MEDICATION COMPLIANCE IN ORGAN TRANSPLANT RECIPIENTS

器官移植受者的用药依从性

• 批准号: 2005757
• 负责人: CARLENE BAUM
• 金额: $ 10.71万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-01 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2005757
• 关键词: FK506; adult human (21+); artificial immunosuppression; behavior prediction; behavioral /social science research tag; clinical research; disease /disorder proneness /risk; human subject; human therapy evaluation; patient monitoring device; prevention; questionnaires; therapy compliance; transplantation

DESCRIPTION: Compliance with the medication regimen is a critical issue in the management of organ transplant patients. Although the limited available literature suggests that a minimum of 10 percent of all graft losses are due to noncompliance, with estimates ranging as high as 80 percent, research in this area has been inhibited by problems with access to large numbers of patients and good measures of compliance. The proposed research will use sophisticated monitoring techniques to assess the extent of compliance with immunosuppressant regimen in a large population of organ transplant patients. It will also identify correlates of noncompliance, evaluate related clinical events, and translate these findings into the design of an intervention program to increase organ transplant patients' compliance with their medication regimen. Four hundred subjects will be recruited from patients aged 18 years and older who received a solid organ transplant from January 1990 onward, who are at least six months post-transplant at the time they are recruited, and who are receiving tacrolimus (Prograf) as their immunosuppressant drug. Participants will be given a questionnaire to assess potential risk factors associated with noncompliant behavior (e.g., perceptions of self-efficacy and life control, social support, sociodemographic characteristics) and issues related to managing their medication regimen. Additional risk-related information will be extracted from their pharmacy profiles and medical records. Medication compliance will be assessed for the following six months by means of Medication Event Monitoring Systems (MEMS) caps on the subjects' tacrolimus vials. The MEMS cap records the date and the time of day that the vial is opened, so it is possible to assess the timing of doses as well as the fact that a daily dose was or was not taken from the bottle. Data will be analyzed to quantify compliance and to identify and quantify variables associated with noncompliant behavior. Information on clinical vents will be collected from medical and pharmacy records for the twelve-month period after compliance monitoring was initiated. Intervention program design will be based on results from this study indicating the appropriate target population and significant modifiable risk factors.

描述：遵守药物治疗方案是一个关键问题 器官移植患者的管理。 虽然有限可用 文献表明，所有移植物损失的至少10％ 对于不合规，估计高达80％，研究 访问大量的问题已抑制了该区域 患者和良好的合规措施。 拟议的研究将使用 复杂的监测技术以评估遵守的程度 大量器官移植中的免疫抑制剂方案 患者。 它还将确定不符合性的相关性，评估 相关的临床事件，并将这些发现转化为 干预计划，以增加器官移植患者遵守 他们的药物治疗方案。 将从18岁的患者中招募400名受试者， 从1990年1月开始接受坚实的器官移植的年龄较大的人 移植后至少六个月被招募时，并且 接受他克莫司（Prograf）作为免疫抑制剂药物的人。 将向参与者提供问卷调查以评估潜在的风险因素 与不合格行为相关（例如，对自我效能感的看法 以及生活控制，社会支持，社会人口统计学特征）和 与管理药物方案有关的问题。 额外的 与风险相关的信息将从其药房配置文件中提取，并且 病历。 将评估以下药物合规性 六个月通过用药事件监测系统（MEMS）盖上限额 受试者的他克莫司小瓶。 MEMS上限记录日期和时间 小瓶打开的一天，因此可以评估 剂量以及每日剂量是或未从中服用的事实 瓶子。 将分析数据以量化合规性和识别和 量化与不合格行为相关的变量。 信息 临床通风口将从医疗和药房记录中收集 启动合规性监测后的十二个月。 干涉 计划设计将基于本研究的结果，表明 适当的目标人群和明显的可修改风险因素。