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临床试验/NCT02722499
NCT02722499已完成不适用

Financial Incentives Augmented Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3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
60
试验地点
2
主要终点
HbA1c

研究概览

简要总结

The aim of this study is to test the efficacy of financial incentives augmented telephone-delivered diabetes education and skills training intervention in improving HbA1c levels in African Americans (AA) with type 2 diabetes (T2DM).

详细描述

African Americans with T2DM have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to White Americans. HbA1c is the primary marker for glycemic control and is a strong independent predictor of development of complications and increased mortality in T2DM. Key self-care behaviors that influence glycemic control (and HbA1c) include diet, physical activity, self-monitoring of blood glucose and medication adherence. Systematic review of multiple RCTs show that self-care interventions that include diabetes education and skills training are effective in improving metabolic control in diabetes. Recent findings indicate that patients with diabetes, especially ethnic minority patients, prefer telephone-delivered diabetes education to group visits or internet-based education. Multiple RCTs have documented the effectiveness of telephone-delivered self-care interventions in T2DM.

The overarching aim of this proposal is test the efficacy of three financial incentive structures in combination with technology intensified diabetes education and skills training intervention on blood pressure and quality of life in AAs with T2DM. 60 AAs with T2DM will be randomized to three groups with varying frequency of financial incentives: 1) High Frequency: financial incentives for weekly uploads plus average glucose, incentives for weekly attendance to educational sessions, and incentives at the end of the study for meeting HbA1c goals 2) Moderate Frequency: financial incentives for weekly uploads plus average glucose, and incentives at the end of the study for meeting HbA1c goals, and 3) Low Frequency: financial incentives at the end of the study for meeting HbA1c goals.

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
Single (Investigator)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥21 years
  • Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
  • Self-identified as AA
  • Subject must be willing to use the FORA monitoring system for 3 months
  • Subjects must be able to communicate in English
  • Subjects must have access to a telephone (landline for data uploads) for the study period

排除标准

  • Mental confusion on interview suggesting significant dementia
  • Participation in other diabetes clinical trials
  • Alcohol or drug abuse/dependency
  • Active psychosis or acute mental disorder
  • Life expectancy <12 months

结局指标

主要结局

HbA1c

时间窗: Baseline to 3 months

Hemoglobin A1c (HbA1c): blood specimens will be collected at the screening visit, as well as the 3-months. Time points used in calculation are baseline to 3 month.

次要结局

  • Resource Utilization and Cost(Baseline to 3 months)

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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