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

T1DES项目摘要 这项拟议的研究侧重于18-26岁黑人年轻人的独特需求，以解决 在研究和临床护理方面存在严重差距。我们的目标是测试一种 文化适应和量身定做的干预措施，以加强黑人青年的糖尿病管理策略 患有T1D的成年人，解决了这一人群在健康结果方面普遍存在的种族差异。OnTrack是一种 经过测试的干预措施表明，成年人(平均)的预后(糖尿病痛苦和糖化血红蛋白)有所改善 年龄45.1岁，SD=15.0)，伴有T1D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在以下人群中降低了糖尿病痛苦的程度 认知功能或情绪调节能力较低、痛苦程度较高、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未知，但形成性工作突出了 自我管理的孤立感、压力和挑战使OnTrack成为 T1D患者。虽然OnTrack改善了T1D的结果，但它与黑人年轻人的相关性并没有 已经测试过了。需要更具代表性和更有文化能力的干预措施。 这项建议利用了团队在开发干预措施方面的专业知识35，KP的能力可以访问我们的 用于收集历史和前瞻性数据的虚拟数据仓库，KPGA的比例较大的黑人患者 顾问委员会和T1D成员，以及来自内分泌学、健康教育和临床的顾问 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来评估文化定制干预T1DES的可行性， 需求(保留、已完成&>80%的课程)、实用性和通过参与者实现的保真度 对参与者和医疗保健提供团队进行的调查和关键线人访谈。 目的2：在先导性随机临床试验中评估T1DES干预对糖尿病预后的影响 在N=40名18-26岁的黑人青年中，T1D和HbA1c升高(&gt；7.5%) 从基线到基线后6个月的HbA1c、糖尿病痛苦和自我管理的变化 参与者随机接受T1DES治疗，与仅接受糖尿病教育的对照条件进行比较。我们假设 T1DES参与者将展示改善HbA1c、减少糖尿病痛苦和增强自我意识 与控制相比，随着时间的推移进行管理。结果将用于生成效果大小并支持 申请更大规模、全功率、更长期的试验，以评估T1DES对健康结局的影响 差距。迫切需要对既包括黑人青年又包括黑人青年的有效策略进行更多研究 24我们的目标是提供糖尿病教育和情感 为黑人年轻人的经历量身定做的监管支持，将导致持续的血糖控制和 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.