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

Diabetes Mellitus, Type 2 Clinical Trial

— MANAGe-DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031428
• Other study ID #: PRO00044942
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: Medical College of Wisconsin
• Contact: Laura Hawks, MD
• Phone: 414-955-8020
• Email: lhawks[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• MANAGe-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.
• Monthly 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

Country	Name	City	State
United States	Center for Advancing Population Science, Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C	Venous draw will be use to obtain HbA1C	6 months post-randomization
Secondary	Blood Pressure	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	6 months post-randomization
Secondary	Quality of Life (Short Form Health Survey, SF-12)	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.	6 months post-randomization