InfluenzaNCT01146912
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations
A study testing Text Message and automated call in people with Influenza, run by Columbia University at 1 site in United States.
Trial summary
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Read more about this study
- Who is it for?
- Ages 6 months to 50 years
- Conditions the study is for
- Influenza
- What is being tested?
- Text Message and automated call
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30,537 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Inclusion criteria Parents (2010-2011 and 2011-2012 influenza seasons)
- Children aged 6 months to 18 years at the beginning of current influenza season
- Children with one previous visit at participating pediatric community health center in last year
- Parent with cell phone number in registry
Pregnant women Pilot (2010-2011 influenza seasons)
- Pregnant women who will be in their 2nd or 3rd trimester during the influenza season
- Own a cell phone with text message capability
Randomized controlled Trial (2011-2012 influenza seasons)
- Pregnant and will be in their 2nd or 3rd trimester during the influenza season
- Cell phone number in registry
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Population
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Nevertheless, targeting and mobilizing these populations has been difficult and influenza immunization rates nationwide remain low. Immunization reminder-recalls have been shown to be effective, but have had limited ability to rapidly identify and reach large target populations in a cost-effective manner. Evidence on how to optimally design these systems is not yet available and thus text message immunization alerts have not been widely implemented. The investigators propose to implement and evaluate tailored, targeted influenza text message reminders in urban pediatric and pregnant populations.
- Conditions
- Influenza
- Being tested
- Text Message, automated call
- Keywords
- Influenza, text message, vaccination
- 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 MessageOther
Also called Health services
Text message vaccine reminders
automated callOther
Also called Health services
Automated call
| Study group | Role | What they receive |
|---|---|---|
| Text message vaccine reminders | Experimental | Receipt of text message vaccine reminders Receives: Other: Text Message; Other: automated call |
| automated phone call from clinic | Active comparator | Receipt of automated phone call from clinic Receives: Other: automated call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Immunization: Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2011
Measured: March 31, 2011
Influenza Immunization: Pregnant Women
percentage of pregnant participants with influenza immunization by December 31, 2011
Measured: by December 31, 2011
Influenza Immunization: Delayed Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2012
Measured: March 31, 2012
Secondary outcomes (2)
Pediatric: Vaccinated at Influenza Clinic
percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
Measured: March 31, 2011
Attendance at Appointment
percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011
Measured: September-December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30,537 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 S Stockwell, MD MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146912
- Sponsor's protocol ID
- AAAF0137
- Other IDs
- R40MC17169-01
- Status last verified
- Sep 2015
- First submitted
- 16 Jun 2010
- Last updated
- 7 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stockwell MS, Westhoff C, Kharbanda EO, Vargas CY, Camargo S, Vawdrey DK, Castano PM. Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):e7-12. doi: 10.2105/AJPH.2013.301620. Epub 2013 Dec 19.
PubMed 24354839Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502.
PubMed 22535855
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Population
- ClinicalTrials.gov ID
- NCT01146912
- Acronym / sponsor ID
- AAAF0137
- Conditions
- Influenza
- Keywords
- Influenza, text message, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30,537 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Nevertheless, targeting and mobilizing these populations has been difficult and influenza immunization rates nationwide remain low. Immunization reminder-recalls have been shown to be effective, but have had limited ability to rapidly identify and reach large target populations in a cost-effective manner. Evidence on how to optimally design these systems is not yet available and thus text message immunization alerts have not been widely implemented. The investigators propose to implement and evaluate tailored, targeted influenza text message reminders in urban pediatric and pregnant populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message vaccine reminders | Experimental | Other: Text Message, Other: automated callReceipt of text message vaccine reminders |
| automated phone call from clinic | Active comparator | Other: automated callReceipt of automated phone call from clinic |
Who may qualify
- Ages
- 6 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 MessageAlso: Health servicesText message vaccine reminders | Other | Text message vaccine reminders |
| automated callAlso: Health servicesAutomated call | Other | Text message vaccine reminders, automated phone call from clinic |
Primary outcome
Influenza Immunization: Pediatric
Time frame: March 31, 2011
percentage of pediatric participants with influenza immunization by March 31 of 2011
Influenza Immunization: Pregnant Women
Time frame: by December 31, 2011
percentage of pregnant participants with influenza immunization by December 31, 2011
Influenza Immunization: Delayed Pediatric
Time frame: March 31, 2012
percentage of pediatric participants with influenza immunization by March 31 of 2012
2 secondary outcomes
Pediatric: Vaccinated at Influenza Clinic
Time frame: March 31, 2011
Attendance at Appointment
Time frame: September-December 2011
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24354839Stockwell MS, Westhoff C, Kharbanda EO, Vargas CY, Camargo S, Vawdrey DK, Castano PM. Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):e7-12. doi: 10.2105/AJPH.2013.301620. Epub 2013 Dec 19.
- Derived from this study: PubMed 22535855Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502.
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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 S 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 and automated call 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?
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 7 Oct 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?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Immunization: Pediatric (time frame: March 31, 2011). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146912, which also lists 2 linked publications.
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 7 Oct 2015.