Smartwatches to Manage Stress and Anxiety in Residential Settings (Smartwatch)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M6J 1H1
- Centre for Addiction and Mental Health - ANS department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- individuals with an intellectual and/or developmental disability
- living in the community or receiving services from CAMH ANS department
Exclusion Criteria:
- Under 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Smartwatch
Individuals receiving the smartwatch
|
Smartwatch apparatus to measure strong emotions (e.g., anxiety)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observed/Self-Reported Emotion
Time Frame: 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)
|
3 months
|
|
Observed/Self-Reported Antecedent Events
Time Frame: 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.
|
3 months
|
|
Observed/Self-Reported Consequent Events
Time Frame: 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)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy
Time Frame: 3 months
|
How accurate is the smartwatch at indicating anxiety?
The emotion variable will be used to calculate accuracy of the smartwatch indicating anxiety.
This will be calculated by dividing the number of times the smartwatch accurately indicated anxiety (using the number of times the person with the ipod indicated the person wearing the smartwatch was experiencing anxiety) divided by the number of total notifications x100
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3 months
|
|
Incident reports
Time Frame: 2-6 months
|
Is there a change in incident reports or the type of incident report before and while wearing the smartwatch.
This is a comparison between the total number of incident reports and the types of incident reports before (1-3 months) and while wearing the watch (1-3 months).
|
2-6 months
|
|
PRN
Time Frame: 2-6 months
|
Is there a change in the use of PRN before and while wearing the smartwatch.
This is a comparison between the total number of PRN delivered before (1-3 months) and while wearing the watch (1-3 months).
|
2-6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kendra Thomson, PhD, BCBA-D, Centre for Addiction and Mental Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 011-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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