Overview

This trial is active, not recruiting.

Condition kidney transplant recipients
Treatments cognitive-behavioral adherence promotion program, standard care
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date January 2010
End date September 2013
Trial size 45 participants
Trial identifier NCT02639949, NIDDK_KUH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Primary purpose treatment
Arm
(Experimental)
cognitive-behavioral adherence promotion program
A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.
(Active Comparator)
standard care

Primary Outcomes

Measure
Adherence as measured by unannounced telephone pill count
time frame: 3 months

Secondary Outcomes

Measure
degree of agreement between pill count data and laboratory tacrolimus levels
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Use of Random Telephone Calls to Measure Immunosuppressive Therapy Adherence in Patients With Renal Transplants
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).