Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine (F2T)

September 3, 2023 updated by: Melissa Stockwell, Columbia University

Flu2Text: A Multi-Site Study Assessing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Itasca, Illinois, United States, 60143
        • American Academy of Pediatrics
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Text message influenza vaccine reminders
Behavioral: Text message influenza vaccine reminders
Text message reminders for second dose of influenza vaccination
No Intervention: Usual care

Season 2017-18: Usual care has no text message

Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to receipt of second dose, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 42 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

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

Investigators

  • Principal Investigator: Melissa Stockwell, MD, MPH, Columbia University
  • Principal Investigator: Alex Fiks, MD, MSCE, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 17, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 3, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAR4101
  • R01HD086045-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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