Episodic to Real-Time Care in Diabetes Self-Management
2020年7月1日 更新者:Duke University
From Episodic to Real-Time Care in Diabetes Self-Management
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University School of Nursing
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- ≥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)
Exclusion Criteria:
- active dementia or psychiatric illness
- reside in a nursing home
- participating in another self-management study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Patients with Type II Diabetes
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Patients with Type 2 Diabetes
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of participants with type II diabetes who adhere to using mobile technologies to self-monitor multiple types of diabetes-related data
大体时间:6 months
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Explore the adaptive challenges of patients self-managing diabetes, using monthly interviews over 6 months.
大体时间:6 months
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6 months
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Explore the successes of patients self-managing diabetes, using monthly interviews over 6 months.
大体时间:6 months
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6 months
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Change in daily blood glucose levels in patients with diabetes over a 6 month period
大体时间:6 months
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Data generated from the phone-tethered glucose monitor and plotted as a trajectory over a 6 month period
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6 months
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Change in daily weight in patients with diabetes over a 6 month period
大体时间:6 months
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Data generated from the cellular body scale and plotted as a trajectory over a 6 month period
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6 months
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Change in daily physical activity in patients with diabetes over a 6 month period
大体时间:6 months
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Data generated from the wrist-worn accelerometer and plotted as a trajectory over a 6 month period
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6 months
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Medication adherence Survey
大体时间:6 months
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bi-weekly text message-based surveys on medication adherence over a 6 month period.
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6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Explore health care providers' perspectives on using real-time data, by conducting one-time, individual interviews over a 2 month period.
大体时间:2 months
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Explore ways to achieve continual communication that addresses real-time challenges with diabetes self-management while presenting data trajectories during provider interviews.
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2 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Ryan J Shaw, PhD, RN、Duke University School of Nursing
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月2日
初级完成 (实际的)
2018年5月1日
研究完成 (实际的)
2020年5月30日
研究注册日期
首次提交
2016年12月21日
首先提交符合 QC 标准的
2017年1月4日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (实际的)
2020年7月2日
上次提交的符合 QC 标准的更新
2020年7月1日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Type 2 Diabetes Self-Management的临床试验
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University of LiverpoolSt Helens & Knowsley Teaching Hospitals NHS Trust尚未招聘
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David BartlettNational Cancer Institute (NCI)完全的
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)招聘中