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Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits

B

Barry Dewitt

Status

Completed

Conditions

Decision Making
COVID-19 Testing

Treatments

Other: decision science-based design

Study type

Interventional

Funder types

Other

Identifiers

NCT04758299
STUDY2020_501

Details and patient eligibility

About

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

Full description

To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC [Centers for Disease Control]-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).

Participants will be randomized to receive either information from the FDA authorized Ellume home test kit for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention). They will be given time to read the documents and the opportunity to download a full "instructions for use" document (the FDA authorized for the ELLUME test kit). They will then be randomized to one of four conditions, asking them to imagine a clinical context: a person with no symptoms and no close COVID-19 contact, no symptoms and close contact,

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants must be >18 years old, communicate in English, reside in the United States.

Exclusion criteria

  • Respondents who complete the survey in under a minute.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

360 participants in 2 patient groups

Standard care
No Intervention group
Description:
information from an FDA authorized home test kit for what actions to take for a negative or positive COVID-19 test
Decision science-based design
Experimental group
Description:
Information from a decision science-based design (of similar length to the FDA authorized home test kit information) for what actions to take for a negative or positive COVID-19 test
Treatment:
Other: decision science-based design

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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