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
1 other identifier
interventional
660
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2012
CompletedFirst Posted
Study publicly available on registry
August 10, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
June 4, 2015
CompletedAugust 7, 2015
July 1, 2015
6 months
August 8, 2012
May 17, 2015
July 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Receipt of 2nd Dose of the Influenza Vaccine.
by April 30th after receipt of first dose (up to 8 months)
Secondary Outcomes (1)
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
by 42 days after dose of first vaccination
Study Arms (3)
Educational Text Message
EXPERIMENTALEducational text message reminder
Plain Text Message
EXPERIMENTALplain text message reminder
Written reminder only
OTHERwritten reminder at time of vaccination
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Parent does not speak English or Spanish
- Parent does not have cell phone with text messages
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 25548329DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Melissa Stockwell, MD MPH
- Organization
- Columbia University
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Stockwell, MD MPH
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics and Population and Family Health
Study Record Dates
First Submitted
August 8, 2012
First Posted
August 10, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
August 7, 2015
Results First Posted
June 4, 2015
Record last verified: 2015-07