Smartphone-Based Diabetes Prevention in the VA: A Cluster-Randomized Trial

项目总结 美国有2600万人患有2型糖尿病，8600万人患有前驱糖尿病。如果这场流行病 如果不立即解决，到2030年，23%的美国人将患有T2D。当前的生活方式计划，以防止 糖尿病提供起来很复杂，成本很高，而且可扩展性有限。药物治疗不会明显地改变 疾病的进程和有许多副作用。需要新的方法来解决这个问题 人口规模的流行病。移动健康技术(如智能手机)已深度融入我们的生活 并可以针对支撑T2D疫情的日常生活方式行为。退伍军人健康 管理(VHA)是测试mHealth方法的理想环境，因为它们处于 随着“退伍军人应用商店”的出现，利用智能手机技术提供护理。作为这个国家的 最大的集成医疗系统，VHA有一个中央传播基础设施来提供智能手机 对超过550万名退伍军人进行干预。我们的团队开发了BeWell24，一种自适应和 根据美国退伍军人的独特需求和愿望开发的多组件智能手机应用程序 和VHA临床团队。BeWell24针对的是24小时内的行为-睡眠、久坐行为和 更积极的行为-我们的初步数据表明，糖尿病前期患者的空腹血糖降低 在短短8周内就达到了12.3%。我们正在向应用程序中添加饮食成分，以进一步增强 干预行动。我们现在的目标是测试这款应用程序的交付和集成到常规临床 护理环境可以改善12个月的血糖控制。我们提出了一个严格的整群随机试验， 随机选择14个以患者为中心的医疗团队(或“协议团队”)，为高危人群提供APP或常规医疗服务 患者(总计N=280名退伍军人)。我们的第一个目标是测试BeWell24是否能显著改善血糖 与常规护理相比，控制(降低空腹血糖和糖化血红蛋白)超过12个月。我们将进一步探索 客观测量的变化是有针对性的行为(睡眠、久坐行为、体力活动和饮食 摄入量)和其他关键的心脏代谢生物标志物(体重/体脂、血压、血脂、胰岛素和hs- C反应蛋白)。我们的第二和第三个目标是评估影响BeWell24可伸缩性的因素 提供者的观点，以优化大规模传播的机会，如果有效的话。我们会监控 计划覆盖/保留、应用程序使用、治疗可接受性、计划成本和临床整合因素。 该方案的独特之处在于严格的集群随机化设计；在高度集成、 全国范围内的临床环境；以及使用专为 并针对影响T2D风险的多种健康行为。长期目标是建立一个 退伍军人中有效的糖尿病预防计划，可用于补充和加强现有的 临床支持。如果有效，这种方法可能会迅速推广到全国退伍军人，并可能具有广泛的 对具有不同T2D风险的其他人群以及其他障碍的适用性。

PROJECT SUMMARY Type 2 diabetes (T2D) affects 26 million Americans and “pre-diabetes” affects 86 million more. If this epidemic is not addressed immediately, 23% of Americans will have T2D by 2030. Current lifestyle programs to prevent diabetes are complex to deliver, costly, and have limited scalability. Medications do not clearly modify the disease process and have a number of side effects. New approaches are needed that can address this epidemic on a population scale. mHealth technologies (e.g., smartphones) are deeply integrated into our lives and can target the daily lifestyle behaviors that underpin the T2D epidemic. The Veterans Health Administration (VHA) is an ideal setting to test mHealth approaches because they are at the forefront of harnessing smartphone technologies to deliver care with the advent of the “VA App Store.” As the nation's largest integrated healthcare system, VHA has a central dissemination infrastructure to deliver smartphone interventions to over 5.5 million Veterans. Our team has developed BeWell24, an adaptive and multicomponent smartphone “app” that was developed based on the unique needs and desires of US Veterans and VHA clinical teams. BeWell24 targets behaviors across the 24 hours – sleep, sedentary behavior, and more active behaviors – and our preliminary data suggest reductions in fasting glucose among prediabetics of 12.3% in just 8 weeks of use. We are adding a dietary component to the app to further enhance the potency of the intervention. Our objective now is to test whether the delivery and integration of this app into routine clinical care settings can improve glycemic control over 12 months. We propose a rigorous cluster- randomized trial, randomizing 14 patient-aligned care teams (or “PACT teams”) to deliver the app or usual care to at-risk patients (total N=280 Veterans). Our first aim is to test whether BeWell24 significantly improves glycemic control (reduce fasting glucose and HbA1c) over 12 months relative to usual care. We will further explore objectively-measured changes is targeted behaviors (sleep, sedentary behavior, physical activity, and dietary intake) and other key cardiometabolic biomarkers (weight/body fat, blood pressure, lipids, insulin, and hs- CRP). Our second and third aims are to assess factors impacting scalability of BeWell24 from patient and provider perspectives to optimize opportunities for large-scale dissemination if efficacious. We will monitor program reach/retention, app usage, treatment acceptability, program costs, and clinical integration factors. Unique features of this proposal are the rigorous cluster-randomized design; testing in a highly integrated, nationwide, clinical setting; and use of a highly sophisticated smartphone platform uniquely designed for the population and targets multiple health behaviors impacting T2D risk. The long-term goal is to establish an effective diabetes prevention program among Veterans that can be used to complement and enhance existing clinical support. If effective, this approach could be rapidly scaled to Veterans nationwide and could have broad applicability for other populations at disparate T2D risk as well as other disorders.