Evaluating the feasibility of Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress among Black young adults

T1DES项目总结 拟议的研究重点是18 - 26岁的黑人年轻人的独特需求，以解决 研究和临床护理中的关键差距。目的是测试一种新的治疗方法的可行性和初步疗效。 文化适应和量身定制的干预措施，以加强黑人年轻人的糖尿病管理策略 T1D成人，解决这一人群健康结果中普遍存在的种族差异。OnTrack是一个 经测试的干预措施在成年人中显示出改善的结局（糖尿病困扰和HbA1c）（平均 年龄45.1岁，SD = 15.0）伴T1 D和HbA1c升高。它包括高度结构化的、基于小组的会议 （由辅导员协助）和个人支持。OnTrack在糖尿病患者中有更大的减少 认知功能或情绪调节能力较低、抑郁程度较高、糖尿病知识水平较高的患者， 基线。尽管KPGA患者的这些基线指标尚不清楚，但形成性工作强调了 孤独感，压力和自我管理的挑战使OnTrack成为一个理想的起点， T1D患者虽然OnTrack改善了T1D的结局，但其与黑人年轻人的相关性并没有 被测试过了需要采取更具代表性和文化能力的干预措施。 这项建议利用了该小组在制定干预措施方面的专门知识35，金伯利进程利用我们的 虚拟数据仓库用于收集历史和前瞻性数据，KPGA的黑人患者比例较大 咨询委员会和T1D成员，以及来自内分泌学、健康教育和 行为健康这项为期三年的研究的具体目标是： 目的1：通过测量干预的可接受性，评估文化定制干预T1DES的可行性， 需求（保留，完成> 80%的会话）、实用性和参与者的实施保真度 调查和与参与者和医疗保健提供团队的关键线人访谈。 目的2：在一项初步随机临床试验中评价T1DES干预对糖尿病结局的影响 在N = 40名18 - 26岁的T1D和HbA1c升高（> 7.5%）的黑人年轻成人中， 基线至基线后6个月HbA1c、糖尿病困扰和自我管理的变化 随机分配至T1DES组的受试者与仅接受糖尿病教育的对照组相比。我们假设 T1DES参与者将表现出HbA1c改善，糖尿病痛苦减少，自我保护能力增强。 与对照组相比，随时间推移的管理。结果将用于生成效应量并支持 申请进行更大规模、充分把握度、更长期的试验，以评价T1DES对健康结局的影响， 差距。迫切需要更多的研究，以制定有效的战略，既包括黑人青年 24我们的目标是提供糖尿病教育和情感教育， 为黑人年轻人量身定制的调节支持，将导致持续的血糖控制， 可以纳入成人内分泌学实践。

T1DES Project Summary The proposed research focuses on the unique needs of Black young adults aged 18-26 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population. OnTrack is a tested intervention that demonstrated improved outcomes (diabetes distress and HbA1c) among adults (mean age 45.1 years, SD=15.0) with T1D and elevated HbA1c. It involves highly structured, group-based sessions (facilitated by a counselor) and individual support. OnTrack had greater reductions in diabetes distress among patients with lower cognitive function or emotion regulation, higher distress, and higher diabetes knowledge at baseline. Though these baseline metrics among KPGA patients are unknown, formative work highlighting feelings of isolation, stress, and challenges with self-management render OnTrack an ideal starting place for patients with T1D. While OnTrack improved outcomes in T1D, its relevance to Black young adults has not been tested. More representative and culturally competent interventions are needed. This proposal leverages the team's expertise in developing interventions35, KP's capacity to access our virtual data warehouse to gather historical and prospective data, KPGA's proportionately large Black patient advisory board and membership with T1D, and clinical advisors from endocrinology, health education, and behavioral health. The specific aims for the 3-year study are to: Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed > 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team. Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-26 years with T1D and elevated HbA1c (>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months post-baseline among participants randomized to T1DES compared to the diabetes education-only control condition. We hypothesize T1DES participants will demonstrate improved HbA1c, reduced diabetes distress, and increased self- management over time compared to controls. Results will be used to generate effect sizes and support an application for larger, fully powered, longer term trial to evaluate the impact of T1DES on health outcomes and disparities. More research is critically needed on effective strategies that are both inclusive of Black young adults and tailored to their unique challenges.24 Our goal is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.