Clinical trial NCT04878965: Smartwatches to Manage Stress and Anxiety in Residential Settings
Official title: Smartwatches to Manage Stress and Anxiety in Residential Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baseline
Technology
Keywords: technology
anxiety
IDD/DD
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be provided with a smartwatch to wear.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Observed/Self-Reported Emotion
timeFrame: 3 months
measure: Observed/Self-Reported Antecedent Events
timeFrame: 3 months
measure: Observed/Self-Reported Consequent Events
timeFrame: 3 months
Secondary outcomes:
measure: Accuracy
timeFrame: 3 months
measure: Incident reports
timeFrame: 2-6 months
measure: PRN
timeFrame: 2-6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health - ANS department
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Kendra Thomson, PhD, BCBA-D
role: PRINCIPAL_INVESTIGATOR
References: