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NCT Number: NCT06031428

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Center for Advancing Population Science, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Laura Hawks, MD

CONTACT

[email protected]

4149558020

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MANAGe-DM - novel nurse case management

Behavioral

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.

Monthly Educational Mailing

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1C

    Time frame: 6 months post-randomization

    Venous draw will be use to obtain HbA1C

Secondary outcomes

  1. Blood Pressure

    Time frame: 6 months post-randomization

    Blood pressure readings (both systolic and diastolic) will be obtained using automated BP monitors programmed to take 3 readings at 2 minute intervals and give average of the 3 readings

  2. Quality of Life (Short Form Health Survey, SF-12)

    Time frame: 6 months post-randomization

    The Short Form Health Survey (SF-12) version 1, developed by Ware et al. in 1996 is a valid and reliable instrument that will be used to measure quality of life. Scores will be reported in physical health related (PCS) and mental health related (MCS). Scores range from 0 to 100 with higher scores indicating better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Hawks, MD

CONTACT

[email protected]

414-955-8020

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Acronym: MANAGe-DM

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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