- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07859579
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT). (VaxNurse-RCT)
Nurses play an important role in providing vaccine information and supporting informed vaccination decisions.
This study will evaluate a digital educational intervention designed for registered nurses in Quebec. The intervention will provide education about vaccination, including immunology, epidemiology, vaccine communication, motivational interviewing, and responding to vaccine misinformation.
Registered nurses will be randomly assigned to either the intervention group or a control group. The study will examine whether the intervention improves vaccine confidence and vaccine communication compared with the control group.
Participants will complete questionnaires before and after the intervention, with follow-up assessments at 3 and 6 months. The study will assess vaccine hesitancy and changes in vaccine-related knowledge, communication skills, and vaccination recommendation practices.
The findings will help determine whether a digital educational intervention can support nurses in their vaccine-related communication and professional practice.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Vaccine hesitancy can influence vaccine acceptance and communication between healthcare professionals and the public. Registered nurses have an important role in vaccination, including providing information, addressing concerns, and recommending vaccination.
This study will evaluate a digital educational intervention designed to strengthen knowledge related to vaccines, confidence, and communication among registered nurses in Quebec. The intervention will complement existing immunization training of INSPQ. It will integrate content on immunology, epidemiology, motivational interviewing, vaccine communication, and responses to vaccine misinformation.
The study will use a randomized controlled design with two parallel groups. Participants will be randomly assigned to the digital educational intervention + immunization training of INSPQ or the control condition (the immunization training of INSPQ, only). The intervention will be evaluated using measurements collected before and after the intervention and during follow-up (3 months and 6 months).
The primary focus will be the effect of the intervention on vaccine hesitancy of nurses. Secondary aims will include vaccine recommendation practices, immunological and epidemiological knowledge, and vaccine communication competencies.
Questionnaires will also examine psychosocial determinants of vaccination attitudes and behaviors. The pilot phase preceding the randomized trial will support refinement of the intervention, questionnaires, study procedures, and measurement instruments.
The study aims to generate evidence on whether digital education can strengthen nurses' vaccine-related competencies and support their communication with patients and the public.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Saint-Jérôme, Canadá, J7Z 0B7
- Université du Québec en Outaouais
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Investigador principal:
- Philippe Corsenac, Ph.D.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Registered nurse authorized to practice in Quebec.
- Aged 18 years or older.
- Able to provide informed consent.
- Able to complete the study questionnaires in French or English and digital educational intervention in French.
Exclusion Criteria:
- Not currently authorized to practice as a registered nurse in Quebec.
- Unable to provide informed consent.
- Previous participation in the VaxNurse pilot study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Digital educational intervention + immunization training of INSPQ
Registered nurses assigned to this arm will receive the digital educational intervention in addition to the existing immunization training provided by the INSPQ. The digital intervention will include immunology, epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation. |
The VaxNurse digital educational intervention is designed for registered nurses. It includes educational content on immunology and epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation. The intervention aims to reduce vaccine hesitancy and strengthen knowledge related to vaccine, confidence, communication skills, and recommendation practices. It complements existing immunization training provided by the INSPQ. |
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Experimental: Control
Registered nurses assigned to this arm will receive the existing immunization training provided by the INSPQ without the additional digital educational intervention. |
The VaxNurse digital educational intervention is designed for registered nurses. It includes educational content on immunology and epidemiology, motivational interviewing, vaccine communication, and strategies for responding to vaccine misinformation. The intervention aims to reduce vaccine hesitancy and strengthen knowledge related to vaccine, confidence, communication skills, and recommendation practices. It complements existing immunization training provided by the INSPQ. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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the Vaccine Hesitancy Scale (VHS)
Periodo de tiempo: Baseline (T0), immediately post-intervention (Ti), 3 months, and 6 months
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Vaccine hesitancy will be assessed using the Vaccine Hesitancy Scale (VHS). The total score ranges from 10 to 50, with higher scores indicating greater vaccine hesitancy. Change from baseline will be compared between the intervention and control groups across follow-up assessments. |
Baseline (T0), immediately post-intervention (Ti), 3 months, and 6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Philippe Corsenac, Ph.D., Université du Québec en Outaouais
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDC-453
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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