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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Text Message | Experimental | Educational text message reminder |
|
| Plain Text Message | Experimental | plain text message reminder |
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| Written reminder only | Other | written reminder at time of vaccination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Message | Other |
| ||
| Written reminder |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of 2nd Dose of the Influenza Vaccine. | by April 30th after receipt of first dose (up to 8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time. | by 42 days after dose of first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Stockwell, MD MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25548329 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Text Message | Educational text message reminder Text Message Written reminder |
| FG001 | Plain Text Message | plain text message reminder Text Message Written reminder |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
|
| FG002 | Written Reminder Only | written reminder at time of vaccination Written reminder |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Text Message | Educational text message reminder Text Message Written reminder |
| BG001 | Plain Text Message | plain text message reminder Text Message Written reminder |
| BG002 | Written Reminder Only | written reminder at time of vaccination Written reminder |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Receipt of 2nd Dose of the Influenza Vaccine. | Posted | Number | percentage of participants | by April 30th after receipt of first dose (up to 8 months) |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time. | One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated | Posted | Number | percentage of participants | by 42 days after dose of first vaccination |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Text Message | Educational text message reminder Text Message Written reminder | 0 | 216 | 0 | 216 | ||
| EG001 | Plain Text Message | plain text message reminder Text Message Written reminder | 0 | 225 | 0 | 225 | ||
| EG002 | Written Reminder Only | written reminder at time of vaccination Written reminder | 0 | 219 | 0 | 219 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Stockwell, MD MPH | Columbia University | 212-342-5372 | mss2112@columbia.edu |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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|