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临床试验/NCT05500339
NCT05500339Unknown不适用

CARE 1000. Randomized Control Trial for the Evaluation of the Effectiveness of a mHealth App for Supporting the First 1000 Days of Life

IRCCS Burlo Garofolo2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
360
试验地点
2
主要终点
Between groups differences in the adherence of pregnant women to Tetanus, Diphtheria, Pertussis (TDaP) vaccination

研究概览

简要总结

Recent development in information and communication technologies has enabled the disruptive expansion of electronic health (eHealth) and mobile health (mHealth). These developments, along with the introduction in clinical practice of technological innovations, such as telemedicine, telemonitoring, and remote screening, are considered essential elements of "game-changing innovations" in the next 25 years. In fact, the widespread distribution of networked devices, which are estimated to reach 29.3 billion in 2023, offers a promising but challenging opportunity of mHealth use for health information seeking, with an important role in health behavior formation. In 2017, more than 325,000 mobile health applications (apps) were available worldwide, and among them, to the best of our knowledge, there were more apps available to support pregnancy than for any other medical domain. These mobile technologies in support of pregnancy have also increased the possibility for both parents and parents-to-be to self-manage health issues; findings from a recent study conducted in 2019 in Switzerland report that 91% of parents declared using digital media for seeking information about their child's health and development. Moreover, a recent meta-analysis showed that social media and mHealth have the potential to be effective in promoting maternal physical health (e.g., weight management), mental health, and knowledge about pregnancy. However, when considering apps addressing children's first 1000 days of life, from conception through age 24 months, many of them just focus on the prenatal or postnatal stage, failing to consider the continuity between the two phases and their joint impact on maternal and child health.

The purpose of this study is to evaluate the mHealth App effectiveness for the support of women during the first 1000 days (from conception through age 24 months) and for improving health prevention behaviors such as vaccination during pregnancy, weight increment during pregnancy, abstinence from smoke and alcohol consumption habits, adherence to child routine vaccination schedule.

In addition, the study aims to understand the level of appreciation of this mHealth App as a tool to overcome information and communication gaps between patients and institution.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women accessing for the first trimester ultrasound.
  • Age >= 18 years
  • Good comprehension of Italian language
  • Possession of a smartphone for the App download
  • Willingness to give birth at Institute for Maternal and Child Health Burlo Garofolo, Trieste

排除标准

  • - Inability to give informed consent

研究组 & 干预措施

Standard care.

Sham Comparator

Pregnant women receive standard supportive and educational methods.

干预措施: Standard care (Other)

mHealth App

Experimental

The mHealth App designed for the support of the first 1000 days of life is provided to pregnant women. Specific contents are presented to the user according to the current trimester of pregnancy or the post-partum period following a scheduled routine; all contents are always available for free consultation during the entire period of use. Links to relevant institutional websites are also reported for any further reading. The app has a frequently asked question (FAQ) section, and a calendar function with the possibility to set appointments and reminders. App contents and topics include information about health prevention behaviors such as vaccination during pregnancy, weight increment during pregnancy, abstinence from smoke and alcohol consumption habits, adherence to child routine vaccination schedule.

干预措施: M-health App (Other)

结局指标

主要结局

Between groups differences in the adherence of pregnant women to Tetanus, Diphtheria, Pertussis (TDaP) vaccination

时间窗: Within the second year of child life

Number of vaccination in pregnancy carried out in the two groups

次要结局

  • Between groups differences in women behaviors(Within the second year of child life)
  • MHealth app usage data(Within the second year of child life)
  • Between groups differences in Health literacy level(Within the second year of child life)
  • Between groups differences in women knowledge(Within the second year of child life)
  • Between groups differences in social and health impact(Within the second year of child life)
  • Appreciation of the mHealth App(Within the second year of child life)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (2)

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