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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01662583
Enrollment
660
Registered
2012-08-10
Start date
2012-09-30
Completion date
2013-06-30
Last updated
2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, text message, vaccination

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.

Interventions

OTHERText Message
OTHERWritten reminder

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 9 Years
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

Design outcomes

Primary

MeasureTime frame
Receipt of 2nd Dose of the Influenza Vaccine.by April 30th after receipt of first dose (up to 8 months)

Secondary

MeasureTime frame
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.by 42 days after dose of first vaccination

Countries

United States

Participant flow

Participants by arm

ArmCount
Educational Text Message
Educational text message reminder Text Message Written reminder
216
Plain Text Message
plain text message reminder Text Message Written reminder
225
Written Reminder Only
written reminder at time of vaccination Written reminder
219
Total660

Baseline characteristics

CharacteristicEducational Text MessagePlain Text MessageWritten Reminder OnlyTotal
Age, Categorical
<=18 years
216 Participants225 Participants219 Participants660 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
United States
216 participants225 participants219 participants660 participants
Sex: Female, Male
Female
105 Participants108 Participants114 Participants327 Participants
Sex: Female, Male
Male
111 Participants117 Participants105 Participants333 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 2160 / 2250 / 219
serious
Total, serious adverse events
0 / 2160 / 2250 / 219

Outcome results

Primary

Receipt of 2nd Dose of the Influenza Vaccine.

Time frame: by April 30th after receipt of first dose (up to 8 months)

ArmMeasureValue (NUMBER)
Educational Text MessageReceipt of 2nd Dose of the Influenza Vaccine.72.7 percentage of participants
Plain Text MessageReceipt of 2nd Dose of the Influenza Vaccine.66.7 percentage of participants
Written Reminder OnlyReceipt of 2nd Dose of the Influenza Vaccine.57.1 percentage of participants
Secondary

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

Time frame: by 42 days after dose of first vaccination

Population: 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

ArmMeasureValue (NUMBER)
Educational Text MessageNumber of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.43.5 percentage of participants
Plain Text MessageNumber of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.33.9 percentage of participants
Written Reminder OnlyNumber of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.25.6 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026