Telehealth Enhancement of Adherence to Medication in Pediatric IBD (TEAM Study)

描述（由申请人提供）：项目摘要/摘要关于儿科炎症性肠病（IBD）药物依从性的研究表明，各种药物的不依从率为50- 88%。这些数据令人震惊，因为1）非依从性患者的IBD复发风险是依从性患者的5.5倍，2）非依从性IBD患者的年度医疗保健费用高出12.5%，3）美国医疗保健的非依从性估计年度成本为1000 - 3000亿美元。与依从性差相关的因素包括对IBD和用于治疗的药物的知识缺乏，组织障碍以及青少年和/或其家庭的行为问题。因此，不依从是IBD中一个复杂而重要的卫生保健问题，需要有效的多组分行为干预来改善治疗结果。我们目前的治疗结果研究证明了以家庭为基础的行为干预对不依从的可行性和初步疗效。这种干预措施受到患者和家属的好评，保留率很高。个体定制的行为治疗是有利的，因为它们能够分析和靶向功能上维持不依从性的特定行为，这在患者之间是不同的。然而，由于缺乏训练有素的提供者和/或患者家庭与其治疗设施之间的距离，只有有限的一部分患者能够接受这类治疗，因此无法参加必要的每周治疗。行为干预的远程医疗服务已成功用于儿科人群，但尚未针对性地促进治疗依从性。确定最佳的治疗方法，使大多数患者从中受益，是这一研究领域的关键下一步。因此，拟议的研究旨在通过随机对照临床试验测试一种新型远程健康行为治疗（TBT）方案在改善IBD儿童和青少年的药物依从性、疾病严重程度、健康相关生活质量和医疗保健利用方面的疗效。将对处于技术性贸易壁垒条件下的参与者与处于仅接受教育（EO）条件下的参与者进行比较。除了使用一种新的远程医疗方法来为服务不足的IBD患者提供个性化的行为治疗外，本研究还将针对可能影响健康结果的大量不依从患者的临床相关样本。这项拟议的研究可能会对公共卫生产生重大影响，为个人定制的行为治疗提供证据基础，以减少获得服务有限的家庭的医疗保健差异。194例患者（11-18岁）及其父母将入组本研究。鉴于IBD不依从的患病率及其对健康和经济的影响，这项研究是及时和重要的，因为它有可能优化不依从的行为治疗，积极影响IBD的健康结果，并作为其他儿科人群依从性干预的模型。

DESCRIPTION (provided by applicant): Project Summary/Abstract Research on medication adherence in pediatric inflammatory bowel disease (IBD) has demonstrated nonadherence rates ranging from 50-88 percent across medications. These data are alarming given that 1) the risk of relapse in IBD is 5.5 times greater in nonadherent patients than in adherent patients, 2) the annual costs of health care in nonadherent IBD patients are 12.5 percent higher, and 3) the estimated annual cost of nonadherence in US health care is $100-300 billion. Factors related to poor adherence include deficits in knowledge about IBD and medications used for treatment, organizational barriers, and behavioral problems in adolescents and/or their families. Thus, nonadherence is a complex and significant health care issue in IBD, requiring effective multicomponent behavioral intervention to improve treatment outcomes. Our current treatment outcome studies demonstrate the feasibility and preliminary efficacy of family based behavioral intervention for nonadherence. This intervention is viewed favorably by patients and families, and retention is high. Individually-tailored behavioral treatments are advantageous because of their ability to analyze and target specific behaviors that functionally maintain nonadherence, which vary across patients. However, only a limited subgroup of patients is able to receive this type of treatment due to a lack of available trained providers and/or distance between patient homes and their treatment facility, making it prohibitive to attend the necessary weekly treatment sessions. Telehealth delivery of behavioral intervention has been used successfully in pediatric populations, but has not targeted treatment adherence promotion. Determining the most optimal method of treatment delivery to the most patients who would benefit from it is a critical next step in this line of research. Thus, the proposed study aims to test, via a randomized controlled clinical trial, the efficacy of a novel telehealth behavioral treatment (TBT) protocol to improve medication adherence, disease severity, health-related quality of life, and health care utilization in children and adolescents with IBD. Participants in the TBT condition will be compared to those in an education only (EO) condition. In addition to using a novel telehealth approach to delivery of an individually-tailored behavioral treatment for nonadherence in underserved IBD patients, this study will target a clinically relevant sample of patients who demonstrate substantial nonadherence that might affect health outcomes. The proposed study may have a significant impact on public health by providing an evidence base for individually-tailored behavioral treatment of nonadherence delivered in a manner that reduces health care disparities for families that have limited access to services. One hundred ninety-four patients (11-18 years of age) and their parents will be enrolled in the study. Given the prevalence of nonadherence in IBD and its health and economic impact, this study is timely and important, as it has the potential to optimize behavioral treatment of nonadherence, positively impact IBD health outcomes, and serve as a model for adherence intervention in other pediatric populations.