NCT01942824

Brief Summary

Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a 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
7,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

September 8, 2013

Last Update Submit

June 22, 2014

Conditions

Influenza Vaccination

Outcome Measures

Primary Outcomes (1)

  • Timeliness of vaccination

    Days from start of intervention to vaccination

    6 months

Secondary Outcomes (2)

  • Receipt of influenza vaccine dose

    15 weeks

  • Receipt of Influenza vaccine dose, end of season

    28 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Text Message

Behavioral: Text Messages

Usual Care

NO INTERVENTION

Interventions

Text MessagesBEHAVIORAL
Intervention

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 2013-2014 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, 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

September 8, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

US(1)