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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Purpose
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 | Intervention |
|---|---|
|
Influenza |
Other: Text Message Other: Written reminder |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
- Number of subjects who receive the 2nd dose of the influenza vaccine. [ Time Frame: Up to 16 weeks post vaccination. ] [ Designated as safety issue: No ]
- Number of subjects who receive the 2nd dose of the influenza vaccine on time. [ Time Frame: Up to 16 weeks post vaccination. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 6 Months to 9 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Melissa Stockwell, MD MPH | 212-342-5732 | mstockwell@columbia.edu |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Melissa Stockwell, MD MPH 212-342-5732 mstockwell@columbia.edu | |
| Principal Investigator: Melissa S Stockwell, MD, MPH | |
| Sub-Investigator: Annika Hofstetter, MD PhD MPH | |
| Principal Investigator: | Melissa Stockwell, MD MPH | Columbia University |
More Information
No publications provided
| Responsible Party: | Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01662583 History of Changes |
| Other Study ID Numbers: | AAAJ9354 |
| Study First Received: | August 8, 2012 |
| Last Updated: | December 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Influenza text message vaccination |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013