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

摘要 对青壮年糖尿病患者的复杂行为干预的评估：弹性的，授权的， 积极生活-远程健康(REAL-T)研究将解决未得到满足的自我管理和心理社会需求 青壮年(YAS)1型糖尿病(T1D)。REAL-T的目的有三个：(1)评估疗效 通过远程医疗实施的真正干预(REAL-T)、改善血糖控制(HbA1c)和 心理社会结果；(2)检查在6-6个月内保持有益干预效果的程度 1个月的随访期；及(3)调查干预行动的调解机制 效果。对于许多患有T1D的人来说，年轻的成年是一个具有挑战性的人生阶段；18-25岁的YA中只有17%，30%的YA 26-30岁的人达到了推荐的HbA1c目标，只有2%的人坚持按照 国家指导方针。然而，这是建立贯穿整个成年期的健康习惯的关键阶段。 在这个生命阶段，有几个问题阻碍了糖尿病的护理：第一，从儿科向成人保健的转移 其次，他们的生活特点是生活方式、角色和惯例的频繁变化，这使得 持续不断的自我照顾挑战；第三，三分之一患有T1D的YAS经历心理健康挑战，以及 一半的人有糖尿病并发症和内科合并症，这进一步使糖尿病管理复杂化。 为了解决这些问题，我们的研究团队开发了REAL，一个为期6个月的个人定制职业 治疗干预侧重于将糖尿病自我护理纳入参与者的日常习惯和例行公事，以及 在一项随机对照试验(n=81)中评价其疗效。REAL在意向治疗分析中显示为 显著改善糖化血红蛋白(降低0.8%；p=0.01)和糖尿病相关生活质量(p=0.04)。虽然是真实的 在对健康和生活质量的影响方面非常有希望，干预是通过家庭进行的 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大量 诊所就诊的后勤障碍(我们的家庭治疗模式的推动力)，我们适应了REAL 通过远程医疗(REAL-T)交付，这在概念验证研究中显示是可行的，高度 可以接受，并承诺提供与实际类似的健康和生活质量福利 人。我们建议进行一项大规模随机对照试验(n=240)，以比较实时护理和常规护理在改善方面的差异。 血糖控制(HbA1c和持续血糖监测衍生的措施)、心理社会健康和 假想的干预调解人。此外，我们将进行卫生经济分析，以确定 Real-T具有成本效益或节省成本的程度。这项研究的具体目标如下： 目的1：评价REAL-T改善血糖控制和心理社会幸福感的效果。目标2： 评估Real-T对血糖的长期影响(干预后3个月和6个月) 控制力和社会心理健康。目的3：检验REAL-T干预的中介机制 通过结构方程建模对血糖控制和心理社会幸福感的影响。

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).