NCT06023615

MITIGAAT: Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants

Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars in those with diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.

Detailed description

The overarching hypothesis for MITIGAAT is that late non-adherence and suboptimal control of diabetes and hypertension are more common in African American kidney recipients and are major contributors to health disparities. A multimodal intervention that addresses these issues will significantly reduce disparities. This hypothesis will be tested through a rigorously conducted, prospective, 2-year randomized controlled trial in 190 kidney transplant recipients from MUSC, designed to assess the following aims: Aim 1. Determine the impact of this multilevel health services intervention on achieving improved adherence to tacrolimus, measured using tacrolimus trough variability and time in range in the treatment vs control arm. Aim 2. Determine the impact of this multilevel health services intervention on blood pressure (BP) and glucose control (in those with DM) in the treatment vs control arm. Aim 3. Conduct a cost-benefit analysis (CBA), assessing the estimated hospitalization and ED visit costs in the intervention arm vs the control arm and compare this to the costs needed to deliver the intervention. Aim 4. Compare the incidence of acute rejection, graft loss and death in the intervention patients vs. a large contemporary national cohort of Veteran kidney transplant recipients while also assessing racial disparities for these health outcomes

Conditions

• Medication Adherence
• Medication Compliance

Interventions

Type	Name	Description
OTHER	mHealth app/dashboard	In the interventional group, the subject would receive the standard care that is provided to all post-transplant kidney recipients plus an additional remote monitoring system and follow-up by utilizing an app known as the mHealth app/dashboard. This app is integrated with home-based monitoring of blood pressures, glucoses, and pharmacist-led scheduled televisits.

Timeline

• Start date: 2024-02-27
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2023-09-05
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States