Behavioral Contract Adherence Intervention

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Renal Transplantation

Clinical Trial Details

NCT number	NCT01739803
Study type	Interventional
Source	University of Tennessee
Contact
Status	Completed
Phase	N/A
Start date	January 2010
Completion date	June 2013

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06026592` - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting	`NCT02444429` - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation	Phase 3
Completed	`NCT02238418` - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.	Phase 4
Completed	`NCT01729494` - Belatacept Early Steroid Withdrawal Trial	Phase 4
Terminated	`NCT01436305` - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation	Phase 2
Completed	`NCT02843295` - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure	N/A
Terminated	`NCT01276834` - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation	Phase 4
Completed	`NCT00842699` - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab	N/A
Completed	`NCT00525681` - Interaction Between Rimonabant and Cyclosporine and Tacrolimus	Phase 4
Completed	`NCT00189735` - A Study to Evaluate FK778 in Kidney Transplant Patients	Phase 2
Completed	`NCT00776750` - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients	Phase 4
Recruiting	`NCT04052867` - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy	N/A
Recruiting	`NCT03114826` - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients	N/A
Completed	`NCT02587052` - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed	`NCT02020642` - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx)	N/A
Completed	`NCT01435291` - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation	Phase 4
Recruiting	`NCT01001065` - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis	N/A
Completed	`NCT00978965` - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting	`NCT00903188` - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation	Phase 4
Completed	`NCT00425308` - Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.	Phase 3