NCT05642754

Brief Summary

Randomized trial testing 6 forms of a communication summarizing the results of a recent study (about the effects of wearing glasses on reducing covid infection risk). The goal of the trial is to test the effect of different language options to describe uncertainty, and of including the margin of error around the main result.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
960

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable covid19

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

November 30, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

November 30, 2022

Last Update Submit

May 20, 2024

Conditions

Keywords

Colloquial languageuncertaintybias

Outcome Measures

Primary Outcomes (4)

  • understanding of overall uncertainty of benefit (of wearing glasses to reduce the chance of covid infection)

    How sure about the effect (4 point scale from very unsure to very sure)

    within 1 day

  • understanding of overall uncertainty of harm (of wearing glasses to reduce the chance of covid infection)

    How sure about the effect (4 point scale from very unsure to very sure)

    within 1 day

  • sufficiency of what is known about the effects of wearing glasses to reduce the chance of covid infection

    How sure about the effect (4 point Likert scale)

    within 1 day

  • Understanding the margin of error around the benefit of wearing glasses to reduce covid

    this is a co-primary outcome which will be used only to compare the 3 versions that include the margin of error to the 3 versions that do not

    within 1 day

Secondary Outcomes (13)

  • perceived effect of wearing glasses to reduce chance of covid infection

    within 1 day

  • how likely is it that wearing glasses reduces the chance of covid infection

    within 1 day

  • intended behavior (if there were a surge in covid in your area, how likely would you be to wear glasses to reduce the chance of covid infection

    within 1 day

  • intended behavior (if there were very few cases of covid in your area, how likely would you be to wear glasses to reduce the chance of covid infection

    within 1 day

  • perceptions fo information provided (trustworthy summary?)

    within 1 day

  • +8 more secondary outcomes

Study Arms (6)

GRADE + margin of error

ACTIVE COMPARATOR

Overall uncertainty using GRADE\* language AND margin of error around main result \* Based on the Cochrane Effective Practice and Organisation of Care Group's guidance for communicating the certainty of evidence based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assessing the certainty of evidence

Other: Overall uncertainty language

Colloquial language AND margin of error

ACTIVE COMPARATOR

Colloquial language developed to describe overall study uncertainty AND margin of error around main result

Other: Overall uncertainty language

No overall uncertainty language AND margin of error

ACTIVE COMPARATOR

No overall uncertainty language AND margin of error around main result

Other: Overall uncertainty language

GRADE -No margin of error

ACTIVE COMPARATOR

Overall uncertainty using GRADE\* language and NO margin of error around main result \* Based on the Cochrane Effective Practice and Organisation of Care Group's guidance for communicating the certainty of evidence based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assessing the certainty of evidence

Other: Overall uncertainty language

Colloquial - No margin of error

ACTIVE COMPARATOR

Colloquial language developed to describe overall study uncertainty and NO margin of error around main result

Other: Overall uncertainty language

No overall uncertainty language AND no margin of error

PLACEBO COMPARATOR

No overall uncertainty language and NO margin of error around main result

Other: Overall uncertainty language

Interventions

Researchers are testing different forms of information about overall study uncertainty and margin of error around main result

Also known as: Margin of error around main result
Colloquial - No margin of errorColloquial language AND margin of errorGRADE + margin of errorGRADE -No margin of errorNo overall uncertainty language AND margin of errorNo overall uncertainty language AND no margin of error

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 18 years old
  • literate in English or Norwegian
  • currently residing in Norway or the United States

You may not qualify if:

  • individuals who regularly wear any kind of glasses (i.e., prescription or sunglasses) all or most of the time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Institute of Public Health

Oslo, Norway

Location

Related Publications (1)

  • Holst C, Woloshin S, Oxman AD, Rose C, Rosenbaum S, Munthe-Kaas HM. Alternative Presentations of Overall and Statistical Uncertainty for Adults' Understanding of the Results of a Randomized Trial of a Public Health Intervention: Parallel Web-Based Randomized Trials. JMIR Public Health Surveill. 2025 Mar 18;11:e62828. doi: 10.2196/62828.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steven Woloshin, MD

    Dartmouth Institute for Health Policy and Clincal Practice

    PRINCIPAL INVESTIGATOR
  • Andy Oxman, MD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 3 options for describing bias/uncertainty about results 2 options for margin of error around main result (we will run the trial twice on 2 different online platforms)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 8, 2022

Study Start

December 1, 2022

Primary Completion

January 31, 2023

Study Completion

March 31, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations