Back to resultsFever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Primary Purpose
Fever, Wheezing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
text message
Sponsored by
About this trial
This is an interventional health services research trial for Fever
Eligibility Criteria
Inclusion Criteria:
- are 2 through 11years of age,
- have a visit at a study site anytime during the study period,
- receive first dose or second dose of LAIV4 or IIV in the season,
- the parent has a cell phone with text messaging capabilities, and
- the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.
Exclusion criteria:
- presence of fever ≥100.4 at time of vaccination,
- administration of any antipyretic in the 6-hour period prior to vaccination,
- stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
- parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
- enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
- parent's inability to read and send text messages,
- sibling already enrolled this season (OR cell phone # already used for another child)
- chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
- current asthma exacerbation, or exacerbation in the last 2 weeks
- use of oral or other systemic steroid within the last 2 weeks
Sites / Locations
- Centers for Disease Control and Prevention
- Boston Medical Center
- Columbia University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
text message
Arm Description
all families will receive text messages to which they can respond to report symptoms
Outcomes
Primary Outcome Measures
feasibility reporting respiratory symptom
Response rates to text messages regarding wheezing, cough or chest tightness symptoms
Secondary Outcome Measures
feasibility reporting fever
Response rates to text messages regarding temperature
Full Information
NCT ID
NCT02295007
First Posted
November 17, 2014
Last Updated
May 10, 2016
Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention, Boston Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02295007
Brief Title
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Official Title
Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention, Boston Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Wheezing
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
266 (Actual)
8. Arms, Groups, and Interventions
Arm Title
text message
Arm Type
Other
Arm Description
all families will receive text messages to which they can respond to report symptoms
Intervention Type
Behavioral
Intervention Name(s)
text message
Primary Outcome Measure Information:
Title
feasibility reporting respiratory symptom
Description
Response rates to text messages regarding wheezing, cough or chest tightness symptoms
Time Frame
days 0-42 days post-vaccination
Secondary Outcome Measure Information:
Title
feasibility reporting fever
Description
Response rates to text messages regarding temperature
Time Frame
days 0-7 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are 2 through 11years of age,
have a visit at a study site anytime during the study period,
receive first dose or second dose of LAIV4 or IIV in the season,
the parent has a cell phone with text messaging capabilities, and
the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.
Exclusion criteria:
presence of fever ≥100.4 at time of vaccination,
administration of any antipyretic in the 6-hour period prior to vaccination,
stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
parent's inability to read and send text messages,
sibling already enrolled this season (OR cell phone # already used for another child)
chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
current asthma exacerbation, or exacerbation in the last 2 weeks
use of oral or other systemic steroid within the last 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip LaRussa, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for Disease Control and Prevention
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29089191
Citation
Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.
Results Reference
derived
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Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
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