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Completed

NCT Number: NCT03287830

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccination Virus Diseases

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Academy of Pediatrics, Itasca, Illinois, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message influenza vaccine reminders

Behavioral

Text message reminders for second dose of influenza vaccination

Primary outcomes

  1. Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year

    Time frame: 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 outcomes

  1. Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination

    Time frame: Up to 42 days after first dose

    Receipt of second dose influenza vaccine by 42 days after first dose

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Academy of Pediatrics
  • Children's Hospital of Philadelphia
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: F2T

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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