Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine

Not Applicable

Completed

• Conditions: Vaccination; Influenza
• Interventions: Behavioral: Text message influenza vaccine reminders

• Registration Number: NCT03287830
• Lead Sponsor: Columbia University

Brief Summary

This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.

Detailed Description

The study is to be conducted over the 1st season (September 2017-April 2018) as an effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. Eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. Current recommendations require 2 doses for certain children 6 months through 8 years old. Within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (Spanish, English).

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-17
• Study First Posted: 2017-09-19
• Study Start: 2017-10-06
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Results First Submitted: 2022-11-28
• Results First Submitted QC: 2023-03-12
• Results First Posted: 2023-03-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-03
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2105

Inclusion Criteria

• Parenting adult (or legal guardian) of a child that:

  • is between 6 months through 8 years at the time of enrollment (or the age for which 2 doses of influenza are recommended should Centers for Disease Control and Prevention (CDC) recommendations change)
  • received 1st dose of influenza vaccine within last 7 days
  • receives care at study site
  • needs 2 doses of influenza vaccine that season as determined by their clinician at the study site
  • plan to continue to receive care through April 30 of that season (to the best of their knowledge) (season 2017-18 only)

• Ability to speak and read English or Spanish

• Has a cell phone that has text message capability

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Exclusion Criteria

• Parenting adult of a child that:

  • already enrolled in the study in this or the previous season
  • will leave practice before end of season (April 30) (to their best knowledge) (2017-18 season only)

• Was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only)

• Unable to speak and read English or speak and read Spanish

• Unable to receive or read text messages on their cell phone

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Text message influenza vaccine reminders	Text message influenza vaccine reminders

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year	Up to receipt of second dose, an average of 6 months	Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination	Up to 42 days after first dose	Receipt of second dose influenza vaccine by 42 days after first dose

Trial Locations

Locations (3)

American Academy of Pediatrics; 🇺🇸 Itasca, Illinois, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States