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

NCT03134274 | Unknown FDA Device

• 1 other identifier: HealthyioJH
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Usability of Dip HBDA

  2-3 months

Study Arms (1)

Pregnant women

EXPERIMENTAL

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.

Device: Dip HBDA

Interventions

Dip HBDA DEVICE

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.

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Own and are familiar with use of a smartphone

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthy.io Ltd.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

• Anne Burke, MD

  Johns Hopkins Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Schoppig, Msc

CONTACT

+972558852042; joel@healthy.io

Ron Zohar

CONTACT

ron@healthy.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Assess usability and preference of digital home urine testing with pregnant women. 300 pregnant women will be given a test kit and smartphone application during a clinic visit. Participants are instructed to conduct the test the next day. After conducting the urine test home participants fill out a survey assessing the satisfaction with digital home urine testing.

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 28, 2017
• Study Start: May 7, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)