Clinical trial NCT04529421: Assocation Between In-person Instruction and COVID-19 Risk
Official title: Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Infection Control
Keywords: COVID-19
Social distancing
Digital instruction
In-person instruction
Campus
University
College
Higher education institutions
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
First posted: 2020-08-27
Enrollment: 26754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All university of university college students who agree to participate.

Brief summary: Whether university teaching on campus with infection control measures in place is associated with higher risk of COVID-19 than online instruction, is unknown. The investigators will assess this by conducting repeated surveys among students at universities and university colleges in Norway, where some instruction is given in-person, and some is provided online (hybrid model). The investigators will ask about the students' COVID-19 status, and how much in-person and online instruction the students are getting. The investigators will estimate the association between in-person instruction and COVID-19-risk using multivariate regression, controlling for likely confounders. The investigators will also assess whether type of instruction is associated with how satisfied the students are with the instruction the students are offered, their quality of life, and learning outcomes.

Detailed description: The investigators are inviting all universities and university colleges in Norway to take part. All students at institutions that agree to participate will receive an SMS (alternatively an e-mail) inviting them to take part in the study. The invitation includes a link that directs participants to a web-based informed consent-form and questionnaire. The investigators will use the University of Oslo's solutions for online consent form, web-based survey (Nettskjema), and secure storage of research data (TSD).

The investigators will ask the participants if the participants have been tested for COVID-19, the results of such a test, how much in-person instruction the students have been offered, and how much online instruction the students have been offered. The investigators will also inquire about other risk factors for COVID-19 and background variables that may be included as potential adjustment factors (confounders) in the analyses (see Attachment 1 - Questionnaire).

The investigators will survey the students every two weeks by new invitations by SMS or e-mail. The study period will last as long as the universities maintain their arrangement with in-person instruction for only select groups of students. The investigators plan for a study period that lasts for the remainder of 2020. The investigators will ask for the participants consent to link the survey results to information on study programme, basis for admission, study status, academic results, sex and age from the Common Student System.

The investigators will run multivariate regressions to test whether there is an association between in-person instruction and the outcomes.

In-person instruction is a continuous variable, defined as

(Number of days offered in-person instruction) / (Number of days offered in-person instruction + Number of days offered online instruction)

The investigators will control for potentially confounding variables, including year of study program, field of study, age, and gender. The investigators plan for separate analyses for each participating university/university college, and a pooled analysis across institutions.

Eligibility criteria: Inclusion Criteria:

* Student in first, second, or third year at university or university college
* Agrees to participate (signed consent form)

Exclusion Criteria:

-

Primary outcomes:
measure: COVID-19 incidence
timeFrame: Through study completion, i.e. 4 months.
Secondary outcomes:
measure: Quality of life
timeFrame: Through study completion, i.e. 4 months.
measure: Satisfaction with teaching
timeFrame: Through study completion, i.e. 4 months.
measure: COVID-19 testing incidence
timeFrame: Through study completion, i.e. 4 months.
measure: Learning outcome
timeFrame: End of term, December 2020.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Metropolitan University
Study officials:
affiliation: Oslo Metropolitan University
name: Atle Fretheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fretheim A, Helleve A, Loyland B, Sandbekken IH, Flato M, Telle K, Watle SV, Schjoll A, Helseth S, Jamtvedt G, Hart RK. Relationship between teaching modality and COVID-19, well-being, and teaching satisfaction (campus & corona): A cohort study among students in higher education. Public Health Pract (Oxf). 2021 Nov;2:100187. doi: 10.1016/j.puhip.2021.100187. Epub 2021 Aug 27.