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

Primary Purpose

Influenza, Vaccination

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message influenza vaccine reminders
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring text message, Short message service (SMS), mHealth

Eligibility Criteria

6 Months - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • American Academy of Pediatrics
  • Columbia University Medical Center
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

Text message influenza vaccine reminders

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2017
Last Updated
September 3, 2023
Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), American Academy of Pediatrics, Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03287830
Brief Title
Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine
Acronym
F2T
Official Title
Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), American Academy of Pediatrics, Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Vaccination
Keywords
text message, Short message service (SMS), mHealth

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The care provider, primary statistician and analyst will be blinded to participant status.
Allocation
Randomized
Enrollment
2105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Text message influenza vaccine reminders
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text message influenza vaccine reminders
Intervention Description
Text message reminders for second dose of influenza vaccination
Primary Outcome Measure Information:
Title
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
Description
Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
Time Frame
Up to receipt of second dose, an average of 6 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
Description
Receipt of second dose influenza vaccine by 42 days after first dose
Time Frame
Up to 42 days after first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Fiks, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Academy of Pediatrics
City
Itasca
State/Province
Illinois
ZIP/Postal Code
60143
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35965283
Citation
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.
Results Reference
derived

Learn more about this trial

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

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