TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations

Influenza Clinical Trial

Official title:

TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146912
• Other study ID #: AAAF0137
• Secondary ID: R40MC17169-01
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: September 6, 2015
• Start date: June 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30537
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Influenza

Intervention

Other:
• Text Message
Text message vaccine reminders
• automated call
Automated call

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza Immunization: Pediatric	percentage of pediatric participants with influenza immunization by March 31 of 2011	March 31, 2011	No
Primary	Influenza Immunization: Pregnant Women	percentage of pregnant participants with influenza immunization by December 31, 2011	by December 31, 2011	No
Primary	Influenza Immunization: Delayed Pediatric	percentage of pediatric participants with influenza immunization by March 31 of 2012	March 31, 2012	No
Secondary	Pediatric: Vaccinated at Influenza Clinic	percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011	March 31, 2011	No
Secondary	Attendance at Appointment	percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011	September-December 2011	No