- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146912
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations
September 6, 2015 updated by: Melissa Stockwell, MD, MPH, Columbia University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30537
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Text message vaccine reminders
Receipt of text message vaccine reminders
|
Text message vaccine reminders
Other Names:
Automated call
Other Names:
|
Active Comparator: automated phone call from clinic
Receipt of automated phone call from clinic
|
Automated call
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influenza Immunization: Pediatric
Time Frame: March 31, 2011
|
percentage of pediatric participants with influenza immunization by March 31 of 2011
|
March 31, 2011
|
Influenza Immunization: Pregnant Women
Time Frame: by December 31, 2011
|
percentage of pregnant participants with influenza immunization by December 31, 2011
|
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
|
March 31, 2012
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pediatric: Vaccinated at Influenza Clinic
Time Frame: March 31, 2011
|
percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
|
March 31, 2011
|
Attendance at Appointment
Time Frame: September-December 2011
|
percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011
|
September-December 2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Stockwell 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 17, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
September 6, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAF0137
- R40MC17169-01 (Other Grant/Funding Number: R40MC17169-01)
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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