NCT06603090

Brief Summary

This multi-site study assesses the impact of text message reminders on the receipt of COVID-19 and influenza text message reminders 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
66,147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

October 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

September 17, 2024

Last Update Submit

July 9, 2025

Conditions

InfluenzaCOVID-19Vaccination Hesitancy

Keywords

text messageShort message service (SMS)mHealth

Outcome Measures

Primary Outcomes (2)

  • Timeliness of influenza vaccination

    Days from study start to influenza vaccine up to December 31 each year

    Up to December 31 each year, up to ~90 days

  • Timeliness of COVID-19 vaccination

    Days from study start to COVID-19 vaccine up to December 31 each year

    Up to December 31 each year, up to ~90 days

Secondary Outcomes (6)

  • Timeliness of influenza vaccination

    Up to April 30 each year, up to ~210 days

  • Timeliness of COVID-19 vaccination

    Up to April 30 each year, up to ~210 days

  • Percentage of Participants Who Received Influenza Vaccine by December 31 Each Year

    ~3 months

  • Percentage of Participants Who Received COVID-19 Vaccine by December 31 Each Year

    ~3 months

  • Percentage of Participants Who Received Influenza Vaccine by April 30 Each Year

    ~7 months

  • +1 more secondary outcomes

Study Arms (4)

Text message influenza and COVID-19 vaccine reminders

EXPERIMENTAL

Text message reminders for both influenza and COVID-19 vaccinations

Behavioral: Text message influenza and COVID-19 vaccine reminders

Text message influenza vaccine reminders

EXPERIMENTAL

Text message reminders only for influenza vaccination

Behavioral: Text message influenza vaccine reminders

Text message COVID-19 vaccine reminders

EXPERIMENTAL

Text message reminders only for COVID-19 vaccination

Behavioral: Text message COVID-19 vaccine reminders

Usual Care

NO INTERVENTION

Usual care has no text message

Interventions

Text message influenza vaccine remindersBEHAVIORAL

Text message influenza vaccine reminders

Text message influenza vaccine reminders
Text message COVID-19 vaccine remindersBEHAVIORAL

Text message COVID-19 vaccine reminders

Text message COVID-19 vaccine reminders
Text message influenza and COVID-19 vaccine remindersBEHAVIORAL

Text message influenza and COVID-19 vaccine reminders

Text message influenza and COVID-19 vaccine reminders

Eligibility Criteria

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

You may qualify if:

  • Child that:
  • is 6 months-17 year-old children
  • due for both a COVID-19 and influenza vaccine
  • Receives care at study site
  • Language listed in electronic health record is English or Spanish
  • Has not opted out of text messages from practice

You may not qualify if:

  • Has opted out of text messages from practice
  • Language listed in electronic health record is not English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

American Academy of Pediatrics

Itasca, Illinois, 60143, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Influenza, HumanCOVID-19Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Alex Fiks, MD MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics; Professor of Population and Family Health

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 19, 2024

Study Start

October 2, 2024

Primary Completion

December 31, 2024

Study Completion

April 30, 2025

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)