Measuring and Improving Medication Adherence in Kidney Transplant Patients

Not Applicable

Completed

• Conditions: Kidney Transplant Recipients
• Interventions: Behavioral: Standard Care; Behavioral: Cognitive-behavioral adherence promotion program

• Registration Number: NCT02639949
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-09
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-21
• Study First Posted: 2015-12-28
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts

Exclusion Criteria

• lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	-
Group CBT	Cognitive-behavioral adherence promotion program	-

Primary Outcome Measures

Name	Time	Method
Adherence as measured by unannounced telephone pill count	3 months

Secondary Outcome Measures

Name	Time	Method
degree of agreement between pill count data and laboratory tacrolimus levels	3 months