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

• ClinicalTrials.gov Identifier: NCT01662583
• Recruitment Status: Completed
• First Posted: August 10, 2012
• Results First Posted: June 4, 2015
• Last Update Posted: August 7, 2015
• Sponsor: Columbia University
• Information provided by (Responsible Party): Melissa Stockwell, MD, MPH, Columbia University

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Other: Text Message; Other: Written reminder	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 660 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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 Start Date: September 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Educational Text Message; Educational text message reminder	Other: Text Message; Other: Written reminder
Experimental: Plain Text Message; plain text message reminder	Other: Text Message; Other: Written reminder
Written reminder only; written reminder at time of vaccination	Other: Written reminder

Outcome Measures

Primary Outcome Measures :

1. Receipt of 2nd Dose of the Influenza Vaccine. [ Time Frame: by April 30th after receipt of first dose (up to 8 months) ]

Secondary Outcome Measures :

1. Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time. [ Time Frame: by 42 days after dose of first vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Columbia University

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

• Principal Investigator: Melissa Stockwell, MD MPH; Columbia University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
• ClinicalTrials.gov Identifier: NCT01662583
• Other Study ID Numbers: AAAJ9354
• First Posted: August 10, 2012
• Results First Posted: June 4, 2015
• Last Update Posted: August 7, 2015
• Last Verified: July 2015

Keywords provided by Melissa Stockwell, MD, MPH, Columbia University:

Influenza; text message; vaccination

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases