InfluenzaTXT4FLUJABNCT01892631
Text Messaging Reminders for Influenza Vaccine in Primary Care
A study testing Text message influenza vaccination reminder in people with Influenza, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza
- What is being tested?
- Text message influenza vaccination reminder
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- practices will not send the text message to pregnant women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, Select County, WC1E 7HT
About this study
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.
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.
- Conditions
- Influenza
- Being tested
- Text message influenza vaccination reminder, Standard care
- Keywords
- Text messaging
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message influenza vaccination reminderOther
Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
Standard careOther
Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Other | Practices in the standard care arm will proceed with their seasonal influenza campaign as planned. Receives: Other: Standard care |
| Text messaging intervention | Experimental | Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza. Receives: Other: Text message influenza vaccination reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients at risk who received flu vaccine
Measured: up to 9 months
Secondary outcomes (4)
Proportion of practices reporting 'yes' to difficulties
Proportion of practices reporting 'yes' that they had difficulties in sending the text message to patients
Measured: up to 3 months
Recruitment rate
This is a pilot feasibility study and recruitment of practices to the trial is an outcome.
Measured: 3 months after initial contact
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.
Measured: One month after study start (October 1st 2013)
Were outcome data available
Were outcome data regarding text message and flu vaccine uptake available.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Health Service, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892631
- Sponsor's protocol ID
- txt4flujab
- Acronym
- TXT4FLUJAB
- Status last verified
- Dec 2015
- First submitted
- 13 Jun 2013
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01892631
- Acronym / sponsor ID
- TXT4FLUJAB / txt4flujab
- Conditions
- Influenza
- Keywords
- Text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Health Service, United Kingdom
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Other | Other: Standard carePractices in the standard care arm will proceed with their seasonal influenza campaign as planned. |
| Text messaging intervention | Experimental | Other: Text message influenza vaccination reminderPractices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- practices will not send the text message to pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message influenza vaccination reminderPractices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza. | Other | Text messaging intervention |
| Standard carePractices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned. | Other | Standard care |
Primary outcome
Proportion of patients at risk who received flu vaccine
Time frame: up to 9 months
4 secondary outcomes
Proportion of practices reporting 'yes' to difficulties
Time frame: up to 3 months
Recruitment rate
Time frame: 3 months after initial contact
Practice delivery of text message
Time frame: One month after study start (October 1st 2013)
Were outcome data available
Time frame: up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message influenza vaccination reminder in people with Influenza, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients at risk who received flu vaccine (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.