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临床试验/NCT06031428
NCT06031428招募中2 期

MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Black Men Recently Released From Incarceration

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月20日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Hawks

Assistant Professor

Medical College of Wisconsin

研究点 (2)

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