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

NCT06031428 · Medical College of Wisconsin
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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
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
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2024-02-20
Estimated completion: 2027-11-01
Last updated: 2025-09-17
Interventions
Behavioral: MANAGe-DM - novel nurse case managementBehavioral: Monthly Educational Mailing
Primary outcomes
  • Hemoglobin A1C (6 months post-randomization)
Sponsor
Medical College of Wisconsin · other
Contacts & investigators
ContactLaura Hawks, MD · contact · lhawks@mcw.edu · 414-955-8020
InvestigatorLaura Hawks, MD · principal_investigator, Medical College of Wisconsin
All locations (1)
Center for Advancing Population Science, Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men · TrialPath