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临床试验/NCT01248520
NCT01248520已完成不适用

Text Messaging For Preventative Health During Pregnancy; Improving Influenza Vaccination Rates In Pregnancy: A Randomized Controlled Trial of Text Messaging to Increase Vaccine Uptake

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2010年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
216
试验地点
2
主要终点
To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.

研究概览

简要总结

A randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

详细描述

History and the 2009 H1N1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. The influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates. Despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. Barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. Cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. Text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. We propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

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
Single (Participant)

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women less than 28 weeks estimated gestation age
  • Between 14-50 years of age
  • Willing to provide informed consent and undergo necessary study procedures

排除标准

  • Unwillingness or inability to receive text messages
  • Receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit
  • Reported history of adverse reaction precluding receipt of the vaccine
  • Unwillingness or inability to provide informed consent and comply with study criteria.

研究组 & 干预措施

General health information

Placebo Comparator

Pregnant women receiving text messages containing general health messages without including information regarding the importance of the influenza vaccination

干预措施: general health information (Other)

Influenza and general health information

Active Comparator

Pregnant women receiving text messages with influenza facts and the importance of the influenza vaccination, as well as general health messages Intervention: Text messages with influenza facts

干预措施: influenza and general health information (Other)

结局指标

主要结局

To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake.

时间窗: at participant post-partum visit

To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. We hypothesize that text messaging will improve the timing (earlier in flu season) and rate of receipt of influenza vaccination in pregnancy.

次要结局

  • To assess the ability of direct education via text messaging to enhance knowledge about influenza infection and vaccination in pregnancy.(at participant post-partum visit)

研究者

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

Richard Beigi

Associate Professor

University of Pittsburgh

研究点 (2)

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