NCT03287830

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,105

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 14, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1.6 years

First QC Date

September 6, 2017

Results QC Date

November 28, 2022

Last Update Submit

September 3, 2023

Conditions

Keywords

text messageShort message service (SMS)mHealth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Up to 42 days after first dose

Study Arms (2)

Intervention

EXPERIMENTAL

Text message influenza vaccine reminders

Behavioral: Text message influenza vaccine reminders

Usual care

NO INTERVENTION

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.

Interventions

Text message reminders for second dose of influenza vaccination

Intervention

Eligibility Criteria

Age6 Months - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Melissa Stockwell
Organization
Columbia University

Study Officials

  • Melissa Stockwell, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Alex Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The care provider, primary statistician and analyst will be blinded to participant status.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 19, 2017

Study Start

October 6, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

September 15, 2023

Results First Posted

March 14, 2023

Record last verified: 2023-09

Locations