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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758299
Recruitment Status : Completed
First Posted : February 17, 2021
Last Update Posted : May 25, 2021
Sponsor:
Collaborators:
Dartmouth College
University of Pittsburgh
Information provided by (Responsible Party):
Barry Dewitt, Carnegie Mellon University

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
COVID-19 Testing Decision Making Other: decision science-based design Not Applicable

Detailed 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,

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomized to receive either information from the FDA authorized 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).

There are 4 groups (clinical scenarios) within each randomized arm (the scenarios are patient with no symptoms and no exposure; no symptoms and exposure; symptoms and no exposure; symptoms and exposure.
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: At Home Self-testing Kits for SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) : A Randomized Trial Assessing How Consumers Interpret and Act on Test Results
Actual Study Start Date : March 13, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard care
information from an FDA authorized home test kit for what actions to take for a negative or positive COVID-19 test
Experimental: Decision science-based design
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
 Other: decision science-based design
decision science-based design explaining actions to take for a negative or positive COVID-19 test


Outcome Measures
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Primary Outcome Measures :
  1. choice of action to take with negative test [ Time Frame: day 1 ]

    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]

    1. Take no additional precautions.
    2. Stay at home except to visit close family or friends. Take no additional precautions at home
    3. Stay at home except when going to the grocery store. Take no additional precautions at home
    4. Stay at home all the time, without exceptions. Take no additional precautions at home.
    5. Stay at home all the time, without exceptions and avoid contact with others, including others in the household


Secondary Outcome Measures :
  1. Likelihood of COVID-19 infection (qualitative) [ Time Frame: day 1 ]

    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)

    1. Definitely yes
    2. Very likely
    3. Likely
    4. Unlikely
    5. Very Unlikely
    6. Definitely not

  2. Likelihood of COVID-19 infection (quantitative) [ Time Frame: day 1 ]

    Judgments about the likelihood of COVID-19 infection with a negative ot positive test result

    Response using a "slider" to capture numeric estimate


  3. safe practices [ Time Frame: day 1 ]

    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

    1. Wash hands often
    2. Avoid close contact with people who seem sick (e.g., cough, sneeze, fever)

    3. Stay home

      Outside your home

    4. Try to avoid crowds
    5. Wear a mask when around others
    6. Keep 6 feet from others
    7. Avoid contact with anyone

  4. ease of use of information rating [ Time Frame: day 1 ]

    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)

    1. Very difficult
    2. Difficult
    3. Neutral
    4. Easy
    5. Very easy

  5. usefulness of information rating [ Time Frame: day 1 ]

    how useful is the information about interpreting test results

    The information about interpreting the home test kit results was (check one)

    1. Extremely useful
    2. Useful
    3. Neutral
    4. Useless
    5. Completely useless

  6. helpfulness of information for what to do given positive test result [ Time Frame: day 1 ]

    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

    1. Agree
    2. Neutral
    3. Disagree
    4. Strongly disagree

  7. helpfulness of information for what to do given negative test result [ Time Frame: day 1 ]

    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

    1. Agree
    2. Neutral
    3. Disagree
    4. Strongly disagree

  8. Assess effect of the FDA authorized description of test accuracy [ Time Frame: day 1 ]

    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



Other Outcome Measures:
  1. ordering postest probability of infection [ Time Frame: day 1 ]
    correct ordering of posttest probability of infection risk (derived from qualitative and quantitative ratings)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758299


Locations
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United States, Pennsylvania
Carnegie Mellon University
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Barry Dewitt
Dartmouth College
University of Pittsburgh
Investigators
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Principal Investigator: Barry Dewitt Carnegie Mellon University
Principal Investigator: Steven Woloshin, MD Dartmouth College
Principal Investigator: Tamar Krishnamurti, PhD University of Pittsburgh
Principal Investigator: Baruch Fischhoff, PhD Carnegie Mellon University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Barry Dewitt, Postdoctoral Research Associate, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT04758299    
Other Study ID Numbers: STUDY2020_501
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases