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

NCT06023615 | Recruiting DMC

• 2 other identifiers: Pro001276661R01DK134326-01A1
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence; Medication Compliance

Outcome Measures

Primary Outcomes (6)

• Medication Adherence

  Medication adherence will be measured by using tacrolimus trough concentration variability, which is a validated proxy measure of medication adherence. This is defined as the intrapatient tacrolimus concentration coefficient of variation (CV): standard deviation divided by the mean for each patient. All outpatient true trough tacrolimus levels drawn will be used to calculate the tacrolimus CV. This will be assessed every 3 months, which aligns with the minimum lab draw schedule for kidney transplant recipients at out center. This will be analyzed using repeated measures methodology, estimating efficacy effect size using the time\*treatment interaction term and disparity using the time\*treatment\*race interaction term.

  2 Years

• Blood Pressure

  Blood pressure control will be defined as the mean of all systolic BPs checked by patients at home and the transplant center (ambulatory measures). Patients with a mean of SBP ≤140 mmHg will be considered controlled. We will aggregate and assess blood pressure levels every month (25 total); analyzed using repeated measures (time\*treatment and disparity using the time\*treatment\*race interaction term).

  2 Years

• Glucose Control

  Glucose control is defined as the mean measure of all glucoses (random or fasting). Those with DM and a mean random glucose ≤160 mg/dL will be considered to controlled. We will aggregate and assess glucose levels every month (25 total); analyzed using repeated measures (time\*treatment and disparity using the time\*treatment\*race interaction term).

  2 Years

• Cost-Benefit Analysis

  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.

  2 Years

• Acute Rejection

  This is defined as the proportion of patients in each arm with a renal allograft biopsy showing at least grade 1A rejection by Banff criteria. Per usual care practices, all patients are required to have biopsy confirmation of rejection episodes within 24 hours of onset of treatment for acute rejection. It is standard care that all kidney allograft biopsies performed for transplant recipients occur at the transplant center (study institution). Biopsies will be read by a blinded local pathologist, as usual care. This will be assessed using time to event analyses..

  2 Years

• Graft Failure

  This is defined as the proportion of patients in each arm with graft failure, which is a composite outcome of either return to chronic dialysis, nephrectomy, re-transplant, or death. The timing and cause of each graft loss will be recorded for comparative analysis.

  2 Years

Study Arms (2)

Intervention Group

EXPERIMENTAL

Usual Care + mHealth/Telehealth

Other: mHealth app/dashboard

Control Group

NO INTERVENTION

Usual Care + Attention Control

Interventions

mHealth app/dashboard 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (1)

• Overstreet M, Culpepper H, DeHoff D, Gebregziabher M, Posadas Salas MA, Su Z, Chandler J, Bartlett F, Dunton P, Carcella T, Taber D. Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 10;13:e57784. doi: 10.2196/57784.

  PMID: 39388231 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Faculty

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 5, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)