- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01892631
Text Messaging Reminders for Influenza Vaccine in Primary Care (TXT4FLUJAB)
A Feasibility Study for a Cluster Randomised Trial of Text Messaging Reminders for Influenza Vaccine in Patients Under 65 in Clinical Risk Groups in English Primary Care.
Influenza morbidity and mortality cause a substantial financial burden to the NHS and to the UK as a whole. Influenza vaccine is safe and effective but is required annually because the circulating strain of virus changes each year. In the UK in 2012, the Chief Medical Officer (CMO) recommended that at least 75% of elderly people (aged 65+) and 75% people under 65 with certain chronic conditions (e.g. chronic heart disease, diabetes, asthma, etc) should be vaccinated. While primary care practices are achieving these targets for elderly patients, those set for younger patients with chronic conditions are not being met, with a third of patients being missed in the 2011/12 flu season and with no substantial improvements in uptake in the past decade. Therefore strategies to increase flu vaccine uptake in these patients are required.
Previous trials have shown that patient reminders can increase vaccine uptake and in particular, text messaging has shown to work in some populations in the United States as a cheap, simple and effective reminder. However, whether the same is true in UK general practice is unclear. The use of text messaging in the NHS for appointment reminders is also increasing as it is cheap, quick and effective. Text messaging is already used in roughly 30% of practices to remind patients about their flu vaccine but there has been no trial addressing its effectiveness. Therefore, we propose a trial of a text messaging flu vaccine reminder in patients aged under 65 who have a chronic condition. We hypothesise that practices that send a text message will have increased flu vaccine uptake.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Select county
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London, Select county, Reino Unido, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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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:
- practices must use text messaging software to communicate with patients;
- practices must not have used a text message to remind patients aged under 65 about influenza vaccine in the 2012/13 influenza season.
- practices will send the text message to eligible patients who are aged between 18 and 65, with one of the following risk conditions: chronic respiratory disease, chronic liver disease, chronic kidney disease, chronic heart disease, chronic neurological disease, immunosuppression
Exclusion Criteria:
- practices will not send the text message to pregnant women.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Standard care
Practices in the standard care arm will proceed with their seasonal influenza campaign as planned.
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Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.
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Experimental: Text messaging intervention
Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
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Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Proportion of patients at risk who received flu vaccine
Periodo de tiempo: up to 9 months
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up to 9 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of practices reporting 'yes' to difficulties
Periodo de tiempo: up to 3 months
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Proportion of practices reporting 'yes' that they had difficulties in sending the text message to patients
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up to 3 months
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Recruitment rate
Periodo de tiempo: 3 months after initial contact
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This is a pilot feasibility study and recruitment of practices to the trial is an outcome.
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3 months after initial contact
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Practice delivery of text message
Periodo de tiempo: One month after study start (October 1st 2013)
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Did the practice send the text message to eligible patients and was the content of the message as described in the protocol.
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One month after study start (October 1st 2013)
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Were outcome data available
Periodo de tiempo: up to 9 months
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Were outcome data regarding text message and flu vaccine uptake available.
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up to 9 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- txt4flujab
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. .