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Measuring and Improving Medication Adherence in Kidney Transplant Patients

NCT02639949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-09-13

No results posted yet for this study

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

BEHAVIORAL

Cognitive-behavioral adherence promotion program

A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.

BEHAVIORAL

Standard Care

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-09-30
Completion
2017-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02639949 on ClinicalTrials.gov