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Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
Written reminder
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Influenza focused on measuring Influenza, text message, vaccination

Eligibility Criteria

6 Months - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Educational Text Message

Plain Text Message

Written reminder only

Arm Description

Educational text message reminder

plain text message reminder

written reminder at time of vaccination

Outcomes

Primary Outcome Measures

Receipt of 2nd Dose of the Influenza Vaccine.

Secondary Outcome Measures

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

Full Information

First Posted
August 8, 2012
Last Updated
July 19, 2015
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01662583
Brief Title
Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Official Title
Pragmatic Clinical Trial of Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, text message, vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational Text Message
Arm Type
Experimental
Arm Description
Educational text message reminder
Arm Title
Plain Text Message
Arm Type
Experimental
Arm Description
plain text message reminder
Arm Title
Written reminder only
Arm Type
Other
Arm Description
written reminder at time of vaccination
Intervention Type
Other
Intervention Name(s)
Text Message
Intervention Type
Other
Intervention Name(s)
Written reminder
Primary Outcome Measure Information:
Title
Receipt of 2nd Dose of the Influenza Vaccine.
Time Frame
by April 30th after receipt of first dose (up to 8 months)
Secondary Outcome Measure Information:
Title
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
Time Frame
by 42 days after dose of first vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Parent does not speak English or Spanish Parent does not have cell phone with text messages
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25548329
Citation
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.
Results Reference
derived

Learn more about this trial

Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children

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