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

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
automated call
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring Influenza, text message, vaccination

Eligibility Criteria

6 Months - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Text message vaccine reminders

automated phone call from clinic

Arm Description

Receipt of text message vaccine reminders

Receipt of automated phone call from clinic

Outcomes

Primary Outcome Measures

Influenza Immunization: Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2011
Influenza Immunization: Pregnant Women
percentage of pregnant participants with influenza immunization by December 31, 2011
Influenza Immunization: Delayed Pediatric
percentage of pediatric participants with influenza immunization by March 31 of 2012

Secondary Outcome Measures

Pediatric: Vaccinated at Influenza Clinic
percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
Attendance at Appointment
percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011

Full Information

First Posted
June 16, 2010
Last Updated
September 6, 2015
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01146912
Brief Title
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations
Official Title
TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, text message, vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30537 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text message vaccine reminders
Arm Type
Experimental
Arm Description
Receipt of text message vaccine reminders
Arm Title
automated phone call from clinic
Arm Type
Active Comparator
Arm Description
Receipt of automated phone call from clinic
Intervention Type
Other
Intervention Name(s)
Text Message
Other Intervention Name(s)
Health services
Intervention Description
Text message vaccine reminders
Intervention Type
Other
Intervention Name(s)
automated call
Other Intervention Name(s)
Health services
Intervention Description
Automated call
Primary Outcome Measure Information:
Title
Influenza Immunization: Pediatric
Description
percentage of pediatric participants with influenza immunization by March 31 of 2011
Time Frame
March 31, 2011
Title
Influenza Immunization: Pregnant Women
Description
percentage of pregnant participants with influenza immunization by December 31, 2011
Time Frame
by December 31, 2011
Title
Influenza Immunization: Delayed Pediatric
Description
percentage of pediatric participants with influenza immunization by March 31 of 2012
Time Frame
March 31, 2012
Secondary Outcome Measure Information:
Title
Pediatric: Vaccinated at Influenza Clinic
Description
percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
Time Frame
March 31, 2011
Title
Attendance at Appointment
Description
percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011
Time Frame
September-December 2011

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa S Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24354839
Citation
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.
Results Reference
derived
PubMed Identifier
22535855
Citation
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.
Results Reference
derived

Learn more about this trial

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

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