Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

摘要 对年轻糖尿病患者的复杂行为干预的评价：有弹性，有能力， 积极生活-远程保健（REAL-T）研究将解决未满足的自我管理和心理社会需求， 1型糖尿病（T1 D）的年轻成人（YAs）。REAL-T的目的有三：（1）评价疗效 通过远程医疗（REAL-T）进行的真实的干预，在改善血糖控制（HbA 1c）方面， 心理社会结果;（2）检查在多大程度上保留了有益的干预效果超过6- 个月的随访期;（3）调查负责干预的调解机制 方面的影响.对于许多T1 D患者来说，青年期是一个具有挑战性的生命阶段;只有17%的18-25岁的YAs和30%的YAs。 26-30岁的人达到推荐的HbA 1c目标，只有2%的人始终按照 国家指导方针。然而，这是一个建立健康习惯的关键阶段，这些习惯将贯穿整个成年期。 有几个问题阻碍了这一生命阶段的糖尿病护理：首先，YAs从儿科转移到成人医疗保健 第二，他们的生活特点是生活方式、角色和惯例经常变化， 一致的自我保健挑战;第三，三分之一的T1 D YAs经历心理健康挑战， 一半人患有糖尿病并发症和内科合并症，这使糖尿病管理更加复杂。 为了解决这些问题，我们的研究团队开发了真实的，这是一个为期6个月的个性化职业培训项目。 治疗干预的重点是将糖尿病自我护理纳入参与者的日常习惯和例程， 在随机对照试验中评价其疗效（n=81）。意向治疗分析显示真实的， 显著改善HbA 1c（降低0.8%; p=0.01）和糖尿病相关生活质量（p=0.04）。而真实的 在对健康和生活质量的影响方面， 访问，限制了其广泛传播的潜力。鉴于我们的目标人群经历了严重的 后勤障碍的诊所出席（推动我们在家里的治疗模式），我们调整真实的， 通过远程保健（REAL-T）提供，这在概念验证研究中被证明是可行的， 可接受，并有望产生与真实的类似的健康和生活质量受益， 人.我们建议进行一项大规模随机对照试验（n=240），比较REAL-T与常规治疗在改善 血糖控制（HbA 1c和动态血糖监测衍生指标）、社会心理健康，以及 假设的干预中介。此外，我们将进行卫生经济分析，以确定 REAL-T的成本效益或节省成本的程度。研究的具体目标如下： 目的1：评价REAL-T在改善血糖控制和心理社会健康方面的疗效。目标二： 评估REAL-T对血糖的有益作用的长期延续（干预后3个月和6个月） 控制和心理健康。目的3：检查REAL-T干预的介导机制 通过结构方程模型（SEM）对血糖控制和社会心理健康的影响。

ABSTRACT Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D). The purpose of REAL-T is threefold: (1) to evaluate the efficacy of the REAL intervention as administered via telehealth (REAL-T), in improving glycemic control (HbA1c) and psychosocial outcomes; (2) to examine the extent to which beneficial intervention effects are retained over a 6- month follow-up period; and (3) to investigate the mediating mechanisms responsible for the intervention's effects. Young adulthood is a challenging life stage for many with T1D; only 17% of YAs ages 18-25 and 30% ages 26-30 attain recommended HbA1c targets, and only 2% consistently perform self-care in accordance with national guidelines. Yet, it is a crucial stage for establishing health habits that persist throughout adulthood. Several issues impede diabetes care during this life stage: first, YAs transfer from pediatric to adult healthcare settings; second, their lives are characterized by frequent changes in lifestyle, roles, and routines, which make consistent self-care challenging; and third, one-third of YAs with T1D experience mental health challenges, and half have diabetes complications and medical comorbidities, which further complicate diabetes management. To address these issues, our research team developed REAL, a 6-month individually tailored occupational therapy intervention focused on incorporating diabetes self-care into participants' daily habits and routines, and evaluated its efficacy in a randomized controlled trial (n=81). REAL was shown in intention-to-treat analysis to significantly improve HbA1c (0.8% reduction; p=0.01) and diabetes-related quality of life (p=0.04). While REAL was highly promising in its impact on health and quality of life, the intervention was delivered through home visits, limiting its potential for broad dissemination. Given that our target population experiences significant logistical barriers to clinic attendance (the impetus for our in-home treatment model), we adapted REAL to be delivered via telehealth (REAL-T), which was shown in a proof-of-concept study to be feasible, highly acceptable, and has promise to induce similar health and quality life of life benefits as did REAL as delivered in person. We propose to conduct a large-scale RCT (n=240) to compare REAL-T to usual care in improving glycemic control (HbA1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings. The study's specific aims are as follows: Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being. Aim 2: Assess the long-term carryover (3- and 6-months post-intervention) of beneficial effects of REAL-T on glycemic control and psychosocial well-being. Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM).