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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: September 6, 2015
Last verified: September 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
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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 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   3790   3784   576   577   1780   1760   1764   14675 [1] 
NOT COMPLETED   817   822   17   17   41   61   56   0 
Already received influenza vaccination                817                822                13                15                41                61                56                0 
< 14 weeks gestational age                0                0                3                2                0                0                0                0 
Duplicate patient                0                0                1                0                0                0                0                0 
[1] Parents are considered subjects but outcomes are on child level



  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
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 
Overall Participants Analyzed 
[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
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1.  Primary:   Influenza Immunization: Pediatric   [ Time Frame: March 31, 2011 ]

Measure Type Primary
Measure Title Influenza Immunization: Pediatric
Measure Description percentage of pediatric participants with influenza immunization by March 31 of 2011
Time Frame March 31, 2011  
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.
Individuals unvaccinated by time intervention start 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 
Participants Analyzed 
[Units: Participants]
 3790   3784 
Influenza Immunization: Pediatric 
[Units: % participant vaccinated with influenza]
 43.6   39.9 

No statistical analysis provided for Influenza Immunization: Pediatric



2.  Primary:   Influenza Immunization: Pregnant Women   [ Time Frame: by December 31, 2011 ]

Measure Type Primary
Measure Title Influenza Immunization: Pregnant Women
Measure Description percentage of pregnant participants with influenza immunization by December 31, 2011
Time Frame by December 31, 2011  
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.
No text entered.

Reporting Groups
  Description
Pregnant Women: Text Message No text entered.
Pregnant Women: Usual Care No text entered.

Measured Values
   Pregnant Women: Text Message   Pregnant Women: Usual Care 
Participants Analyzed 
[Units: Participants]
 576   577 
Influenza Immunization: Pregnant Women 
[Units: %participants vaccinated with influenza]
 49.3   46.6 

No statistical analysis provided for Influenza Immunization: Pregnant Women



3.  Primary:   Influenza Immunization: Delayed Pediatric   [ Time Frame: March 31, 2012 ]

Measure Type Primary
Measure Title Influenza Immunization: Delayed Pediatric
Measure Description percentage of pediatric participants with influenza immunization by March 31 of 2012
Time Frame March 31, 2012  
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.
No text entered.

Reporting Groups
  Description
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

Measured Values
   Delayed Pediatrics: Interactive Text Message Vaccine Reminders   Delayed Pediatric: Conventional Text Message   Delayed Pediatric: Usual Care 
Participants Analyzed 
[Units: Participants]
 1780   1760   1764 
Influenza Immunization: Delayed Pediatric 
[Units: %participants vaccinated with influenza]
 38.5   35.3   34.8 

No statistical analysis provided for Influenza Immunization: Delayed Pediatric



4.  Secondary:   Pediatric: Vaccinated at Influenza Clinic   [ Time Frame: March 31, 2011 ]

Measure Type Secondary
Measure Title Pediatric: Vaccinated at Influenza Clinic
Measure Description percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011
Time Frame March 31, 2011  
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 
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



5.  Secondary:   Attendance at Appointment   [ Time Frame: September-December 2011 ]

Measure Type Secondary
Measure Title Attendance at Appointment
Measure Description percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011
Time Frame September-December 2011  
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.
No text entered.

Reporting Groups
  Description
Text Message Vaccine Reminders

Receipt of text message vaccine reminders

Text Message: Text message vaccine reminders

automated call: Automated call

Automated Phone Call From Clinic

Receipt of automated phone call from clinic

automated call: Automated call


Measured Values
   Text Message Vaccine Reminders   Automated Phone Call From Clinic 
Participants Analyzed 
[Units: Participants]
 576   577 
Attendance at Appointment 
[Units: % participants attending appointment]
 85.0   87.6 

No statistical analysis provided for Attendance at Appointment




  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
No text entered.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier: NCT01146912     History of Changes
Other Study ID Numbers: AAAF0137
R40MC17169-01 ( Other Grant/Funding Number: R40MC17169-01 )
Study First Received: June 16, 2010
Results First Received: August 8, 2012
Last Updated: September 6, 2015
Health Authority: United States: Institutional Review Board