FluSAFE: Flu SMS Alerts to Freeze Exposure
Primary Purpose
Influenza, Acute Respiratory Infection, Influenza-like Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational text messages
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Text message, Influenza-like Illness, Acute Respiratory Infection
Eligibility Criteria
Inclusion Criteria:
- ≥3 persons per household
- At least one person who is less than 18 years old
- English or Spanish speaking
- Household reporter has cell phone with text messaging capabilities
- Household reporter willing to use text messages to report
- Reside within study neighborhoods in New York City
Exclusion Criteria
- Intention to move away from New York City area in <12 months
- Language other than English or Spanish
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surveillance + Education arm
Surveillance-only arm
Arm Description
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
No intervention solely surveillance messages
Outcomes
Primary Outcome Measures
Household transmission of laboratory-confirmed influenza
One self-swab of the index case and self-swabs of other household members will be analyzed using reverse transcription polymerase chain reaction (RT-PCR) to identify household transmission of laboratory-confirmed influenza
Secondary Outcome Measures
Household transmission of symptomatic ILI/ARI
Cases of household members meeting symptomatic criteria for ILI/ARI
Household transmission of non-influenza respiratory viruses
One self-swab of the index case and self-swabs of other household members will be analyzed using RT-PCR to identify household transmission of non-influenza respiratory viruses
Full Information
NCT ID
NCT03274310
First Posted
September 4, 2017
Last Updated
April 9, 2022
Sponsor
Columbia University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT03274310
Brief Title
FluSAFE: Flu SMS Alerts to Freeze Exposure
Official Title
FluSAFE: Flu SMS Alerts to Freeze Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
May 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Influenza infection results in an estimated 31 million outpatient visits, 55,000 to 974,200 hospitalizations, and 3,000 to 49,000 deaths. Membership in household in which someone else has influenza is the major risk factor for contracting influenza. The household secondary attack rate (SAR) is as high as 19% based on laboratory-confirmed influenza and 30% based on symptoms. Non-pharmaceutical preventive measures, including education, may play a role in decreasing transmission, but are only effective if started within 36 hours of symptom onset in index cases. Yet, most interventions are delayed because they are not initiated until care is sought. The investigators have demonstrated in one primarily Latino, urban community sample, that text messaging can be used to rapidly identify community members with influenza-like illness (ILI) early in an illness. This early identification would enable implementation of an educational intervention in the optimal time frame to reduce influenza transmission. Providing education within a text message is a proven successful strategy to influence behavior. Text messaging itself is scalable, low-cost, and can be used in low literacy populations. However, using text-message based surveillance to trigger a real-time text-message behavioral educational intervention to decrease household influenza transmission has not been assessed.
Detailed Description
The study will enroll approximately 400 households with ≥1 child recruited from four contiguous communities in New York City. Households will be randomized, stratified by community 1:1 to receive surveillance-only (no text message education) vs. surveillance plus text message educational intervention. For symptom surveillance, households in both arms will receive text messages 3x/week during each influenza season and report if someone in the household has ILI symptoms. For those in the educational intervention arm, when an ILI/acute respiratory infections (ARI) is reported, a series of educational text messages will be sent with information to decrease household transmission.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Acute Respiratory Infection, Influenza-like Illness
Keywords
Influenza, Text message, Influenza-like Illness, Acute Respiratory Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1918 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surveillance + Education arm
Arm Type
Experimental
Arm Description
Receipt of educational text message about ways to decrease household transmission of influenza and other respiratory infections in addition to surveillance messages
Arm Title
Surveillance-only arm
Arm Type
No Intervention
Arm Description
No intervention solely surveillance messages
Intervention Type
Behavioral
Intervention Name(s)
Educational text messages
Intervention Description
Educational text message about ways to decrease household transmission of influenza and other respiratory infections
Primary Outcome Measure Information:
Title
Household transmission of laboratory-confirmed influenza
Description
One self-swab of the index case and self-swabs of other household members will be analyzed using reverse transcription polymerase chain reaction (RT-PCR) to identify household transmission of laboratory-confirmed influenza
Time Frame
Up to 5 days
Secondary Outcome Measure Information:
Title
Household transmission of symptomatic ILI/ARI
Description
Cases of household members meeting symptomatic criteria for ILI/ARI
Time Frame
Up to 5 days
Title
Household transmission of non-influenza respiratory viruses
Description
One self-swab of the index case and self-swabs of other household members will be analyzed using RT-PCR to identify household transmission of non-influenza respiratory viruses
Time Frame
Up to 5 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥3 persons per household
At least one person who is less than 18 years old
English or Spanish speaking
Household reporter has cell phone with text messaging capabilities
Household reporter willing to use text messages to report
Reside within study neighborhoods in New York City
Exclusion Criteria
Intention to move away from New York City area in <12 months
Language other than English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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FluSAFE: Flu SMS Alerts to Freeze Exposure
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