PregnancyNCT03134274
Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.
A study testing Dip HBDA in people with Pregnancy, run by Healthy.io Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Dip HBDA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2017to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English Speaking
- Own and are familiar with use of a smartphone
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Ron Zohar contact
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Anne Burke, MD, 410-550-0337, aburke@jhmdi.edu
Anne Burke, MD
About this study
Official title: Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Dip HBDA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dip HBDADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | 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. Receives: Device: Dip HBDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use and preference questionnaire
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)
Measured: 2-3 months
Secondary outcomes (1)
Usability of Dip HBDA
Success rate in conducting the test at home (i.e. successfully completed/total participants)
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start7 May 2017
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthy.io Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Anne Burke, MD, Principal investigator, Johns Hopkins Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134274
- Sponsor's protocol ID
- HealthyioJH
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy.io Urine Dipstick Home Testing: a Pilot Study Among Pregnant Women
- ClinicalTrials.gov ID
- NCT03134274
- Acronym / sponsor ID
- HealthyioJH
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Healthy.io Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 7 May 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Device: Dip HBDAPregnant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English Speaking
- Own and are familiar with use of a smartphone
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dip HBDAParticipant 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. | Device | Pregnant women |
Primary outcome
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)
1 secondary outcome
Usability of Dip HBDA
Time frame: 2-3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
RecruitingObservational study
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
Not yet recruiting
Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy
Hypertensive Disorders of Pregnancy (HDP), Hypertension, Pregnancy Induced
Recruiting
The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
Early Pregnancy Bleeding
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Zohar contact
Anne Burke, MD principal investigator
Johns Hopkins Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dip HBDA in people with Pregnancy, run by Healthy.io Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joel Schoppig, Msc (+972558852042, joel@healthy.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use and preference questionnaire (time frame: 2-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.