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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01146912
First received: June 16, 2010
Last updated: May 17, 2015
Last verified: May 2015
Results First Received: August 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Health Services Research
Condition: Influenza
Interventions: Other: Text Message
Other: automated call

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children and pregnant women receiving care at 4 community-based clinics in the United States during the 2010-2011, 2011-2012 influenza season

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Children previously vaccinated for influenza before the season of interest were excluded from primary analysis

Reporting Groups
  Description
Pediatric Text Message Vaccine Reminders/Automated Phone Call Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
Pediatric: Automated Phone Call From Clinic Only Receipt of automated phone call from clinic
Pregnant Women: Text Message Received text message reminders
Pregnant Women: Usual Care Received usual care
Delayed Pediatrics: Interactive Text Message Vaccine Reminders Vaccination of children not yet vaccinated by mid-November: interactive message
Delayed Pediatric: Conventional Text Message Vaccination of children not yet vaccinated by mid-November: conventional text message
Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Parents Included in enrollment but not in outcomes which are on child level

Participant Flow:   Overall Study
    Pediatric Text Message Vaccine Reminders/Automated Phone Call     Pediatric: Automated Phone Call From Clinic Only     Pregnant Women: Text Message     Pregnant Women: Usual Care     Delayed Pediatrics: Interactive Text Message Vaccine Reminders     Delayed Pediatric: Conventional Text Message     Delayed Pediatric: Usual Care     Parents  
STARTED     4607     4606     593     594     1821     1821     1820     14675  
COMPLETED     4607     4606     593     594     1821     1821     1820     14675 [1]
NOT COMPLETED     0     0     0     0     0     0     0     0  
[1] Parents are considered subjects but outcomes are on child level



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Text Message Vaccine Reminders/Automated Telephone Call Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
Automated Phone Call From Clinic Only Receipt of automated phone call from clinic
Pregnant Women: Text Message No text entered.
Pregnant Women: Usual Care No text entered.
Delayed Pediatrics: Interactive Text Message No text entered.
Delayed Pediatrics: Conventional Text Message No text entered.
Delayed Pediatrics: Usual Care No text entered.
Total Total of all reporting groups

Baseline Measures
    Text Message Vaccine Reminders/Automated Telephone Call     Automated Phone Call From Clinic Only     Pregnant Women: Text Message     Pregnant Women: Usual Care     Delayed Pediatrics: Interactive Text Message     Delayed Pediatrics: Conventional Text Message     Delayed Pediatrics: Usual Care     Total  
Number of Participants  
[units: participants]
  4607     4606     593     594     1821     1821     1820     15862  
Age  
[units: participants]
               
<=18 years     4607     4606     0     0     1821     1821     1820     14675  
Between 18 and 65 years     0     0     593     594     0     0     0     1187  
>=65 years     0     0     0     0     0     0     0     0  
Gender  
[units: participants]
               
Female     2335     2332     593     594     869     926     862     8511  
Male     2272     2274     0     0     952     895     958     7351  
Region of Enrollment  
[units: participants]
               
United States     4607     4606     593     594     1821     1821     1820     15862  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Influenza Immunization: Pediatric   [ Time Frame: March 31 ]

2.  Primary:   Influenza Immunization: Pregnant Women   [ Time Frame: by December 31 ]

3.  Primary:   Influenza Immunization: Delayed Pediatric   [ Time Frame: March 31 ]

4.  Secondary:   Pediatric: Vaccinated at Influenza Clinic   [ Time Frame: March 31 ]

5.  Secondary:   Attendance at Appointment   [ Time Frame: appointment reminder sent for ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Melissa Stockwell, MD MPH
Organization: Columbia University
phone: 212-342-5372
e-mail: mss2112@columbia.edu


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier: NCT01146912     History of Changes
Other Study ID Numbers: AAAF0137, R40MC17169-01
Study First Received: June 16, 2010
Results First Received: August 8, 2012
Last Updated: May 17, 2015
Health Authority: United States: Institutional Review Board