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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05072210
Other study ID # 20-176
Secondary ID SMH-20-037ML4258
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date September 12, 2023

Study information

Verified date September 2023
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stress, anxiety, distress and depression are exceptionally high among healthcare providers at the frontline of the COVID-19 pandemic. Knowledge of factors underlying distress and resilience and evidence based interventions to impact the mental wellbeing of frontline healthcare providers is limited. This study will evaluate a novel mobile platform to gather the "distress experience" of healthcare workers at Unity Health Toronto in real time during and after the COVID-19 pandemic, use automated personalized mobile interventions (e.g. routine, sleep, exercise) to nudge active/passive parameters to manage distress.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date September 12, 2023
Est. primary completion date September 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Staff or healthcare providers working at Unity Health Toronto - 18 years of age or older - Must own a mobile phone running Android Version 6.0 and higher, or an iPhone 6 running OS 14 and higher) Exclusion Criteria: - Non-Unity Health Toronto staff

Study Design


Intervention

Other:
Mobile Intervention
Active mobile data will be used to provide automated, personalized notifications to frontline healthcare workers. Key information on mental health and links to access additional health resources will be available on the mobile platform.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
Unity Health Toronto Toronto Metropolitan University, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived Stress Scale The primary outcome measure will be the ten-item Perceived Stress Scale. Scores range from 0 to 40, and higher scores indicate more severe stress. At 4 weeks from baseline
Secondary Perceived Stress Scale The primary outcome measure will be the ten-item Perceived Stress Scale. Scores range from 0 to 40, and higher scores indicate more severe stress. At 12 weeks from baseline
Secondary Active Data - Short UCLA Loneliness Scale Short, 3-item scale; scores range from 3 to 9, and higher scores indicate more severe loneliness symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. At 4 weeks from baseline
Secondary Active Data - Generalized Anxiety Disorder Scale 7-item scale; scores range from 0 to 21, and higher scores indicate more severe anxiety symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. At 4 weeks from baseline
Secondary Active Data - Patient Health Questionnaire 9-item scale; scores range from 0 to 27, and higher scores indicate more severe depression symptoms. Feasibility of the mobile platform will be indicated by a significant reduction in score. At 4 weeks from baseline
Secondary Passive Data - GPS Sample Point Metrics Feasibility of the mobile platform will be determined by the number of GPS sample points (mobility metrics) collected per user per day. At 4 weeks from baseline
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