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
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 17, 2015
CompletedFirst Posted
Study publicly available on registry
December 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedSeptember 13, 2017
September 1, 2017
3.7 years
December 17, 2015
September 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence as measured by unannounced telephone pill count
3 months
Secondary Outcomes (1)
degree of agreement between pill count data and laboratory tacrolimus levels
3 months
Study Arms (2)
Group CBT
EXPERIMENTALStandard Care
ACTIVE COMPARATORInterventions
A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.
Eligibility Criteria
You may qualify if:
- \- current prescription of tacrolimus less than 98% adherence to medication prescription as determined by three baseline pill counts
You may not qualify if:
- \- lack of telephone to complete pill counts lack of English proficiency to participate in adherence promotion sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PMID: 36094829DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2015
First Posted
December 28, 2015
Study Start
January 1, 2010
Primary Completion
September 1, 2013
Study Completion
July 1, 2017
Last Updated
September 13, 2017
Record last verified: 2017-09