NCT01199666

Brief Summary

Although the investigators have reached the Healthy People 2010 goal of 80% coverage among U.S. children 19-35 months of age for the primary immunization series, 20% of children still remain underimmunized. In addition, pockets of low immunization coverage and outbreaks of vaccine preventable disease persist. Immunization reminder-recalls have been shown to be successful, but have been limited by the ability to identify and reach large target populations in a real-time, automated fashion. Reminder-recalls via text message may offer an innovative opportunity to improve vaccination coverage. Currently, 91% of Americans own a cell phone. Prior research by our team suggests that text messages reminder recalls may be an effective tool to remind parents about their children's vaccines. In this study, the investigators will demonstrate the effectiveness of tailored text message appointment and immunization reminders linked to a well-established and functional immunization registry to increase coverage rates and timeliness of the sentinel vaccines of MMR and HepA. The investigators will target parents of young children from an underserved population that is primarily Latino, with low socioeconomic status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,586

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

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

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

2.1 years

First QC Date

September 9, 2010

Last Update Submit

July 24, 2014

Conditions

Keywords

Underimmunization, text message, vaccinationUnderimmunization

Outcome Measures

Primary Outcomes (1)

  • Receipt of MMR1

    by 13 and 16 months of age

Secondary Outcomes (2)

  • Timeliness of HepA vaccination post-recall

    4,12, 24 weeks

  • Attendance at appointments

    after appointment

Study Arms (2)

Text message reminders

EXPERIMENTAL
Other: Text message

standard of care for MMR, letter reminder for Hep A

ACTIVE COMPARATOR

MMR: automated phone call appointment reminder Hep A: recall letter, automated phone call appointment reminder

Other: Text message

Interventions

text message appointment and immunization reminders

Text message remindersstandard of care for MMR, letter reminder for Hep A

Eligibility Criteria

Age9 Months - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Parents of child \>9 months to 25 months
  • Child with at least one visit to one of the participating clinical sites in the previous 12 months
  • Parental cell phone number recorded in the registration system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Melissa S Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Annika Hofstetter, MD PhD MPH

    Columbia University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
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

September 9, 2010

First Posted

September 13, 2010

Study Start

June 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 25, 2014

Record last verified: 2014-07

Locations