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

糖尿病困扰的补救措施 (R2D2)：针对学龄家庭的可扩展筛查治疗计划

• 批准号: 10264072
• 负责人: Susana R Patton
• 金额: $ 64.8万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-05 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10264072
• 关键词: 12 year old; 8 year old; Address; Adopted; American; Anger; Behavior Therapy; Behavioral; Behavioral Model; Caregivers; Caring; Child; Childhood diabetes; Clinic; Clinic Visits; Clinical; Clinical Trials; Cognitive; Cognitive Therapy; Complex; Complications of Diabetes Mellitus; Consumption; Data; Depressed mood; Diabetes Mellitus; Distress; Educational Curriculum; Emotional Stress; Family; Foundations; Fright; Future; Glucose; Glycosylated Hemoglobin; Grief reaction; Guidelines; Hybrids; Hypoglycemia; Insulin-Dependent Diabetes Mellitus; Intervention; Knowledge; Longitudinal Studies; Mathematics; Measures; Memory; Mental Depression; Modality; Modeling; Modernization; Outcome; Parents; Pathway interactions; Persons; Phase; Public Health; Reporting; Research; Research Design; Research Personnel; Resources; School-Age Population; Schools; Scientist; Series; System; Techniques; Testing; Therapeutic; Time; United States; Youth; acceptability and feasibility; base; clinical care; clinically relevant; comparative effectiveness; coping; cost effective; crowdsourcing; data registry; design; diabetes distress; diabetes self-management; evidence base; experience; feasibility testing; glucose monitor; glycemic control; hemoglobin P; high risk; implementation science; improved; innovation; interest; mHealth; mindfulness; multidisciplinary; novel; patient subsets; programs; recruit; resilience; response; restraint; routine screening; screening; screening program; skills; standard of care; telehealth; therapy development; time use; trend; uptake

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.

项目概要 虽然约 25% 的 1 型糖尿病 (T1D) 学龄儿童的 HbA1c 低于 7.5%，但大多数 学龄儿童则不会，并且发生 T1D 相关并发症的风险较高。实现最佳 T1D 自我治疗 护理是目前改善 HbA1c 的唯一直接途径，即使添加现代治疗方法 模式（例如混合闭环），T1D 自我护理是一项复杂、耗时且不懈的任务。学校- 适龄儿童需要父母的支持才能有效控制 T1D，因此父母和青少年都需要支持 患有 T1D 的人容易遭受糖尿病困扰 (DD)。目前，美国糖尿病协会（ADA） 护理标准建议在青少年及其青少年的常规糖尿病门诊就诊期间对 DD 进行评估 照顾者从青少年约 8 岁开始。不幸的是，虽然 DD 筛查可能是 ADA 护理的一种 标准，没有实用且基于证据的筛查治疗计划可供诊所采用来满足这一要求 护理标准。我们提交这个新的 R01 是为了回应 RFA-DK-19-021，治疗糖尿病困扰 改善 1 型糖尿病的血糖结果。我们的目标是测试一个方案的可行性和可接受性 针对学龄儿童及其家长的 DD 的新颖、实用且可扩展的筛查治疗计划（称为 糖尿病困扰的补救措施 [R2D2]）并测试 R2D2 减少 DD 改善儿童的初步功效 血糖控制。我们的具体目标是： 1) 定义并迭代完善我们新的筛选治疗计划 (R2D2) 学龄家庭中的 DD，以最大限度地提高利益相关者的可行性和可接受性，以及 2) 建立 R2D2的初步功效是减少父母和孩子的DD，改善孩子的血糖控制。为增强科学 为了严谨起见，我们将使用行为干预开发的 ORBIT 模型来指导我们的研究设计。这 ORBIT 模型提出了一种分阶段的方法，使用一系列小型的、具有成本效益的研究来确定临床- 有意义的目标，并在开始大规模临床之前测试治疗的可接受性和初步疗效 审判。对于 ORBIT 1a 期：定义，我们将进行一项简短的纵向研究，以确定临床试验的切点 家长和学龄儿童的相关DD，让诊所质量改进团队参与制定实用的 基于临床的筛查方法，并使用众包技术获取家庭对新移动医疗的意见 治疗。对于 ORBIT 阶段 1b：Refine，我们将测试 R2D2 筛选计划的实施情况 多家诊所，我们将进行一项小型试验，以确定初步有效且实用的移动医疗治疗方法 R2D2 的交付方法。最后，对于 ORBIT 2a 期，我们将继续在临床筛查 DD 并招募 将临床相关 DD 报告给概念验证试点的家庭，以检查是否改善父母 和/或儿童 DD 可以改善儿童血糖控制。我们相信我们的研究对 FOA 做出了最佳反应 因为我们的： 1-研究团队是多学科的，并且包括行为科学家之间真正的合作伙伴关系 和一位糖尿病学家，2-R2D2 筛查治疗计划反映了一种可能实际发生的实用方法 在临床上，实施科学的3-使用将进一步增强R2D2未来的可持续性和传播。