Department of Preventive Medicine, Gachon University College of Medicine, Incheon, Republic of Korea.
Center for Public Health, Gachon University Gil Medical Center, Incheon, 21565, Republic of Korea.
Trials. 2022 Jun 13;23(1):486. doi: 10.1186/s13063-022-06425-3.
The 4th Industrial Revolution with the advent of the smart era, in which artificial intelligence, such as big data analysis and machine learning, is expected, and the provision of healthcare services using smartphones has become a reality. In particular, high-risk mothers who experience gestational diabetes, gestational hypertension, and prenatal and postpartum depression are highly likely to have adverse effects on the mother and newborn due to the disease. Therefore, continuous observation and intervention in health management are needed to prevent diseases and promote healthy behavior for a healthy life.
This randomized controlled trial will provide mothers 18 years of age or older with health care information collected based on evidence-based literature data using a smartphone app for 6 weeks. About 500 mothers will be selected in consideration of the dropout rate due to the characteristics of mothers. The study group and control group will be computer-generated in a 1:1 ratio through random assignment. The research group will receive health management items through the app, and health management information suitable for the pregnancy cycle is pushed to an alarm. The control group will receive the health management information of the paper. We also followed the procedure for developing mobile apps using the IDEAS framework.
These results show the effectiveness of smart medical healthcare services and promote changes in health behaviors throughout pregnancy in high-risk mothers.
Clinical trial registration information for this study has been registered with WHO ICTRP and CRIS (Korea Clinical Research Information Service, CRIS). Clinical trial registration information is as follows: Study of development of integrated smart health management service for the whole life cycle of high-risk mothers and newborns based on community, KCT0007193 . Registered on April 14, 2022, prospectively registered. This protocol version is Version 1.0. April 14, 2022.
随着智能时代的到来，第四次工业革命即将到来，预计将出现人工智能，如大数据分析和机器学习，并且使用智能手机提供医疗保健服务已经成为现实。特别是患有妊娠糖尿病、妊娠高血压和产前产后抑郁症的高危母亲，由于疾病很可能对母亲和新生儿产生不良影响。因此，需要持续观察和干预健康管理，以预防疾病并促进健康行为，实现健康生活。
本随机对照试验将为年龄在 18 岁及以上的母亲提供基于循证文献数据使用智能手机应用程序收集的健康护理信息，为期 6 周。考虑到母亲的特点，将有 500 名左右的母亲被选中。研究组和对照组将通过随机分组以 1:1 的比例进行计算机生成。研究组将通过应用程序接收健康管理项目，并向警报推送适合妊娠周期的健康管理信息。对照组将收到纸质的健康管理信息。我们还按照使用 IDEAS 框架开发移动应用程序的程序进行操作。
这些结果表明智能医疗保健服务的有效性，并促进高危母亲在整个怀孕期间健康行为的改变。
本研究的临床试验注册信息已在世界卫生组织 ICTRP 和 CRIS（韩国临床研究信息服务，CRIS）上注册。临床试验注册信息如下：基于社区的高危母亲和新生儿全生命周期综合智能健康管理服务的开发研究，KCT0007193。于 2022 年 4 月 14 日注册，前瞻性注册。本协议版本为 1.0 版。2022 年 4 月 14 日。
