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临床试验/NCT03274310
NCT03274310已完成不适用

FluSAFE: Flu SMS Alerts to Freeze Exposure

Columbia University1 个研究点 分布在 1 个国家目标入组 1,918 人开始时间: 2017年10月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,918
试验地点
1
主要终点
Number of Laboratory-confirmed Influenza Infections

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • ≥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

排除标准

  • 未提供

结局指标

主要结局

Number of Laboratory-confirmed Influenza Infections

时间窗: Up to 5 days

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.

次要结局

  • Number of Cases of Household Members Meeting Symptomatic Criteria for ILI/ARI(Up to 5 days)
  • Number of Infections of Non-influenza Respiratory Viruses(Up to 5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Stockwell

Associate Professor of Pediatrics and Population and Family Health

Columbia University

研究点 (1)

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