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

Medical College of Wisconsin

Status and phase: Enrolling; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: MANAGe-DM - novel nurse case management; Behavioral: Monthly Educational Mailing

Study type: Interventional

Funder types: Other

Identifiers

NCT06031428

PRO00044942

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Monthly Educational Mailing

MANAGe-DM

Experimental group

Description:

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

Treatment:

Behavioral: MANAGe-DM - novel nurse case management