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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04758299
Other study ID # STUDY2020_501
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2021
Est. completion date April 30, 2021

Study information

Verified date May 2021
Source Carnegie Mellon University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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,


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date April 30, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
decision science-based design
decision science-based design explaining actions to take for a negative or positive COVID-19 test

Locations

Country Name City State
United States Carnegie Mellon University Pittsburgh Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Barry Dewitt Dartmouth College, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other ordering postest probability of infection correct ordering of posttest probability of infection risk (derived from qualitative and quantitative ratings) day 1
Primary choice of action to take with negative test choice of actions consistent with CDC-recommendations (eg, isolate or not) for various clinical scenarios (eg, with/without known exposure, with/without symptoms)
Which of the following are safe for Jamie to do over the next week about being around others? [safe, not safe]
Take no additional precautions.
Stay at home except to visit close family or friends. Take no additional precautions at home
Stay at home except when going to the grocery store. Take no additional precautions at home
Stay at home all the time, without exceptions. Take no additional precautions at home.
Stay at home all the time, without exceptions and avoid contact with others, including others in the household
day 1
Secondary Likelihood of COVID-19 infection (qualitative) Judgments about the likelihood of COVID-19 infection with a negative or positive test result
How likely is it that Jamie is infected with COVID-19? (choose one)
Definitely yes
Very likely
Likely
Unlikely
Very Unlikely
Definitely not
day 1
Secondary Likelihood of COVID-19 infection (quantitative) Judgments about the likelihood of COVID-19 infection with a negative ot positive test result
Response using a "slider" to capture numeric estimate
day 1
Secondary safe practices Change in intent to practice standard public health practices to reduce COVID-19 transmission (hand washing, social distancing, masks) - question asked before and after seeing test result
What else do you think Jamie should do to protect himself and others from COVID-19? [choose: all of the time, most of the time, some of the time, a little of the time, none of the time] In general
Wash hands often
Avoid close contact with people who seem sick (e.g., cough, sneeze, fever)
Stay home
Outside your home
Try to avoid crowds
Wear a mask when around others
Keep 6 feet from others
Avoid contact with anyone
day 1
Secondary ease of use of information rating how easy/hard is it to use information about interpreting test results
How easy or difficult was it to read the information about interpreting the test result?" (check one)
Very difficult
Difficult
Neutral
Easy
Very easy
day 1
Secondary usefulness of information rating how useful is the information about interpreting test results
The information about interpreting the home test kit results was (check one)
Extremely useful
Useful
Neutral
Useless
Completely useless
day 1
Secondary helpfulness of information for what to do given positive test result How helpful was the information for what to if test was positive
The information helped me know what to do if test result is positive
a. Strongly agree
Agree
Neutral
Disagree
Strongly disagree
day 1
Secondary helpfulness of information for what to do given negative test result How helpful was the information for what to if test was negative
The information helped me know what to do if test result is negative
a. Strongly agree
Agree
Neutral
Disagree
Strongly disagree
day 1
Secondary Assess effect of the FDA authorized description of test accuracy According to the test's FDA-authorized label, a clinical study conducted in the USA in 2020 showed that the test "correctly identified 96% of positive samples and 100% of negative samples in patients with symptoms. In people without symptoms the test correctly identified 91% of positive samples and 96% of negative samples."
Based on this information, if Jamie has COVID now, what is the chance that the test will be wrong and say that he does not?
RESPONSE (probability estimate) using slider
day 1
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