COVID-19 TestingNCT04758299

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

A study testing decision science-based design in people with COVID-19 Testing and Decision Making, run by Barry Dewitt at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19 Testing, Decision Making
What is being tested?: decision science-based design
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2021to 30 Apr 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Respondents who complete the survey in under a minute.

Trial locations and contacts

1 site in 1 country.

United States1 site

Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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).

Read the 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,

Conditions: COVID-19 Testing, Decision Making
Being tested: decision science-based design

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04758299
Study group	Role	What they receive
Standard care	No intervention	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	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 Receives: Other: decision science-based design

What is being measured

The primary outcome is the main question the study is designed to answer.

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]
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
Measured: day 1

Secondary outcomes (8)

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)
1. Definitely yes
2. Very likely
3. Likely
4. Unlikely
5. Very Unlikely
6. Definitely not
Measured: day 1
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
Measured: day 1
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
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
Measured: day 1
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)
1. Very difficult
2. Difficult
3. Neutral
4. Easy
5. Very easy
Measured: day 1
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)
1. Extremely useful
2. Useful
3. Neutral
4. Useless
5. Completely useless
Measured: day 1
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
1. Strongly agree
2. Agree
3. Neutral
4. Disagree
5. Strongly disagree
Measured: day 1
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
1. Strongly agree
2. Agree
3. Neutral
4. Disagree
5. Strongly disagree
Measured: day 1
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
Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202130 Apr 2021

First posted17 Feb 2021
Study start13 Mar 2021
Primary completion15 Apr 2021
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19 TestingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Investigator
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04758299
Sponsor's protocol ID: STUDY2020_501
Status last verified: May 2021
First submitted: 12 Feb 2021
Last updated: 25 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Woloshin S, Dewitt B, Krishnamurti T, Fischhoff B. Assessing How Consumers Interpret and Act on Results From At-Home COVID-19 Self-test Kits: A Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):332-341. doi: 10.1001/jamainternmed.2021.8075.
PubMed 35099501

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04758299
Acronym / sponsor ID: STUDY2020_501
Conditions: COVID-19 Testing, Decision Making
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Barry DewittUniversity, hospital or other
Collaborators: Dartmouth College, University of Pittsburgh
Study start: 13 Mar 2021 (actual)
Primary completion: 15 Apr 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 17 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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.

Arm	Type	Receives
Standard care	No intervention	–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	Other: decision science-based designInformation 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Respondents who complete the survey in under a minute.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
decision science-based designdecision science-based design explaining actions to take for a negative or positive COVID-19 test	Other	Decision science-based design

Primary outcome

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

8 secondary outcomes

Likelihood of COVID-19 infection (qualitative)
Time frame: day 1
Likelihood of COVID-19 infection (quantitative)
Time frame: day 1
safe practices
Time frame: day 1
ease of use of information rating
Time frame: day 1
usefulness of information rating
Time frame: day 1
helpfulness of information for what to do given positive test result
Time frame: day 1
helpfulness of information for what to do given negative test result
Time frame: day 1
Assess effect of the FDA authorized description of test accuracy
Time frame: day 1

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
Derived from this study: PubMed 35099501Woloshin S, Dewitt B, Krishnamurti T, Fischhoff B. Assessing How Consumers Interpret and Act on Results From At-Home COVID-19 Self-test Kits: A Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):332-341. doi: 10.1001/jamainternmed.2021.8075.
Individual participant dataSharing planned: No

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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barry Dewitt principal investigator

Carnegie Mellon University

Steven Woloshin, MD principal investigator

Dartmouth College

Tamar Krishnamurti, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing decision science-based design in people with COVID-19 Testing and Decision Making, run by Barry Dewitt at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

choice of action to take with negative test (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04758299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.