Longitudinal study of determinants of medication adherence in COPD

 描述（由申请人提供）：COPD是美国第三大死亡原因和主要残疾原因。尽管COPD的有效药物治疗越来越多，但患者仍然承受着巨大的疾病负担，超过一半的患者报告功能严重受损。因此，COPD药物在临床试验中的疗效与患者在真实的世界中经历的不良结局形成鲜明对比。这种差距的一个可能解释是药物依从性低。只有25%的COPD患者是依从性的，这低于其他慢性疾病，包括糖尿病，高血压和充血性心力衰竭。尽管COPD干预中的不依从性发生率很高，但在依从性干预的开发和评价方面存在显著差距。以前的研究是基于横断面研究，使用自我报告的坚持措施，主要是理论。在缺乏数据的情况下，许多医院系统正在开发干预措施，以解决药物依从性问题，作为其临床计划的一部分，以减少再次入院并避免CMS的经济处罚。本研究拟招募360例COPD患者，以自我调节理论为基础，纵向评估依从性和疾病进展的潜在决定因素。参与者将使用新型电子药物监测器来测量长期控制和急救药物的依从性，并使用生态瞬时评估来测量患者报告的呼吸道症状和患者反应，包括预期结局、对管理症状的自我效能和药物健康信念。这些数据将用于评估COPD的自我调节理论。参与者还将完成一年两次的临床访视，以跟踪临床结局的疾病进展（例如，肺功能、功能状态、生活质量）和心理/认知功能。本研究的影响是确定COPD行为干预的新的和潜在的强有力的目标，尽管其对整体公共卫生的巨大不利影响，但尚未得到充分研究。

 DESCRIPTION (provided by applicant): COPD is the third leading cause of death and the leading cause of disability in the US. Despite the growing availability of efficacious pharmacotherapy for COPD, patients still experience a significant disease burden and with more than half reporting significant impairment in functioning. Thus the efficacy of COPD medications in clinical trials stands in stark contrast to the poor outcomes experienced by patients in the real world. One possible explanation for this gap is low rates of medication adherence. Only 25% of COPD patients are adherent, which is the lower than other chronic illnesses including diabetes, hypertension and congestive heart failure. Despite the high prevalence of nonadherence in COPD interventions there are significant gaps in the development and evaluation of interventions for adherence. Previous research has been based on cross sectional studies using self-reported measures of adherence and largely a theoretical. In the absence of data, many hospital systems are developing interventions to address medication adherence as part of their clinical program to reduce hospital readmissions and avoid financial penalties from CMS. This project proposes to recruit 360 patients with COPD to longitudinally evaluate potential determinants on adherence and disease progression based on theory of self-regulation. Participants will use novel electronic medication monitors to measure adherence to long term controller and rescue medications and ecological momentary assessments to measure patient reported respiratory symptoms and patients reactions including outcome expectancies, self-efficacy to management symptoms and medication health beliefs. This data will be used to evaluate the theory of self-regulation in COPD. Participants will also complete bi-annual clinical visits to track disease progression on clinical outcomes (e.g., lung function, functional status, quality of life) and psychological/ cognitive functioning. The impact f this study is to identify novel and potentially powerful targets for behavioral interventions in COPD which has been understudied despite its tremendous detrimental impact on overall public health.