MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MANAGe-DM - novel nurse case management, Monthly Educational Mailing.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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. 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.
Interventions
- 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. - 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.
Primary outcome measures
- Hemoglobin A1C [Time frame: 6 months post-randomization]
Secondary outcome measures (2)
- Blood Pressure [Time frame: 6 months post-randomization]
- Quality of Life (Short Form Health Survey, SF-12) [Time frame: 6 months post-randomization]
Eligibility criteria
Inclusion criteria
- age ≥18 years
- identify as Black or African American
- identify as male
- formerly incarcerated in a state or federal prison system or county jail
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Center for Advancing Population Science, Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06031428 · PRO00044942