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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


  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.
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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
  Show All Outcome Measures

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

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

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

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

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


  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


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