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

对年轻糖尿病患者的复杂行为干预的评估：弹性、赋权、积极的生活远程医疗 (REAL-T) 研究

• 批准号: 10083731
• 负责人: Elizabeth F Pyatak
• 金额: $ 71.95万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-13 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10083731
• 关键词: Address; Adherence; Adult; Aftercare; Age; Behavior; Behavior Therapy; Blinded; Blood Glucose Self-Monitoring; Caring; Childhood; Clinic; Clinical; Complex; Complications of Diabetes Mellitus; Consensus; Control Groups; Cost Savings; Data; Diabetes Mellitus; Equation; Evaluation; Evidence based intervention; Face; Glycosylated hemoglobin A; Guidelines; Habits; Health; Home; Home visitation; Hyperglycemia; Hypoglycemia; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intention; Intervention; Life; Life Style; Logistics; Long-Term Effects; Measures; Mediating; Mediator of activation protein; Medical; Mental Health; Modeling; Occupational Therapy; Outcome; Participant; Performance; Personal Satisfaction; Persons; Process; Quality of life; Quality-Adjusted Life Years; Randomized Controlled Trials; Research; Resources; Role; Self Care; Self Efficacy; Self Management; Service delivery model; Structure; Target Populations; Therapeutic Intervention; Time; Vulnerable Populations; acceptability and feasibility; active lifestyle; adolescent health; attentional control; clinical practice; cohort; comorbidity; cost; cost effective; cost-effectiveness evaluation; depressive symptoms; diabetes distress; diabetes management; diabetes self-management; economic evaluation; efficacy evaluation; empowered; ethnic diversity; experience; follow-up; glucose monitor; glycemic control; health care settings; health economics; improved; innovation; intervention effect; low socioeconomic status; middle age; novel; post intervention; primary outcome; psychosocial; public health relevance; secondary outcome; self-management program; telehealth; treatment as usual; young adult

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).

抽象的 评估糖尿病年轻人的复杂行为干预措施：弹性，有能力， 积极的Like-Telehealth（Real-T）研究将满足未满足的自我管理和社会心理需求 具有1型糖尿病（T1D）的年轻人（YA）。 Real-T的目的是三倍：（1）评估功效 通过远程医疗（Real-T）进行的实际干预措施，改善血糖控制（HBA1C）和 社会心理结果； （2）检查在6-- 月随访期； （3）调查负责干预措施的中介机制 效果。对于许多T1D来说，年轻的成年是一个充满挑战的生活阶段。 YAS只有17％的18-25岁和30％ 年龄在26-30岁的人达到建议的HBA1C目标，只有2％的人始终如一地执行自我保健 国家准则。然而，这是建立整个成年期健康习惯的关键阶段。 在这个生命阶段，几个问题阻碍了糖尿病护理：首先，YA从小儿转移到成人医疗保健 设置;其次，他们的生活的特征是经常改变生活方式，角色和惯例，这使得 一致的自我保健挑战；第三，具有T1D的YA的三分之一经历了心理健康挑战，并且 一半患有糖尿病并发症和医学合并症，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个月的个人量身定制的职业 治疗干预措施着重于将糖尿病自我保健纳入参与者的日常习惯和常规，以及 在一项随机对照试验中评估了其功效（n = 81）。在意向性治疗分析中显示了真实的 显着改善了HBA1C（降低0.8％； P = 0.01）和与糖尿病相关的生活质量（P = 0.04）。而真实 对健康和生活质量的影响非常有前途，干预是通过家庭进行的 访问，限制了其广泛传播的潜力。鉴于我们的目标人口经历了重大的 诊所出勤的后勤障碍（我们的家庭治疗模型的动力），我们改编了真实的 通过远程医疗（Real-T）提供的，该研究在概念证明的研究中表现为可行，高度 可以接受，并有望诱导与实际交付的类似的健康和质量生活利益 人。我们建议进行大规模的RCT（n = 240），以比较现实T与通常的护理相比 血糖控制（HBA1C和连续葡萄糖监测范围的措施），社会心理健康和 假设的干预媒介。此外，我们将进行健康经济分析，以确定 Real-T具有成本效益或节省成本的程度。该研究的具体目的如下： AIM 1：评估Real-T在改善血糖控制和社会心理健康方面的功效。目标2： 评估房地产对血糖的有益作用的长期结转（干预后3个月和6个月） 控制和社会心理福祉。目标3：检查实用干预的中介机制 通过结构方程建模（SEM）对血糖控制和社会心理健康的影响。