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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Device: Dip HBDA

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joel Schoppig, Msc; Phone Number: +972558852042; Email: joel@healthy.io
• Study Contact Backup: Name: Ron Zohar; Email: ron@healthy.io

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Bayview Medical Center
      • Contact: Anne Burke, MD; Phone Number: 410-550-0337; Email: aburke@jhmdi.edu
      • Principal Investigator: Anne Burke, MD
      • Sub-Investigator: Jill Edwardson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of Dip HBDA	Success rate in conducting the test at home (i.e. successfully completed/total participants)	2-3 months

Collaborators and Investigators

• Sponsor: Healthy.io Ltd.
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Anne Burke, MD, Johns Hopkins Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HealthyioJH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes