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事件的风险却有所增加。临床试验表明，行为生活方式干预在降低糖尿病患者心血管疾病风险和心血管疾病相关死亡方面是有效的。面对面的干预是劳动和成本密集型的，但可能并不比其他交付方式更有效，特别是在获取和运输是一个重大问题的情况下。研究表明，电话干预是有效的，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（无论是固定电话还是移动电话）对低收入人群来说是很容易获得的。然而，在高风险、低收入的非裔美国人（AA）糖尿病患者中，使用一种新的基于片剂的方法降低心血管疾病风险干预措施的有效性的数据很少。本研究将确定一种多组分、片剂辅助行为干预对自我管理的影响（tablet）干预在改变行为（慢性病自我管理）和临床结果（心血管疾病风险）方面的有效性，以满足患有心血管疾病高风险的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，以检验理论驱动的多组分TABLET干预在改善高风险、低收入AAs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个月时心血管疾病危险行为的改变，次要结局是血糖控制（A1c）、血压、血脂以及生活质量。提出的新方法将通过实施基于平板电脑的视频会议作为干预的增强，最大限度地提高干预的有效性和影响。本研究的目标是一个高度优先的研究领域- 2型糖尿病的不同负担，导致不良的自我管理。这项应用的长期目标是测试生活方式行为改变的新方法，以减少心血管疾病并发症和死亡率，并消除高风险，低收入AA成人糖尿病患者的健康差异。

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.