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

Healthy.io

Status: Unknown

Conditions: Pregnancy

Treatments: Device: Dip HBDA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03134274

HealthyioJH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Pregnant women

Experimental group

Description:

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.

Treatment:

Device: Dip HBDA