代谢控制，将通过HbA 1c进行测量。次要结局包括糖尿病管理和糖尿病门诊就诊率。SDT结构的内在动机，自我效能感，和质量的病人提供者的关系（即，相关性）是假设的调解人。抑郁症状和新生儿的性别是假设的调节因子。我们将使用混合效应线性模型进行析因设计的方差分析，以分析连续的纵向实验数据;广义线性模型将用于分类结局（例如，治疗出勤率）。该实验的动力是检测干预对主要结局的主要影响。共有20名参与者登记并在审查一个或多个干预组件后完成了定性访谈。访谈数据的分析正在进行中，预计将于2020年秋季报告这些结果。该临床试验将于2020年秋季启动，参与者将于2023年5月入组，数据收集将持续到2023年11月。在本实验结束时，我们将获得经验证据来支持一项针对年龄较大的青少年和T1 D控制不良的新兴成人进行优化的干预方案的大规模、多中心有效性试验。ClinicalTrials.gov NCT 04066959; https://clinicaltrials.gov/ct2/show/NCT04066959 DERR 1 -10.2196/20191
Poor diabetes self-management in emerging adulthood (age 18-25 years) is associated with poorer diabetes health and diabetes complications. Emerging adults’ focus on individuation and independence underlies their poor diabetes outcomes, offering a lever for behavior change. Self-determination theory (SDT) suggests that interventions leveraging emerging adults’ innate developmental need for autonomy may offer a route to improving diabetes outcomes by increasing feelings of responsibility for and control over diabetes self-management activities. This research project will use the multiphase optimization strategy to test the efficacy of three autonomy-supportive intervention components to elicit a clinically significant improvement in metabolic control, assessed by a 0.5% improvement in hemoglobin A1c (HbA1c), among older adolescents and emerging adults (16-25 years) with poorly controlled type 1 diabetes (T1D; HbA1c≥9.0%). A question prompt list (QPL) is a tool to empower patients to assume a more active role during medical visits by asking questions and stating concerns. The motivation enhancement system (MES) is a brief counseling intervention that uses motivational interviewing communication strategies to build intrinsic motivation and self-efficacy for self-management. Text message reminders to complete diabetes care tasks may increase self-efficacy for diabetes self-management. After refining these intervention components for emerging adults, we will conduct a component selection experiment using an eight-arm full factorial design: 2 (QPL yes or no)×2 (MES yes or no)×2 (Text yes or no). Participants will complete 3 study visits: baseline, treatment end at 2 months, and a follow-up at 6 months. The primary outcome is metabolic control, which will be measured via HbA1c. Secondary outcomes include diabetes management and diabetes clinic attendance. SDT constructs of intrinsic motivation, self-efficacy, and the quality of the patient-provider relationship (ie, relatedness) are hypothesized mediators. Depression symptoms and emerging adults’ gender are hypothesized moderators. We will use the mixed-effects linear model for the analysis of variance of a factorial design to analyze continuous longitudinal experimental data; the generalized linear model will be used with categorical outcomes (eg, treatment attendance). The experiment was powered to detect the main effects of the intervention on the primary outcome. A total of 20 participants have enrolled and completed a qualitative interview after reviewing one or more intervention components. Analysis of interview data are underway, with a report of these results anticipated in the fall of 2020. The clinical trial will be launched in the fall 2020, with participants enrolled through May 2023 and data collection continuing through November 2023. At the end of this experiment, we will have empirical evidence to support a large-scale, multisite effectiveness trial of an intervention package that has been optimized for older adolescents and emerging adults with poorly controlled T1D. ClinicalTrials.gov NCT04066959; https://clinicaltrials.gov/ct2/show/NCT04066959 DERR1-10.2196/20191