Glassy Trial for Effects of Wearing Glasses

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05642754
• Other study ID #: 557972
• Secondary ID: CPHS 32615
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2024
• Source: Trustees of Dartmouth College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Overall uncertainty language
Researchers are testing different forms of information about overall study uncertainty and margin of error around main result

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Trustees of Dartmouth College	Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	perceived effect of wearing glasses to reduce chance of covid infection	What is the effect on a 5 point scale (lowers a lot, lowers a little, no effect, increase a little, increases a lot	within 1 day
Secondary	how likely is it that wearing glasses reduces the chance of covid infection	4 point scale (very likely, likely, unlikely, very unlikely)	within 1 day
Secondary	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	4 point scale (very likely, likely, unlikely, very unlikely	within 1 day
Secondary	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	4 point scale (very likely, likely, unlikely, very unlikely	within 1 day
Secondary	perceptions fo information provided (trustworthy summary?)	4 point Likert scale (strongly agree, agree, disagree, strongly disagree)	within 1 day
Secondary	perceptions fo information provided (sufficient summary?)	4 point Likert scale (strongly agree, agree, disagree, strongly disagree)	within 1 day
Secondary	perceptions fo information provided (clarity of info about benefit)	4 point scale (very clear, clear, unclear, very unclear)	within 1 day
Secondary	perceptions fo information provided (clarity of info about harm)	4 point scale (very clear, clear, unclear, very unclear)	within 1 day
Secondary	perceptions fo information provided (info helpful?)	4 point scale (very helpful, helpful, unhelpful, very unhelpful)	within 1 day
Secondary	perceptions fo information provided (share info with others?)	4 point scale (definitely yes, probably yes, probably no, definitely no)	within 1 day
Secondary	Decisional conflict (hard to make decision)	4 point LIkert scale (strongly agree, agree, disagree, strongly disagree)	within 1 day
Secondary	Decisional conflict (made informed decision)	4 point LIkert scale (strongly agree, agree, disagree, strongly disagree)	within 1 day
Secondary	Decisional conflict (satisfied with decision)	4 point LIkert scale (strongly agree, agree, disagree, strongly disagree)	within 1 day