Cristin-prosjekt-ID: 2532110
Sist endret: 11. januar 2024, 13:31

Cristin-prosjekt-ID: 2532110
Sist endret: 11. januar 2024, 13:31
Prosjekt

The GLasses Against transmission of SARS-CoV-2 in the communitY (GLASSY) trial: A pragmatic randomized trial

prosjektleder

Atle Fretheim
ved Folkehelseinstituttet

prosjekteier / koordinerende forskningsansvarlig enhet

  • Folkehelseinstituttet

Klassifisering

Vitenskapsdisipliner

Helsefag

Emneord

Covid-19

HRCS-helsekategori

  • Infeksjon

Kategorier

Prosjektkategori

  • Anvendt forskning

Kontaktinformasjon

Telefon
91649828
Sted
Atle Fretheim

Tidsramme

Avsluttet
Start: 1. februar 2022 Slutt: 31. mai 2022

Beskrivelse Beskrivelse

Tittel

The GLasses Against transmission of SARS-CoV-2 in the communitY (GLASSY) trial: A pragmatic randomized trial

Populærvitenskapelig sammendrag

Det er en del som tyder på at bruk av vanlige briller kan ha en viss beskyttende effekt mot å bli smittet av korona- og andre luftveisvirus, men det er høyst usikkert om det har noen virkning. Vi vil derfor gjennomfør et stort forskningsprosjekt der frivillige deltakere blir fordelt ved loddtrekning, til å bruke vanlige briller/solbriller når de er ute blant folk, eller å ikke bruke briller. Dette skal deltakerne gjøre over 2 uker. Vi vil bl.a. sammenlikne forekomst av covid-19 og luftveissymptomer i de to gruppene. Bruk av briller er et billig og lite inngripende tiltak. Dersom det viser seg at briller/solbriller bidrar til å bremse smittespredningen, kan det bli et viktig smitteverntiltak både under den pågående og framtidige epidemier. 

Vitenskapelig sammendrag

Background: A systematic review of observational studies indicated that eye protection may be an effective measure to prevent SARS-CoV-2 infections. Randomized trials are needed to assess whether the observed associations are caused by protection of the eye or confounding factors such as other systematic differences between users and non-users of eye protection, co-interventions, or changes in COVID-19 incidence when comparisons were done over time.

Methods: Pragmatic, virtual, parallel group, 1:1 randomized, superiority trial. We will recruit and randomize participants via an online portal. The trial will be fully remote and virtual without any personal interaction between investigators and participants. All members of the public are eligible who confirm that they are at least 18 years of age, do not regularly wear glasses, have not contracted COVID-19 since December 15th 2021, and are willing to be randomized to wear, or not wear glasses in public when close to other people, for a 2-week period. Persons who are dependent on visual aids but typically use contact lenses are eligible. The participants will be randomized (1:1) to wear glasses (sunglasses or other types of glasses) in public spaces when close to others (public transport, shopping centers etc.), or to the control group. The control group will be asked not to wear glasses in public spaces when close to others. The primary outcome is positive test for COVID-19. We aim to include about 25,000 participants to have a statistical power of 80% to detect a relative risk reduction of 25% for the primary outcome.

Discussion: Many have easy access to sunglasses or other glasses. Wearing glasses may provide eye protection and repurposing sunglasses for infection control could be a simple, readily available, environmentally friendly, safe, and sustainable infection prevention measure.

Metode

We will recruit participants via an online portal that will be distributed as widely as possible to the Norwegian public. The trial will be fully remote and virtual without any personal interaction between investigators and participants.

NOTE: A similar study is about to be implemented in Denmark. We are closely collaborating with colleagues in other countries to ensure that our protocols are as similar as possible, so facilitate synthesis of findings.

All members of the public can take part as long as they confirm that they

  1. are at least 18 years of age
  2. do not regularly wear glasses
  3. own or can borrow glasses that they can use (e.g. sun-glasses)
  4. have not contracted COVID-19 since December 15th 2021.
  5. are willing to be randomized to wear, or not wear glasses outside their home when close to others for a 2-week period.
  6. provide informed consent

Persons who are dependent on visual aids but typically use contact lenses are eligible.

Informed, electronically signed consent (MinID or BankID) will be collected on the same web-page where people can sign up to participate and consent to being randomized to the intervention or control group. Participants will also consent to the collection and use of information from questionnaires and national registers.

This study aims to determine the impact of wearing glasses, in real life circumstances. The intervention is to wear sunglasses or other types of glasses when close to other people outside their home (on public transport, in shopping centres etc.). Consequently, the control group will be encouraged not to wear glasses close to other people outside their home.

The intervention group will be asked to wear sunglasses (or other types of glasses) when close to others outside their home, e.g. on public transport, in shopping centres etc.

Outcomes

Day 1 of trial period is the first day the individual participates in the trial. The intervention group will be asked to wear glasses until day 14. Three days later (day 17), the participants will complete an online questionnaire.

 

The primary outcome is

  • positive COVID-19 test result registered in public registry (from day 3 to day 17; MSIS database).

Secondary outcomes are

  • health care use for respiratory symptoms (from day 3 to day 28; KPR and NPR databases)
  • health care use for injuries (from day 1 to day 21; KPR and NPR databases)
  • health care use (all causes) from day 1 to day 21 (data source: KPR and NPR databases)
  • any positive COVID-19 test result (from day 1 to day 17; self report)
  • respiratory symptoms from day 1 to day 17 (self report)
  • health care use for respiratory symptoms (from day 1 to day 17; self report)
  • health care use for injuries (from day 1 to day 17; self report)
  • health care use (all causes) (from day 1 to day 17; self report)

prosjektdeltakere

prosjektleder
Aktiv cristin-person

Atle Fretheim

  • Tilknyttet:
    Prosjektleder
    ved Folkehelseinstituttet
  • Tilknyttet:
    Prosjektdeltaker
    ved OsloMet - storbyuniversitetet

Lars G. Hemkens

  • Tilknyttet:
    Prosjektdeltaker
    ved Universität Basel

Arnfinn Helleve

  • Tilknyttet:
    Prosjektdeltaker
    ved Folkehelseinstituttet

Petter Elstrøm

  • Tilknyttet:
    Prosjektdeltaker
    ved Folkehelseinstituttet

Ingeborg Hess Elgersma

  • Tilknyttet:
    Prosjektdeltaker
    ved Folkehelseinstituttet
1 - 5 av 6 | Neste | Siste »

Resultater Resultater

Effect of Wearing Glasses on Risk of Infection With SARS-CoV-2 in the Community: A Randomized Clinical Trial.

Fretheim, Atle; Elgersma, Ingeborg Hess; Helleve, Arnfinn; Elstrøm, Petter; Kacelnik, Oliver; Hemkens, Lars G.. 2022, JAMA Network Open. SU, FHI, OSLOMET, UHSBASEL, BERVitenskapelig artikkel
1 - 1 av 1