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Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01662583
First Posted: August 10, 2012
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
Results First Submitted: May 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Influenza
Interventions: Other: Text Message
Other: Written reminder

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Educational Text Message

Educational text message reminder

Text Message

Written reminder

Plain Text Message

plain text message reminder

Text Message

Written reminder

Written Reminder Only

written reminder at time of vaccination

Written reminder


Participant Flow:   Overall Study
    Educational Text Message   Plain Text Message   Written Reminder Only
STARTED   216   225   219 
COMPLETED   216   225   219 
NOT COMPLETED   0   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
Educational Text Message

Educational text message reminder

Text Message

Written reminder

Plain Text Message

plain text message reminder

Text Message

Written reminder

Written Reminder Only

written reminder at time of vaccination

Written reminder

Total Total of all reporting groups

Baseline Measures
   Educational Text Message   Plain Text Message   Written Reminder Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 216   225   219   660 
Age 
[Units: Participants]
       
<=18 years   216   225   219   660 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   105   108   114   327 
Male   111   117   105   333 
Region of Enrollment 
[Units: Participants]
       
United States   216   225   219   660 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Receipt of 2nd Dose of the Influenza Vaccine.   [ Time Frame: by April 30th after receipt of first dose (up to 8 months) ]

2.  Secondary:   Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.   [ Time Frame: by 42 days after dose of first vaccination ]


  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: NCT01662583     History of Changes
Other Study ID Numbers: AAAJ9354
First Submitted: August 8, 2012
First Posted: August 10, 2012
Results First Submitted: May 17, 2015
Results First Posted: June 4, 2015
Last Update Posted: August 7, 2015