Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06023615
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-08-21
Brief Title:
MITIGAAT Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Multifaceted Intervention To Improve Graft Outcome Disparities in African American Kidney Transplants MITIGAAT
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK134326-01A1 | NIH | None | httpsreporternihgovquickSearch1R01DK134326-01A1 |