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1型糖尿病（T1 D）青少年通常血糖控制不良，心血管疾病（CVD）风险状况不良。迫切需要制定和测试干预措施，以改善这些高危青年的糖尿病自我管理和健康结果。我们提出了一个试点和可行性研究DM健康，一个综合的，以证据为基础的糖尿病自我管理干预，是连贯的和用户友好的，并利用国家的最先进的技术和行为策略。干预是基于行为方法（动机访谈，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）;我们的研究团队先前已证明每一种方法都是有效的。参与者将从三个临床研究中心招募，这些临床研究中心具有人口统计学上多样化的患者人群，各种提供者设置以及已建立的临床研究基础设施。具体目标是：1。记录DM-健康试验的可行性。我们将完善最佳招募和保留策略，并建立有效执行多中心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DM-健康干预的短期疗效和潜在效应量。我们会招募年轻人（年龄12-16岁，T1 D持续时间e1年，基线糖化血红蛋白A1 c（A1 c）8.0% - 12.0%），基于社会人口统计学特征，目标为至少70%处于高风险（少数民族/种族，医疗补助/SCHIP保险，单亲家庭），参加随机对照试验（n= 60，3个部位各10个干预部位和10个对照部位）。我们将在基线和4个月时评估主要（A1 c）和次要（CVD风险因素，健康相关的生活质量）结果，以及潜在的中介因素（糖尿病自我管理行为，家庭沟通模式，解决问题的技能）。3.记录不同人口统计学亚组和研究中心的DM-健康干预保真度和可接受性。这项试点和可行性研究将为设计一项全面的多中心临床试验提供信息，以测试这种干预措施的疗效和潜在的成本效益。 公共卫生相关性：拟议的创新研究利用年轻人常用的手机作为手段，将糖尿病自我管理工具与理论上合理的，经验支持的行为策略相结合，以改善糖尿病的结果。这项工作是非常重要的，相关的公共卫生，因为这种干预措施的潜力，有一个巨大的影响与T1 D青少年在整个美国的短期和长期的健康结果。

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.