Clinical trial NCT05642754: Glassy Trial for Effects of Wearing Glasses
Official title: Communicating Uncertainty About the Effects of Wearing Glasses to Reduce the Chance of Getting COVID (Corona Virus Disease): Protocol for a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Colloquial language
uncertainty
bias
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
First posted: 2022-12-08
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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)
Primary purpose: OTHER

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.

Detailed description: The study is designed as a proof-of-concept exercise to develop and test a communication meant to summarize the results of a recent randomized trial examining the effects of wearing glasses on the chance of developing COVID-19.

The objectives of the randomized trial are:

* To compare the effects of three ways of communicating the overall uncertainty of the effects of wearing glasses to reduce the chance of getting COVID and
* To compare the effects of including the margin of error (confidence interval) compared to not including it.

Researchers will conduct an online, parallel group, individually randomized, pragmatic trial using a 3x2 factorial design, ie, 3 uncertainly language options (GRADE language, colloquial language or none 2 options for the statistical margin of error for the main results (margin of error language or none).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: understanding of overall uncertainty of benefit (of wearing glasses to reduce the chance of covid infection)
timeFrame: within 1 day
measure: understanding of overall uncertainty of harm (of wearing glasses to reduce the chance of covid infection)
timeFrame: within 1 day
measure: sufficiency of what is known about the effects of wearing glasses to reduce the chance of covid infection
timeFrame: within 1 day
measure: Understanding the margin of error around the benefit of wearing glasses to reduce covid
timeFrame: within 1 day
Secondary outcomes:
measure: perceived effect of wearing glasses to reduce chance of covid infection
timeFrame: within 1 day
measure: how likely is it that wearing glasses reduces the chance of covid infection
timeFrame: within 1 day
measure: 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
timeFrame: within 1 day
measure: 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
timeFrame: within 1 day
measure: perceptions fo information provided (trustworthy summary?)
timeFrame: within 1 day
measure: perceptions fo information provided (sufficient summary?)
timeFrame: within 1 day
measure: perceptions fo information provided (clarity of info about benefit)
timeFrame: within 1 day
measure: perceptions fo information provided (clarity of info about harm)
timeFrame: within 1 day
measure: perceptions fo information provided (info helpful?)
timeFrame: within 1 day
measure: perceptions fo information provided (share info with others?)
timeFrame: within 1 day
measure: Decisional conflict (hard to make decision)
timeFrame: within 1 day
measure: Decisional conflict (made informed decision)
timeFrame: within 1 day
measure: Decisional conflict (satisfied with decision)
timeFrame: within 1 day
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Dartmouth Institute for Health Policy and Clincal Practice
name: Steven Woloshin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian Institute of Public Health
name: Andy Oxman, MD
role: PRINCIPAL_INVESTIGATOR
References: