NCT01662583

Brief Summary

Influenza remains a potentially significant and largely preventable source of morbidity and mortality, yet vaccine coverage is low. Young children are at particular risk for underimmunization because they may need to receive 2 doses in a current season. Even among those young children that initiate vaccination, only 40% receive the important second dose, yet one dose does not confer adequate protection. Low-income, urban children may be at particular risk of not receiving two doses. While traditional mail and phone immunization reminders notifying families that a vaccine is due have had limited efficacy in low-income, urban populations, we have demonstrated the success of using text messages. Comparing the effectiveness of different forms of reminders on receipt of this critical second dose of influenza vaccine has not been studied. Besides failure to remember to return for subsequent doses, receipt of 2 doses of influenza vaccine in a season can be affected by limited health literacy regarding influenza vaccination, particularly associated with understanding the need for a second dose since not all children require it. Text messaging offers the ability to combine health literacy promoting information and reminders in a scalable, efficient manner for populations at high risk for underimmunization, limited health literacy, and influenza spread. Therefore, the purpose of this study is to determine whether the provision of interactive vaccine health literacy-promoting information in text message vaccine reminders improves receipt and timeliness of the second dose of influenza vaccine within a season for underserved children in need of two doses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 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

First Submitted

Initial submission to the registry

August 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2 years until next milestone

Results Posted

Study results publicly available

June 4, 2015

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

August 8, 2012

Results QC Date

May 17, 2015

Last Update Submit

July 19, 2015

Conditions

Keywords

Influenzatext messagevaccination

Outcome Measures

Primary Outcomes (1)

  • Receipt of 2nd Dose of the Influenza Vaccine.

    by April 30th after receipt of first dose (up to 8 months)

Secondary Outcomes (1)

  • Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.

    by 42 days after dose of first vaccination

Study Arms (3)

Educational Text Message

EXPERIMENTAL

Educational text message reminder

Other: Text MessageOther: Written reminder

Plain Text Message

EXPERIMENTAL

plain text message reminder

Other: Text MessageOther: Written reminder

Written reminder only

OTHER

written reminder at time of vaccination

Other: Written reminder

Interventions

Educational Text MessagePlain Text Message
Educational Text MessagePlain Text MessageWritten reminder only

Eligibility Criteria

Age6 Months - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parenting adult of child age 6 months through 8 years
  • Child receives care at study site (visit in last 12 mths)
  • child received influenza vaccine and needs a second this season
  • Parent has cell phone has text message capability
  • Parent speak English or Spanish
  • Can read text messages

You may not qualify if:

  • Parent does not speak English or Spanish
  • Parent does not have cell phone with text messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • Stockwell MS, Hofstetter AM, DuRivage N, Barrett A, Fernandez N, Vargas CY, Camargo S. Text message reminders for second dose of influenza vaccine: a randomized controlled trial. Pediatrics. 2015 Jan;135(1):e83-91. doi: 10.1542/peds.2014-2475.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Melissa Stockwell, MD MPH
Organization
Columbia University

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 10, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

August 7, 2015

Results First Posted

June 4, 2015

Record last verified: 2015-07

Locations