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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03134274
• Other study ID #: HealthyioJH
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: August 17, 2017
• Start date: May 7, 2017
• Est. completion date: October 2017

Study information

• Verified date: August 2017
• Source: Healthy.io Ltd.
• Contact: Joel Schoppig, Msc
• Phone: +972558852042
• Email: joel[@]healthy.io
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Healthy.io Ltd.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of use and preference questionnaire	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)	2-3 months
Secondary	Usability of Dip HBDA	Success rate in conducting the test at home (i.e. successfully completed/total participants)	2-3 months