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CompletedNCT01662583Updated Aug 7, 2015Results posted

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

An interventional study of Text Message and Written reminder in Influenza, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 6 Months to 9 Years. Per ClinicalTrials.gov, last updated 2015-08-07.

Sponsored by Columbia University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
660
Allocation
Randomized
Ages
6 Months to 9 Years
Sex
All
01

Study 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.

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Conditions studied

  • Influenza

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Keywords

  • Influenza
  • text message
  • vaccination
03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's enrollment of 660 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Columbia University is the lead sponsor of 1,135 studies on the registry; 195 are open to participants now.

Of its 179 completed or terminated interventional studies of FDA-regulated products, 146 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Parent does not speak English or Spanish
  • Parent does not have cell phone with text messages
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
660 participants (actual)

Study arms

  • Experimental
    Educational Text Message

    Educational text message reminder

    Other: Text Message · Other: Written reminder

  • Experimental
    Plain Text Message

    plain text message reminder

    Other: Text Message · Other: Written reminder

  • Other
    Written reminder only

    written reminder at time of vaccination

    Other: Written reminder

Interventions

  • OtherText Message
  • OtherWritten reminder
06

What researchers measure

Primary outcomes

  1. Receipt of 2nd Dose of the Influenza Vaccine.

    Time frame: 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.

    Time frame: by 42 days after dose of first vaccination

07

Results

Posted Jun 4, 2015

Participant flow

Participant flow — Overall Study
MilestoneEducational Text MessagePlain Text MessageWritten Reminder Only
Started216225219
Completed216225219
Not completed000

Outcome measures

PrimaryReceipt of 2nd Dose of the Influenza Vaccine.
Time frame:
by April 30th after receipt of first dose (up to 8 months)
Reported as:
Number · percentage of participants
Receipt of 2nd Dose of the Influenza Vaccine.
percentage of participantsEducational Text MessagePlain Text MessageWritten Reminder Only
Receipt of 2nd Dose of the Influenza Vaccine.72.766.757.1
SecondaryNumber of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
Time frame:
by 42 days after dose of first vaccination
Reported as:
Number · percentage of participants
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
percentage of participantsEducational Text MessagePlain Text MessageWritten Reminder Only
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.43.533.925.6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Educational Text Message—0/216 (0%)0/216 (0%)
Plain Text Message—0/225 (0%)0/225 (0%)
Written Reminder Only—0/219 (0%)0/219 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Educational Text MessagePlain Text MessageWritten Reminder OnlyTotal
<=18 years216225219660
Between 18 and 65 years0000
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)Educational Text MessagePlain Text MessageWritten Reminder OnlyTotal
Female105108114327
Male111117105333
Region of Enrollment
Region of Enrollment(participants)Educational Text MessagePlain Text MessageWritten Reminder OnlyTotal
United States216225219660
08

Study locations

1 site
  • Columbia University
    New York, New York 10032, United States
09

References and documents

Publications

  • 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. PubMed 25548329 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01662583
Responsible party
Melissa Stockwell, MD, MPH (Assistant Professor of Pediatrics and Population and Family Health, Columbia University) — Principal investigator
First posted
Aug 10, 2012
Start date
Sep 2012
Primary completion
Mar 2013
Completion
Jun 2013
Results posted
Jun 4, 2015
Last update
Aug 7, 2015

Study contacts

Melissa Stockwell, MD MPH
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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