MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT06031428
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

The study is a randomized control trial involving 100 participants (Black men with poorly controlled diabetes within 1 year of release from incarceration) 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 (Black men within 1 year of release from incarceration) 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.

Study Timeline

• Study First Submitted: 2023-09-02
• Study First Submitted QC: 2023-09-02
• Study First Posted: 2023-09-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Study Start: 2023-12-01
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• age ≥18 years
• identify as Black or African American
• identify as male
• released from the state or federal prison system or county jail in prior 12 months
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1C	6 months post-randomization	Venous draw will be use to obtain HbA1C

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Short Form Health Survey, SF-12)	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.
Blood Pressure	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

Trial Locations

Locations (1)

Center for Advancing Population Science, Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States