Clinical trial NCT05271006: COVID-19 Research: COPE Trial in Health Care Workers
Official title: COvid-19 Pandemic and Exercise for Health Care Workers (COPE HCW) Trial: A Randomized Study Examining Physical Activities and Wellbeing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Physical Inactivity
Keywords: Exercise
Intervention
mhealth
Depression
Heatlh care workers
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2022-03-08
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Power analysis with three different effect sizes δ: .30, .40, and .50.

Using Optimal Design Software, to detect a small effect size δ= .30 based on a two-level (non)linear growth model (six time points; level-1 residual variability = 8.798; level-1 coefficient variability = 22.548) with Power (1 - b) = .80 and alpha = .05 for 7 time points repeated measures design, 357 participants required across the four arms. With an additional 10 recruitment sites, investigators require an additional 90 participants (for the possibility of nesting or for creation of 9 dummy variables to covary locations). With a 20% expected attrition, a total of 560 HCWs will be randomized. Investigators will be employing this conservative target for this study.

In order to detect a small effect size δ= .40 and a 20% expected attrition, a total of 366 HCWs will be randomized.

In order to detect a small effect size δ= .50 and a 20% expected attrition, a total of 276 HCWs will be randomized.
Primary purpose: PREVENTION

Brief summary: The present project is designed to address the problem of elevated depression and stress among health care workers (HCWs). Investigators will test the extent to which a 12-week mobile health aerobic exercise intervention (4 days/week for 20 minutes/day) impacts HCWs reported depression. Investigators propose a 2-arm (exercise and waitlist control) parallel randomised controlled trial, with 560 underactive participants recruited from Providence Health Care. Participants will complete an online questionnaire (baseline and every 2 weeks until week 12, and again at week 24) assessing depressive symptoms (primary outcome), stress, flourishing, resilience, life satisfaction, burnout, work-family spillover, , sleep quality, workplace engagement, and absenteeism (secondary outcomes).

Detailed description: HCWs account for the largest sector of government employees in Canada. Regulated nurses - registered nurses, nurse practitioners, licensed practical nurses, and registered psychiatric nurses - constitute the most common HCW, with over 93% of HCWs being registered nurses across Canada. The most recent National Survey of the Work and Health of Nurses reported that compared with the average working Canadian, nurses work longer shifts, more overtime, more unpaid overtime, and have more conflict at work. Nurses also report greater stress, depression, more absenteeism, higher rates of medication use, and poorer physical health than the average employed Canadian. Shift work, high job strain and low autonomy have all been linked with decreased physical and mental health among nurses. Similarly, physicians are highly stressed and at risk for burnout and disease: 92% of physicians - including family medicine, medical specialists, and surgical specialists - work in urban areas and work more than 54 hours per week, excluding on-calls. A recent National Physician Health Survey, sampling over 2500 physicians, reported high levels of emotional exhaustion (26%), overall burnout (30%), depression (34%), and suicidal ideation (9-19%). Physicians experience more than twice as much high work stress (64% compared to 27%) as the general Canadian population. The mental health conditions reported by physicians is a direct consequence of their workload, which is physically demanding and accompanied by sleep deprivation.

To investigators knowledge, there are no studies that have used a mobile application promoting exercise to reduce the depressive symptomatology, psychological distress, and physical symptoms among HCWs in a hospital or home setting. Dr. Puterman's COVID-19 Pandemic and Exercise (COPE) trial (https://www.copetrial.ca/) is the first to study the impact of a mhealth-delivered program designed for physically distanced adults at the start of the pandemic. Results indicate significant treatment effects between those randomized to the active groups (who experienced a reduction in depressive symptoms over the 6-week period) compared to waitlist control (who remained elevated in depressive symptoms). Importantly, these effects were even more apparent in the adults with pre-randomization high levels of depression. Also, the group that was given access to both the HIIT and yoga apps had the highest adherence rates for trial completion (58%) compared to those who received access to either but not both apps (53% or 40% for yoga and HIIT, respectively). Considering the above, the purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".

The purpose of the present study is to evaluate the uptake and adherence of a 12-week mhealth physical activity (access to all the mobile "Down Dog" apps: HIIT, yoga, barre, running) intervention in physically less active HCWs, to examine whether the intervention leads to improvement in depressive symptomatology among those randomized to the intervention versus waitlist control group. Specifically, investigators aim to focus on physical activities requiring little physical space and/or equipment that are easily completed at home, in one's neighbourhood, or in a small office using the suite of mobile apps from the company "Down Dog".

The primary objectives of this project are to test a mhealth physical activity intervention, using the "Down Dog" suite of apps, in physically less active HCWs, and to test whether the intervention leads to improvement in depressive symptomatology among those who are randomized to the intervention compared to the waitlist control group. The secondary objectives of this project are to test the intervention effects on a broader suite of mental health concepts, including stress, flourishing, resilience, life satisfaction, burnout, work-family spillover, sleep quality, and absenteeism. Thirdly, investigators seek to identify barriers and facilitators to increasing levels of physical activity during the intervention, from the perspective of stakeholders such as nurses, health service administrators, and physicians, and to determine the efficacy of the intervention, using qualitative interviews and focus group discussions.

Eligibility criteria: Inclusion Criteria:

* All individuals who currently do not meet recommendations for a physically active lifestyle, are over the age of 18 inclusive, who are not retired, work at a PHC centre, and are without risk factors for cardiovascular events are eligible for inclusion.
* To screen for the low active participants, investigators will use the L-CAT (see Section 9.5). All participants who score 1-3 will be included in the study. Those who score 4-6 will be excluded.
* They must also work at a Providence Health Care centre.

Exclusion Criteria:

* Participants must be cleared to participate in exercise. The 2021 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+; Section 9.5) will be used to minimize any risk of exercise and ensure the safety of individuals (Warburton, Jamnik, Bredin, Shephard, \& Gledhill, 2018). Given that exercise is a risk factor for cardiovascular events, participants must report any family history of cardiovascular disease, stroke or myocardial infarction (American College of Sports Medicine, 2018). If participants do report a family history of cardiovascular events, they must receive a note from their family physician clearing them for moderate to high intensity training. If payment is required for this clearance, participants will be reimbursed.
* In addition, as informed consent requires individuals to be at least 18 years old, participants under the age of 18 will be excluded.
* Participants who are currently retired from their work or who do not currently work at a PHC centre are ineligible to participate.
* Participants without personal smartphones or computers, and those without internet service at home will be excluded.

Primary outcomes:
measure: Changes in depressive symptomology over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).
Secondary outcomes:
measure: Changes in psychological stress as measured by the SCSQ over the course of the exercise intervention.
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention).
measure: Changes in flourishing over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in life satisfaction over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in burnout as measured by the MBI-GU over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in resilience as measured by the BRS over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Change in work-family spillover over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Change in absenteeism over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Change in sleep quality over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in leisure time physical activity over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in physical health symptomology over the course of the exercise intervention
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Tracking the amount of exercise variety
timeFrame: Tracked biweekly for 12 weeks (baseline, followed by 12 weeks of exercise intervention)
measure: Changes in use of apps over the course of the exercise intervention
timeFrame: Tracked weekly for 12 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: The University of British Columbia
name: Eli Puterman, PhD
role: PRINCIPAL_INVESTIGATOR
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