Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2010-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Group
Behavioral contract intervention
Behavioral Contract
Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).
Control Group
No intervention
No interventions assigned to this group
Interventions
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Behavioral Contract
Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).
Eligibility Criteria
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Inclusion Criteria
* at least 21 years of age
* receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus
* be at least one year post-transplant
* obtain immunosuppressant therapy from Avella Specialty Pharmacy for at least one year prior to study enrollment and during the study period
Exclusion Criteria
* prisoner
* institutionalized
* unable to give informed consent
21 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Marie A Chisholm-Burns, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee College of Pharmacy
Locations
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University of Arizona College of Pharmacy
Tucson, Arizona, United States
Countries
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References
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Chisholm-Burns MA, Erickson SR, Spivey CA, Gruessner RW, Kaplan B. Concurrent validity of kidney transplant questionnaire in US renal transplant recipients. Patient Prefer Adherence. 2011;5:517-22. doi: 10.2147/PPA.S24261. Epub 2011 Oct 13.
Chisholm-Burns MA, Erickson SR, Spivey CA, Kaplan B. Health-related quality of life and employment among renal transplant recipients. Clin Transplant. 2012 May-Jun;26(3):411-7. doi: 10.1111/j.1399-0012.2011.01541.x. Epub 2011 Oct 28.
Chisholm-Burns MA, Spivey CA, Graff Zivin J, Lee JK, Sredzinski E, Tolley EA. Improving outcomes of renal transplant recipients with behavioral adherence contracts: a randomized controlled trial. Am J Transplant. 2013 Sep;13(9):2364-73. doi: 10.1111/ajt.12341. Epub 2013 Jul 2.
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.
Other Identifiers
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