- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05298488
The Effect of Working at Home to Reduce Risk of Respiratory Infection
The Effect of Working at Home Versus at the Office on Risk of Transmission of SARS-CoV-2 and Other Respiratory Agents. A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Working in the office entails to various extent contact with colleagues, and for some it includes close contact to others when using public transport to and from work. This likely increases the risk of transmission and many workplaces along with health authorities have strongly advised employees to work from home as much as possible during the COVID-19 pandemic. On the other hand, most people are infected from other family members, and working from home increases exposure to other family members.
There are few, if any trials on the effects of teleworking/home office on the risk of transmission of SARS-CoV-2 and other respiratory agents. Studies that have looked at associations between teleworking and COVID-19 have found a negative correlation.
A systematic review from the National Institute of Occupational Health (STAMI) showed that workers working from home experienced higher work satisfaction and productivity, while also reporting negative effects on work-life balance, professional isolation and working outside core hours. Effects on health outcomes were mixed. The quality of the studies was generally judged as low.
However, working at the office could mean increased exposure to transmission of SARS-CoV-2 and other respiratory agents. Thus, both interventions do pose potential benefits and harms for the participants.
Working from home is a broadly applied intervention nationally and internationally during the COVID-19 pandemic. Establishing what effect this intervention has on actual spread of SARS-CoV-2 and other respiratory agents could hence provide valuable insight to national and local authorities and decision-makers.
The researchers propose to conduct a trial to assess whether working at home impacts on employees' risk of respiratory infection and reduce the risk of work-related outbreaks. The aim is to reject the null hypothesis that working at home does not reduce the risk of respiratory infections or outbreaks among employees.
The researchers plan to conduct the trial as a two-arm multi-period crossover superiority trial where the employees are allocated into two equally sized groups. If this eases the recruitment of firms, the cross-over structure will be dropped.
The first and second arm will cross-over (change treatment) after four weeks. Week 1 and week 5 will be considered run-in periods for these arms, and the data collected these run-in weeks will not be used as outcome data in the statistical analysis.
The plan is to recruit 3-5 large firms with over 2000 eligible participants. Firms located in Oslo and neighbouring municipalities will be included. These are the areas That are seeing the highest incidence rates of SARS-CoV-2 in the ongoing covid-19 pandemic in Norway.
All consenting employees in the selected organizations are eligible to participate in the trial. The organizations can define in advance certain key personnel that cannot take part in the trial.
The investigators will compare the following interventions:
- Participants will strive to be working from home every day. Participants can go to the office in order to complete tasks that cannot be completed from home.
- Participants will be working from the office most days, but at least three days a week.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Atle Fretheim, PhD
- Email: Atle.Fretheim@fhi.no
Study Contact Backup
- Name: Petter Elstrom, PhD
- Phone Number: +47 91149202
- Email: petter.elstrom@fhi.no
Study Locations
-
-
-
Oslo, Norway, 0213
- Recruiting
- Norwegian Institute of Public Health
-
Contact:
- Petter Elstrom, PhD
- Email: petter.elstrom@fhi.no
-
Contact:
- Ingeborg H Elgersma, MA
- Email: ingeborgHess.Elgersma@fhi.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Over 18 years old
- Employee in a company/organisation that has agreed to let their employees take part
- Willing and able to work form home for 4 weeks (most of the time)
Exclusion crieria:
- Unable to work from home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home office for first 4 weeks, and office for the last 4 weeks
Participants will work from home for first 4 weeks, and at the office for the last 4 weeks
|
Working from home
Working at the office
|
Active Comparator: Office for first 4 weeks, and home office for the last 4 weeks
Participants will work at the office for the first 4 weeks, and from home during the last 4 weeks
|
Working from home
Working at the office
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory infection
Time Frame: 8 weeks
|
The proportion of participants who report having had symptoms of respiratory disease
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19
Time Frame: 8 weeks
|
Proportion of participants who test positive for SARS-CoV-2 (based on both self-reported and registry data)
|
8 weeks
|
Absenteeism
Time Frame: 8 weeks
|
Number of days of absence from work.
|
8 weeks
|
Secondary cases of respiratory infection
Time Frame: 8 weeks
|
Number of secondary cases (transmission from participants in the study) or outbreaks (2 or more cases)
|
8 weeks
|
Work-satisfaction
Time Frame: 8 weeks
|
Self-reported work-satisfaction (Question: To what extent were you able to carry out your work in a good way during the last week?
5-unit ordinal scale from Very little to Very much).
|
8 weeks
|
Work-life balance.
Time Frame: 8 weeks
|
Perceived work-life balance (Question: To what extent has your work been at the expense of your own or other family members' free time?) Ordinal 5-unit scale from Very little to Very much.
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Atle Fretheim, PhD, Head of Centre for Epidemic Interventions Research (CEIR)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CristinID2535463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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