- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557241
Brief Informational Intervention for COVID-19 Misinformation Prophylaxis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47404
- Digital Intervention (Prolific Study Panel)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Intervention arm
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 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 Comparator: Placebo Control arm
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in trust in science
Time Frame: Pre-intervention and immediately post-intervention
|
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
|
|
Believability profiles
Time Frame: Immediately post-intervention
|
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
|
|
Preventive behavioral intentions
Time Frame: Immediately post-intervention
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Political orientation (covariate 1)
Time Frame: Immediately post-intervention
|
Scale variable (0: Conservative to 10: Liberal) as in our prior work [2, 6]
|
Immediately post-intervention
|
|
Religious commitment (covariate 2)
Time Frame: Immediately post-intervention
|
Scale variable (0: Low commitment to 10: High commitment) as in our prior work [2, 6]
|
Immediately post-intervention
|
|
Sociodemographics (covariates 3 through 6)
Time Frame: Immediately post-intervention
|
Race/ethnicity, gender, age, and education level using standardized questions
|
Immediately post-intervention
|
|
COVID-19 diagnosis (covariates 7 and 8)
Time Frame: Immediately post-intervention
|
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
|
|
Perceived severity of COVID-19 (covariate 9)
Time Frame: Immediately post-intervention
|
Based on the Health Belief Model as used in Yıldırıma & Gülerc [8].
|
Immediately post-intervention
|
|
Self-efficacy to act regarding COVID-19
Time Frame: Immediately post-intervention
|
Based on the Health Belief Model as used in Yıldırıma & Gülerc [8].
|
Immediately post-intervention
|
|
Normative beliefs about friends' and family's COVID-19 behaviors
Time Frame: Immediately post-intervention
|
Single item from Chambon et al [9].
|
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- Agley J, Xiao Y. Existence of differential belief profiles of COVID-19 narratives: The role of trust in science. Research Square. 2020;Preprint.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Indiana_CTSI_Agley_2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID19 Behavioral Prophylaxis
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); University of Witwatersrand, South...CompletedDepression | Pre-Exposure ProphylaxisSouth Africa
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Merck Sharp & Dohme LLCRecruitingCytomegalovirus ProphylaxisUnited States
-
Rutgers, The State University of New JerseyEnrolling by invitationAntibiotic Prophylaxis SurgeryUnited States
-
Aswan UniversityRecruitingPost Exposure ProphylaxisEgypt
-
Penn State UniversityCompleted
-
Fenway Community HealthHarvard UniversityCompletedPre-Exposure ProphylaxisUnited States
-
Poitiers University HospitalCompletedAntibiotic Prophylaxis SurgeryFrance
-
GlaxoSmithKlineCompleted
-
Johann Wolfgang Goethe University HospitalUnknownAnticoagulant Prophylaxis/TherapyGermany
Clinical Trials on Brief informational infographic
-
The Miriam HospitalNational Institute of Mental Health (NIMH); University of Rochester; Syracuse...CompletedHIV Infections | Sexually Transmitted DiseasesUnited States
-
University Paul Sabatier of ToulouseInstitut Claudius Regaud; National Cancer Institute, France; Réseau Onco-Occitanie and other collaboratorsRecruitingBreast CancerFrance
-
Syracuse UniversityCompleted
-
University of MalagaCompletedElite Basketball AthletesSpain
-
Columbia UniversityNational Institute of Nursing Research (NINR)CompletedHealth CommunicationDominican Republic
-
Columbia UniversityNational Institute of Nursing Research (NINR)CompletedHealth CommunicationUnited States
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA); University of Stellenbosch and other collaboratorsCompletedFetal Alcohol Spectrum DisordersSouth Africa
-
Lady Davis InstituteNot yet recruitingSystemic Sclerosis | Scleroderma
-
University of WashingtonPatient-Centered Outcomes Research Institute; National Institutes of Health...Completed
-
London School of Hygiene and Tropical MedicineNot yet recruiting