BaselineSmartwatchNCT04878965
Smartwatches to Manage Stress and Anxiety in Residential Settings
A study testing Smartwatch in people with Baseline and Technology, run by Centre for Addiction and Mental Health at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Baseline, Technology
- What is being tested?
- Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with an intellectual and/or developmental disability
- living in the community or receiving services from CAMH ANS department
Who cannot join
- Under 18 years old
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Addiction and Mental Health - ANS department
Toronto, Ontario, M6J 1H1
About this study
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.
Read the 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.
- Conditions
- Baseline, Technology
- Being tested
- Smartwatch
- Keywords
- technology, anxiety, IDD/DD
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartwatchDevice
Smartwatch apparatus to measure strong emotions (e.g., anxiety)
| Study group | Role | What they receive |
|---|---|---|
| Smartwatch | Other | Individuals receiving the smartwatch Receives: Device: Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: 3 months
Secondary outcomes (3)
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
Measured: 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).
Measured: 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).
Measured: 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Apr 2021
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BaselineStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be provided with a smartwatch to wear.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kendra Thomson, PhD, BCBA-D, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878965
- Sponsor's protocol ID
- 011-2020
- Acronym
- Smartwatch
- Status last verified
- May 2024
- First submitted
- 27 Apr 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be aggregated before shared with other researchers or published.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartwatches to Manage Stress and Anxiety in Residential Settings
- ClinicalTrials.gov ID
- NCT04878965
- Acronym / sponsor ID
- Smartwatch / 011-2020
- Conditions
- Baseline, Technology
- Keywords
- technology, anxiety, IDD/DD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be provided with a smartwatch to wear.
| Arm | Type | Receives |
|---|---|---|
| Smartwatch | Other | Device: SmartwatchIndividuals receiving the smartwatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- individuals with an intellectual and/or developmental disability
- living in the community or receiving services from CAMH ANS department
Key exclusion criteria (1 listed)
- Under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartwatchSmartwatch apparatus to measure strong emotions (e.g., anxiety) | Device | Smartwatch |
Primary outcome
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)
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.
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)
3 secondary outcomes
Accuracy
Time frame: 3 months
Incident reports
Time frame: 2-6 months
PRN
Time frame: 2-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No. Data will be aggregated before shared with other researchers or published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kendra Thomson, PhD, BCBA-D principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartwatch in people with Baseline and Technology, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed/Self-Reported Emotion (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.