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OpenTrials
Completed

NCT Number: NCT02639949

Measuring and Improving Medication Adherence in Kidney Transplant Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral adherence promotion program

Behavioral

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

Standard Care

Behavioral

Primary outcomes

  1. Adherence as measured by unannounced telephone pill count

    Time frame: 3 months

Secondary outcomes

  1. degree of agreement between pill count data and laboratory tacrolimus levels

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2017
First posted
Dec 28, 2015
Registry last updated
Sep 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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