- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803812
Supporting the Wellness of Ontario Physicians During COVID-19
November 29, 2021 updated by: Ontario Medical Association
In light of the coronavirus pandemic, the challenge of physician burnout has taken on a new urgency.
Long-hours and difficult, sometimes unsafe work conditions are creating a severe strain for emergency physicians and others on the frontlines of Ontario's response to COVID-19.
There are a variety of evidence-informed ways that physicians can protect their wellbeing with modest investments of time and energy that will be applied.
The evaluation will be a randomized trial comparing the outcomes from each of the three treatment arms.
Researchers may also use a pre-post comparison with control parameters to conduct an exploratory analysis to assess efficacy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 3C1
- Ontario Medical Association
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Active membership to the Ontario Medical Association (OMA). Up-to-date cell phone information registered to the OMA.
Exclusion Criteria:
- Participation in the OMA Physician Burnout Task Force. Opt-out from the intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Receive weekly SMS containing wellness stories shared by other Ontario physicians
|
Assessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing.
|
|
Experimental: Receive weekly SMS containing aim wellness resources/strategies.
|
Assessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing.
|
|
Experimental: Receive weekly SMS combining wellness stories & resources/strategies
|
Assessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wellbeing (Short Warwick-Edinburgh Mental Well-being Scale measure)
Time Frame: 6 months
|
Self-reported wellbeing scores, as measured by the short Warwick-Edinburgh Mental Well-being Scale--(S)WEMWBS.
The (S)WEMWBS is designed to measure positive mental wellbeing and asks people to what extent they agree with statements such as "I've been feeling optimistic about the future", "I've been feeling relaxed", and "I've been feeling close to people".
This scale has a range of 7 to 35; higher scores indicate higher positive mental wellbeing.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Happiness (UK ONS measure)
Time Frame: 6 months
|
Self-reported happiness scores, as measured through weekly pulse surveys using a question developed by the UK Office for National Statistics (ONS) - hereby referred to as ONS-happiness ("on a scale where 0 is "not at all" and 10 is "completely", overall, how happy did you feel yesterday?").
This scale has a range from 0 to 10, with higher scores indicating greater happiness.
|
6 months
|
|
Anxiety (UK ONS measure)
Time Frame: 6 months
|
Self-reported anxiety scores, as measured through pulse surveys using an ONS question, hereby referred to as ONS-anxiety ("on a scale where 0 is "not at all" and 10 is "completely", overall, how anxious did you feel yesterday?").
This scale has a range from 0 to 10, with higher scores indicating greater anxiety.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: James Wright, Ontario Medical Association
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2021
Primary Completion (Actual)
September 2, 2021
Study Completion (Actual)
September 2, 2021
Study Registration Dates
First Submitted
February 8, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
November 30, 2021
Last Update Submitted That Met QC Criteria
November 29, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 39707
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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