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

Medical University of South Carolina (MUSC)

Status

Enrolling

Conditions

Medication Adherence

Medication Compliance

Treatments

Other: mHealth app/dashboard

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06023615

Pro00127666

1R01DK134326-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment

190 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years of age
≥2 years post-kidney transplant

Exclusion criteria

Non-kidney transplant recipient (liver, lung, heart, intestine, pancreas, bone marrow)
Not capable of measuring own BP and glucose in those with diabetes
Not capable of using mobile health application after adequate training
Not capable of speaking, hearing, and reading English