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: April 8, 2013
Last verified: April 2013
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children receiving care at 4 community-based clinics in the United States during the 2010-2011 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 in the 2010-2011 season were excluded from primary analysis

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

Participant Flow:   Overall Study
    Text Message Vaccine Reminders/Automated Telephone Call     Automated Phone Call From Clinic Only  
STARTED     4607     4606  
COMPLETED     4607     4606  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Total Total of all reporting groups

Baseline Measures
    Text Message Vaccine Reminders/Automated Telephone Call     Automated Phone Call From Clinic Only     Total  
Number of Participants  
[units: participants]
  4607     4606     9213  
Age  
[units: participants]
     
<=18 years     4607     4606     9213  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  5.49  ± 5.1     5.5  ± 5.0     5.5  ± 5.0  
Gender  
[units: participants]
     
Female     2335     2332     4667  
Male     2272     2274     4546  
Region of Enrollment  
[units: participants]
     
United States     4607     4606     9213  



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

2.  Secondary:   Pediatric: Vaccinated at Influenza Clinic   [ Time Frame: March 31 ]
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Measure Type Secondary
Measure Title Pediatric: Vaccinated at Influenza Clinic
Measure Description pediatric intervention
Time Frame March 31  
Safety Issue No  

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.
those unvaccinated by the start date for their cohort

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

Measured Values
    Pediatric: Text Message Vaccine Reminders/Automated Phone Call     Pediatric: Automated Phone Call From Clinic Only  
Number of Participants Analyzed  
[units: participants]
  3790     3784  
Pediatric: Vaccinated at Influenza Clinic  
[units: % participant vaccinated at flu clinic]
  6.1     2.8  

No statistical analysis provided for Pediatric: Vaccinated at Influenza Clinic



3.  Secondary:   Attendance at Appointment   [ Time Frame: appointment reminder sent for ]
Results not yet posted.   Anticipated Posting Date:   06/2013   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: April 8, 2013
Health Authority: United States: Institutional Review Board