Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-Age Families

项目总结 虽然大约25%的患有1型糖尿病(T1D)的学龄儿童的糖化血红蛋白达到7.5%，但大多数学龄儿童的HbA1c 学龄儿童不会，而且患T1D相关并发症的风险更高。实现最优的T1D自我 目前，护理是改善HbA1c的唯一直接途径，即使添加了现代治疗方法 在医疗模式(例如，混合闭环)中，T1D自理是一项复杂、耗时和无情的任务。学校- 适龄儿童需要父母的支持才能有效地管理T1D，因此父母和青少年都需要 患有T1D的人容易患糖尿病窘迫(DD)。目前，美国糖尿病协会(ADA) 护理标准建议在青少年和青少年糖尿病门诊常规就诊期间评估DD 从青少年8岁开始的照顾者。不幸的是，虽然DD筛查可能是ADA的一项护理 护理标准。 针对学龄儿童及其家长的新颖、实用且可扩展的屏幕治疗计划(称为 治疗糖尿病困难症[R2D2])，并测试R2D2减少DD改善儿童智力障碍的初步疗效 血糖控制。我们的具体目标是：1)定义并迭代改进我们新的筛查治疗计划(R2D2) 为了最大限度地提高可行性和利益相关者的接受度，在学龄儿童家庭中开展发展性教育，以及2)建立 R2D2减少父母和儿童DD改善儿童血糖控制的初步疗效。提高科学性 严格来说，我们将使用行为干预发展轨道模型来指导我们的研究设计。这个 有意义的目标，并在开始大规模临床试验之前测试治疗的可接受性和初步疗效 审判。对于眼眶1a期：定义，我们将进行一项简短的纵向研究，以确定临床上的切入点 基于诊所的筛查方法，并使用众包技术获取家庭对新mHealth的投入 治疗。 多家诊所，我们将进行一项小型试验，以确定一种初步有效和实用的mHealth治疗方法 R2D2的交付方法。最后，对于轨道阶段2a，我们将继续在临床上筛查DD并招募 向概念验证试点报告临床相关的DD的家庭，以检查是否改善了父母 和/或儿童DD导致改善儿童血糖控制。我们相信，我们的研究是对FOA的最佳回应 因为我们的1：1研究团队是多学科的，包括真正的行为科学家之间的伙伴关系 作为一名糖尿病专家，2-R2D2筛选治疗计划反映了一种可能现实发生的实用方法 在临床上，3-实施科学的使用将进一步增强R2D2未来的可持续性和传播。

PROJECT SUMMARY While ~25% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5%, the majority of school-age children do not and are at a higher risk for T1D-related complications. Achieving optimal T1D self- care is currently the only direct pathway to better HbA1c and even with the addition of modern therapeutic modalities (e.g., hybrid closed loop), T1D self-care is a complex, time-consuming, and relentless task. School- age children need support from their parents to effectively manage T1D and therefore both parents and youth with T1D are vulnerable to Diabetes Distress (DD). Presently, the American Diabetes Association (ADA) Standards of Care recommend assessment of DD during routine diabetes clinic visits in youth and their caregivers starting when youth are ~8-years-old. Unfortunately, while DD screening may be an ADA Care Standard, there are no practical and evidence-based screen-to-treat programs for clinics to adopt to meet this Standard of Care. We submit this new R01 in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. Our objective is to test the feasibility and acceptability of a novel, practical, and scalable screen-to-treat program for DD in school-age children and their parents (called Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce DD to improve children's glycemic control. Our specific aims are: 1) Define and iteratively refine our new screen-to-treat program (R2D2) for DD in school-age families in order to maximize feasibility and acceptability to stakeholders, and 2) Establish initial efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. To enhance scientific rigor, we will use the ORBIT Model for Behavioral Intervention Development to guide our study design. The ORBIT Model proposes a phased approach using a series of small, cost-effective studies to determine clinically- meaningful targets and to test a treatment's acceptability and initial efficacy before embarking on a large clinical trial. For ORBIT Phase 1a: Define, we will conduct a brief longitudinal study to establish cut-points for clinically relevant DD in parents and school-age children, engage clinic Quality Improvement teams to develop a practical clinic-based screening approach, and use crowdsourcing techniques to obtain family input on a new mHealth treatment. For ORBIT Phase 1b: Refine, we will test implementation of our R2D2 screening program across multiple clinics and we will conduct a small trial to identify an initially efficacious and practical mHealth treatment delivery approach for R2D2. Finally, for ORBIT Phase 2a, we will continue to screen for DD in clinic and recruit families who report clinically relevant DD into a Proof of Concept Pilot to examine whether ameliorating parent and/or child DD leads to improved child glycemic control. We believe our study optimally responds to the FOA because our: 1-research team is multidisciplinary and includes a true partnership between a behavioral scientist and a diabetologist, 2-R2D2 screen-to-treat program reflects a practical approach that could realistically occur in clinic, 3-use of Implementation Science will further enhance future sustainability and dissemination of R2D2.