Smartwatches to Manage Stress and Anxiety in Residential Settings

Technology Clinical Trial

— Smartwatch  

Official title:

Smartwatches to Manage Stress and Anxiety in Residential Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04878965
• Other study ID #: 011-2020
• Status: Completed
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Baseline
• Technology

Intervention

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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health - ANS department	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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