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临床试验/NCT01373489
NCT01373489已完成不适用

Effectiveness of Technology-Assisted Case Management in Low Income Adults With Type 2 Diabetes

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
2
主要终点
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization

研究概览

简要总结

The purpose of this study is to help low income patients achieve and maintain better self-management skills and improve blood sugar levels, using a 2-in-1 blood glucose and blood pressure monitoring system and nurse case management. Patients must be served at a Federally Qualified Health Center (FQHC) in coastal South Carolina.

详细描述

The long-term goal is to develop a practical and sustainable system of diabetes management that will help low income patients achieve and maintain goals within established treatment guidelines regardless of geographic location. This randomized clinical trial will employ the innovative FORA system, an inexpensive, off-the-shelf, state-of-the-art technology comprised of a 2-in-1 Blood Glucose and Blood Pressure monitor, coupled with nurse case management (TACM) to optimize diabetes care for low income, rural adults with type 2 diabetes (T2DM). The target population will be low income patients served in Federally Qualified Health Care Centers (FQHCs) with poorly controlled T2DM residing in coastal South Carolina. Two hundred patients will be randomly assigned to two groups of 100 patients each; Group A (Usual Care) and Group B (Technology-assisted Case Management, TACM). Each patient will be followed for 6 months, with study visits at baseline, 3, and 6 months. The primary outcome will be Hemoglobin A1c (HbA1c) at 6 months post-randomization while the secondary outcomes will be blood pressure control and quality of life (qol) at 6 months post-randomization.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years and receiving care within the Franklin C. Fetter Family Health Center
  • Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
  • Subject must be willing to use the FORA 2-in-1 system
  • Subject must have a working land-line for the duration of the study in order to be able to upload the readings from the FORA 2-in-1 machine
  • Subjects must be able to communicate in English

排除标准

  • Mental confusion on interview suggesting significant dementia
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency using a screening questionnaire
  • Active psychosis or acute mental disorder
  • Life expectancy <6 months
  • Pregnant and/or lactating females

结局指标

主要结局

Hemoglobin A1c (HbA1c) at 6 Months Post Randomization

时间窗: 6 months post randomization

Hemoglobin A1c (HbA1c) was measured at 6 months post randomization

次要结局

未报告次要终点

研究者

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

Leonard Ehianu Egede

Professor & Chair, Department of Medicine

State University of New York at Buffalo

研究点 (2)

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