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临床试验/NCT03505424
NCT03505424已完成不适用

Supporting All Families of Premature Infants At Prentice Women's Hospital from Admission Through Discharge

Northwestern University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年4月20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
400
试验地点
2
主要终点
The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey.

研究概览

简要总结

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents' anticipated concerns and their infant's clinical status, is effective in: 1) improving parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay, readmission rates.)

详细描述

There will be four groups of participants based on when the infant is in the NICU.

Parents of infants born from April -Mid-August 2018 (Group 1) Group 1 participants will receive usual care which includes 1) a welcome packet from the nursing staff, 2) access to their infant's medical team including doctors and nurse, 3) opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.

At NICU admission, parents in Group 1 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

Parents of infants born from Mid-August - January 2019 (Group 2) At NICU admission, parents in Group 2 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

In addition to the usual care made available to Group 1 and described above, Group 2 parents will also be asked to download the NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app. In case there are difficulties downloading or using the app, the research team will be available to assist parents with any questions or concerns.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Parents of premature infants (<37 weeks) admitted to Prentice NICU
  • Competent in English (i.e. to fully understand the questions asked in the surveys)
  • Smartphone owner

排除标准

  • None Adults unable to consent/Cognitively Impaired
  • Pregnant women (where the activities of the research may affect the pregnancy or the fetus)
  • Prisoners or other detained individuals

结局指标

主要结局

The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey.

时间窗: 2-3 months

We will use the PSOC Survey for this outcome.

次要结局

  • The primary outcome measure will be the level of stress caring for their premature infants while in the NICU and once at home measured through a survey.(2-3 months)
  • Relationship quality will be measured through survey.(2-3 months)

研究者

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

Craig Garfield

Associate Professor in Pediatrics

Northwestern University

研究点 (2)

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