Measuring and Improving Medication Adherence in Kidney Transplant Patients

Kidney Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02639949
• Other study ID #: NIDDK_KUH
• Status: Completed
• Phase: N/A
• First received: December 17, 2015
• Last updated: September 12, 2017
• Start date: January 2010
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2017
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Behavioral:
• Cognitive-behavioral adherence promotion program
A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.
• Standard Care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence as measured by unannounced telephone pill count		3 months
Secondary	degree of agreement between pill count data and laboratory tacrolimus levels		3 months