Smartwatches to Manage Stress and Anxiety in Residential Settings

NCT ID: NCT04878965

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2024-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Baseline Technology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will be provided with a smartwatch to wear.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smartwatch

Individuals receiving the smartwatch

Group Type OTHER

Smartwatch

Intervention Type DEVICE

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

Interventions

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Smartwatch

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kendra Thomson, PhD, BCBA-D

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health - ANS department

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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011-2020

Identifier Type: -

Identifier Source: org_study_id

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