Trial Outcomes & Findings for TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations (NCT NCT01146912)

Results Overview

percentage of pediatric participants with influenza immunization by March 31 of 2011

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30537 participants

Primary outcome timeframe

March 31, 2011

Results posted on

2015-10-07

Participant Flow

Children and pregnant women receiving care at 4 community-based clinics in the United States during the 2010-2011, 2011-2012 influenza season

Children previously vaccinated for influenza before the season of interest were excluded from primary analysis

Participant milestones

Participant milestones
Measure	Pediatric Text Message Vaccine Reminders/Automated Phone Call Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only Receipt of automated phone call from clinic	Pregnant Women: Text Message Received text message reminders	Pregnant Women: Usual Care Received usual care	Delayed Pediatrics: Interactive Text Message Vaccine Reminders Vaccination of children not yet vaccinated by mid-November: interactive message	Delayed Pediatric: Conventional Text Message Vaccination of children not yet vaccinated by mid-November: conventional text message	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care	Parents Included in enrollment but not in outcomes which are on child level
Overall Study STARTED	4607	4606	593	594	1821	1821	1820	14675
Overall Study COMPLETED	3790	3784	576	577	1780	1760	1764	14675
Overall Study NOT COMPLETED	817	822	17	17	41	61	56	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pediatric Text Message Vaccine Reminders/Automated Phone Call Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only Receipt of automated phone call from clinic	Pregnant Women: Text Message Received text message reminders	Pregnant Women: Usual Care Received usual care	Delayed Pediatrics: Interactive Text Message Vaccine Reminders Vaccination of children not yet vaccinated by mid-November: interactive message	Delayed Pediatric: Conventional Text Message Vaccination of children not yet vaccinated by mid-November: conventional text message	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Overall Study Already received influenza vaccination	817	822	13	15	41	61	56
Overall Study < 14 weeks gestational age	0	0	3	2	0	0	0
Overall Study Duplicate patient	0	0	1	0	0	0	0

Baseline Characteristics

TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Text Message Vaccine Reminders/Automated Telephone Call n=4607 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Automated Phone Call From Clinic Only n=4606 Participants Receipt of automated phone call from clinic	Pregnant Women: Text Message n=593 Participants	Pregnant Women: Usual Care n=594 Participants	Delayed Pediatrics: Interactive Text Message n=1821 Participants	Delayed Pediatrics: Conventional Text Message n=1821 Participants	Delayed Pediatrics: Usual Care n=1820 Participants	Total n=15862 Participants Total of all reporting groups
Age, Categorical <=18 years	4607 Participants n=5 Participants	4606 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1821 Participants n=21 Participants	1821 Participants n=8 Participants	1820 Participants n=8 Participants	14675 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	593 Participants n=5 Participants	594 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1187 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Sex: Female, Male Female	2335 Participants n=5 Participants	2332 Participants n=7 Participants	593 Participants n=5 Participants	594 Participants n=4 Participants	869 Participants n=21 Participants	926 Participants n=8 Participants	862 Participants n=8 Participants	8511 Participants n=24 Participants
Sex: Female, Male Male	2272 Participants n=5 Participants	2274 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	952 Participants n=21 Participants	895 Participants n=8 Participants	958 Participants n=8 Participants	7351 Participants n=24 Participants
Region of Enrollment United States	4607 participants n=5 Participants	4606 participants n=7 Participants	593 participants n=5 Participants	594 participants n=4 Participants	1821 participants n=21 Participants	1821 participants n=8 Participants	1820 participants n=8 Participants	15862 participants n=24 Participants

PRIMARY outcome

Timeframe: March 31, 2011

Population: Individuals unvaccinated by time intervention start for their cohort

percentage of pediatric participants with influenza immunization by March 31 of 2011

Outcome measures

Outcome measures
Measure	Pediatric: Text Message Vaccine-reminders/Automated Phone Call n=3790 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only n=3784 Participants Receipt of automated phone call from clinic	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Influenza Immunization: Pediatric	43.6 % participant vaccinated with influenza	39.9 % participant vaccinated with influenza	—

PRIMARY outcome

Timeframe: by December 31, 2011

percentage of pregnant participants with influenza immunization by December 31, 2011

Outcome measures

Outcome measures
Measure	Pediatric: Text Message Vaccine-reminders/Automated Phone Call n=576 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only n=577 Participants Receipt of automated phone call from clinic	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Influenza Immunization: Pregnant Women	49.3 %participants vaccinated with influenza	46.6 %participants vaccinated with influenza	—

PRIMARY outcome

Timeframe: March 31, 2012

percentage of pediatric participants with influenza immunization by March 31 of 2012

Outcome measures

Outcome measures
Measure	Pediatric: Text Message Vaccine-reminders/Automated Phone Call n=1780 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only n=1760 Participants Receipt of automated phone call from clinic	Delayed Pediatric: Usual Care n=1764 Participants Vaccination of children not yet vaccinated by mid-November: usual care
Influenza Immunization: Delayed Pediatric	38.5 %participants vaccinated with influenza	35.3 %participants vaccinated with influenza	34.8 %participants vaccinated with influenza

SECONDARY outcome

Timeframe: March 31, 2011

Population: those unvaccinated by the start date for their cohort

percentage of pediatric participants vaccinated at an influenza immunization clinic by March 31 of 2011

Outcome measures

Outcome measures
Measure	Pediatric: Text Message Vaccine-reminders/Automated Phone Call n=3790 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only n=3784 Participants Receipt of automated phone call from clinic	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Pediatric: Vaccinated at Influenza Clinic	6.1 % participant vaccinated at flu clinic	2.8 % participant vaccinated at flu clinic	—

SECONDARY outcome

Timeframe: September-December 2011

percentage of pregnant participants who attended an appointment a reminder for from Sept-December 2011

Outcome measures

Outcome measures
Measure	Pediatric: Text Message Vaccine-reminders/Automated Phone Call n=576 Participants Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic	Pediatric: Automated Phone Call From Clinic Only n=577 Participants Receipt of automated phone call from clinic	Delayed Pediatric: Usual Care Vaccination of children not yet vaccinated by mid-November: usual care
Attendance at Appointment	85.0 % participants attending appointment	87.6 % participants attending appointment	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Stockwell, MD MPH

Columbia University

Phone: 212-342-5372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place