Assocation Between In-person Instruction and COVID-19 Risk (Campus&Corona)

May 2, 2021 updated by: Atle Fretheim, Oslo Metropolitan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26754

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0130
        • Oslo Metropolitan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All university of university college students who agree to participate.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Students, Higher Education Institution 1
All first, second, and third year students at Higher Education Institution 1 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 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
COVID-19 incidence
Time Frame: Through study completion, i.e. 4 months.
Self-reported positive test results
Through study completion, i.e. 4 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Through study completion, i.e. 4 months.
Self-reported ("Overall, how satisfied are you with life right now?")
Through study completion, i.e. 4 months.
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?")
Through study completion, i.e. 4 months.
COVID-19 testing incidence
Time Frame: Through study completion, i.e. 4 months.
Self-reported
Through study completion, i.e. 4 months.
Learning outcome
Time Frame: End of term, December 2020.
Exam results from Common Student System
End of term, December 2020.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian Institute of Public Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Atle Fretheim, PhD, Oslo Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 172155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to make the full data set publicly available, after ensuring the re-identification of individuals is not possible.

IPD Sharing Time Frame

From spring 2021 and for at least 5 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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