InfectionCampus&CoronaNCT04529421
Assocation Between In-person Instruction and COVID-19 Risk
An observational study of Infection and Infection Control, run by Oslo Metropolitan University at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Infection Control
- What is being tested?
- Online instruction and In-person instruction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26,754 participants
- Where
- 1 siteNorway
- Study dates
- 4 Sep 2020to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All university of university college students who agree to participate.
Who may be able to join
- Student in first, second, or third year at university or university college
- Agrees to participate (signed consent form)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Infection, Infection Control
- Being tested
- Online instruction, In-person instruction
- Keywords
- COVID-19, Social distancing, Digital instruction, In-person instruction, Campus, University, College, Higher education institutions
- Medical subject headings
- Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online instructionBehavioural
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
In-person instructionBehavioural
For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).
| Study group | Role | What they receive |
|---|---|---|
| Students, Higher Education Institution 1 | All first, second, and third year students at Higher Education Institution 1 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 2 | All first, second, and third year students at Higher Education Institution 2 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 3 | All first, second, and third year students at Higher Education Institution 3 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 4 | All first, second, and third year students at Higher Education Institution 4 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 5 | All first, second, and third year students atHigher Education Institution 5 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 6 | All first, second, and third year students at Higher Education Institution 6 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 7 | All first, second, and third year students at Higher Education Institution 7 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 8 | All first, second, and third year students at Higher Education Institution 8 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 9 | All first, second, and third year students at Higher Education Institution 9 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 10 | All first, second, and third year students at Higher Education Institution 10 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 11 | All first, second, and third year students at Higher Education Institution 11 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 12 | All first, second, and third year students at Higher Education Institution 12 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| Students, Higher Education Institution 13 | All first, second, and third year students at Higher Education Institution 13 who agree to take part in study. Receives: Behavioral: Online instruction; Behavioral: In-person instruction | |
| 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. Receives: Behavioral: Online instruction; Behavioral: In-person instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 incidence
Self-reported positive test results
Measured: Through study completion, i.e. 4 months.
Secondary outcomes (4)
Quality of life
Self-reported ("Overall, how satisfied are you with life right now?")
Measured: Through study completion, i.e. 4 months.
Satisfaction with teaching
Self-reported ("Overall, how satisfied have you been with the teaching you have received in the past 14 days?")
Measured: Through study completion, i.e. 4 months.
COVID-19 testing incidence
Self-reported
Measured: Through study completion, i.e. 4 months.
Learning outcome
Exam results from Common Student System
Measured: End of term, December 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start4 Sep 2020
- Primary completion31 Dec 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Institute of Public Health
- Responsible party
- Principal investigator, Atle Fretheim, Oslo Metropolitan University
- Investigators
- Atle Fretheim, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529421
- Sponsor's protocol ID
- 172155
- Acronym
- Campus&Corona
- Status last verified
- Nov 2023
- First submitted
- 25 Aug 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make the full data set publicly available, after ensuring the re-identification of individuals is not possible.
Publications
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.
PubMed 34467258
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04529421
- Acronym / sponsor ID
- Campus&Corona / 172155
- Conditions
- Infection, Infection Control
- Keywords
- COVID-19, Social distancing, Digital instruction, In-person instruction, Campus, University, College, Higher education institutions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,754 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Institute of Public Health
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Students, Higher Education Institution 1 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 1 who agree to take part in study. |
| Students, Higher Education Institution 2 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 2 who agree to take part in study. |
| Students, Higher Education Institution 3 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 3 who agree to take part in study. |
| Students, Higher Education Institution 4 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 4 who agree to take part in study. |
| Students, Higher Education Institution 5 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students atHigher Education Institution 5 who agree to take part in study. |
| Students, Higher Education Institution 6 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 6 who agree to take part in study. |
| Students, Higher Education Institution 7 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 7 who agree to take part in study. |
| Students, Higher Education Institution 8 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 8 who agree to take part in study. |
| Students, Higher Education Institution 9 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 9 who agree to take part in study. |
| Students, Higher Education Institution 10 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 10 who agree to take part in study. |
| Students, Higher Education Institution 11 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 11 who agree to take part in study. |
| Students, Higher Education Institution 12 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 12 who agree to take part in study. |
| Students, Higher Education Institution 13 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higher Education Institution 13 who agree to take part in study. |
| Students, Higher Education Institution 14 | – | Behavioral: Online instruction, Behavioral: In-person instructionAll first, second, and third year students at Higer Education Institution 14 who agree to take part in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All university of university college students who agree to participate.
Key inclusion criteria (2 listed)
- Student in first, second, or third year at university or university college
- Agrees to participate (signed consent form)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online instructionFor some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus. | Behavioural | Students, Higher Education Institution 1, Students, Higher Education Institution 10, Students, Higher Education Institution 11, Students, Higher Education Institution 12, Students, Higher Education Institution 13, Students, Higher Education Institution 14, Students, Higher Education Institution 2, Students, Higher Education Institution 3, Students, Higher Education Institution 4, Students, Higher Education Institution 5, Students, Higher Education Institution 6, Students, Higher Education Institution 7, Students, Higher Education Institution 8, Students, Higher Education Institution 9 |
| In-person instructionFor some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere). | Behavioural | Students, Higher Education Institution 1, Students, Higher Education Institution 10, Students, Higher Education Institution 11, Students, Higher Education Institution 12, Students, Higher Education Institution 13, Students, Higher Education Institution 14, Students, Higher Education Institution 2, Students, Higher Education Institution 3, Students, Higher Education Institution 4, Students, Higher Education Institution 5, Students, Higher Education Institution 6, Students, Higher Education Institution 7, Students, Higher Education Institution 8, Students, Higher Education Institution 9 |
Primary outcome
COVID-19 incidence
Time frame: Through study completion, i.e. 4 months.
Self-reported positive test results
4 secondary outcomes
Quality of life
Time frame: Through study completion, i.e. 4 months.
Satisfaction with teaching
Time frame: Through study completion, i.e. 4 months.
COVID-19 testing incidence
Time frame: Through study completion, i.e. 4 months.
Learning outcome
Time frame: End of term, December 2020.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Results publication: PubMed 34467258Fretheim 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.
- Pre-print version of study report manuscript.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to make the full data set publicly available, after ensuring the re-identification of individuals is not possible.
Related trials for Infection
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atle Fretheim, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Infection Control, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 incidence (time frame: Through study completion, i.e. 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.