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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04529421
Other study ID # 172155
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 4, 2020
Est. completion date August 31, 2021

Study information

Verified date November 2023
Source Oslo Metropolitan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26754
Est. completion date August 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Student in first, second, or third year at university or university college - Agrees to participate (signed consent form) Exclusion Criteria: -

Study Design


Intervention

Behavioral:
Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
In-person instruction
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Locations

Country Name City State
Norway Oslo Metropolitan University Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo Metropolitan University Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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 stud — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 incidence Self-reported positive test results Through study completion, i.e. 4 months.
Secondary Quality of life Self-reported ("Overall, how satisfied are you with life right now?") Through study completion, i.e. 4 months.
Secondary Satisfaction with teaching Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?") Through study completion, i.e. 4 months.
Secondary COVID-19 testing incidence Self-reported Through study completion, i.e. 4 months.
Secondary Learning outcome Exam results from Common Student System End of term, December 2020.
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