Mobile Interventions for the Prevention and Detection of Distress

NCT ID: NCT05072210

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Anxiety Stress Loneliness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Mobile Intervention Group

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

Group Type EXPERIMENTAL

Mobile Intervention

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Toronto Metropolitan University

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Venkat Bhat, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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SMH-20-037

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ML42588

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20-176

Identifier Type: -

Identifier Source: org_study_id

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