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临床试验/NCT04459520
NCT04459520已完成不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2020年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,400
试验地点
1
主要终点
Behavioral Intentions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

Open label (participants will be randomized to receive different scenarios, but will not be aware of the other two scenario types)

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •<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

研究组 & 干预措施

Testing Unavailable Group

Experimental

This 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.

干预措施: Unavailable COVID Test Result - Hypothetical Scenario (Behavioral)

Positive Test Result

Active Comparator

This 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.

干预措施: Positive COVID Test Result - Hypothetical Scenario (Behavioral)

Negative Test Result

Placebo Comparator

This 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.

干预措施: Negative COVID Test Result - Hypothetical Scenario (Behavioral)

结局指标

主要结局

Behavioral Intentions

时间窗: Immediate (cross-sectional survey)

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

次要结局

  • Voting Behavior Question(Immediate (cross-sectional survey))
  • Protest Question(Immediate (cross-sectional survey))
  • Social Expectations Subscale(Immediate (cross-sectional survey))
  • Transportation(Immediate (cross-sectional survey))
  • Personal Decisions Subscale(Immediate (cross-sectional survey))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel M. Croymans, MD, MBA, MS

Principal Investigator

University of California, Los Angeles

研究点 (1)

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