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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Dip HBDA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women<br>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<br>* 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.<br>|

What is the study measuring?
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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 |