- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892631
Text Messaging Reminders for Influenza Vaccine in Primary Care (TXT4FLUJAB)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Select county
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London, Select county, United Kingdom, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard care
Practices in the standard care arm will proceed with their seasonal influenza campaign as planned.
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Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.
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Experimental: Text messaging intervention
Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
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Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients at risk who received flu vaccine
Time Frame: up to 9 months
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up to 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of practices reporting 'yes' to difficulties
Time Frame: up to 3 months
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Proportion of practices reporting 'yes' that they had difficulties in sending the text message to patients
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up to 3 months
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Recruitment rate
Time Frame: 3 months after initial contact
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This is a pilot feasibility study and recruitment of practices to the trial is an outcome.
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3 months after initial contact
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Practice delivery of text message
Time Frame: One month after study start (October 1st 2013)
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Did the practice send the text message to eligible patients and was the content of the message as described in the protocol.
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One month after study start (October 1st 2013)
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Were outcome data available
Time Frame: up to 9 months
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Were outcome data regarding text message and flu vaccine uptake available.
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up to 9 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- txt4flujab
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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