The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Adherence as measured by unannounced telephone pill count
研究概览
简要总结
Nonadherence to medication is a major obstacle to successful treatment of renal transplant patients. This study has two primary aims. The first is to test whether a culturally sensitive cognitive-behavioral adherence promotion program could significantly improve medication adherence to tacrolimus prescription. Participants will be randomly assigned to either group CBT or to standard care. The second aim is to pilot a novel strategy of adherence measurement - unannounced telephone pill counts, which has been shown to be a valid and reliable means to measure medication adherence in other patient populations. Participants will be recruited from waiting area of the kidney transplant clinic at SUNY Downstate Medical Center in Brooklyn, NY. Three unannounced telephone pill counts will be conducted prior to start of the intervention in order to establish baseline adherence and three pill counts will be conducted post-intervention. Tacrolimus trough concentration levels will also be collected as an additional biological measure of adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts
排除标准
- •lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions
研究组 & 干预措施
Group CBT
干预措施: Cognitive-behavioral adherence promotion program (Behavioral)
Standard Care
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Adherence as measured by unannounced telephone pill count
时间窗: 3 months
次要结局
- degree of agreement between pill count data and laboratory tacrolimus levels(3 months)
