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

NCT ID: NCT04758299

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-13

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Testing Decision Making

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard care

information from an FDA authorized home test kit for what actions to take for a negative or positive COVID-19 test

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

decision science-based design

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

decision science-based design

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dartmouth College

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Barry Dewitt

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barry Dewitt

Postdoctoral Research Associate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barry Dewitt

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

Steven Woloshin, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Tamar Krishnamurti, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Baruch Fischhoff, PhD

Role: PRINCIPAL_INVESTIGATOR

Carnegie Mellon University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Carnegie Mellon University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35099501 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY2020_501

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promoting Cholesterol Screening
NCT01930149 COMPLETED NA
Patient Education Video to Reduce OTC NSAIDs
NCT06575205 ACTIVE_NOT_RECRUITING NA