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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 Formerly Incarcerated Black Men

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
干预措施

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 (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.

详细描述

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.

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
  • •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.

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

研究组 & 干预措施

Control

Active Comparator

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.

干预措施: Monthly Educational Mailing (Behavioral)

MANAGe-DM

Experimental

Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. 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. . Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.

干预措施: MANAGe-DM - novel nurse case management (Behavioral)

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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