Promoting Treatment Adherence in Pediatric Inflammatory Bowel Disease

描述（由申请人提供）： 对小儿克罗恩病和溃疡性结肠炎（统称炎症性肠病（IBD））的药物依从性研究表明，各种药物的不依从率为50 - 88%。这些数据令人担忧，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）美国医疗保健中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。初步证据表明，以家庭为基础的群体行为治疗可以提高IBD青少年的依从性，受到患者和家庭的好评，这与其他人群中不依从的群体干预一致。然而，由于群体治疗必然针对"典型"患者中常见的行为，因此个体患者和家庭依从性障碍可能无法得到最佳解决。研究人员已经承认，个体定制的行为治疗是有利的，因为它们能够分析和针对特定的行为，这些行为在功能上维持不依从性，这些行为在患者中各不相同;然而，个体定制的治疗与团体干预相结合的附加效益尚未得到检验。这是确定儿科IBD不依从的最佳治疗的关键步骤。因此，拟议的研究旨在初步测试一种新的治疗方法的可行性和初步疗效，该方法涉及补充现有的以家庭为基础的群体行为干预方案，并提供个性化的治疗成分，以优化药物依从性，改善疾病严重程度和健康相关的生活质量。这种团体+个人定制（团体+IT）干预将结合对依从性障碍的密集功能行为分析，并使用提供自动行为提示的蜂窝电话技术，以鼓励患者参与并最大限度地提高这种创新行为治疗的疗效。将对分组+IT治疗的受试者与仅分组治疗的受试者进行比较。24名青少年（13 - 17岁）及其父母将入组本研究。鉴于IBD患者不依从的患病率以及不依从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并对IBD健康结果产生积极影响。 公共卫生相关性：大量患有炎症性肠病（IBD）的青少年很难有效地管理他们的疾病。导致自我管理和健康结果不佳的因素包括对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。本研究提出了一种新的团体+个体定制的干预措施，以改善儿童IBD的治疗自我管理，疾病严重程度和健康相关的生活质量。

DESCRIPTION (provided by applicant): Research on medication adherence in pediatric Crohn's disease and ulcerative colitis, collectively inflammatory bowel disease (IBD), has demonstrated nonadherence rates ranging from 50-88% 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% 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. Preliminary evidence suggests that a family-based group behavioral treatment improves adherence in adolescents with IBD, is viewed favorably, and is well-attended by patients and families, which is consistent with group interventions for nonadherence in other populations. However, because group treatment necessarily targets behaviors that are common across "typical" patients, individual patient and family adherence barriers may not be optimally addressed. Researchers have acknowledged that individually-tailored behavioral treatments are advantageous because of their ability to analyze and target specific behaviors that functionally maintain nonadherence, which vary across patients; yet, the additive benefit of individually-tailored treatment combined with group intervention has not been examined. This is a critical step in determining optimal treatment of nonadherence in pediatric IBD. Thus, the proposed study aims to pilot test the feasibility and preliminary efficacy of a novel treatment approach involving supplementation of an existing family-based group behavioral intervention protocol with an individually-tailored treatment component to optimize medication adherence and improve disease severity and health-related quality of life. This Group + Individually-tailored (Group+IT) intervention will incorporate intensive functional behavioral analysis of adherence barriers and use cellular telephone technology that provides automated behavioral prompts in order to encourage patient engagement and maximize the efficacy of this innovative behavioral treatment. Participants in the Group+IT treatment will be compared to participants in a Group only treatment. Twenty-four adolescents (13-17 years of age) and their parents will be enrolled in the study. Given the prevalence of nonadherence in IBD and the health and economic impact of nonadherence, this study is timely and important, as it has the potential to optimize behavioral treatment of nonadherence and positively impact IBD health outcomes. PUBLIC HEALTH RELEVANCE: A large number of adolescents with inflammatory bowel disease (IBD) have significant difficulty managing their illness effectively. Factors that contribute to poor self-management and health outcomes include deficits in knowledge about IBD and medications used for treatment, organizational barriers, and behavioral problems in adolescents and/or their families. This study proposes a novel group + individually-tailored intervention to improve treatment self-management, disease severity, and health-related quality of life in pediatric IBD.