Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS)

描述（由申请人提供）：虽然心血管疾病（CVD）的死亡率有所下降，但糖尿病患者发生CVD事件的风险增加。临床试验表明，行为生活方式干预可有效降低糖尿病患者的CVD风险和CVD相关死亡。面对面的干预是劳动力和成本密集型的，但可能不会比其他交付方式更有效，特别是在访问和运输是一个重大问题的情况下。研究表明，电话干预措施是有效的，但更重要的是，患者可能更喜欢通过技术方式进行健康教育。电话（固定电话或手机）对低收入人口来说是很容易获得的。然而，关于在高风险、低收入的非裔美国人（AA）糖尿病患者中使用新型基于平板电脑的方法降低CVD风险干预措施的有效性的数据很少。本研究将确定多组分、平板电脑辅助行为干预自我管理（TABLETS）干预对改变行为（慢性病自我管理）和临床结局（CVD风险）的有效性，以满足CVD高风险低收入少数糖尿病人群的需求。我们提出了一项试点随机临床试验，以检查理论驱动的多组分片剂干预在改善高风险、低收入AA糖尿病患者的行为结局（活动、饮食、药物依从性、自我监测）和临床结局方面的可行性和有效性。主要结局是随访6个月时CVD风险行为的变化，次要结局是血糖控制（A1 c）、血压和血脂以及生活质量。拟议的新方法将通过实施基于平板电脑的视频会议来最大限度地提高干预措施的有效性和影响。这项研究的目标是一个高优先级的研究领域-不同的负担2型糖尿病，造成不良的自我管理。该应用程序的长期目标是测试改变生活方式行为的新方法，以减少CVD并发症和死亡率，并消除高风险，低收入AA糖尿病成年人的健康差异。

DESCRIPTION (provided by applicant): Though rates of death from cardiovascular disease (CVD) have declined the risk of CVD events increased among those with diabetes. Clinical trials have shown behavioral lifestyle interventions are effective at decreasing CVD risk and decreasing CVD-related deaths among those with diabetes. Face-to-face interventions are labor and cost intensive, but may not be more effective than alternative modes of delivery, especially where access and transportation are a significant problem. Studies have shown that telephone- delivered interventions are effective but, more importantly, that patients likely prefer health education via a technology modality. The telephone (either landline or cell phone) is highly accessible for low-income populations. Yet, there is little data on the effectiveness of CVD risk reduction interventions using a novel tablet-based approach among high-risk, low-income African Americans (AA) with diabetes. This study will determine the effectiveness of a multi-component, Tablet-Aided BehavioraL intervention EffecT on Self- management (TABLETS) intervention on changing behavioral (chronic disease self-management) and clinical outcomes (CVD risk) given the needs of a low-income minority population with diabetes at high risk for CVD. We propose a pilot randomized clinical trial to examine the feasibility and efficacy of a theory-driven, multi- component TABLET intervention on improving behavioral outcomes (activity, diet, medication adherence, self-monitoring) and clinical outcomes in high-risk, low-income AAs with diabetes. The primary outcome is change in CVD risk behaviors at 6 months of follow-up and secondary outcomes are glycemic control (A1c), blood pressure, and lipids as well as quality of life. The proposed novel approach will maximize the effectiveness and impact of the intervention by implementing tablet-based videoconferencing as an enhancement of the intervention. This study targets a high-priority research area - disparate burden of type 2 diabetes, resulting from poor self- management. The long-term goal of this application is to test novel approaches to lifestyle behavior change that reduce CVD complications and mortality, and eliminate health disparities in high-risk, low-income AA adults with diabetes.