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Using Text Messages to Improve COVID-19 Vaccination Uptake

20 de mayo de 2021 actualizado por: Imperial College Healthcare NHS Trust

Can Behavioural-science Informed Text Messages Improve COVID-19 Vaccination Uptake in North West London? A RCT

COVID-19 vaccinations significantly reduce the risk of getting seriously ill or dying from COVID-19. Since December 2020, the UK has rolled out vaccinations according to the Joint Committee for Vaccinations and Immunity (JCVI) priority groups. However, despite data indicating that more than 90% of the UK population intends to get vaccinated, there are geographical and ethnic variations in vaccination acceptance. As younger cohorts with lower risk from COVID-19 become eligible for vaccination, it is expected that uptake rates may also be lower than they have been in previous cohorts.

It was recently announced that a national NHS text message service will be introduced to invite individuals eligible for the COVID-19 vaccine to book a vaccination appointment. Many GP practices and CCGs have already implemented text messages to invite eligible residents and patients for the vaccine.

However, recent research has shown that the message content of text messages inviting members of the public to other preventative health opportunities (e.g. personalised messages and GP-endorsements in cancer screening) can impact uptake.

This 3-arm randomised controlled trial will be conducted across the Central London (CL) Clinical Commissioning Group (CCG) which to-date has seen the lowest rates of COVID-19 vaccination uptake in the country. The study aims to investigate the most effective text message strategy to inform local, regional and national practice.

The intervention text message content to be tested is informed by behavioural science theory is personalised to include the recipient's name and GP practice name. All patients in the Central London CCG who are unvaccinated, aged 18-49, who have not declined the vaccine will be included as their cohort becomes eligible for vaccination according to the JCVI guidelines. The trial will compare the uptake of the COVID-19 vaccination by trial arm at 3 and 8 weeks after the intervention is deployed.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The COVID-19 vaccine is an effective way to reduce morbidity and mortality from COVID-19. Increasing uptake of the COVID-19 vaccine is a major public health priority. People's willingness to receive the COVID- 19 vaccine in the UK has been at record highs - 9 in 10 people said they would receive it when the NHS notifies them that it is their turn. However, evidence suggests that willingness to get vaccinated is lower amongst younger age groups and BAME populations. Additionally, high willingness to be vaccinated may not translate into high uptake, particularly as the vaccine rollout extends to younger, less vulnerable cohorts.

Uptake of the COVID-19 vaccine may be influenced by many factors, including personal beliefs such as perceived low personal risk from COVID-19, perceived social and cultural norms or a concerns around vaccine safety or efficacy. Additionally, process barriers, such as the effort required to attend an appointment may reduce vaccine uptake. With more than 95% of UK households having a mobile phone, text messages can be an effective way to improve uptake of healthcare services and medicine adherence. In particular, recent research has shown that reminder text messages about flu vaccination appointments can improve uptake by up to 10%, and that some messages may be more effective for specific groups. However, more research is needed to maximise the effectiveness of messages to increase uptake of the COVID-19 vaccine specifically and to explore how the effectiveness of messaging differs across different age and ethnicity groups.

The proposed research will determine which message strategy increases COVID-19 vaccine vaccination rates in the cohort aged between 18 and 49 years old as they become eligible for the vaccine according to JCVI categories.

During the trial, each cohort that newly becomes eligible to be vaccinated will be randomised to one of the five trial text message strategies.

The trial arms will include the current practice text message invitation which will act as the control and four intervention trial arms. The intervention text message strategies and message content have been based on behavioural science theory.

The usual care team will deploy the text messages according to the trial arm allocation. The vaccination status will be recorded in the patients electronic health record (EHR) as per usual practice. Researchers will have access to the pseudonymised datasets through a secure data platform which only holds pseudonomised data (see data Study Procedure section).

Analysis will measure and compare the vaccination uptake across trial arms.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120000

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.

Estudio Contacto

  • Nombre: Sarah Huf, MBBS PhD
  • Número de teléfono: 07496632732
  • Correo electrónico: s.huf@imperial.ac.uk

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 a 49 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Residents registered with a GP practice in the Central London (Westminster) Clinical Commissioning Group (CCG)
  • Age 18-49
  • Not previously invited for COVID-19 vaccination

Exclusion Criteria:

  • Patients who have notified their GP that they wish to decline the COVID-19 vaccination.
  • Patients' whose medical records report a severe allergy to medicines (as per the JCVI guidance)

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm 1 - Control SMS
Control (current practice) text message invitation
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
Experimental: Arm 2 - Behavioural Science informed SMS content
Experimental text message invitation
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
Experimental: Arm 3 - Pre-alert and behavioural science informed SMS content
Two text messages, including a pre-alert SMS and the text message intervention in trial arm 2.
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
COVID-19 vaccination uptake at 3 weeks
Periodo de tiempo: 3 weeks from invitation text message
COVID-19 vaccination uptake at 3 weeks
3 weeks from invitation text message

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
COVID-19 vaccination uptake at 8 weeks
Periodo de tiempo: 8 weeks from invitation text message
COVID-19 vaccination uptake at 8 weeks
8 weeks from invitation text message
COVID-19 vaccination uptake by demographics
Periodo de tiempo: 3 and 8 weeks
Exploratory analysis of COVID-19 vaccination uptake by demographics (age, gender, IMD decile, ethnicity, previous flu vaccination)
3 and 8 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Sarah Huf, MBBS PhD, Imperial College Health Care Trust

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 (Anticipado)

11 de mayo de 2021

Finalización primaria (Anticipado)

31 de diciembre de 2021

Finalización del estudio (Anticipado)

11 de mayo de 2022

Fechas de registro del estudio

Enviado por primera vez

17 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

17 de mayo de 2021

Publicado por primera vez (Actual)

20 de mayo de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de mayo de 2021

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

20 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

The data is only available through the WSIC dataset through a de-identified dataset platform. The get access to this platform, researchers would need to get approval through the usual process to be able to access the data. The de-identified dataset cannot be exported from this trusted research environment.

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 COVID-19

Ensayos clínicos sobre Text message content

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