Recruiting

Digital Urinalysis

Sponsor:

Healthy.io Ltd.

Code:

NCT03134274

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dip HBDA

Study Details

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.

Conditions

Pregnancy

Study ID

NCT03134274

Start date

May 7, 2017

Status verified date

Aug, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Ease of use and preference questionnaire [ Time Frame: 2-3 months ]

Central Contacts and Locations

Central contacts

Joel Schoppig, Msc

+972558852042joel@healthy.io

Ron Zohar

ron@healthy.io

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Anne Burke, MD

410-550-0337aburke@jhmdi.edu

Principal Investigator:

Anne Burke, MD

More Information

Sponsor

Healthy.io Ltd.

Last update posted

Aug 22, 2017

Last verified

Aug, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Healthy.io Ltd. on 2017-08-22.