NCT04529421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,754

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

September 4, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

August 25, 2020

Last Update Submit

November 7, 2023

Conditions

Keywords

COVID-19Social distancingDigital instructionIn-person instructionCampusUniversityCollegeHigher education institutions

Outcome Measures

Primary Outcomes (1)

  • COVID-19 incidence

    Self-reported positive test results

    Through study completion, i.e. 4 months.

Secondary Outcomes (4)

  • Quality of life

    Through study completion, i.e. 4 months.

  • Satisfaction with teaching

    Through study completion, i.e. 4 months.

  • COVID-19 testing incidence

    Through study completion, i.e. 4 months.

  • Learning outcome

    End of term, December 2020.

Study Arms (14)

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 instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: 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.

Behavioral: Online instructionBehavioral: In-person instruction

Interventions

For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.

Students, Higher Education Institution 1Students, Higher Education Institution 10Students, Higher Education Institution 11Students, Higher Education Institution 12Students, Higher Education Institution 13Students, Higher Education Institution 14Students, Higher Education Institution 2Students, Higher Education Institution 3Students, Higher Education Institution 4Students, Higher Education Institution 5Students, Higher Education Institution 6Students, Higher Education Institution 7Students, Higher Education Institution 8Students, Higher Education Institution 9

For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).

Students, Higher Education Institution 1Students, Higher Education Institution 10Students, Higher Education Institution 11Students, Higher Education Institution 12Students, Higher Education Institution 13Students, Higher Education Institution 14Students, Higher Education Institution 2Students, Higher Education Institution 3Students, Higher Education Institution 4Students, Higher Education Institution 5Students, Higher Education Institution 6Students, Higher Education Institution 7Students, Higher Education Institution 8Students, Higher Education Institution 9

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All university of university college students who agree to participate.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo Metropolitan University

Oslo, 0130, Norway

Location

Related 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 students in higher education. Public Health Pract (Oxf). 2021 Nov;2:100187. doi: 10.1016/j.puhip.2021.100187. Epub 2021 Aug 27.

Related Links

MeSH Terms

Conditions

InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Atle Fretheim, PhD

    Oslo Metropolitan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 27, 2020

Study Start

September 4, 2020

Primary Completion

December 31, 2020

Study Completion

August 31, 2021

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
From spring 2021 and for at least 5 years.

Locations