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: 10372937
• 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/10372937
• 关键词: Achievement; Address; Adherence; Adolescent; Aftercare; Age; Algorithms; Behavior; Chronic Disease; Clinic; Clinical; Collection; Complex; Data; Devices; Diabetes Mellitus; Disease; Ensure; Feedback; Future; Glycosylated hemoglobin A; 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; base; care systems; clinical care; comparison intervention; design; digital; digital health; economic cost; effectiveness study; efficacy testing; empowered; experimental study; financial incentive; glucose monitor; glycemic control; health care service utilization; high risk; improved; improved outcome; innovation; intervention delivery; 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.

摘要 许多患有1型糖尿病（T1D）的年轻人都在努力满足复杂的日常需求， 他们的医疗方案，并未能实现良好的血糖控制。然而，很少有干预措施得到 专门为这个年龄段的人设计的。在拟议的研究中，我们将向所有人提供一个应用程序（SweetGoals） 参与者作为“核心”参与者。该应用程序提示参与者每周将他们的糖尿病设备上传到 与设备无关的上传程序（Glooko）将自动检索上传的数据，并应用有关 每天和每周的自我管理目标，并将生成有关目标实现的反馈信息。 此外，拟议的研究将测试两个独特的干预组成部分，旨在支持和优化 数字化自我监控、目标设定和目标实现。这些内容包括：（1）激励措施， 促进一致的日常坚持目标，（2）网络健康辅导，教有效的解决问题 专注于自我管理的个性化障碍。我们将使用一种新颖的数字化直接面向患者的招募方法 方法和干预提供模式，超越了诊所。而不是依靠诊所改造 它的护理系统，我们的干预将直接帮助年轻的成年患者发展技能，以提高他们的 利用卫生保健系统。既往试点RCT（N = 61）比较了这种干预方法与常规方法 青少年的护理对A1c有显著和持续的影响。这些结果非常有希望， 我们相信这种干预非常适合年轻人。在这项拟议中的研究中，300名年轻人年龄 将通过社交媒体招募19 - 25例T1D患者和目标（Hb）A1c（≥ 8.0%）以上患者。所有参与者将 接收建立在开源干预平台MobileCoach（www.移动的- Coach.eu该应用程序自动化了我们试点干预的许多功能，大大提高了可传播性。 这些包括自动检索Glooko“消化”的糖尿病设备数据，并提示和提供 关于坚持目标的反馈。依从性目标包括（a）每日血糖监测;和（B）进餐时间 行为。将使用22因子设计来测试以下因素的主要和交互作用：（1）适度的财务 满足坚持目标的激励措施和（2）网络健康辅导。教练会教一个解决问题的方法 这是一种针对依从性挑战生成个性化解决方案的方法。干预将持续6个月。 主要结局将是A1 c降低。我们假设， 参与者接受辅导和奖励。此外，我们假设一种协同作用 这些组成部分之间的相互作用，导致接受两者的人取得更大的积极成果。我们 还将测试四个关键的自我监管机制和应用程序参与指标作为结果的预测因素。 成功完成这些目标将有助于对这一干预措施的传播和效果研究 旨在改善高风险和未充分研究的T1D年轻成人人群的血糖控制。