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.

抽象的 许多患有 1 型糖尿病 (T1D) 的年轻人都在努力应对复杂的日常需求 然而，他们的医疗方案并未能实现良好的血糖控制。 在拟议的研究中，我们将专门为这个年龄段开发一个应用程序（SweetGoals）。 该应用程序提示参与者每周将他们的糖尿病设备上传到一个“核心”干预措施。 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的决策规则 每日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种独特的干预成分，旨在支持和优化 数字化自我监控、目标设定和目标实现包括 (1) 激励。 促进日常坚持目标，以及 (2) 网络健康辅导，教授有效解决问题的方法 我们将重点关注自我管理的个性化障碍。 超越诊所的方法和干预实施模式，而不是依赖诊所进行改造。 在其护理系统中，我们的干预措施将直接帮助年轻的成年患者发展技能，以提高他们的能力 先前的试点随机对照试验 (N=61) 将这种干预方法与通常的干预方法进行了比较。 青少年的护理对 A1c 产生了显着且持续的影响。这些结果非常有希望， 我们相信这种干预措施非常适合年轻人。在拟议的研究中，有 300 名年轻人参与。 19-25 岁患有 T1D 及以上目标 (Hb)A1c (≥ 8.0%) 的患者将通过社交媒体招募。 接收基于开源干预平台 MobileCoach (www.Mobile- Coach.eu）。该应用程序自动化了我们试点干预的许多功能，大大提高了传播性。 其中包括自动检索 Glooko“消化”的糖尿病设备数据并提示和提供 遵守目标的反馈包括 (a) 每日血糖监测；以及 (b) 进餐时间。 将使用 22 因子设计来测试 (1) 适度财务的主要影响和交互影响。 达到遵守目标的激励措施和（2）网络健康辅导将教授解决问题的方法。 为应对依从性挑战提供个性化解决方案的方法，干预将持续 6 个月。 主要成果是糖化血红蛋白 (A1c) 的降低。 接受辅导和激励的参与者此外，我们还进行了协同作用。 这些成分之间的相互作用，使同时接受这两种成分的人产生更大的积极成果。 还将测试四个关键的自我监管机制和应用程序参与度指标作为结果的预测指标。 成功完成这些目标将支持该干预措施的传播和有效性研究 该项目旨在改善这一高危且研究不足的 1 型糖尿病年轻成人人群的血糖控制。