NCT02639949

Measuring and Improving Medication Adherence in Kidney Transplant Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavioral adherence promotion program	A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.
BEHAVIORAL	Standard Care

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-09-01
• Completion: 2017-07-01
• First posted: 2015-12-28
• Last updated: 2017-09-13