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

Influenza Clinical Trial

— F2T  

Official title:

Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287830
• Other study ID #: AAAR4101
• Secondary ID: R01HD086045-01A1
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2105
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 8 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Vaccination

Intervention

Behavioral:
• Text message influenza vaccine reminders
Text message reminders for second dose of influenza vaccination

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Columbia University	American Academy of Pediatrics, Children's Hospital of Philadelphia, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year	Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year	Up to receipt of second dose, an average of 6 months
Secondary	Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination	Receipt of second dose influenza vaccine by 42 days after first dose	Up to 42 days after first dose