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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03134274
Recruitment Status : Unknown
Verified August 2017 by Healthy.io Ltd..
Recruitment status was:  Recruiting
First Posted : April 28, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy Device: Dip HBDA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Ease of use and preference questionnaire [ Time Frame: 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 :
  1. Usability of Dip HBDA [ Time Frame: 2-3 months ]
    Success rate in conducting the test at home (i.e. successfully completed/total participants)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03134274


Contacts
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Contact: Joel Schoppig, Msc +972558852042 joel@healthy.io
Contact: Ron Zohar ron@healthy.io

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Anne Burke, MD    410-550-0337    aburke@jhmdi.edu   
Principal Investigator: Anne Burke, MD         
Sub-Investigator: Jill Edwardson, MD         
Sponsors and Collaborators
Healthy.io Ltd.
Johns Hopkins University
Investigators
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Principal Investigator: Anne Burke, MD Johns Hopkins Medical
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Responsible Party: Healthy.io Ltd.
ClinicalTrials.gov Identifier: NCT03134274    
Other Study ID Numbers: HealthyioJH
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes