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

描述(由申请人提供)：尽管心血管疾病(CVD)的死亡率下降，但糖尿病患者发生心血管事件的风险增加。临床试验表明，行为生活方式干预在降低糖尿病患者的心血管风险和减少与心血管相关的死亡方面是有效的。面对面的干预是劳动和成本密集型的，但可能不会比替代的提供方式更有效，特别是在交通和交通是一个严重问题的情况下。研究表明，电话传递的干预措施是有效的，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。对于低收入人群来说，电话(无论是固定电话还是手机)都很容易获得。然而，几乎没有数据表明在患有糖尿病的高危、低收入非裔美国人(AA)中使用一种新的基于片剂的方法来降低心血管疾病风险干预的有效性。这项研究将确定自我管理(片剂)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)方面的多成分、片剂辅助行为干预效果的有效性，以满足低收入少数群体糖尿病心血管疾病高危人群的需求。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片剂干预在改善糖尿病高风险、低收入AA患者的行为结果(活动、饮食、服药依从性、自我监测)和临床结果方面的可行性和有效性。主要结果是6个月随访时心血管危险行为的改变，次要结果是血糖控制(A1c)、血压、血脂以及生活质量。拟议的新办法将通过实施平板电脑视频会议来加强干预，从而最大限度地提高干预的效力和影响。这项研究的目标是一个高度优先的研究领域--由糟糕的自我管理造成的2型糖尿病的不同负担。这项应用的长期目标是测试改变生活方式行为的新方法，以减少心血管并发症和死亡率，并消除患有糖尿病的高风险、低收入AA成年人的健康差距。

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.