Brief Informational Intervention for COVID-19 Misinformation Prophylaxis

COVID19 Behavioral Prophylaxis Clinical Trial

Official title:

Brief Informational Intervention for COVID-19 Misinformation Prophylaxis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557241
• Other study ID #: Indiana_CTSI_Agley_2020
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1017
• Est. completion date: January 31, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID19 Behavioral Prophylaxis

Intervention

Behavioral:
• Brief informational infographic
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).
• Placebo control (non-behavioral infographic)
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.

Locations

Country	Name	City	State
United States	Digital Intervention (Prolific Study Panel)	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute

Country where clinical trial is conducted

United States, 

References & Publications (9)

Agley J, Xiao Y. Existence of differential belief profiles of COVID-19 narratives: The role of trust in science. Research Square. 2020;Preprint.

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. — View 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.

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. — View 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.

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.

Herzberg KN, Sheppard SC, Forsyth JP, Credé 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. — View 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.

Yildirim M, Güler A. COVID-19 severity, self-efficacy, knowledge, preventive behaviors, and mental health in Turkey. Death Stud. 2020 Jul 16:1-8. doi: 10.1080/07481187.2020.1793434. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Political orientation (covariate 1)	Scale variable (0: Conservative to 10: Liberal) as in our prior work [2, 6]	Immediately post-intervention
Other	Religious commitment (covariate 2)	Scale variable (0: Low commitment to 10: High commitment) as in our prior work [2, 6]	Immediately post-intervention
Other	Sociodemographics (covariates 3 through 6)	Race/ethnicity, gender, age, and education level using standardized questions	Immediately post-intervention
Other	COVID-19 diagnosis (covariates 7 and 8)	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].	Immediately post-intervention
Other	Perceived severity of COVID-19 (covariate 9)	Based on the Health Belief Model as used in Yildirima & Gülerc [8].	Immediately post-intervention
Other	Self-efficacy to act regarding COVID-19	Based on the Health Belief Model as used in Yildirima & Gülerc [8].	Immediately post-intervention
Other	Normative beliefs about friends' and family's COVID-19 behaviors	Single item from Chambon et al [9].	Immediately post-intervention
Primary	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.	Pre-intervention and immediately post-intervention
Primary	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).	Immediately post-intervention
Primary	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].	Immediately post-intervention