Behavioral Contract Adherence Intervention
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Purpose
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 | Intervention |
|---|---|
|
Renal Transplantation |
Behavioral: Behavioral Contract |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients |
- Comparison of Immunosuppressant Therapy Adherence at Baseline, 3, 6, 9, and 12 Months [ Time Frame: Baseline, 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]Immunosuppressant therapy adherence as measured by pharmacy refill records
- Health-related Quality of Life [ Time Frame: Baseline, 6, and 12 months ] [ Designated as safety issue: No ]
- Healthcare Utilizations [ Time Frame: Baseline and monthly for one year ] [ Designated as safety issue: No ]
| Enrollment: | 135 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Arizona | |
| University of Arizona College of Pharmacy | |
| Tucson, Arizona, United States, 85721 | |
| Principal Investigator: | Marie A Chisholm-Burns, PharmD | University of Tennessee College of Pharmacy |
More Information
Publications:
| Responsible Party: | University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT01739803 History of Changes |
| Other Study ID Numbers: | 7R01DK081347-04, 7R01DK081347-04 |
| Study First Received: | November 29, 2012 |
| Last Updated: | November 30, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Tennessee:
|
Immunosuppressant therapy adherence Quality of life Economic outcomes |
ClinicalTrials.gov processed this record on June 17, 2013