NCT03134274

Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.

Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Healthy.io Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Dip HBDA	Participant receive Dip HBDA semiquantitative urinalyiss kit to be used at home one day after routine prenatal consultation. Dip HBDA consists of a testing kit containing calibration color board, 10 parameter urine dipstick and a urine cup as well as a smartphone application. Application guides participant through the test flow. Dipstick is immersed in urine cup, placed on color board and scanned with smartphone.

Timeline

• Start date: 2017-05-07
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2017-04-28
• Last updated: 2017-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study