Glassy Trial for Effects of Wearing Glasses

Trustees of Dartmouth College

Status: Completed

Conditions: COVID-19

Treatments: Other: Overall uncertainty language

Study type: Interventional

Funder types: Other

Identifiers

NCT05642754

557972

CPHS 32615 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 960 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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960 participants in 6 patient groups, including a placebo group

GRADE + margin of error

Active Comparator group

Description:

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

Treatment:

Other: Overall uncertainty language

Colloquial language AND margin of error

Active Comparator group

Description:

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

Treatment:

Other: Overall uncertainty language

No overall uncertainty language AND margin of error

Active Comparator group

Description:

No overall uncertainty language AND margin of error around main result

Treatment:

Other: Overall uncertainty language

GRADE -No margin of error

Active Comparator group

Description:

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

Treatment:

Other: Overall uncertainty language

Colloquial - No margin of error

Active Comparator group

Description:

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

Treatment:

Other: Overall uncertainty language

No overall uncertainty language AND no margin of error

Placebo Comparator group

Description:

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

Treatment:

Other: Overall uncertainty language