Measuring and improving medication adherence in kidney transplant patients

测量和改善肾移植患者的药物依从性

• 批准号: 7978468
• 负责人: Daniel Cukor
• 金额: $ 7.95万
• 依托单位: SUNY DOWNSTATE MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-16 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7978468
• 关键词: Adherence; Adult; Adverse effects; Affect; Behavior Therapy; Behavioral; Cognitive; Cognitive Therapy; Economic Burden; End stage renal failure; Epidemic; Future; Goals; Human; Immunosuppression; Immunosuppressive Agents; Intervention; Interviewer; Kidney; Kidney Failure; Kidney Transplantation; Measures; Medical; Medical center; Meta-Analysis; Methods; Minority; Monitor; Organ; Outcome; Participant; Patients; Pharmaceutical Preparations; Phase; Population; Public Health; Recruitment Activity; Regimen; Resources; Structure; Study Subject; Telephone; Testing; Therapeutic immunosuppression; Time; Transplant Recipients; Transplantation; United States; Visit; Waiting Lists; coping; cost; design; disorder later incidence prevention; economic cost; effective intervention; graft failure; improved; medication compliance; motivational enhancement therapy; pill; psychoeducation; public health relevance; success; therapy design

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.

描述(由申请人提供)：肾移植后缺乏对免疫抑制治疗的坚持是一个严重的公共卫生问题，因为它是在这种日益流行的医疗条件下导致器官损失的主要因素。这项提案的主要目标是测试未公布的电话药片计数作为衡量免疫抑制药物依从性的可靠和有效方法，并测试旨在改善肾移植患者药物依从性的行为干预措施。这项研究将在布鲁克林的DownState医疗中心进行。在研究的评估阶段，受试者将接到一个未经宣布的电话，并被要求与面试者在电话中清点他们的免疫抑制药物。还将进行五次电话访问，目标是让受试者在三个月内大约每两周接到一次电话。基线遵守水平低于理想水平(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个疗程。干预将包括心理教育、动机访谈、识别依从性障碍、自我监控、应对副作用、制定用药策略、开发支持资源、识别负面情绪、行为激活、认知重建、预防复发和规划未来。成功完成干预的参与者将接受另一个3个月的评估期，类似于他们干预前的评估。这项研究采用多基线设计，将有助于确定行为干预在改善肾移植患者的用药依从性和免疫抑制方面是否成功。 与公共卫生相关：三分之一的肾衰竭是由于药物治疗不力所致。这项研究将验证未公布的电话药片计数是否是肾移植患者免疫抑制治疗用药依从性的可靠和可行的方法，并确定我们的行为干预是否有效地提高用药依从性。这是第一次在这一人群中进行行为干预以提高依从性的结构化试验。