Viewing Study NCT05271006



Ignite Creation Date: 2024-05-06 @ 5:20 PM
Last Modification Date: 2024-10-26 @ 2:26 PM
Study NCT ID: NCT05271006
Status: COMPLETED
Last Update Posted: 2023-05-11
First Post: 2022-03-02

Brief Title: COVID-19 Research COPE Trial in Health Care Workers
Sponsor: University of British Columbia
Organization: University of British Columbia

Study Overview

Official Title: COvid-19 Pandemic and Exercise for Health Care Workers COPE HCW Trial A Randomized Study Examining Physical Activities and Wellbeing
Status: COMPLETED
Status Verified Date: 2023-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 daysweek for 20 minutesday 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 Putermans COVID-19 Pandemic and Exercise COPE trial httpswwwcopetrialca 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 andor equipment that are easily completed at home in ones 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 andor equipment that are easily completed at home in ones 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None