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临床试验/NCT03012074
NCT03012074已完成不适用

From Episodic to Real-Time Care in Diabetes Self-Management

Duke University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data

研究概览

简要总结

This study will use mobile health technologies to provide everyday data to help patients and their care providers better understand illness dynamics and develop adaptive approaches to improve health outcomes in diabetes. Specifically, the study will identify strategies to help patients adapt using multiple types of self-generated diabetes-related data and help providers guide patients to better self-manage in real-time, when guidance is needed most.

详细描述

The investigators will conduct a mixed-methods exploratory designed study and recruit 60 adult patients (age ≥ 18) with type 2 diabetes who will track relevant clinical data over 6 months. Participants will be asked to use a wireless glucose monitor, a cellular body scale, and a wrist-worn accelerometer, and respond to short bi-weekly text message-based surveys on medication adherence for 6 months. Data generated from the devices will be plotted as trajectories that will allow us to conduct trajectory analyses and identify missing data points and trends leading to attrition, in order to assess the feasibility of having patients engage in this type of self-monitoring for 6 months. A subset of 20 patients will be interviewed via telephone at the end of their 6 month self-monitoring period to discuss their adaptive challenges and successes over the study period. The investigators will present the trajectories of their data during patient interviews using a visual that we will e-mail or postal mail, depending on patient preference. This will facilitate discussion of the challenges participants face in self-management and adaptive practices participants use. Following the 6 months of self-monitoring, we will conduct interviews with health care providers in which the investigators will present the data trajectories and explore ways to achieve continual communication and address real-time challenges with diabetes self-management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • ≥18 years old
  • able to speak and read English
  • diagnosed with type 2 diabetes mellitus
  • told by their primary care provider to monitor their blood sugar daily
  • owning and using a smart phone
  • capable of giving informed consent
  • with no pre-existing severe medical condition(s) that would interfere with study participation (e.g., renal failure, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, or cancer)

排除标准

  • active dementia or psychiatric illness
  • reside in a nursing home
  • participating in another self-management study

结局指标

主要结局

Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data

时间窗: 6 months

次要结局

  • Change in daily physical activity in patients with diabetes over a 6 month period(6 months)
  • Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.(6 months)
  • Change in daily blood glucose levels in patients with diabetes over a 6 month period(6 months)
  • Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.(6 months)
  • Change in daily weight in patients with diabetes over a 6 month period(6 months)
  • Medication adherence Survey(6 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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