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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
August 8, 2012
August 10, 2012
May 17, 2015
June 4, 2015
August 7, 2015
September 2012
March 2013   (Final data collection date for primary outcome measure)
Receipt of 2nd Dose of the Influenza Vaccine. [ Time Frame: by April 30th after receipt of first dose (up to 8 months) ]
Number of subjects who receive the 2nd dose of the influenza vaccine. [ Time Frame: Up to 16 weeks post vaccination. ]
Complete list of historical versions of study NCT01662583 on ClinicalTrials.gov Archive Site
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time. [ Time Frame: by 42 days after dose of first vaccination ]
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time. [ Time Frame: Up to 16 weeks post vaccination. ]
Not Provided
Not Provided
 
Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. Young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. Even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. Low-income, urban children may be at particular risk of not receiving two doses. While traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. Comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. Besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. Text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. Therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Influenza
  • Other: Text Message
  • Other: Written reminder
  • Experimental: Educational Text Message
    Educational text message reminder
    Interventions:
    • Other: Text Message
    • Other: Written reminder
  • Experimental: Plain Text Message
    plain text message reminder
    Interventions:
    • Other: Text Message
    • Other: Written reminder
  • Written reminder only
    written reminder at time of vaccination
    Intervention: Other: Written reminder
Stockwell MS, Hofstetter AM, DuRivage N, Barrett A, Fernandez N, Vargas CY, Camargo S. Text message reminders for second dose of influenza vaccine: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):e83-91. doi: 10.1542/peds.2014-2475.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
660
June 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parenting adult of child age 6 months through 8 years
  • Child receives care at study site (visit in last 12 mths)
  • child received influenza vaccine and needs a second this season
  • Parent has cell phone has text message capability
  • Parent speak English or Spanish
  • Can read text messages

Exclusion Criteria:

  • Parent does not speak English or Spanish
  • Parent does not have cell phone with text messages
Sexes Eligible for Study: All
6 Months to 9 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01662583
AAAJ9354
No
Not Provided
Not Provided
Melissa Stockwell, MD, MPH, Columbia University
Columbia University
Not Provided
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Columbia University
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP