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Completed

NCT Number: NCT04878965

Smartwatches to Manage Stress and Anxiety in Residential Settings

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.

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Key information

Conditions

Baseline Anxiety Disorders Mental Disorders Technology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health - ANS department

Toronto, Ontario, M6J 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartwatch

Device

Smartwatch apparatus to measure strong emotions (e.g., anxiety)

Primary outcomes

  1. 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)

  2. 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. 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)

Secondary outcomes

  1. 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

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Acronym: Smartwatch

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 10, 2021
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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