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COVID-19NCT04459520

Effect of Availability of COVID-19 Testing on Choice to Isolate and Socially Distance

A study testing Positive COVID Test Result - Hypothetical Scenario, Negative COVID Test Result - Hypothetical Scenario and Unavailable COVID Test Result - Hypothetical Scenario in people with COVID-19, run by University of California, Los Angeles 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

The purpose of this research is to conduct a cross-sectional survey to investigate how people's lifestyle decisions and social distancing choices are affected by the medical information they receive. Read more about this study

Who is it for?
Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Positive COVID Test Result - Hypothetical Scenario, Negative COVID Test Result - Hypothetical Scenario and Unavailable COVID Test Result - Hypothetical Scenario
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,400 participants
Where
1 siteUnited States
Study dates
23 Jul 2020to 29 Jul 2020
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 to 110 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • U.S.-based (based off self-reported zip code)
  • Able to read and agree to English-based consent form
  • Able to pass the attention check questions in the pre-test survey
  • Able to pass the attention check questions in the main survey
  • Complete the main survey in 120 seconds or more

Who cannot join

  • <18 years of age
  • Unable to complete English-based consent form
  • Fail any of the attention check questions from the pre-test and main survey
  • Complete the main survey in 119 seconds or under

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Health Department of Medicine, Quality Office

    Los Angeles, California, 90095

Other trials in United States

About this study

The purpose of this research is to conduct a cross-sectional survey to investigate how people's lifestyle decisions and social distancing choices are affected by the medical information they receive. The hypothesis is that a positive COVID-19 test result will lead to study participants having the greatest self-isolation intentions compared to those who are only clinically diagnosed for COVID-19 without a confirmatory diagnostic test result or those who receive a negative COVID-19 test result.

Read the detailed description

When people make choices about how to socially distance, they may make different choices when they have information from a doctor or other medical provider versus when they have information from a test result. Are people's lifestyle decisions and choices to socially distance or isolate affected by how information about their health status is communicated? Does the presence of testing change the lifestyle decisions people make? We study and attempt to answer these questions through a cross-sectional, online survey.

Two pilot studies will be run prior to the launching the main survey. The preliminary results from these two surveys will be analyzed through EFA (exploratory factor analysis) and power analysis in order to determine subscales, effect size, and appropriate sample size for the main study. Additionally, a focus group consisting of approximately 15 college-educated individuals will be asked to take the main survey in order to evaluate a reasonable time of completion for the survey. The lower bound of this study completion duration will then be utilized to establish reasonable survey completion time and thus create an exclusion criterion based on time to survey completion.

Study participants will be first invited to complete a 9 question, pre-test survey on Amazon's Mechanical Turk. Respondents who pass the 4 attention check questions within the pre-test will then be invited to complete the main survey.

An estimated 1400 participants will be recruited using Amazon's Mechanical Turk to complete the main survey. Of those, we anticipate 1194 participants to meet all inclusion criteria who will then be included in the main study analysis. Participants will be included in the main survey analysis if they read and agree to the English language consent form, are U.S. residents (based on zip code data), correctly answer the attention check questions in both the pre-test and main survey, and complete the main survey within a reasonable amount of time (deemed to be 120 seconds or more).

Participants will be first invited to complete a 9 question, pre-test survey on Amazon's Mechanical Turk. Respondents who pass the 4 attention check questions within the pre-test will then be invited to complete the main survey. After consenting to participate, participants will be randomized to take one of three surveys each describing a different scenario: one where they likely have COVID-19 but testing is not available, one where they likely have COVID-19 and testing results show a positive result, and one where they likely have COVID-19 and testing results show a negative result. Then, participants will be asked questions about their activity and behavior intentions (e.g., stay in a specific room in my home and stay away from all other people and pets, visit a friend or family member in person). Participants will also be asked construct questions based off of Theory of Planned Behavior/Reason Action Approach (located in the pre-test survey), along with a set of demographic questions.

Survey responses will be summarized for the full sample, as well as stratified by testing scenario. Quantitative responses will be summarized using means, standard deviations and quartiles, and categorical and ordinal responses will be summarized using frequency distributions. Comparisons between scenarios will be performed using one-way analysis of variance (ANOVA) for quantitative variables, Kruskal-Wallis tests for ordinal variables, and chi-squared or Fisher's exact tests as appropriate for categorical variables.

The primary outcome is a difference in the behavioral sum score constructed using 11 items, composed of two subscales. Secondary outcomes include the 'personal decisions' and 'social expectations' subscales respectively. The 'personal decisions' subscale will consist of the items pertaining to masking, self-isolation, visiting friends, purchasing supplies, undertaking physical activity, eating at a restaurant and having dinner at home with friends. The 'social expectations' subscale will consist of the items pertaining to getting a haircut, attending weddings, funerals, and birthday parties. Other secondary outcomes including likelihood of voting, protesting/political gathering, and public transportation 1-item questions will also be analyzed in a similar fashion across the three different arms.

The primary hypothesis is that there will be a statistically significant difference in willingness to engage in risky behavior based on COVID test results. This will be evaluated using a linear regression model of the total 11-item score. The primary model term will be scenario, and covariates will include age, sex, race/ethnicity, political affiliation, education level, location, and type of residence. We will perform pairwise comparisons of the 3 scenarios, and use an 0.017 significance level (3-fold Bonferroni correction for an overall alpha of 0.05). Secondary analyses will evaluate the subscales separately using a similar approach. We will also perform exploratory analyses evaluating individual item responses using ordinal logistic regression models with similar specifications. A 5% significance level will be used for all secondary and exploratory hypothesis tests. All analyses will be performed using R v. 3.6.2 (http://www.r-project.org).

Conditions
COVID-19
Being tested
Positive COVID Test Result - Hypothetical Scenario, Negative COVID Test Result - Hypothetical Scenario, Unavailable COVID Test Result - Hypothetical Scenario
Keywords
Behavior intentions, Testing, COVID-19, Theory of Planned Behavior, Reason Action Approch, SARS-CoV-2
Medical subject headings
COVID-19

What participants receive

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

  • Positive COVID Test Result - Hypothetical ScenarioBehavioural

    Participants will be asked to imagine that they have tested positive (PCR) for an active COVID-19 infection and that their physician has clinically diagnosed them with COVID-19.

  • Negative COVID Test Result - Hypothetical ScenarioBehavioural

    Participants will be asked to imagine that they have tested negative (PCR) for an active COVID-19 infection.

  • Unavailable COVID Test Result - Hypothetical ScenarioBehavioural

    Participants will be asked to imagine that testing is not available for active COVID-19 infections but that their physician has clinically diagnosed them with COVID-19.

Study groups in NCT04459520
Study groupRoleWhat they receive
Testing Unavailable GroupExperimentalThis arm will complete an online survey where they will be presented a vignette asking them to imagine they have symptoms consistent with COVID-19, a physician telling them they likely have COVID-19, but that COVID-19 testing is not available. All arms will then be asked to fill out the same questions regarding behavior intentions and demographic questions. All participants will have completed five construct questions based off of Theory of Planned Behavior/Reason Action Approch during the pre-test survey.
Receives: Behavioral: Unavailable COVID Test Result - Hypothetical Scenario
Positive Test ResultActive comparatorThis arm will complete an online survey where they will be presented a vignette asking them to imagine they have symptoms consistent with COVID-19, a physician telling them they likely have COVID-19, and a positive COVID-19 test result. All arms will then be asked to fill out the same questions regarding behavior intentions and demographic questions. All participants will have completed five construct questions based off of Theory of Planned Behavior/Reason Action Approch during the pre-test survey.
Receives: Behavioral: Positive COVID Test Result - Hypothetical Scenario
Negative Test ResultPlacebo comparatorThis arm will complete an online survey where they will be presented a vignette asking them to imagine they have symptoms consistent with COVID-19, a physician telling them they likely have COVID-19, and a negative COVID-19 test result. All arms will then be asked to fill out the same questions regarding behavior intentions and demographic questions. All participants will have completed five construct questions based off of Theory of Planned Behavior/Reason Action Approch during the pre-test survey.
Receives: Behavioral: Negative COVID Test Result - Hypothetical Scenario

What is being measured

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

  1. Behavioral Intentions

    Sum score constructed of 11 behavior items from 2 subscales (Personal Decisions and Social Expectations)

    Measured: Immediate (cross-sectional survey)

Secondary outcomes (5)
  1. Personal Decisions Subscale

    This 7-item subscale will consist of the items pertaining to masking, self-isolation, visiting friends, purchasing supplies, undertaking physical activity, eating at a restaurant and having dinner at home with friends

    Measured: Immediate (cross-sectional survey)

  2. Social Expectations Subscale

    This 4-item subscale will consist of the items pertaining to getting a haircut, attending weddings, funerals, and birthday parties.

    Measured: Immediate (cross-sectional survey)

  3. Voting Behavior Question

    1-item question assessing likelihood of voting across the three different study arms

    Measured: Immediate (cross-sectional survey)

  4. Protest Question

    1-item question assessing likelihood to protest or engage in political gatherings across the three different study arms.

    Measured: Immediate (cross-sectional survey)

  5. Transportation

    1-item question assessing likelihood of avoiding public transportation (e.g. ridesharing, bus, metro, etc.) across the three different study arms.

    Measured: Immediate (cross-sectional survey)

Timeline

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

  1. First posted7 Jul 2020
  2. Study start23 Jul 2020
  3. Primary completion28 Jul 2020
  4. Study completion29 Jul 2020

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel 3-arm, cross-sectional, behavioral intervention study
Masking
None (open label)
Enrolment
1,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459520
Sponsor's protocol ID
IRB#20-000980
Status last verified
Aug 2020
First submitted
5 Jul 2020
Last updated
20 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teasdale E, Yardley L. Understanding responses to government health recommendations: public perceptions of government advice for managing the H1N1 (swine flu) influenza pandemic. Patient Educ Couns. 2011 Dec;85(3):413-8. doi: 10.1016/j.pec.2010.12.026. Epub 2011 Feb 3.

    PubMed 21295434
  • Qazi A, Qazi J, Naseer K, Zeeshan M, Hardaker G, Maitama JZ, Haruna K. Analyzing situational awareness through public opinion to predict adoption of social distancing amid pandemic COVID-19. J Med Virol. 2020 Jul;92(7):849-855. doi: 10.1002/jmv.25840. Epub 2020 Apr 15.

    PubMed 32266990
  • Lees et al. Intentions to Comply with COVID-19 Preventive Behaviors are Associated with Personal Beliefs, Independent of Perceived Social Norms. OSF. 2020.

  • Bults M, Beaujean DJ, de Zwart O, Kok G, van Empelen P, van Steenbergen JE, Richardus JH, Voeten HA. Perceived risk, anxiety, and behavioural responses of the general public during the early phase of the Influenza A (H1N1) pandemic in the Netherlands: results of three consecutive online surveys. BMC Public Health. 2011 Jan 3;11:2. doi: 10.1186/1471-2458-11-2.

    PubMed 21199571
  • Teasdale E, Yardley L, Schlotz W, Michie S. The importance of coping appraisal in behavioural responses to pandemic flu. Br J Health Psychol. 2012 Feb;17(1):44-59. doi: 10.1111/j.2044-8287.2011.02017.x. Epub 2011 Mar 7.

    PubMed 22233104
  • Zhang JC, Christensen KL, Leuchter RK, Vangala S, Han M, Croymans DM. Examining the role of COVID-19 testing availability on intention to isolate: A Randomized hypothetical scenario. PLoS One. 2022 Feb 2;17(2):e0262659. doi: 10.1371/journal.pone.0262659. eCollection 2022.

    PubMed 35108307

Questions about this trial

What is this clinical trial studying?

A study testing Positive COVID Test Result - Hypothetical Scenario, Negative COVID Test Result - Hypothetical Scenario and Unavailable COVID Test Result - Hypothetical Scenario in people with COVID-19, run by University of California, Los Angeles 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 6 inclusion and 4 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 20 Aug 2020. 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. Some participants in this study may receive a placebo. 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?

Behavioral Intentions (time frame: Immediate (cross-sectional survey)). 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 NCT04459520, which also lists 6 linked publications.

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 20 Aug 2020.

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