Text Messaging Reminders for Influenza Vaccine in Primary Care

Influenza Clinical Trial

— TXT4FLUJAB  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892631
• Other study ID #: txt4flujab
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: October 21, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Other:
• Text message influenza vaccination reminder
Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
• Standard care
Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London	Select county

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	National Health Service, United Kingdom, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients at risk who received flu vaccine		up to 9 months	No
Secondary	Proportion of practices reporting 'yes' to difficulties	Proportion of practices reporting 'yes' that they had difficulties in sending the text message to patients	up to 3 months	No
Secondary	Recruitment rate	This is a pilot feasibility study and recruitment of practices to the trial is an outcome.	3 months after initial contact	No
Secondary	Practice delivery of text message	Did the practice send the text message to eligible patients and was the content of the message as described in the protocol.	One month after study start (October 1st 2013)	No
Secondary	Were outcome data available	Were outcome data regarding text message and flu vaccine uptake available.	up to 9 months	No