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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459520
• Other study ID #: IRB#20-000980
• Status: Completed
• Phase: N/A
• Start date: July 23, 2020
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: July 29, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria

• <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

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Positive COVID Test Result - Hypothetical Scenario
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 Scenario
Participants will be asked to imagine that they have tested negative (PCR) for an active COVID-19 infection.
• Unavailable COVID Test Result - Hypothetical Scenario
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.

Locations

Country	Name	City	State
United States	UCLA Health Department of Medicine, Quality Office	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral Intentions	Sum score constructed of 11 behavior items from 2 subscales (Personal Decisions and Social Expectations)	Immediate (cross-sectional survey)
Secondary	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	Immediate (cross-sectional survey)
Secondary	Social Expectations Subscale	This 4-item subscale will consist of the items pertaining to getting a haircut, attending weddings, funerals, and birthday parties.	Immediate (cross-sectional survey)
Secondary	Voting Behavior Question	1-item question assessing likelihood of voting across the three different study arms	Immediate (cross-sectional survey)
Secondary	Protest Question	1-item question assessing likelihood to protest or engage in political gatherings across the three different study arms.	Immediate (cross-sectional survey)
Secondary	Transportation	1-item question assessing likelihood of avoiding public transportation (e.g. ridesharing, bus, metro, etc.) across the three different study arms.	Immediate (cross-sectional survey)