Measuring and improving medication adherence in kidney transplant patients

描述（由申请人提供）：肾移植后缺乏免疫抑制治疗依从性是一个严重的公共卫生问题，因为它是这种日益普遍的医疗状况中器官丧失的主要原因。这项提案的主要目标是测试未宣布的电话药丸计数作为测量免疫抑制药物依从性的可靠和有效的方法，并测试旨在改善肾移植患者药物依从性的行为干预。这项研究将在布鲁克林的Downstate医疗中心进行。对于研究的评估阶段，受试者将接到一个未经通知的电话，并被要求在电话中与采访者一起计算他们的免疫抑制药物药丸。将再进行5次电话访视，目标是让受试者大约每2周接受一次电话访视，持续3个月。基线依从性水平低于理想水平（低于98%）的受试者将被招募参加研究的第二阶段，即行为干预。干预将在不超过12周的时间内进行8次。干预将有专门的心理教育，动机访谈，确定坚持障碍，自我监测，应对副作用，制定服药策略，开发支持资源，识别负面影响，行为激活，认知重建，复发预防和规划未来。成功完成干预的参与者将接受另外3个月的评估期，类似于他们的干预前评估。本研究采用多基线设计，将有助于确定行为干预是否能成功改善肾移植患者的药物依从性和免疫抑制。 公共卫生相关性：三分之一的肾衰竭是由于药物不依从性。这项研究将验证未通知的电话药丸计数是否是肾移植患者免疫抑制治疗药物依从性的可靠和可行的方法，并确定我们的行为干预是否能有效改善药物依从性。这是第一个结构化的行为干预试验，以提高这一人群的依从性。

DESCRIPTION (provided by applicant): Lack of adherence to immunosuppressive therapy following kidney transplantation is a serious public health issue, as it is a major contributor to organ loss in this increasingly prevalent medical condition. The major goals of this proposal are to test unannounced phone pill counts as a reliable and valid method of measuring immunosuppressive medication adherence and to test a behavioral intervention designed to improve medication adherence in kidney transplant patients. The study will take place at Downstate Medical Center in Brooklyn. For the assessment phase of the study, subjects will receive an unannounced phone call and be asked to count their immunosuppressive medication pills on the phone with the interviewer. Five more phone visits will take place, with a goal of having subjects receiving a phone call approximately every 2 weeks for 3 months. Subjects whose baseline levels of adherence are less than ideal (below 98%) will be recruited to participate in the second phase of the study, the behavioral intervention. The intervention will be 8 sessions over no more than 12 weeks. The intervention will have sessions devoted to psychoeducation, motivational interviewing, identifying adherence barriers, self monitoring, coping with side effects, develop medication taking strategy, developing support resources, identifying negative affect, behavioral activation, cognitive restructuring, relapse prevention, and planning for the future. Participants who successfully complete the intervention will then undergo another 3 month assessment period, similar to their pre-intervention assessment. This study utilizes a multiple baseline design and will help determine if behavioral intervention is successful at improving medication adherence and immunosupression in kidney transplant patients. PUBLIC HEALTH RELEVANCE: One third of kidney failures are due to medication non-adherence. This study will verify whether unannounced phone pill counts are a reliable and feasible method for immunosuppressive therapy medication adherence in kidney transplant patients and determine if our behavioral intervention is effective at improving medication adherence. This is the first structured trial of a behavioral intervention to improve adherence in this population.