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

NCT ID: NCT03287830

Last Updated: 2023-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Vaccination

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The care provider, primary statistician and analyst will be blinded to participant status.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Text message influenza vaccine reminders

Group Type EXPERIMENTAL

Text message influenza vaccine reminders

Intervention Type BEHAVIORAL

Text message reminders for second dose of influenza vaccination

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Text message influenza vaccine reminders

Text message reminders for second dose of influenza vaccination

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melissa Stockwell

Associate Professor of Pediatrics and Population and Family Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa Stockwell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Alex Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

American Academy of Pediatrics

Itasca, Illinois, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Stockwell MS, Shone LP, Nekrasova E, Wynn C, Torres A, Griffith M, Shults J, Unger R, Ware LA, Kolff C, Harris D, Berrigan L, Montague H, Localio AR, Fiks AG. Text Message Reminders for the Second Dose of Influenza Vaccine for Children: An RCT. Pediatrics. 2022 Sep 1;150(3):e2022056967. doi: 10.1542/peds.2022-056967.

Reference Type DERIVED
PMID: 35965283 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HD086045-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR4101

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.