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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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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

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Medication Adherence Medication Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Usual Care + mHealth/Telehealth

Group Type EXPERIMENTAL

mHealth app/dashboard

Intervention Type OTHER

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.

Control Group

Usual Care + Attention Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No