Health TrialsbyHealthPanel

MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men

ConditionDiabetes Mellitus, Type 2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMedical College of Wisconsin

About this trial

The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years

identify as Black or African American

identify as male

formerly incarcerated in a state or federal prison system or county jail

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MANAGe-DM - novel nurse case management

    Behavioral

    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

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: MANAGe-DMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin A1C

Venous draw will be use to obtain HbA1C

Time frame
6 months post-randomization

Secondary outcomes

1

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

Time frame
6 months post-randomization
2

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.

Time frame
6 months post-randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

Source ClinicalTrials.gov
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