RecruitingPhase 2NCT06031428

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


Sponsor

Medical College of Wisconsin

Enrollment

100 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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

BEHAVIORALMANAGe-DM - novel nurse case management

Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.

BEHAVIORALMonthly Educational Mailing

All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education. Topics covered will include diabetes basics, monitoring and medications, healthy eating and exercise, overview of common comorbidities, basics of foot care, and strategies for overcoming common pitfalls.


Locations(1)

Center for Advancing Population Science, Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT06031428


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