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Measuring and Improving Medication Adherence in Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02639949
Recruitment Status : Completed
First Posted : December 28, 2015
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplant Recipients Behavioral: Cognitive-behavioral adherence promotion program Behavioral: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants
Study Start Date : January 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group CBT Behavioral: Cognitive-behavioral adherence promotion program
A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.

Active Comparator: Standard Care Behavioral: Standard Care

Primary Outcome Measures :
  1. Adherence as measured by unannounced telephone pill count [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. degree of agreement between pill count data and laboratory tacrolimus levels [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT02639949    
Other Study ID Numbers: NIDDK_KUH
First Posted: December 28, 2015    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017