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

Not Applicable

• Conditions: Pregnancy
• Interventions: Device: Dip HBDA

• Registration Number: NCT03134274
• Lead Sponsor: Healthy.io Ltd.

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.

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 Timeline

• Study First Submitted: 2017-04-24
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-04-28
• Study Start: 2017-05-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women	Dip HBDA	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.

Primary Outcome Measures

Name	Time	Method
Ease of use and preference questionnaire	2-3 months	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States