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Measuring and Improving Medication Adherence in Kidney Transplant Patients

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Kidney Transplant Recipients

Treatments

Behavioral: Cognitive-behavioral adherence promotion program
Behavioral: Standard Care

Study type

Interventional

Funder types

NIH

Identifiers

NCT02639949
NIDDK_KUH

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

Group CBT
Experimental group
Treatment:
Behavioral: Cognitive-behavioral adherence promotion program
Standard Care
Active Comparator group
Treatment:
Behavioral: Standard Care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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