Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Healthy.io Ltd.
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Ease of use and preference questionnaire
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •English Speaking
- •Own and are familiar with use of a smartphone
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Dip HBDA (Device)
Outcomes
Primary Outcomes
Ease of use and preference questionnaire
Time Frame: 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)
Secondary Outcomes
- Usability of Dip HBDA(2-3 months)