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Behavioral Contract Adherence Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739803
Recruitment Status : Completed
First Posted : December 3, 2012
Results First Posted : February 7, 2014
Last Update Posted : February 7, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Tennessee

Brief Summary:
There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.

Condition or disease Intervention/treatment Phase
Renal Transplantation Behavioral: Behavioral Contract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients
Study Start Date : January 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention Group
Behavioral contract intervention
Behavioral: 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).

No Intervention: Control Group
No intervention

Primary Outcome Measures :
  1. Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period [ Time Frame: 12 months ]

    Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows:

    1 - [(Days Between Refills - Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period

    At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period.

Secondary Outcome Measures :
  1. Health-related Quality of Life (HQoL) [ Time Frame: 12 months ]
    The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting "no problems," "some problems," and "extreme problems." A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death.

  2. Days in Hospital [ Time Frame: 12 months ]

    We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.

    Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • renal transplant recipient
  • 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:

  • pregnant
  • prisoner
  • institutionalized
  • unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739803

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United States, Arizona
University of Arizona College of Pharmacy
Tucson, Arizona, United States, 85721
Sponsors and Collaborators
University of Tennessee
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Marie A Chisholm-Burns, PharmD University of Tennessee College of Pharmacy

Publications of Results:
Other Publications:
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Responsible Party: University of Tennessee Identifier: NCT01739803    
Other Study ID Numbers: 7R01DK081347-04 ( U.S. NIH Grant/Contract )
7R01DK081347-04 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2012    Key Record Dates
Results First Posted: February 7, 2014
Last Update Posted: February 7, 2014
Last Verified: December 2013
Keywords provided by University of Tennessee:
Immunosuppressant therapy adherence
Quality of life
Economic outcomes