MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Hemoglobin A1C
时间窗: 6 months post-randomization
Venous draw will be use to obtain HbA1C
次要结局
- Quality of Life (Short Form Health Survey, SF-12)(6 months post-randomization)
- Blood Pressure(6 months post-randomization)
研究者
Laura Hawks
Assistant Professor
Medical College of Wisconsin
