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

NCT04758299 | Completed

• 1 other identifier: STUDY2020_501
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19 Testing; Decision Making

Outcome Measures

Primary Outcomes (1)

• 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

  day 1

Secondary Outcomes (8)

• Likelihood of COVID-19 infection (qualitative)

  day 1

• Likelihood of COVID-19 infection (quantitative)

  day 1

• safe practices

  day 1

• ease of use of information rating

  day 1

• usefulness of information rating

  day 1

Other Outcomes (1)

• ordering postest probability of infection

  day 1

Study Arms (2)

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

Other: decision science-based design

Interventions

decision science-based design OTHER

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

Decision science-based design

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Respondents who complete the survey in under a minute.

Sponsors & Collaborators

• Barry Dewitt: lead
• Dartmouth College: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 35099501 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoctoral Research Associate

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: March 13, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)