- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04895683
Using Text Messages to Improve COVID-19 Vaccination Uptake
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sarah Huf, MBBS PhD
- Numéro de téléphone: 07496632732
- E-mail: s.huf@imperial.ac.uk
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Arm 1 - Control SMS
Control (current practice) text message invitation
|
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
|
Expérimental: Arm 2 - Behavioural Science informed SMS content
Experimental text message invitation
|
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
COVID-19 vaccination uptake at 3 weeks
Délai: 3 weeks from invitation text message
|
COVID-19 vaccination uptake at 3 weeks
|
3 weeks from invitation text message
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
COVID-19 vaccination uptake at 8 weeks
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sarah Huf, MBBS PhD, Imperial College Health Care Trust
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21SM6815
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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