Mobile Interventions for the Prevention and Detection of Distress

Sponsor
Unity Health Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072210
Collaborator
Ryerson University (Other), University of Toronto (Other)
50
Enrollment
1
Location
2
Arms
14
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Mobile Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Upon logging into the study platform, half of the participants will be automatically randomized to receive (for 4 weeks) daily-personalized automated alerts (The mobile intervention). This feature will be made available to all participants after 4 weeks. Hence, for the first 4 weeks, this study can be described as having a parallel group study model. After 4 weeks, the study switches to a single group study model, and can therefore be described as having a single group interventional model after 4 weeks from the start date until the rest of the duration of the study.Upon logging into the study platform, half of the participants will be automatically randomized to receive (for 4 weeks) daily-personalized automated alerts (The mobile intervention). This feature will be made available to all participants after 4 weeks. Hence, for the first 4 weeks, this study can be described as having a parallel group study model. After 4 weeks, the study switches to a single group study model, and can therefore be described as having a single group interventional model after 4 weeks from the start date until the rest of the duration of the study.
Masking:
Double (Participant, Investigator)
Masking Description:
Participants will be issued a specific ID number to be used within the mobile app to ensure that any identifiable information within this app will remain anonymous. A master linking log will serve as the only link between participants and the study data collected in the mobile app.
Primary Purpose:
Other
Official Title:
Could Mobile-based Interventions Aid To "Understand and Flatten the Curve" of Stress, Anxiety, Distress and Depression Among Healthcare Providers at Unity Health Toronto During and After the COVID-19 Pandemic?
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mobile Intervention Group

One half of the participants will receive personalized automated alerts throughout their involvement.

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.

No Intervention: Control Group

For 4 weeks, the other half of the participants will not receive personalized automated alerts. After 4 weeks, these alerts will be enabled.

Outcome Measures

Primary Outcome Measures

  1. Perceived Stress Scale [At 4 weeks from baseline]

    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.

Secondary Outcome Measures

  1. Perceived Stress Scale [At 12 weeks from baseline]

    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.

  2. Active Data - Short UCLA Loneliness Scale [At 4 weeks from baseline]

    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.

  3. Active Data - Generalized Anxiety Disorder Scale [At 4 weeks from baseline]

    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.

  4. Active Data - Patient Health Questionnaire [At 4 weeks from baseline]

    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.

  5. Passive Data - Feasibility of Collection of Passive Data - GPS Mobility [At 4 weeks from baseline]

    Feasibility of the mobile platform will be determined by the number of GPS sample points collected per user per day.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1St. Michael's HospitalTorontoOntarioCanadaM5B 1W8

Sponsors and Collaborators

  • Unity Health Toronto
  • Ryerson University
  • University of Toronto

Investigators

  • Principal Investigator: Venkat Bhat, MD MSc, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Venkat.Bhat, Principal Investigator, Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT05072210
Other Study ID Numbers:
  • 20-176
  • SMH-20-037
  • ML42588
First Posted:
Oct 8, 2021
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Venkat.Bhat, Principal Investigator, Unity Health Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021