Motivating Improved Self-Management Among Older Teens & Adults with CF

描述(由申请人提供)：在过去的二十年中，在治疗CF方面的治疗进展导致了存活率的提高，并以防止肺功能的丧失为中心。2005年，囊性纤维化基金会患者登记处患者的中位生存期为36.8年，超过40%的囊性纤维症患者是成年人。然而，治疗方案已经演变成一个复杂的家庭治疗计划，需要大量患者承诺执行，而且对CF治疗的许多组成部分的依从性往往很差。虽然该疗法在改善肺部健康和死亡率方面是有效的，但关于最大化健康结果所需的坚持水平的数据有限。同样，在CF中发表的促进依从性的研究很少，而且这些研究仅限于儿科人群。因此，需要以年长的青少年和成人为重点的干预措施，这些干预措施针对的是随着一个人年龄增长和更加独立而管理CF的独特挑战。动机访谈是一种很有前途的干预方法，它使用以客户为中心的非指导性方法来增强改变健康行为的动机，并有前景的数据作为一种有效的依从性促进干预措施，适用于患有其他慢性病的青少年和成年人。MI并不认为健康将是激励客户的最重要因素，而是承认并纳入客户确定的其他激励因素。我们建议评估以动机访谈为重点的干预(MI)与标准的CF教育干预(CFE；注意控制组)相比，在提高老年青少年和成人的CF依从性和降低CF相关发病率方面的有效性。具体地说，我们假设，与CFE对照组相比，MI将导致改善疾病自我管理和降低CFE对照组的发病率，样本为153名年龄在16岁以上、临床上稳定在基线水平的患者。我们的主要假设是，与CFE组相比，接受MI的参与者在随机化后12个月(通过药房再灌装记录衡量)的综合服药依从性评分更高。次要结果包括自我报告的依从性、肺功能(FEV1的CF特有百分位数)、肺恶化、体重指数和生活质量。这项研究将使我们能够评估依从性和健康结果之间的纵向联系。我们还将评估自我效能感、动机和心理健康知识对干预结果的中介作用，以及年龄、自主性、抑郁、社会支持和生活事件等调节作用。

DESCRIPTION (provided by applicant): Treatment advances during the past two decades in the treatment of CF have resulted in improved survival and center around preventing the loss of lung function. In 2005 the median predicted survival for people on the Cystic Fibrosis Foundation Patient Registry was 36.8 years and over 40% of all living people with CF are adults. The therapeutic treatment regimen, however, has evolved into a complex home treatment program that requires a substantial amount of patient commitment to perform and adherence to many components of CF treatment is often poor. While the regimen is efficacious in improving lung health and mortality, there is limited data on the level of adherence needed to maximize health outcomes. Similarly, there are few published adherence-promoting studies in CF and these have been limited to pediatric populations. Older adolescent and adult-focused interventions are therefore needed that target the unique challenges managing CF as one gets older and more independent. Motivational Interviewing (MI) is a promising interventional approach that uses a client-centered, non- directive approach for enhancing motivation to change health behaviors and has promising data as an effective adherence promoting intervention for adolescents and adults with other chronic illnesses. MI does not assume that health will be the most important factor motivating the client, but rather acknowledges and incorporates other motivators identified by the client. We propose to evaluate the efficacy of an Motivational Interviewing-focused intervention (MI) in improving adherence and reducing CF-related morbidity among older adolescents and adults compare to a standard CF education intervention (CFE; attention control group). Specifically, we hypothesize that MI will result in improved disease self-management and reduced CF morbidity compared to the CFE control group in a sample of 153 individuals with CF age 16+ years who are clinically stable at baseline. Our primary hypothesis is that participants receiving MI will have a higher composite medication adherence score at 12-months post-randomization (measured by pharmacy refill records) compared to the CFE group. Secondary outcomes include self-reported adherence, lung function (CF-specific percentiles of FEV1), pulmonary exacerbations, body mass index, and quality of life. This study will allow us to evaluate the longitudinal association between adherence and health outcomes. We will also evaluate the mediating effects of self-efficacy, motivation and CF knowledge on the intervention outcomes as well as moderator effects, such as age, autonomy, depression, social support, and life events.