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Behavioral Intervention

Nurse Case Management for Diabetes (MANAGe-DM Trial)

Phase 2

Recruiting

Led By Laura Hawks, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Identify as male

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post-randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial examines how a nurse case manager can help 100 Black men with diabetes manage their condition and improve their health and quality of life.

Who is the study for?

This trial is for Black men over 18 years old with poorly controlled type 2 diabetes (HbA1c ≥8%), who have been released from incarceration within the last year. They must be able to communicate in English and not be on house arrest or under electronic monitoring, involved in other diabetes trials, facing imminent legal proceedings, or have significant dementia or acute mental disorders.

What is being tested?

The MANAGe-DM study tests a tailored nurse case management approach versus monthly educational mailings to improve blood sugar control and quality of life in participants. It's a randomized trial with two groups: one receiving the novel intervention and the other standard information.

What are the potential side effects?

Since this trial involves case management and education rather than medication, there are no direct medical side effects. However, participants may experience stress or anxiety related to lifestyle changes recommended by their nurse case manager.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I identify as male.

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I have type 2 diabetes with an HbA1c level of 8% or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1C

Secondary study objectives

Blood Pressure

Quality of Life (Short Form Health Survey, SF-12)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MANAGe-DMExperimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

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.

0 / 3Eligibility criteria met