N/A
N=150
Behavioral Contract Adherence Intervention
Renal Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01739803 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period — 0.88; 0.81 medication possession ratio (proportion) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral Contract (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Tennessee
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period |
0.88; 0.81 | <0.05 sig |
| SECONDARY Health-related Quality of Life (HQoL) |
0.84; 0.85 | 0.05 |
| SECONDARY Days in Hospital |
51; 29 | 0.05 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01739803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.