Trial Outcomes & Findings for Flu2Text: Text Message Reminders for 2nd Dose of Influenza Vaccine (NCT NCT03287830)
NCT ID: NCT03287830
Last Updated: 2023-09-15
Results Overview
Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2105 participants
Primary outcome timeframe
Up to receipt of second dose, an average of 6 months
Results posted on
2023-09-15
Participant Flow
Participant milestones
| Measure |
Intervention
Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination
|
Usual Care
Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
|
|---|---|---|
|
Overall Study
STARTED
|
1050
|
1055
|
|
Overall Study
COMPLETED
|
1044
|
1042
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
| Measure |
Intervention
Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination
|
Usual Care
Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
not meeting inclusion criteria
|
5
|
12
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=1044 Participants
Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination
|
Usual Care
n=1042 Participants
Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
|
Total
n=2086 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
age 6-23 month
|
966 Participants
n=1044 Participants
|
965 Participants
n=1042 Participants
|
1931 Participants
n=2086 Participants
|
|
Age, Customized
2-8 years
|
78 Participants
n=1044 Participants
|
77 Participants
n=1042 Participants
|
155 Participants
n=2086 Participants
|
|
Sex: Female, Male
Female
|
521 Participants
n=1044 Participants
|
492 Participants
n=1042 Participants
|
1013 Participants
n=2086 Participants
|
|
Sex: Female, Male
Male
|
523 Participants
n=1044 Participants
|
550 Participants
n=1042 Participants
|
1073 Participants
n=2086 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Preferred Language for Texting
English
|
966 Participants
n=1044 Participants
|
964 Participants
n=1042 Participants
|
1930 Participants
n=2086 Participants
|
|
Preferred Language for Texting
Spanish
|
78 Participants
n=1044 Participants
|
78 Participants
n=1042 Participants
|
156 Participants
n=2086 Participants
|
PRIMARY outcome
Timeframe: Up to receipt of second dose, an average of 6 monthsReceipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
Outcome measures
| Measure |
Intervention
n=1044 Participants
Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination
|
Usual Care
n=1042 Participants
Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
|
|---|---|---|
|
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
|
875 Participants
|
843 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after first doseReceipt of second dose influenza vaccine by 42 days after first dose
Outcome measures
| Measure |
Intervention
n=1044 Participants
Text message influenza vaccine reminders
Text message influenza vaccine reminders: Text message reminders for second dose of influenza vaccination
|
Usual Care
n=1042 Participants
Season 2017-18: Usual care has no text message
Season 2018-19: Usual care includes on text message with a link to American Academy of Pediatrics parenting information page. The purpose is to provide those randomized to usual care with tangible benefit that is not related to the study.
|
|---|---|---|
|
Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination
|
651 Participants
|
580 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place