NCT01761734

Brief Summary

Influenza is an important and potentially preventable cause of morbidity and mortality, yet only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite influenza vaccination being widely recommended, effective, and safe. Influenza vaccination rates are even lower in racial/ethnic minority groups. In order to address the problem of low influenza vaccination rates in minority adults, we plan to build on the well-accepted practice of immunization recall-reminders and the emerging practice of using text message to pilot the feasibility of using text messaging to improve influenza vaccination coverage rates in a low health literacy, largely minority, publicly insured adult population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

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

December 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

December 30, 2012

Last Update Submit

June 22, 2014

Conditions

Influenza

Keywords

Influenza vaccination

Outcome Measures

Primary Outcomes (1)

  • Receipt of an influenza vaccine dose

    Proportion of individuals in each group receiving an influenza dose by the end of the influenza season

    March 31, 2013

Study Arms (2)

text message

EXPERIMENTAL

receipt of text message

Behavioral: text message

usual care

NO INTERVENTION

usual care

Interventions

text messageBEHAVIORAL
text message

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> or = 18 years of age,
  • at least one visit to the AIM clinic during the previous year
  • a cell phone number in the registration system

You may not qualify if:

  • Receipt of influenza vaccination during the 2012-2013 influenza season prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Melissa Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Steven Shea, MD MS

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Jessica Singer, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

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

December 30, 2012

First Posted

January 7, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

US(1)