- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529421
Assocation Between In-person Instruction and COVID-19 Risk (Campus&Corona)
Relationship Between In-person Instruction and COVID-19 Incidence Among University Students: A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Oslo, Norway, 0130
- Oslo Metropolitan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Students, Higher Education Institution 1
All first, second, and third year students at Higher Education Institution 1 who agree to take part in study.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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.
|
For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
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
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Atle Fretheim, PhD, Oslo Metropolitan University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 172155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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