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Brief Informational Intervention for COVID-19 Misinformation Prophylaxis

Primary Purpose

COVID19 Behavioral Prophylaxis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief informational infographic
Placebo control (non-behavioral infographic)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID19 Behavioral Prophylaxis focused on measuring misinformation, trust, prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • To be included, participants must be identified by Prolific as part of a nationally-representative sample. Participants will also be required to be age 18 or older, and to reside in the United States.

Exclusion Criteria:

  • Individuals who decline to digitally sign the informed consent document will be excluded and replaced. Per recent best practice recommendations for crowdsourced digital research, attention checks and screens for "bots" and international users with virtual private networks to mimic US internet protocol addresses will be embedded within the instruments, and failure of more than one attention check, or any bot/location check will result in subject exclusion and replacement.

Sites / Locations

  • Digital Intervention (Prolific Study Panel)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Brief Intervention arm

Placebo Control arm

Arm Description

The primary intervention in this study will be an infographic that is designed to build trust in the scientific process (as described in the Intervention section). This arm will introduce the intervention and then instruct the participant to review it carefully (including a mandated pause on the infographic screen) before continuing to the remaining data collection.

The comparator in this study will be a control ("placebo") infographic that is completely unrelated to science (As described in the Placebo Control section). This arm will introduce the control infographic and then instruct the participant to review it carefully (including a mandated pause on the infographic screen) before continuing to the remaining data collection.

Outcomes

Primary Outcome Measures

Change in trust in science
21-item scale developed by Nadelson et al [1] called the Trust in Science Inventory. It is scored from 1 to 5, where 1 indicates low trust and 5 indicates high trust.
Believability profiles
Will be computed using latent profile analysis of believability measures. These measures were developed and first used in our recent study of COVID-19 narratives [2]. Response options for these measures used well-established semantic differential responses for believability of different statements (e.g., as in Herzberg et al.) [3] ranging from [1: Extremely unbelievable] to [7: Extremely believable]. Exact measures used to generate profiles for this study will be available in the published protocol paper (to be submitted).
Preventive behavioral intentions
A series of six questions based on the US Centers for Disease Control and Prevention's recommended COVID-19 preventive behaviors. [4] Questions will be written according to Azjen's guide to intention questionnaires [5].

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
February 8, 2021
Sponsor
Indiana University
Collaborators
Indiana Clinical and Translational Sciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04557241
Brief Title
Brief Informational Intervention for COVID-19 Misinformation Prophylaxis
Official Title
Brief Informational Intervention for COVID-19 Misinformation Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana Clinical and Translational Sciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As the coronavirus disease 2019 (COVID-19) pandemic has continued to affect life in the United States, the important role of non-pharmaceutical preventive behaviors (such as wearing a face mask) in reducing harm has become clear. In parallel to the pandemic, researchers have observed an "infodemic" of misinformed or inconsistent narratives about COVID-19. There is growing evidence that misinformed COVID-19 narratives are associated with a wide variety of undesirable behavior (e.g., burning down cell towers). Further, individuals' adherence to recommended COVID-19 preventive guidelines has been inconsistent, and such mandates have engendered opposition and controversy. Recent research suggests the possibility that trust in science and scientists may be an important thread to weave throughout these seemingly disparate components of the modern public health landscape. Thus, this paper describes the protocol for a randomized trial of a brief, digital intervention to increase trust in science. The objective of this trial is to examine if exposure to a curated infographic can increase trust in science, reduce believability of misinformed narratives, and increase likelihood to engage in preventive behaviors.
Detailed Description
The investigators propose a single-stage, randomized, superiority trial with 2 parallel groups allocated with a 1:1 ratio. The comparator in this study will be a control ("placebo") infographic that is completely unrelated to science (e.g., about cats), but that is developed using the same communication and graphical style. Subjects will be recruited using the Prolific data collection platform, which is one of two primary online crowdsourced research platforms (the other is Amazon's Mechanical Turk, or mTurk). To be included, participants must be identified by Prolific as part of a nationally-representative sample. Participants will also be required to be age 18 or older, and to reside in the United States. Individuals who decline to digitally sign the informed consent document will be excluded and replaced. Per recent best practice recommendations for crowdsourced digital research, attention checks and screens for "bots" and international users with virtual private networks to mimic US IP addresses will be embedded within the instruments, and failure of more than one attention check, or any bot/location check will result in subject exclusion and replacement. Replacements will be drawn in such a way as to preserve the representativeness of the sample. Missing data will be addressed using either full information maximum likelihood or Markov Chain Monte Carlo multiple imputation strategies. When there is a violation of missing at random (which is unlikely) in preliminary analyses, the investigators will incorporate strategies representing the missingness. The researchers will further explore data quality in terms of outliers, measurement error, non-normality, and variance heterogeneity. Robust methods of analysis (e.g., Huber-White robust standard errors) will be used, as appropriate. For all multi-item measures, reliability will be evaluated prior to computation of the variable.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19 Behavioral Prophylaxis
Keywords
misinformation, trust, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Although this is, in practice, a double-blind study since participants will be unaware that they are randomized and all study mechanics will be processed by computer, analysts will not be blinded to the meaning of the assignment variable. However, two independent consultant analysts have been retained to verify all results and subsequent interpretation.
Allocation
Randomized
Enrollment
1017 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Intervention arm
Arm Type
Experimental
Arm Description
The primary intervention in this study will be an infographic that is designed to build trust in the scientific process (as described in the Intervention section). This arm will introduce the intervention and then instruct the participant to review it carefully (including a mandated pause on the infographic screen) before continuing to the remaining data collection.
Arm Title
Placebo Control arm
Arm Type
Placebo Comparator
Arm Description
The comparator in this study will be a control ("placebo") infographic that is completely unrelated to science (As described in the Placebo Control section). This arm will introduce the control infographic and then instruct the participant to review it carefully (including a mandated pause on the infographic screen) before continuing to the remaining data collection.
Intervention Type
Behavioral
Intervention Name(s)
Brief informational infographic
Intervention Description
The primary intervention in this study will be an infographic that is designed to build trust in the scientific process. Infographics are preferable to narratives or text because they center visuals as part of the storytelling process and facilitate cognitive information processing, knowledge absorption, and enhanced persuasion. The study's infographic design will follow best practices in health communication. The message will be simple and jargon free. Visuals will include individuals (scientists), charts, text, and numbers. Attention will be paid to images, color, frames, representation, and composition (e.g., how the elements in the infographic are organized to show their relationship to each other).
Intervention Type
Behavioral
Intervention Name(s)
Placebo control (non-behavioral infographic)
Intervention Description
The comparator in this study will be a control ("placebo") infographic that is completely unrelated to science (e.g., about cats), but that is developed using the same communication and graphical style.
Primary Outcome Measure Information:
Title
Change in trust in science
Description
21-item scale developed by Nadelson et al [1] called the Trust in Science Inventory. It is scored from 1 to 5, where 1 indicates low trust and 5 indicates high trust.
Time Frame
Pre-intervention and immediately post-intervention
Title
Believability profiles
Description
Will be computed using latent profile analysis of believability measures. These measures were developed and first used in our recent study of COVID-19 narratives [2]. Response options for these measures used well-established semantic differential responses for believability of different statements (e.g., as in Herzberg et al.) [3] ranging from [1: Extremely unbelievable] to [7: Extremely believable]. Exact measures used to generate profiles for this study will be available in the published protocol paper (to be submitted).
Time Frame
Immediately post-intervention
Title
Preventive behavioral intentions
Description
A series of six questions based on the US Centers for Disease Control and Prevention's recommended COVID-19 preventive behaviors. [4] Questions will be written according to Azjen's guide to intention questionnaires [5].
Time Frame
Immediately post-intervention
Other Pre-specified Outcome Measures:
Title
Political orientation (covariate 1)
Description
Scale variable (0: Conservative to 10: Liberal) as in our prior work [2, 6]
Time Frame
Immediately post-intervention
Title
Religious commitment (covariate 2)
Description
Scale variable (0: Low commitment to 10: High commitment) as in our prior work [2, 6]
Time Frame
Immediately post-intervention
Title
Sociodemographics (covariates 3 through 6)
Description
Race/ethnicity, gender, age, and education level using standardized questions
Time Frame
Immediately post-intervention
Title
COVID-19 diagnosis (covariates 7 and 8)
Description
Two self report questions. The first asks whether the respondent has been diagnosed with COVID-19, and the second asks more broadly whether the respondent believes they have had COVID-19. Question wording will be per Bruine de Bruin (2020) [7].
Time Frame
Immediately post-intervention
Title
Perceived severity of COVID-19 (covariate 9)
Description
Based on the Health Belief Model as used in Yıldırıma & Gülerc [8].
Time Frame
Immediately post-intervention
Title
Self-efficacy to act regarding COVID-19
Description
Based on the Health Belief Model as used in Yıldırıma & Gülerc [8].
Time Frame
Immediately post-intervention
Title
Normative beliefs about friends' and family's COVID-19 behaviors
Description
Single item from Chambon et al [9].
Time Frame
Immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: To be included, participants must be identified by Prolific as part of a nationally-representative sample. Participants will also be required to be age 18 or older, and to reside in the United States. Exclusion Criteria: Individuals who decline to digitally sign the informed consent document will be excluded and replaced. Per recent best practice recommendations for crowdsourced digital research, attention checks and screens for "bots" and international users with virtual private networks to mimic US internet protocol addresses will be embedded within the instruments, and failure of more than one attention check, or any bot/location check will result in subject exclusion and replacement.
Facility Information:
Facility Name
Digital Intervention (Prolific Study Panel)
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Fully de-identified data (full dataset) will be made available along with the publication of the primary results paper from this study.
IPD Sharing Time Frame
Fully de-identified data will be made available along with the publication of the primary results paper from this study.
Citations:
Citation
Nadelson L, Jorcyk C, Yang D, et al. I just don't trust them: The development and validation of an assessment instrument to measure trust in science and scientists. School Science and Mathematics. 2014;114(2):76-86.
Results Reference
background
Citation
Agley J, Xiao Y. Existence of differential belief profiles of COVID-19 narratives: The role of trust in science. Research Square. 2020;Preprint.
Results Reference
background
PubMed Identifier
22486595
Citation
Herzberg KN, Sheppard SC, Forsyth JP, Crede M, Earleywine M, Eifert GH. The Believability of Anxious Feelings and Thoughts Questionnaire (BAFT): a psychometric evaluation of cognitive fusion in a nonclinical and highly anxious community sample. Psychol Assess. 2012 Dec;24(4):877-91. doi: 10.1037/a0027782. Epub 2012 Apr 9.
Results Reference
background
Citation
CDC. How to protect yourself & others. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Published 2020. Accessed July 17, 2020.
Results Reference
background
Citation
Ajzen I. Theory of planned behavior questionnaire. Measurement Instrument Database for Social Science. https://www.midss.org/sites/default/files/tpb.construction.pdf. Published 2013. Accessed July 17, 2020.
Results Reference
background
PubMed Identifier
32405095
Citation
Agley J. Assessing changes in US public trust in science amid the COVID-19 pandemic. Public Health. 2020 Jun;183:122-125. doi: 10.1016/j.puhe.2020.05.004. Epub 2020 May 13.
Results Reference
background
PubMed Identifier
32470120
Citation
Bruine de Bruin W. Age Differences in COVID-19 Risk Perceptions and Mental Health: Evidence From a National U.S. Survey Conducted in March 2020. J Gerontol B Psychol Sci Soc Sci. 2021 Jan 18;76(2):e24-e29. doi: 10.1093/geronb/gbaa074.
Results Reference
background
PubMed Identifier
32673183
Citation
Yildirim M, Guler A. COVID-19 severity, self-efficacy, knowledge, preventive behaviors, and mental health in Turkey. Death Stud. 2022;46(4):979-986. doi: 10.1080/07481187.2020.1793434. Epub 2020 Jul 16.
Results Reference
background
Citation
Chambon M, Dalege J, Elberse JE, Harreveld Fv. A psychological network approach to factors related to preventive behaviors during pandemics: A European COVID-19 study. PsyArXiv. 2020:https://doi.org/10.31234/osf.io/es31245v.
Results Reference
background
PubMed Identifier
34581678
Citation
Agley J, Xiao Y, Thompson EE, Chen X, Golzarri-Arroyo L. Intervening on Trust in Science to Reduce Belief in COVID-19 Misinformation and Increase COVID-19 Preventive Behavioral Intentions: Randomized Controlled Trial. J Med Internet Res. 2021 Oct 14;23(10):e32425. doi: 10.2196/32425.
Results Reference
derived
PubMed Identifier
33175694
Citation
Agley J, Xiao Y, Thompson EE, Golzarri-Arroyo L. COVID-19 Misinformation Prophylaxis: Protocol for a Randomized Trial of a Brief Informational Intervention. JMIR Res Protoc. 2020 Dec 7;9(12):e24383. doi: 10.2196/24383.
Results Reference
derived

Learn more about this trial

Brief Informational Intervention for COVID-19 Misinformation Prophylaxis

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