Medication AdherenceNCT06023615
MITIGAAT: Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants
A study testing mHealth app/dashboard in people with Medication Adherence and Medication Compliance, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Medication Compliance
- What is being tested?
- mHealth app/dashboard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- ≥2 years post-kidney transplant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)
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.
Read the 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
- Being tested
- mHealth app/dashboard
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth app/dashboardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Usual Care + mHealth/Telehealth Receives: Other: mHealth app/dashboard |
| Control Group | No intervention | Usual Care + Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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..
Measured: 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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start27 Feb 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023615
- Sponsor's protocol ID
- Pro00127666
- Other IDs
- 1R01DK134326-01A1
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39388231
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)
- ClinicalTrials.gov ID
- NCT06023615
- Acronym / sponsor ID
- Pro00127666
- Conditions
- Medication Adherence, Medication Compliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: mHealth app/dashboardUsual Care + mHealth/Telehealth |
| Control Group | No intervention | –Usual Care + Attention Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years of age
- ≥2 years post-kidney transplant
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth app/dashboardIn 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. | Other | Intervention Group |
Primary outcome
Medication Adherence
Time frame: 2 Years
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.
Blood Pressure
Time frame: 2 Years
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).
Glucose Control
Time frame: 2 Years
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).
Cost-Benefit Analysis
Time frame: 2 Years
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.
Acute Rejection
Time frame: 2 Years
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..
Graft Failure
Time frame: 2 Years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 39388231Overstreet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth app/dashboard in people with Medication Adherence and Medication Compliance, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 2 Years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06023615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.