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

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ClinicalTrials.gov Identifier: NCT06031428
Recruitment Status : Recruiting
First Posted : September 11, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
Laura Hawks, Medical College of Wisconsin

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: MANAGe-DM - novel nurse case management Behavioral: Monthly Educational Mailing Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2027
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control
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.
 Behavioral: 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.
Experimental: MANAGe-DM
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: 6 months post-randomization ]
    Venous draw will be use to obtain HbA1C


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 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

  2. Quality of Life (Short Form Health Survey, SF-12) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self-representation of gender identity
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06031428


Contacts
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Contact: Laura Hawks, MD 414-955-8020 lhawks@mcw.edu

Locations
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United States, Wisconsin
Center for Advancing Population Science, Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Laura Hawks, MD    414-955-8020    lhawks@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Laura Hawks, MD Medical College of Wisconsin
More Information
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Responsible Party: Laura Hawks, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT06031428    
Other Study ID Numbers: PRO00044942
First Posted: September 11, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases