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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Hemoglobin A1C [Срок оценки: 6 months post-randomization]

Вторичные конечные точки (2)

• Blood Pressure [Срок оценки: 6 months post-randomization]
• Quality of Life (Short Form Health Survey, SF-12) [Срок оценки: 6 months post-randomization]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Center for Advancing Population Science, Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT06031428 · PRO00044942

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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