DMHEALTH: FEASIBILITY OF A CELL-PHONE ADHERENCE TRIAL FOR UNDERSERVED T1DM YOUTH

描述（由申请人提供）：低收入和少数民族青少年1型糖尿病（T1D）通常有较差的血糖控制和不良的心血管疾病（CVD）风险概况。迫切需要制定和试验干预措施，以改善这些高风险青年的糖尿病自我管理和健康结果。我们建议对DM-Health进行试点和可行性研究，这是一种综合的、以证据为基础的糖尿病自我管理干预措施，具有连贯性和用户友好性，并利用了最先进的技术和行为策略。干预是基于行为方法（动机性访谈，解决问题的技能培训和行为家庭系统治疗）和通信技术（基于手机的信息交换）；我们的研究小组之前都证明了它们是有效的。参与者将从三个临床站点招募，这些站点具有人口统计学上不同的患者群体，各种提供者设置和已建立的临床研究基础设施。具体目标是：1。记录DM-Health试验的可行性。我们将完善最佳招聘和保留策略，并建立有效执行多地点临床试验所需的行政、中心实验室、数据管理和数据分析系统。2. 确定糖尿病-健康干预的短期疗效和潜在效应大小。我们将招募青少年（年龄12-16岁，T1D持续时间为1年，基线糖化血红蛋白A1c (A1c) 8.0% - 12.0%），根据社会人口统计学特征（少数种族/民族，医疗补助/SCHIP保险，单亲家庭），目标为至少70%的高危人群参加一项随机对照试验（n= 60, 3个地点各10个干预组和10个对照组）。我们将在基线和4个月时评估原发性（A1c）和继发性（心血管疾病危险因素、健康相关生活质量）结局，以及潜在的调节因素（糖尿病自我管理行为、家庭沟通模式、问题解决能力）。3. 记录DM-Health干预的保真度和可接受性。这项试点和可行性研究将为设计一项全面的多地点临床试验提供信息，以测试这种干预措施的疗效和潜在的成本效益。

DESCRIPTION (provided by applicant): Low income and minority adolescents with type 1 diabetes (T1D) commonly have poor glycemic control and an adverse cardiovascular disease (CVD) risk profile. There is a critical need to develop and test interventions to improve diabetes self-management and health outcomes for these high-risk youth. We propose a pilot and feasibility study of DM-Health, an integrated, evidence-based diabetes self-management intervention that is coherent and user-friendly and takes advantage of state-of-the-art technologies and behavioral strategies. The intervention is based on behavioral approaches (motivational interviewing, problem- solving skills training, and behavioral family systems therapy) and communication technology (cell phone based information exchange); each previously shown by our research team to be efficacious. Participants will be recruited from three clinical sites with demographically diverse patient populations, a variety of provider settings, and established infrastructures for clinical research. Specific Aims are: 1. Document the feasibility of the DM-Health trial. We will refine strategies for optimal recruitment and retention and establish administrative, central laboratory, data management, and data analysis systems necessary to the efficient execution of a multi-site clinical trial. 2. Determine short-term efficacy and potential effect size of the DM- Health intervention. We will recruit youth (ages 12-16 yr, T1D duration of e1 yr, baseline glycated hemoglobin A1c (A1c) 8.0% - 12.0%) with a goal of at least 70% at high risk based on socio-demographic characteristics (minority race/ethnicity, Medicaid/SCHIP insurance, single-parent household), to participate in a randomized controlled trial (n= 60, 10 intervention and 10 control at each of 3 sites). We will assess primary (A1c) and secondary (CVD risk factors, health-related quality of life) outcomes, as well as potential mediators (diabetes self-management behaviors, family communication patterns, problem solving skills) at baseline and 4 months. 3. Document DM-Health intervention fidelity and acceptability across demographic subgroups and sites. This pilot and feasibility study will inform design of a fully-powered multi-site clinical trial to test the efficacy and potential cost effectiveness of this intervention. PUBLIC HEALTH RELEVANCE: The proposed innovative research takes advantage of cell phones, commonly used by youth, as the means to integrate tools of diabetes self-management with theoretically sound, empirically supported behavioral strategies to improve diabetes outcomes. The work is highly significant and relevant to public health because of the potential for such an intervention to have a substantial impact on both the short- and long-term health outcomes of adolescents with T1D throughout the United States.