InfluenzaNCT02284594
Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts
A study testing text message in people with Influenza, run by Columbia University at 1 site in United States.
Trial summary
Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- text message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,026 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > or = 18 years of age
- at least one visit to the AIM clinic during previous 6 months
- a cell phone number in the registration system
- fluent in English or Spanish
Who cannot join
- Receipt of influenza vaccination during the 2014-2015 influenza season prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center/ NewYork Presbyterian Hospital Ambulatory Care Network
New York, New York, 10032
About this study
Influenza infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.
- Conditions
- Influenza
- Being tested
- text message
- 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 messageBehavioural
series of text messages regarding influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| text message | Experimental | Receipt of series of text messages regarding influenza vaccination Receives: Behavioral: text message |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza vaccination
receipt of influenza vaccine
Measured: up to 5 months
Secondary outcomes (2)
influenza vaccination
receipt of influenza vaccine
Measured: up to 2 months
captured opportunity
receipt of influenza vaccination during a visit
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 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.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Stockwell, MD, MPH, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284594
- Sponsor's protocol ID
- AAAK5058_3
- Status last verified
- May 2015
- First submitted
- 3 Nov 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Influenza Vaccination Text Message Reminders With Electronic Health Record Alerts
- ClinicalTrials.gov ID
- NCT02284594
- Acronym / sponsor ID
- AAAK5058_3
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,026 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Nov 2014 (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 infection leads to on average 3000-49,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population. We will also assess if the patient having received a text message makes the patient more likely to accept vaccination when their provider has received in electronic alert regarding need for influenza vaccination in the electronic health record.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| text message | Experimental | Behavioral: text messageReceipt of series of text messages regarding influenza vaccination |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > or = 18 years of age
- at least one visit to the AIM clinic during previous 6 months
- a cell phone number in the registration system
- fluent in English or Spanish
Key exclusion criteria (1 listed)
- Receipt of influenza vaccination during the 2014-2015 influenza season prior to randomization
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 messageseries of text messages regarding influenza vaccination | Behavioural | text message |
Primary outcome
influenza vaccination
Time frame: up to 5 months
receipt of influenza vaccine
2 secondary outcomes
influenza vaccination
Time frame: up to 2 months
captured opportunity
Time frame: up to 5 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 19 May 2015.
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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.
Melissa Stockwell, MD MPH principal investigator
Columbia University
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 in people with Influenza, run by Columbia University at 1 site in United States.
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 4 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 19 May 2015. 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 States. 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?
influenza vaccination (time frame: up to 5 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 19 May 2015.