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NCT06031428PHASE2Recruiting

MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men

Medical College of Wisconsin

Start Date

2/20/2024

Completion Date

11/1/2027

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 participant's 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * age ≥18 years * identify as Black or African American * identify as male * formerly incarcerated in a state or federal prison system or county jail * clinical diagnosis of type 2 diabetes with HbA1c ≥8% at the screening visit * able to communicate in English. Exclusion Criteria: * mental confusion on screening interview suggesting significant dementia * current participation in other diabetes clinical trials * active psychosis or acute mental disorder * life expectancy \<12 months * awaiting arraignment, trial, sentencing in the criminal legal system * on active surveillance by the criminal legal system, meaning on house arrest or subject to electronic monitoring

Interventions

BEHAVIORAL

MANAGe-DM - novel nurse case management

BEHAVIORAL

Monthly Educational Mailing

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Conditions

Diabetes Mellitus, Type 2

Locations

Center for Advancing Population Science, Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States