search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MANAGe-DM - novel nurse case management
Monthly Educational Mailing
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Advancing Population Science, Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

MANAGe-DM

Arm 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.

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1C
Venous draw will be use to obtain HbA1C

Secondary Outcome Measures

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
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.

Full Information

First Posted
September 2, 2023
Last Updated
September 28, 2023
Sponsor
Medical College of Wisconsin
search

1. Study Identification

Unique Protocol Identification Number
NCT06031428
Brief Title
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration
Acronym
MANAGe-DM
Official Title
MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm 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.
Arm Title
MANAGe-DM
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
MANAGe-DM - novel nurse case management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Monthly Educational Mailing
Intervention 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. 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 Outcome Measure Information:
Title
Hemoglobin A1C
Description
Venous draw will be use to obtain HbA1C
Time Frame
6 months post-randomization
Secondary Outcome Measure Information:
Title
Blood Pressure
Description
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
Time Frame
6 months post-randomization
Title
Quality of Life (Short Form Health Survey, SF-12)
Description
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.
Time Frame
6 months post-randomization

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Hawks, MD
Phone
414-955-8020
Email
lhawks@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Hawks, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Advancing Population Science, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Hawks, MD
Phone
414-955-8020
Email
lhawks@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs