FL3X: An Adaptive Intervention to Improve Outcomes for Youth with Type 1 Diabetes

描述(由申请人提供)：有效的糖尿病自我管理是维持正常血糖和减少1型糖尿病(T1D)相关发病率的关键。对于患有T1D的青少年来说，坚持达到理想血红蛋白A1C(HbA1C)所需的复杂方案通常是次优的。因此，迫切需要一种糖尿病自我管理干预方法，这种方法以一种对临床管理具有实际意义并立即适用的方式，整合已证明的战略的关键要素，并为患有T1D的青年个体解决坚持治疗的障碍。我们的具体目标是完成开始招募患者参加灵活生活方式(FL3X)随机对照试验所需的研究小组管理任务。由我们团队(R21 DK085483，Mayer-Davis and Seid)开发并试行的FL3X干预，使用MI来促进问题解决技能培训，以实现特定的行为目标。具体来说，FL3X将采用适应性干预方法，即患者对一线治疗(FL3X基本治疗)的反应决定后续分配到二线治疗(对应答者的FL3X支持或对无响应者的FL3X增强)。FL3X Enhance使用其他模块化组件或工具箱来进一步定制FL3X干预，以满足患者在以下方面的依从性障碍 家庭沟通、糖尿病教育、社会支持以及饮食和体力活动的坚持。我们最近完成的FL3X Basic多点试验包括61名13-16岁的T1D青少年，随机分为31组干预，30名对照组(总体53%的风险来自低收入、少数民族种族/民族或单亲家庭)，并证明了可行性、可接受性和良好的效果。在为期3个月的3次必要干预会议中，出席率非常高(每次出席率均为90%)，61人中有58人(95%)参加了研究结束后的测量访问。干预的可接受性高：100%的干预青年表示他们会向其他人推荐Fl3X。在41%的干预参与者中，糖化血红蛋白下降了0.5%，而对照组参与者中的这一比例为24%。至于我们的试点工作，全能的FL3X随机对照试验将由北卡罗来纳大学教堂山分校协调，将包括200名青年，他们在参与FL3X试点的2个地点(科罗拉多大学丹佛分校芭芭拉·戴维斯儿童糖尿病中心(n=120)和辛辛那提儿童医院医学中心儿科内分泌科(n=80))中随机抽取。这项计划资助的目标是：目标1：完善和补充提交给每个参与地点的机构审查委员会所需的现有FL3X材料，目标2：更新现有的FL3X网站，包括研究人员和参与者界面，并更新基础数据管理系统我们的团队拥有合作历史和经验，可以高保真地建立一个全面的FL3X随机对照试验。在规划拨款的工作完成后，我们将准备立即实施FL3X RCT。 公共卫生相关性：FL3X适应性干预是一种创新的行为方法，旨在解决患有T1D的青少年经历的引人注目的健康风险和独特的日常生活挑战，以实现最佳的糖尿病自我管理。如果被证明有效，FL3X将立即在临床上适用于改善患有T1D的青年的代谢状况和生活质量

DESCRIPTION (provided by applicant): Effective diabetes self-management is key to maintaining euglycemia and reducing the morbidities associated with type 1 diabetes mellitus (T1D). Adherence to the complex regimen required to achieve ideal hemoglobin A1C (HbA1C) is commonly sub-optimal in adolescents with T1D. Thus, there is a critical need for a diabetes self-management intervention approach that integrates the key elements of proven strategies in a way that is of practical relevance to clinical management and immediately applicable, and that is tailored to address barriers to adherence for individual youth living with T1D. Our specific objective is to complete the study group administrative tasks required to begin enrolling patients in the Flexible Lifestyles (FL3X) RCT. The FL3X intervention, developed and piloted by our team (R21 DK085483, Mayer-Davis and Seid), uses MI to facilitate problem-solving skills training to achieve specific behavioral targets. Specifically, FL3X will employ the methods of adaptive interventions in which patient response to a first-line treatment (FL3X Basic) determines subsequent assignment to a second-line treatment (FL3X Support for responders or FL3X Enhance for non- responders). FL3X Enhance uses additional modular components or 'toolboxes' to further tailor the FL3X intervention to a patient's barriers to adherence related to family communication, diabetes education, social support and diet and physical activity adherence. Our recently completed multisite pilot of FL3X Basic included 61 youth with T1D age 13-16 yrs, randomized to 31 intervention, 30 control (overall 53% at-risk due to low income, minority race/ethnicity, or single parent household) and demonstrated feasibility, acceptability, and promising effects. Attendance at 3 required intervention sessions over a 3-month period was excellent (>90% attendance at each) and 58 of 61 (95%) attended the end-of-study measurement visit. Intervention acceptability was high: 100% of intervention youth said they would recommend FL3X to others. HbA1c decreased by > 0.5% among 41% of intervention participants, compared to 24% of control participants. As for our pilot work, the fully powered FL3X RCT will be coordinated from the University of North Carolina at Chapel Hill, and will include 200 youth, randomized within each of 2 sites that participated in the FL3X Pilot (University of Colorado Denver, Barbara Davis Center for Childhood Diabetes (n=120); and Cincinnati Children's Hospital Medical Center, Division of Pediatric Endocrinology (n=80)). Aims for this Planning Grant are: Aim 1: To refine and supplement the existing FL3X materials required for submission to the Institutional Review Boards at each participating site, Aim 2: To update the existing FL3X website, including both study staff and participant interfaces, and including an update of the underlying data management system Our team has the collaborative history and experience to mount a fully powered RCT of FL3X with high fidelity. Upon completion of work in Planning Grant, we will be ready for immediate implementation of the FL3X RCT. PUBLIC HEALTH RELEVANCE: The FL3X adaptive intervention is an innovative behavioral approach to address the compelling health risks and unique daily life challenges to optimal diabetes self-management experienced by youth with T1D. If proven effective, FL3X will have immediate clinical applicability to improve metabolic status and quality of life for youth with T1D