Thinking Outside the Clinic: A Digital Health Approach for Young Adults with Type 1 Diabetes

临床之外的思考：针对年轻 1 型糖尿病患者的数字健康方法

• 批准号: 10597661
• 负责人: CATHERINE STANGER
• 金额: $ 59.19万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10597661
• 关键词: Achievement; Address; Adherence; Adolescent; Aftercare; Age; Algorithms; Behavior; Chronic Disease; Clinic; Clinical; Collection; Complex; Data; Devices; Diabetes Mellitus; Disease; Educational process of instructing; Ensure; Feedback; Future; Goals; Health; Health behavior; Healthcare Systems; Incentives; Incidence; Informal Social Control; Injections; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Internet; Intervention; Intervention Studies; Learning; Mediation; Medical; Mental Depression; Methods; Modeling; Monitor; Outcome; Participant; Patient Recruitments; Patients; Persons; Play; Population; Populations at Risk; Problem Solving; Public Health; Randomized; Randomized, Controlled Trials; Regimen; Retrieval; Role; Self Efficacy; Self Management; Series; Technology; Testing; Thinking; Transcend; age group; care systems; clinical care; comparison intervention; design; digital; digital health; economic cost; effectiveness study; efficacy testing; empowerment; experimental study; financial incentive; glucose monitor; glycemic control; health care service utilization; high risk; improved; improved outcome; innovation; intervention delivery; medical complication; meetings; model design; mortality; multiphase optimization strategy; novel; open source; outcome prediction; pilot test; primary outcome; recruit; sex; skills; social media; therapy design; traditional care; treatment as usual; young adult

Abstract Many young adults with type 1 diabetes (T1D) struggle with the complex daily demands of adherence to their medical regimen and fail to achieve good glycemic control. However, few interventions have been developed specifically for this age group. In the proposed study, we will provide an app (SweetGoals) to all participants as a “core” intervention. The app prompts participants to upload their diabetes devices weekly to a device-agnostic uploader (Glooko), will automatically retrieve uploaded data and apply decision rules about daily and weekly self-management goals, and will generate feedback messages about goal attainment. Further, the proposed study will test two unique intervention components designed to support and optimize digital self-monitoring, goal setting, and goal achievement. These components include (1) incentives to promote consistent daily adherence to goals, and (2) web health coaching to teach effective problem solving focused on personalized barriers to self-management. We will use a novel digital direct-to-patient recruitment method and intervention delivery model that transcends the clinic. Instead of relying on the clinic to transform its system of care, our intervention will directly assist young adult patients in developing skills to improve their utilization of the health care system. A prior pilot RCT (N=61) comparing this intervention approach to usual care among adolescents showed significant and sustained impact on A1c. These results were very promising, and we believe this intervention is well suited to young adults. In the proposed study, 300 young adults ages 19-25 with T1D and above target (Hb)A1c (≥ 8.0%) will be recruited via social media. All participants will receive the SweetGoals app built on an open-source intervention platform MobileCoach (www.Mobile- Coach.eu). The app automates many features of our piloted intervention, greatly increasing disseminability. These include automatic retrieval of diabetes device data “digested” by Glooko and prompting and providing feedback on adherence goals. Adherence targets include (a) daily glucose monitoring; and (b) mealtime behaviors. A 22 factorial design will be used to test the main and interactive effects of (1) modest financial incentives for meeting adherence targets and (2) web health coaching. Coaches will teach a problem-solving approach that generates personalized solutions to adherence challenges. The intervention will last 6 months. The primary outcome will be reduction in A1c. We hypothesize greater sustained A1c improvements in participants who receive coaching and who receive incentives. Further, we hypothesize a synergistic interaction between these components, resulting in greater positive outcomes among those receiving both. We will also test four key self-regulation mechanisms and app engagement metrics as predictors of outcomes. Successful completion of these aims will support dissemination and effectiveness studies of this intervention that seeks to improve glycemic control in this high-risk and understudied population of young adults with T1D.

抽象的 许多患有1型糖尿病（T1D）的年轻人与遵守复杂的日常需求斗争 他们的医疗方案和无法获得良好的血糖控制。但是，很少有干预措施 专门为该年龄段的人开发。在拟议的研究中，我们将向所有人提供一个应用程序（sweetgoals） 参与者是“核心”干预措施。该应用提示参与者每周上传糖尿病设备 设备不合时宜的上传器（Glooko）将自动检索上传的数据，并应用有关的决策规则 每天和每周的自我管理目标，并会产生有关目标实现的反馈信息。 此外，拟议的研究将测试旨在支持和优化的两个独特的干预组件 数字自我监控，目标设定和目标成就。这些组件包括（1）激励措施 促进每日遵守目标的持续遵守，以及（2）网络健康教练以教授有效的问题解决 专注于自我管理的个性化障碍。我们将使用新颖的数字直接招聘 超越诊所的方法和干预输送模型。而不是依靠诊所转变 它的护理体系，我们的干预将直接帮助年轻的成年患者发展技能，以改善他们的 医疗保健系统的利用。将这种干预方法与通常的试点RCT（n = 61） 青少年的护理对A1C显示出重大和持续的影响。这些结果非常有前途， 我们认为这种干预非常适合年轻人。在拟议的研究中，有300名年轻人 T1D及以上的19-25（HB）A1C（≥8.0％）将通过社交媒体招募。所有参与者都会 接收在开源干预平台MobileCoach（www.mobile- coach.eu）。该应用程序可以自动化我们试验的干预措施的许多功能，从而极大地增加了性能。 其中包括通过Glooko“消化”糖尿病设备数据的自动检索，并提示和提供 关于依从性目标的反馈。依从性目标包括（a）每日葡萄糖监测； （b）进餐时间 行为。 22个阶乘设计将用于测试（1）适度财务的主要和互动效果 实现依从性目标和（2）网络健康教练的激励措施。教练将教一个问题 产生个性化解决方案来遵守挑战的方法。干预将持续6个月。 主要结果将是A1C的减少。我们假设更大的持续A1C改进 接受教练并获得激励措施的参与者。此外，我们假设一种协同作用 这些组件之间的相互作用，从而在接受两者的人群之间产生了更大的积极结果。我们 还将测试四种关键的自我调节机制和应用程序参与度指标作为结果的预测指标。 这些目标的成功完成将支持对这种干预的传播和有效性研究 在这种高风险和了解的年轻人中，旨在改善血糖控制。