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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02639949

Enrollment

Registered

2015-12-28

Start date

2010-01-31

Completion date

2017-07-31

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

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.

Interventions

BEHAVIORALCognitive-behavioral adherence promotion program

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

BEHAVIORALStandard Care

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026