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Brief Informational Intervention for COVID-19 Misinformation Prophylaxis

8 de febrero de 2021 actualizado por: Jon Agley, Indiana University

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

1017

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Indiana
      • Bloomington, Indiana, Estados Unidos, 47404
        • Digital Intervention (Prolific Study Panel)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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).
Comparador de placebos: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in trust in science
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Political orientation (covariate 1)
Periodo de tiempo: Immediately post-intervention
Scale variable (0: Conservative to 10: Liberal) as in our prior work [2, 6]
Immediately post-intervention
Religious commitment (covariate 2)
Periodo de tiempo: 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)
Periodo de tiempo: Immediately post-intervention
Race/ethnicity, gender, age, and education level using standardized questions
Immediately post-intervention
COVID-19 diagnosis (covariates 7 and 8)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Immediately post-intervention
Single item from Chambon et al [9].
Immediately post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de enero de 2020

Finalización primaria (Actual)

14 de enero de 2021

Finalización del estudio (Actual)

31 de enero de 2021

Fechas de registro del estudio

Enviado por primera vez

16 de septiembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2020

Publicado por primera vez (Actual)

21 de septiembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

8 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Fully de-identified data (full dataset) will be made available along with the publication of the primary results paper from this study.

Marco de tiempo para compartir IPD

Fully de-identified data will be made available along with the publication of the primary results paper from this study.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre COVID19 Behavioral Prophylaxis

Ensayos clínicos sobre Brief informational infographic

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