Flu2Text: A Multi-Site Study Assessing Text Message Reminders for 2nd Dose of Influenza Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,105
- 试验地点
- 5
- 主要终点
- Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
研究概览
简要总结
This multi-site study assesses the impact of text message reminders on the receipt of the second dose of influenza vaccine, and takes place primarily in practices from the American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) network.
详细描述
The study is to be conducted over the 1st season (September 2017-April 2018) as an effectiveness trial and the 2nd (September 2018-April 2019) as a replication study. This approach tests that the intervention effects can be replicated across seasons, during which the severity and incidence of influenza disease may vary. Eligible parents will have a child who received his/her first vaccine dose and is in need of 2 doses that season. Current recommendations require 2 doses for certain children 6 months through 8 years old. Within each practice site, parents will be randomized to receive either: 1) text message reminders embedded with influenza vaccine health-literacy promoting information, or 2) usual care. Randomization is to be stratified by practice site, age (6-23 months, 2-8 years) and language (Spanish, English).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The care provider, primary statistician and analyst will be blinded to participant status.
入排标准
- 年龄范围
- 6 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parenting adult (or legal guardian) of a child that:
- •is between 6 months through 8 years at the time of enrollment (or the age for which 2 doses of influenza are recommended should Centers for Disease Control and Prevention (CDC) recommendations change)
- •received 1st dose of influenza vaccine within last 7 days
- •receives care at study site
- •needs 2 doses of influenza vaccine that season as determined by their clinician at the study site
- •plan to continue to receive care through April 30 of that season (to the best of their knowledge) (season 2017-18 only)
- •Ability to speak and read English or Spanish
- •Has a cell phone that has text message capability
排除标准
- •Parenting adult of a child that:
- •already enrolled in the study in this or the previous season
- •will leave practice before end of season (April 30) (to their best knowledge) (2017-18 season only)
- •Was told by a health care provider that child should not get the flu shot again due to an allergic reaction or anaphylaxis (2017-18 season only)
- •Unable to speak and read English or speak and read Spanish
- •Unable to receive or read text messages on their cell phone
结局指标
主要结局
Percentage of Participants Who Receive Influenza Vaccination by April 30 Each Year
时间窗: Up to receipt of second dose, an average of 6 months
Receipt of second dose influenza vaccine by the end of flu season, which is April 30 each year
次要结局
- Percentage of Participants Who Receive a Second Vaccination by Day 42 From the Initial Influenza Vaccination(Up to 42 days after first dose)
研究者
Melissa Stockwell
Associate Professor of Pediatrics and Population and Family Health
Columbia University