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

Sponsor

Healthy.io Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03134274

Collaborator

Johns Hopkins University (Other)

300

Enrollment

Location

Arm

4.8

Anticipated Duration (Months)

62.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Device: Dip HBDA	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

May 7, 2017

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Oct 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

Healthy.io Ltd.
Johns Hopkins University

Investigators

Principal Investigator: Anne Burke, MD, Johns Hopkins Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Healthy.io Ltd.

ClinicalTrials.gov Identifier:

NCT03134274

Other Study ID Numbers:

HealthyioJH

First Posted:

Apr 28, 2017

Last Update Posted:

Aug 22, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Study Results

No Results Posted as of Aug 22, 2017