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临床试验/NCT02639949
NCT02639949已完成不适用

The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 个研究点目标入组 45 人开始时间: 2010年1月最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Cognitive-behavioral adherence promotion program (Behavioral)

Standard Care

Active Comparator

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)

研究者

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