Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06031428
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-09-02
Brief Title:
MANAGe-DM Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
MANAGe-DM Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
Status:
RECRUITING
Status Verified Date:
2024-09
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:
MANAGe-DM
Brief Summary:
The study is a randomized control trial involving 100 participants formerly incarcerated Black men with poorly controlled diabetes to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes self-care behaviors and quality of life at 6 months post-randomization
Detailed Description:
The study is a randomized control trial involving 100 participants formerly incarcerated Black men with poorly controlled diabetes to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes self-care behaviors and quality of life at 6 months post-randomization Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention Nurse case managers are trained RNs who support patients with T2DM by coordinating services supporting self-care and implementing disease management strategies Welch 2010 MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM MANAGe-DM will include three components 1 diabetes education and skills training 2 healthcare navigation and 3 basic needs navigation The NCM will serve as an adjunct to the participants primary care provider they will not be embedded within a clinic but instead interact with the participant over the phone after study recruitment from a community setting
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?:
None
Is an FDA AA801 Violation?:
None