Clinical trial NCT06031428: MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
Official title: MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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 \&lt;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

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 6 months post-randomization
Secondary outcomes:
measure: Blood Pressure
timeFrame: 6 months post-randomization
measure: Quality of Life (Short Form Health Survey, SF-12)
timeFrame: 6 months post-randomization
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Center for Advancing Population Science, Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Laura Hawks, MD
role: PRINCIPAL_INVESTIGATOR
References: