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

描述(由申请人提供)：患有1型糖尿病(T1D)的低收入和少数族裔青少年通常血糖控制较差，并有不利的心血管疾病(CVD)风险特征。迫切需要开发和测试干预措施，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DM-Health的试点和可行性研究，这是一种综合的、基于证据的糖尿病自我管理干预措施，具有连贯性和用户友好性，并利用最先进的技术和行为策略。干预基于行为方法(激励性访谈、解决问题的技能培训和行为家庭系统疗法)和通信技术(基于手机的信息交换)；我们的研究团队之前证明每一种方法都是有效的。参与者将从人口统计学上不同的患者群体、不同的提供者设置和已建立的临床研究基础设施的三个临床地点招募。具体目标是：1.记录DM-Health试验的可行性。我们将完善最优招募和保留战略，并建立有效执行多地点临床试验所需的行政、中央实验室、数据管理和数据分析系统。2.确定DM-Health干预的短期效果和潜在效果大小。我们将招募年轻人(年龄12-16岁，T1 d持续时间1年，基线糖化血红蛋白(A1c)8.0%-12.0%)，根据社会人口学特征(少数族裔种族/民族，Medicaid/SCIP保险，单亲家庭)，以至少70%的高危人群为目标，参加随机对照试验(n=60，3个地点每个地点10个干预和10个对照)。我们将在基线和4个月时评估初级(A1c)和次级(心血管疾病危险因素、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.记录人口子组和地点的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能的多地点临床试验提供信息，以测试这种干预措施的有效性和潜在的成本效益。 与公共健康相关：这项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、有经验支持的行为策略相结合，以改善糖尿病结果。这项工作对公共卫生意义重大，因为这样的干预措施有可能对全美患有T1D的青少年的短期和长期健康结果产生重大影响。

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.