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

退伍军人管理局基于智能手机的糖尿病预防：整群随机试验

• 批准号: 9346671
• 负责人: Matthew P Buman
• 金额: $ 24.52万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-07 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346671
• 关键词: Address; Adverse effects; Affect; Age; American; Behavior; Behavior Therapy; Biological Markers; Blood Pressure; Body Weight; Body fat; Caring; Cellular Phone; Characteristics; Clinic; Clinical; Clinical Trials; Cluster randomized trial; Complement; Complex; Data; Development; Diabetes Mellitus; Diabetes prevention; Dietary Component; Dietary intake; Disease; Dyslipidemias; Education; Environment; Epidemic; Ethnic Origin; Evaluation Research; Feasibility Studies; Focus Groups; Fostering; Future; General Population; Glucose; Glycosylated hemoglobin A; Goals; Health; Health behavior; Healthcare Systems; Home environment; Hospital Administration; Hospitals; Hour; Hyperinsulinism; Insulin; Intervention; Life Style; Lipids; Measures; Medical; Modeling; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Patient risk; Patients; Pharmaceutical Preparations; Physical activity; Population; Prediabetes syndrome; Prevention approach; Primary Health Care; Process; Provider; Race; Randomized; Reporting; Research Infrastructure; Resources; Risk; Self Management; Series; Sleep; Societies; System; Target Populations; Technology; Testing; Time; Traumatic Brain Injury; Veterans; Weight; base; clinical care; clinical practice; clinically relevant; cohort; combat; cost; data exchange; design; diabetes prevention program; diabetes risk; efficacy study; evidence base; fasting glucose; glucose metabolism; glycemic control; health administration; high risk; high risk population; improved; mHealth; novel; novel strategies; post-traumatic stress; preference; prevent; programs; secondary outcome; sedentary lifestyle; treatment as usual

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.

项目摘要 2型糖尿病（T2 D）影响着2600万美国人，“糖尿病前期”影响着8600万人。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T2 D。目前的生活方式计划，以防止 糖尿病的治疗是复杂的、昂贵的，并且具有有限的可扩展性。药物并不能明显改变 疾病的过程，并有一些副作用。需要新的方法来解决这个问题 在人口规模上流行。移动健康技术（例如，智能手机）已深深融入我们的生活 并可以针对T2 D流行病的日常生活方式行为。退伍军人健康 管理（VHA）是测试移动健康方法的理想环境，因为它们处于以下方面的最前沿： 利用智能手机技术，随着“VA应用程序商店”的出现提供护理。作为国家的 最大的综合医疗保健系统，VHA有一个中央传播基础设施，提供智能手机 为550多万退伍军人提供服务。我们的团队已经开发了BeWell 24，一个自适应和 多组件智能手机“应用程序”，是根据美国退伍军人的独特需求和愿望开发的 VHA临床团队BeWell 24针对24小时内的行为-睡眠，久坐行为， 我们的初步数据表明，糖尿病前期患者的空腹血糖降低， 12.3%在短短8周的使用。我们正在添加一个饮食组件的应用程序，以进一步提高效力， 干预。我们现在的目标是测试该应用程序的交付和集成是否可以用于常规临床 护理环境可以在12个月内改善血糖控制。我们提出了一个严格的随机分组试验， 随机分配14个与患者一致的护理团队（或“PACT团队”），向风险患者提供应用程序或常规护理， 患者（总计N=280名退伍军人）。我们的第一个目标是测试BeWell 24是否显著改善血糖 对照组（降低空腹血糖和HbA 1c）超过12个月。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、脂质、胰岛素和hs- CRP）。我们的第二个和第三个目标是评估影响BeWell 24可扩展性的因素， 提供者的观点，以优化大规模传播的机会，如果有效的话。我们会监察 项目覆盖率/保留率、应用程序使用率、治疗可接受性、项目成本和临床整合因素。 该提案的独特之处在于严格的聚类随机设计;在高度集成的， 在全国范围内，临床环境;并使用专为 人群和目标影响T2 D风险的多种健康行为。长期目标是建立一个 在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，这种方法可以迅速扩展到全国范围内的退伍军人，并可以广泛地 适用于不同T2 D风险的其他人群以及其他疾病。