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临床试验/NCT04878965
NCT04878965已完成不适用

Smartwatches to Manage Stress and Anxiety in Residential Settings

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Observed/Self-Reported Emotion

研究概览

简要总结

The purpose of the study is to conduct a prospective evaluation of a smartwatch technology and an associated application (developed by Awake Labs) in a clinical cohort from Centre for Addiction and Mental Health (CAMH) Adult Neurodevelopmental Services (ANS) and adults with developmental disabilities in the community who have received a watch.

详细描述

Tools that help predict the onset of anxiety and agitation can not only help a person learn to self-monitor their emotions, but can may also help others feel more efficacious in understanding the internal state of the person they are supporting (especially if not able to communicate), and help them respond in a way that keeps the individual and others safe.

The purpose of the study is to conduct a prospective evaluation of the smartwatch technology with modifications recommended by the researchers (based on a previous retrospective study) in a clinical cohort at CAMH Adult Neurodevelopmental Services (ANS) and in adults with developmental disabilities in the community.

Specifically, this study seeks to evaluate the utility and validity of the smartwatch and associated mobile application as a clinical tool by gathering behavioral data when the applications gives a notification. The person wearing the watch or those in their environment will be asked to report the following in the application after the smartwatch gives a notification: 1) the valence of the emotion of the person wearing the smartwatch, 2) what events were occurring prior to notification (e.g., potential triggers for behaviours that challenge), and 3) what happened after the notification (e.g., how the person or others in their environment responded to the notification).

Results will be used to inform future iterations of the technology and make recommendations for clinical use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • individuals with an intellectual and/or developmental disability
  • living in the community or receiving services from CAMH ANS department

排除标准

  • Under 18 years old

结局指标

主要结局

Observed/Self-Reported Emotion

时间窗: 3 months

What is the person's perceived emotion? The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate which emotion they are experiencing (e.g., anxiety, happiness)

Observed/Self-Reported Antecedent Events

时间窗: 3 months

What was happening before the notification? The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate what the person who is wearing the smartwatch was doing before immediately before the notification.

Observed/Self-Reported Consequent Events

时间窗: 3 months

What happened after the notification?The person with the ipod (clinician, support worker) will receive a real-time notification when the smartwatch indicates the individual wearing the watch is experiencing strong emotions. The person with the ipod is to indicate what happened once they received the notification (e.g., deep breathing)

次要结局

  • Accuracy(3 months)
  • PRN(2-6 months)
  • Incident reports(2-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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