Pregnancy
Conditions
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.
Interventions
DEVICEDip 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.
Sponsors
Johns Hopkins University
Healthy.io Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Usability of Dip HBDA | 2-3 months | Success rate in conducting the test at home (i.e. successfully completed/total participants) |
Countries
United States
Contacts
Primary ContactJoel Schoppig, Msc
Backup ContactRon Zohar
Outcome results
None listed