Trial Outcomes & Findings for Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children (NCT NCT01662583)
NCT ID: NCT01662583
Last Updated: 2015-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
660 participants
Primary outcome timeframe
by April 30th after receipt of first dose (up to 8 months)
Results posted on
2015-08-07
Participant Flow
Participant milestones
| Measure |
Educational Text Message
Educational text message reminder
Text Message
Written reminder
|
Plain Text Message
plain text message reminder
Text Message
Written reminder
|
Written Reminder Only
written reminder at time of vaccination
Written reminder
|
|---|---|---|---|
|
Overall Study
STARTED
|
216
|
225
|
219
|
|
Overall Study
COMPLETED
|
216
|
225
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vaccine Health Literacy Related Text Message Reminders to Increase Receipt of Second Dose of Influenza Vaccine for Young, Low Income, Urban Children
Baseline characteristics by cohort
| Measure |
Educational Text Message
n=216 Participants
Educational text message reminder
Text Message
Written reminder
|
Plain Text Message
n=225 Participants
plain text message reminder
Text Message
Written reminder
|
Written Reminder Only
n=219 Participants
written reminder at time of vaccination
Written reminder
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
216 Participants
n=93 Participants
|
225 Participants
n=4 Participants
|
219 Participants
n=27 Participants
|
660 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=93 Participants
|
108 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
327 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
333 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
216 participants
n=93 Participants
|
225 participants
n=4 Participants
|
219 participants
n=27 Participants
|
660 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: by April 30th after receipt of first dose (up to 8 months)Outcome measures
| Measure |
Educational Text Message
n=216 Participants
Educational text message reminder
Text Message
Written reminder
|
Plain Text Message
n=225 Participants
plain text message reminder
Text Message
Written reminder
|
Written Reminder Only
n=219 Participants
written reminder at time of vaccination
Written reminder
|
|---|---|---|---|
|
Receipt of 2nd Dose of the Influenza Vaccine.
|
72.7 percentage of participants
|
66.7 percentage of participants
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: by 42 days after dose of first vaccinationPopulation: 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
Outcome measures
| Measure |
Educational Text Message
n=216 Participants
Educational text message reminder
Text Message
Written reminder
|
Plain Text Message
n=224 Participants
plain text message reminder
Text Message
Written reminder
|
Written Reminder Only
n=219 Participants
written reminder at time of vaccination
Written reminder
|
|---|---|---|---|
|
Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.
|
43.5 percentage of participants
|
33.9 percentage of participants
|
25.6 percentage of participants
|
Adverse Events
Educational Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Plain Text Message
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Written Reminder Only
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