Measuring and Improving Medication Adherence in Kidney Transplant Patients

NCT ID: NCT02639949

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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Group CBT

Group Type EXPERIMENTAL

Cognitive-behavioral adherence promotion program

Intervention Type BEHAVIORAL

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

Standard Care

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Interventions

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Cognitive-behavioral adherence promotion program

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

Intervention Type BEHAVIORAL

Standard Care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 36094829 (View on PubMed)

Other Identifiers

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NIDDK_KUH

Identifier Type: -

Identifier Source: org_study_id

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