COVID-19 Preventive Behavior in African Americans
2 de noviembre de 2021 actualizado por: Johns Hopkins University
Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans
The Center Disease Control has published a set of guidelines to contain the spread of the virus, since it is known to spread from person-to-person.
Given the vaccine and specific antiviral treatment for Coronavirus disease (COVID-19) remain under development and will take months or years to develop, intermittent and sustained preventive behaviors may be needed into 2022 unless effective treatments or vaccines are developed.
Thus, effectively implementing preventive behaviors remains a critical step in bringing the pandemic under long-term control.
Leveraging the ecological momentary assessment (EMA) method developed in the parent R01 for smartphones, which allows for real-time data collection on individual's behaviors, the investigators propose a prospective single arm and longitudinal study to examine the effectiveness of self-monitoring EMA (SM-EMA) in promoting adherence to COVID-19 preventative behaviors.
SM-EMA users will download the smartphone app which includes: (1) instructional videos to provide knowledge of preventative behaviors; (2) self-monitoring of preventative behaviors during intervention and follow-up phases; (3) tailored-feedback messages to encourage preventative behaviors; and (4) mobile-enabled website to provide an interactive learning platform.
If proven efficacious, this intervention could be efficiently disseminated to reach the larger public and foster preventive behaviors into self-management as effective strategies for long-term control of the COVID-19 pandemic.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Given the vaccine and specific antiviral treatment for COVID-19 will take months or years to develop and finalize, preventive behaviors remain the most effective strategy thus far and may be needed until 2022 to control the pandemic.
African Americans, who have 3-fold higher infection rate and 6-fold higher death rate compared to the white counterparts, are an especially vulnerable population to COVID-19.
Immediately initiating a project that promotes and maximizes adherence to preventative behaviors is vital to addressing the ongoing COVID-19 pandemic.
The investigators propose a prospective single arm and longitudinal study to examine the effectiveness of SM-EMA in promoting adherence to COVID-19 preventative behaviors.
The intervention will include two daily pop-up messages during Week 1 (one in the morning and one in the afternoon), one daily pop-message in Week 2, and two pop-up messages a week in Weeks 3 and 4. The duration for the intervention will be four weeks.
The study outcomes will be collected at baseline (pre-intervention, T1), post-(completion of the intervention, T2, primary endpoint), and monthly follow-up for three months (T3-T5).
The total study duration will be four months.
Tipo de estudio
Intervencionista
Inscripción (Actual)
250
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
-
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins School of Nursing
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-
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
60 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- African American aged 60 or older
- Able to read and write English
- Willing to commit to use the smartphone app with the pop-up messages and then four follow-up surveys (total four months).
Exclusion Criteria:
- No children or others aged 59 years or younger
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sm-EMA
Participants will receive the Self-monitoring ecological momentary assessment behavior change tool.
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Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e.
COVID-19 preventative behaviors).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Knowledge Test score as assessed by a questionnaire
Periodo de tiempo: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
It is a measure of one's knowledge of COVID-19 preventative behaviors, with a score range of 0-18, higher scores indicating better knowledge.
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Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
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Change in Self-efficacy as assessed by self-efficacy questionnaire
Periodo de tiempo: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
It is a measure of one's belief that they will be successful in reaching a behavior goal, with 6-items of questionnaire, with a score of 0-60, higher score indicating higher level of self-efficacy.
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Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
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Change in preventive Behavior Score
Periodo de tiempo: Pre-intervention, Daily during intervention week 1 and bi-weekly during intervention weeks 3-4, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
It is a measure of one's adherence to COVID-19 preventative behaviors, with a score range 0-18, higher score indicating worsening preventive behaviors.
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Pre-intervention, Daily during intervention week 1 and bi-weekly during intervention weeks 3-4, Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
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Change in System Usability Scale (SUS) score
Periodo de tiempo: Immediately Post-intervention
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It is used to assess the global view of the participant's assessment about usability of SM-EMA, with a score of 1-7, higher score indicting more useable for the app.
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Immediately Post-intervention
|
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Change in Global Impression of Change as assessed by a questionnaire
Periodo de tiempo: Immediately Post-intervention, 1, 2, and 3 months Post-intervention
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It is a single item used to assess the participant's perceived behavior change, with a score of 1-7, higher score indicating better global impression of change.
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Immediately Post-intervention, 1, 2, and 3 months Post-intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chao Hsing Yeh, PhD, Johns Hopkins School of Nursing
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)
5 de febrero de 2021
Finalización primaria (Actual)
30 de octubre de 2021
Finalización del estudio (Actual)
30 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
6 de enero de 2021
Primero enviado que cumplió con los criterios de control de calidad
6 de enero de 2021
Publicado por primera vez (Actual)
7 de enero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
2 de noviembre de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00250644
- 3R01AG056587-03S1 (Subvención/contrato del NIH de EE. UU.)
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
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