NCT01146912

Brief Summary

The Advisory Committee on Immunization Practices (ACIP)recommends that the flu vaccine be administered annually to all children aged 6 months to 18 years as well as women who are pregnant during the influenza season. Nevertheless, targeting and mobilizing these populations has been difficult and influenza immunization rates nationwide remain low. Immunization reminder-recalls have been shown to be effective, but have had limited ability to rapidly identify and reach large target populations in a cost-effective manner. Evidence on how to optimally design these systems is not yet available and thus text message immunization alerts have not been widely implemented. The investigators propose to implement and evaluate tailored, targeted influenza text message reminders in urban pediatric and pregnant populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,537

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 31, 2013

Completed
Last Updated

October 7, 2015

Status Verified

September 1, 2015

Enrollment Period

1.8 years

First QC Date

June 16, 2010

Results QC Date

August 8, 2012

Last Update Submit

September 6, 2015

Conditions

Keywords

Influenza, text message, vaccination

Outcome Measures

Primary Outcomes (3)

  • Influenza Immunization: Pediatric

    percentage of pediatric participants with influenza immunization by March 31 of 2011

    March 31, 2011

  • Influenza Immunization: Pregnant Women

    percentage of pregnant participants with influenza immunization by December 31, 2011

    by December 31, 2011

  • Influenza Immunization: Delayed Pediatric

    percentage of pediatric participants with influenza immunization by March 31 of 2012

    March 31, 2012

Secondary Outcomes (2)

  • Pediatric: Vaccinated at Influenza Clinic

    March 31, 2011

  • Attendance at Appointment

    September-December 2011

Study Arms (2)

Text message vaccine reminders

EXPERIMENTAL

Receipt of text message vaccine reminders

Other: Text MessageOther: automated call

automated phone call from clinic

ACTIVE COMPARATOR

Receipt of automated phone call from clinic

Other: automated call

Interventions

Text message vaccine reminders

Also known as: Health services
Text message vaccine reminders

Automated call

Also known as: Health services
Text message vaccine remindersautomated phone call from clinic

Eligibility Criteria

Age6 Months - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children aged 6 months to 18 years at the beginning of current influenza season
  • Children with one previous visit at participating pediatric community health center in last year
  • Parent with cell phone number in registry
  • Pregnant women Pilot (2010-2011 influenza seasons)
  • Pregnant women who will be in their 2nd or 3rd trimester during the influenza season
  • Own a cell phone with text message capability
  • Randomized controlled Trial (2011-2012 influenza seasons)
  • Pregnant and will be in their 2nd or 3rd trimester during the influenza season
  • Cell phone number in registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • Stockwell MS, Westhoff C, Kharbanda EO, Vargas CY, Camargo S, Vawdrey DK, Castano PM. Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):e7-12. doi: 10.2105/AJPH.2013.301620. Epub 2013 Dec 19.

  • Stockwell MS, Kharbanda EO, Martinez RA, Vargas CY, Vawdrey DK, Camargo S. Effect of a text messaging intervention on influenza vaccination in an urban, low-income pediatric and adolescent population: a randomized controlled trial. JAMA. 2012 Apr 25;307(16):1702-8. doi: 10.1001/jama.2012.502.

MeSH Terms

Conditions

Influenza, Human

Interventions

Health Services

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Results Point of Contact

Title
Melissa Stockwell, MD MPH
Organization
Columbia University

Study Officials

  • Melissa S Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Prof of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 7, 2015

Results First Posted

May 31, 2013

Record last verified: 2015-09

Locations