- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sarah Huf, MBBS PhD
- Numero di telefono: 07496632732
- Email: s.huf@imperial.ac.uk
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Arm 1 - Control SMS
Control (current practice) text message invitation
|
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
|
|
Sperimentale: Arm 2 - Behavioural Science informed SMS content
Experimental text message invitation
|
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
COVID-19 vaccination uptake at 3 weeks
Lasso di tempo: 3 weeks from invitation text message
|
COVID-19 vaccination uptake at 3 weeks
|
3 weeks from invitation text message
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
COVID-19 vaccination uptake at 8 weeks
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Sarah Huf, MBBS PhD, Imperial College Health Care Trust
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 21SM6815
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Covid19
-
Anavasi DiagnosticsNon ancora reclutamento
-
Ain Shams UniversityReclutamento
-
Israel Institute for Biological Research (IIBR)Completato
-
Colgate PalmoliveCompletato
-
Christian von BuchwaldCompletato
-
Luye Pharma Group Ltd.Shandong Boan Biotechnology Co., LtdAttivo, non reclutante
-
University of ZurichLabor Speiz; Swiss Armed Forces; Universitatsspital ZurichIscrizione su invito
-
Alexandria UniversityCompletato
Prove cliniche su Text message content
-
Fundació d'investigació Sanitària de les Illes...CompletatoDiabete mellito, tipo 2Spagna
-
The University of Hong KongNon ancora reclutamentoIntervento | ControlloHong Kong
-
Fundació d'investigació Sanitària de les Illes...CompletatoStato prediabeticoSpagna
-
Washington University School of MedicineNovartis; National Comprehensive Cancer NetworkNon ancora reclutamentoCancro al seno | Cancro al senoStati Uniti
-
Taipei Medical UniversityCompletato
-
Fundació d'investigació Sanitària de les Illes...CompletatoDiabete mellito, tipo 2Spagna
-
Scripps Whittier Diabetes InstituteReclutamentoDiabete di tipo 2Stati Uniti
-
Brooke Army Medical CenterUniversity of Colorado, DenverCompletatoOstruzione delle vie aeree | Intubazione; Difficile o fallitoStati Uniti
-
Yale UniversityCompletatoCancro al seno | Aderenza, Farmaco | Effetto collateraleStati Uniti
-
Boston UniversityNational Cancer Institute (NCI); Brown University; National Institutes of Health... e altri collaboratoriCompletato