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临床试验/NCT02664233
NCT02664233已完成早期 1 期

Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care

The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
60
试验地点
4
主要终点
Change in weight measures from baseline to 3 months

研究概览

简要总结

In order to facilitate the evidence-based goal setting and self-monitoring intervention into the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an electronic system provided available to the American Diabetes Association diabetes education programs, to set patient diet and physical activity goals, and connect patient self-monitoring information collected from smart phones and fitness trackers to Chronicle Diabetes system to facilitate educators' monitoring of patient adherence to their goals.

详细描述

Specific Aim 1: To develop and test an interface with Chronicle Diabetes to transfer smartphone collected self-monitoring diet and physical activity information from patients to diabetes educators.

Specific Aim 2: To 2a) conduct usability testing and 2b) examine efficacy of this connected interface technology in a 3-month randomized clinical trial in 60 overweight or obese patients with type 2 diabetes in Houston, Texas and Pittsburgh, Pennsylvania.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Diagnosed with type 2 diabetes
  • Overweight or obese with an BMI > 25
  • Able to read and write English
  • Own a smart phone that is Jawbone compatible

排除标准

  • Currently undergoing current treatment for a severe psychiatric disorder.

结局指标

主要结局

Change in weight measures from baseline to 3 months

时间窗: baseline and 3 months post enrollment

Participant weight will be measured via a weight scale or via self-report.

Change in HbA1c levels from baseline to 3 months

时间窗: baseline and 3 months post enrollment

Glycemic control will be determined by HbA1c level. HbA1c will be measured using the A1c NOW self check system via a finger stick or extracted from clinical visit data.

次要结局

  • Usability of the connected interface technology as indicated by a System Usability Scale(3 months post enrollment)

研究者

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

Jing Wang

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (4)

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