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临床试验/NCT02088658
NCT02088658已完成不适用

Technology Intensified Diabetes Education Study in African Americans With Type 2 Diabetes

State University of New York at Buffalo1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Hemoglobin A1c

研究概览

简要总结

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.

详细描述

African Americans (AA) with type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control (i.e. poorer blood glucose, blood pressure, and lipid control), and greater risk for complications and death compared to White Americans. Hemoglobin A1c (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 randomized clinical trials (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. Preliminary data from our group also suggest that a culturally-tailored telephone-delivered diabetes education and skills training intervention is an effective strategy to improve metabolic control in AA patients with T2DM.

This study provides a unique opportunity to address gaps in the literature by testing the efficacy of a technology-intensified diabetes education/skills training (TIDES) intervention in AAs with poorly controlled T2DM. The long-term goal of the project is to identify effective strategies to improve metabolic control and hence reduce diabetes complications and mortality rates in AAs with T2DM.

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 12 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

研究组 & 干预措施

Techonology Intensified

Experimental

Subjects randomized to this group will receive: 1) the FORA system for self-monitoring; 2) weekly telephone-delivered diabetes education/skills training; 3) patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions); and 4) patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools). The intervention will be delivered by telephone once a week for 12 weeks with each session lasting ~30 minutes.

干预措施: Technology Intensified (Behavioral)

Usual Care

No Intervention

Apart from study visits, patients will be followed by their primary care providers. The provider will be responsible for determining treatment parameters, making changes in the treatment regimen, and determining the timing of follow up visits. Between scheduled office encounters, contact between patient and provider will be patient initiated. The provider may use clinic nurses to follow up on problematic patients or patients with abnormal results. In essence, this group will receive the current standard of care at the study clinics.

结局指标

主要结局

Hemoglobin A1c

时间窗: 12 months post randomization

Hemoglobin A1c (HbA1c): blood specimens collected at the 12-months follow-up visit

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 (1)

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