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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Device: Dip HBDA||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
- Ease of use and preference questionnaire [ Time Frame: 2-3 months ]
- 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)
- Usability of Dip HBDA [ Time Frame: 2-3 months ]Success rate in conducting the test at home (i.e. successfully completed/total participants)
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
|Contact: Joel Schoppig, Mscfirstname.lastname@example.org|
|Contact: Ron Zoharemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Anne Burke, MD 410-550-0337 firstname.lastname@example.org|
|Principal Investigator: Anne Burke, MD|
|Sub-Investigator: Jill Edwardson, MD|
|Principal Investigator:||Anne Burke, MD||Johns Hopkins Medical|