Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Ease of use and preference questionnaire
研究概览
简要总结
The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.
详细描述
300 pregnant women receive home testing kit and smartphone application (Dip HBDA) during regular prenatal visit. They are instructed to conduct a urine test (regular 10 parameter dipstick included in kit) at home using the Dip HBDA. After conducting the urine test, participants are to fill out a short questionnaire regarding ease of use, preference of testing and any problems encountered.
This study only assesses usability and questionnaire outcomes. The results of the test (indications on dipstick) are not subject to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •English Speaking
- •Own and are familiar with use of a smartphone
排除标准
- •They do not have use of both hands.
- •Are visually impaired (cannot read user manual)
- •Have dementia or mental disorder.
- •Are not able to fill urine receptacle.
- •Are not willing to adhere to study procedures.
- •Do not own or are not familiar with the use of a smartphone.
- •Have no access to a wifi / or cellular data connection at their home.
- •Have impaired vision that prevents them from reading instructions.
研究组 & 干预措施
Pregnant women
Pregnant women above the age of 18 years, undergoing routine pre-natal care, who own and are familiar with use of a smartphone receive a Dip HBDA kit for home use.
干预措施: Dip HBDA (Device)
结局指标
主要结局
Ease of use and preference questionnaire
时间窗: 2-3 months
Questionnaire contains: * Ease of use among pregnant women (Ease of use ranking 1-5 measured) * Problems encountered while doing the test * Likelihood that digital home urine testing would be recommended (Net Promoter Score) * Preference of home testing compared to traditional testing (Prefer home testing, no preference, prefer traditional testing)
次要结局
- Usability of Dip HBDA(2-3 months)