Smartwatches to Manage Stress and Anxiety in Residential Settings (Smartwatch)

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.

Study Overview

• Status: Completed
• Conditions: Technology; Baseline
• Intervention / Treatment: Device: Smartwatch

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: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H1
      • Centre for Addiction and Mental Health - ANS department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Smartwatch; Individuals receiving the smartwatch	Device: 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	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	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	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	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	3 months
Incident reports	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	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

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Kendra Thomson, PhD, BCBA-D, Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; technology; IDD/DD
• Other Study ID Numbers: 011-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be aggregated before shared with other researchers or published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No