Assocation Between In-person Instruction and COVID-19 Risk (Campus&Corona)
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| ClinicalTrials.gov Identifier: NCT04529421 |
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Recruitment Status : Unknown
Verified May 2021 by Atle Fretheim, Oslo Metropolitan University.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2020
Last Update Posted : May 6, 2021
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Sponsor:
Oslo Metropolitan University
Collaborator:
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Atle Fretheim, Oslo Metropolitan University
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Infection Infection Control | Behavioral: Online instruction Behavioral: In-person instruction |
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.
| Study Type : | Observational |
| Actual Enrollment : | 26754 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study |
| Actual Study Start Date : | September 4, 2020 |
| Actual Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | August 31, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Group/Cohort | Intervention/treatment |
|---|---|
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Students, Higher Education Institution 1
All first, second, and third year students at Higher Education Institution 1 who agree to take part in study.
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Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 2
All first, second, and third year students at Higher Education Institution 2 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 3
All first, second, and third year students at Higher Education Institution 3 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 4
All first, second, and third year students at Higher Education Institution 4 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 5
All first, second, and third year students atHigher Education Institution 5 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 6
All first, second, and third year students at Higher Education Institution 6 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 7
All first, second, and third year students at Higher Education Institution 7 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 8
All first, second, and third year students at Higher Education Institution 8 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 9
All first, second, and third year students at Higher Education Institution 9 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 10
All first, second, and third year students at Higher Education Institution 10 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 11
All first, second, and third year students at Higher Education Institution 11 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 12
All first, second, and third year students at Higher Education Institution 12 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 13
All first, second, and third year students at Higher Education Institution 13 who agree to take part in study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
|
Students, Higher Education Institution 14
All first, second, and third year students at Higer Education Institution 14 who agree to take part in the study.
|
Behavioral: Online instruction
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. Behavioral: In-person instruction For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). |
Primary Outcome Measures :
- COVID-19 incidence [ Time Frame: Through study completion, i.e. 4 months. ]Self-reported positive test results
Secondary Outcome Measures :
- Quality of life [ Time Frame: Through study completion, i.e. 4 months. ]Self-reported ("Overall, how satisfied are you with life right now?")
- Satisfaction with teaching [ Time Frame: Through study completion, i.e. 4 months. ]Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?")
- COVID-19 testing incidence [ Time Frame: Through study completion, i.e. 4 months. ]Self-reported
- Learning outcome [ Time Frame: End of term, December 2020. ]Exam results from Common Student System
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
All university of university college students who agree to participate.
Criteria
Inclusion Criteria:
- Student in first, second, or third year at university or university college
- Agrees to participate (signed consent form)
Exclusion Criteria:
-
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529421
Locations
| Norway | |
| Oslo Metropolitan University | |
| Oslo, Norway, 0130 | |
Sponsors and Collaborators
Oslo Metropolitan University
Norwegian Institute of Public Health
Investigators
| Principal Investigator: | Atle Fretheim, PhD | Oslo Metropolitan University |
Additional Information:
| Responsible Party: | Atle Fretheim, Adjunct Professor, Oslo Metropolitan University |
| ClinicalTrials.gov Identifier: | NCT04529421 |
| Other Study ID Numbers: |
172155 |
| First Posted: | August 27, 2020 Key Record Dates |
| Last Update Posted: | May 6, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | We plan to make the full data set publicly available, after ensuring the re-identification of individuals is not possible. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | From spring 2021 and for at least 5 years. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Atle Fretheim, Oslo Metropolitan University:
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COVID-19 Social distancing Digital instruction In-person instruction |
Campus University College Higher education institutions |
Additional relevant MeSH terms:
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Infections Communicable Diseases COVID-19 Disease Attributes Pathologic Processes Pneumonia, Viral Pneumonia Respiratory Tract Infections |
Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |