HemophiliaNCT03168685
Hemophilia Mobile App Usability Pilot
A study testing SureSource Engage application in people with Hemophilia, run by Healthcare Innovation Technology Lab at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- What is being tested?
- SureSource Engage application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 11 May 2018
- 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 to 63 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You own an iPhone or a Samsung (S5 or higher) smartphone
- Your age is between 18 and 63 years
- You reside in the New York metropolitan area
- You are able to read, write, and speak English
- You have participated in a concluded clinical trial in the past two years
Who cannot join
- You do not own an iPhone or a Samsung (S5 or higher) smartphone
- Your age is not between 18 and 63 years
- You do not reside in the New York metropolitan area
- You are not able to read, write, and speak English
- You have not participated in a concluded clinical trial in the past two years
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Innovation and Technology Lab
New York, New York, 10032
About this study
Official title: Bayer/HITLAB - Hemophilia Mobile App Usability Pilot
The purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale.
Read the detailed description
HITLAB will conduct a segmented rapid user acceptance study ("rapid UX study") of a smart phone app and an actigraphy device with a connected scale. During the first segment, of one month's duration, subjects will use the app, actigraphy device, and scale. Next, over an interphase period of up to 6 weeks, subjects will only use the app. During this time, the app will be modified based on data collected during the first segment. Finally, during the second period, also of one month's duration, subjects will use the modified app, actigraphy device, and scale.
- Conditions
- Hemophilia
- Being tested
- SureSource Engage application
- Keywords
- smartphones, clinical trials, weight, actigraph, tracking, hemophilia
- Medical subject headings
- Hemophilia A, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SureSource Engage applicationDevice
Also called ActiGraph GT9X Link, weight scale
Eligible patients who choose to participate in the study will be asked to wear an actigraphy device [ActiGraph GT9X Link "Actigraph Link"] on their wrist continuously during both 4-week study phases.
The ActiGraph Link is a small (3.5 X 3.5 X 1 cm) wristwatch like device weighing approximately 14 grams that measures indicators of the wearer's activity and sleep patterns, including: acceleration, energy expenditure, steps, basal metabolic rate, activity intensity, sleep time, sleep efficiency, sleep latency, and body position.
The application being utilized is SureSource Engage application from Clinical Ink. The application is compatible to most Android and iOS devices.
Participants will also use a basic Bluetooth-enabled weight scale that syncs with the application.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Multiple device intervention
1. SureSource Engage mobile application
2. ActiGraph Link
3. weight scale Receives: Device: SureSource Engage application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of the SureSource Engage application as assessed by ActiLife software
Measured: 128 days
Device usability as assessed by the System Usability Scale (SUS)
Measured: 128 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start22 May 2017
- Primary completion11 May 2018 (estimated)
- Study completion11 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthcare Innovation Technology Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Stan Kachnowski, PhD, MPA, Principal investigator, Healthcare Innovation Technology LabRyan Dammerman, MD, Principal investigator, Healthcare Innovation Technology Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168685
- Sponsor's protocol ID
- Pro00021564
- Status last verified
- Apr 2018
- First submitted
- 23 May 2017
- Last updated
- 19 Apr 2018
- 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 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bayer/HITLAB - Hemophilia Mobile App Usability Pilot
- ClinicalTrials.gov ID
- NCT03168685
- Acronym / sponsor ID
- Pro00021564
- Conditions
- Hemophilia
- Keywords
- smartphones, clinical trials, weight, actigraph, tracking, hemophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Healthcare Innovation Technology LabIndustry (pharma, biotech, devices)
- Collaborators
- Bayer
- Study start
- 22 May 2017 (actual)
- Primary completion
- 11 May 2018 (estimated)
- Study completion
- 11 May 2018 (estimated)
- First posted
- 30 May 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 purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale.
Detailed description
HITLAB will conduct a segmented rapid user acceptance study ("rapid UX study") of a smart phone app and an actigraphy device with a connected scale. During the first segment, of one month's duration, subjects will use the app, actigraphy device, and scale. Next, over an interphase period of up to 6 weeks, subjects will only use the app. During this time, the app will be modified based on data collected during the first segment. Finally, during the second period, also of one month's duration, subjects will use the modified app, actigraphy device, and scale.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: SureSource Engage applicationMultiple device intervention 1. SureSource Engage mobile application 2. ActiGraph Link 3. weight scale |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- You own an iPhone or a Samsung (S5 or higher) smartphone
- Your age is between 18 and 63 years
- You reside in the New York metropolitan area
- You are able to read, write, and speak English
- You have participated in a concluded clinical trial in the past two years
Key exclusion criteria (5 listed)
- You do not own an iPhone or a Samsung (S5 or higher) smartphone
- Your age is not between 18 and 63 years
- You do not reside in the New York metropolitan area
- You are not able to read, write, and speak English
- You have not participated in a concluded clinical trial in the past two years
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 |
|---|---|---|
| SureSource Engage applicationAlso: ActiGraph GT9X Link, weight scaleEligible patients who choose to participate in the study will be asked to wear an actigraphy device [ActiGraph GT9X Link "Actigraph Link"] on their wrist continuously during both 4-week study phases. The ActiGraph Link is a small (3.5 X 3.5 X 1 cm) wristwatch like device weighing approximately 14 grams that measures indicators of the wearer's activity and sleep patterns, including: acceleration, energy expenditure, steps, basal metabolic rate, activity intensity, sleep time, sleep efficiency, sleep latency, and body position. The application being utilized is SureSource Engage application from Clinical Ink. The application is compatible to most Android and iOS devices. Participants will also use a basic Bluetooth-enabled weight scale that syncs with the application. | Device | Experimental |
Primary outcome
Usage of the SureSource Engage application as assessed by ActiLife software
Time frame: 128 days
Device usability as assessed by the System Usability Scale (SUS)
Time frame: 128 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Stan Kachnowski, PhD, MPA principal investigator
Healthcare Innovation Technology Lab
Ryan Dammerman, MD principal investigator
Healthcare Innovation Technology Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SureSource Engage application in people with Hemophilia, run by Healthcare Innovation Technology Lab 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 5 inclusion and 5 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 19 Apr 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of the SureSource Engage application as assessed by ActiLife software (time frame: 128 days). The study lists 2 primary outcomes in all. 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 19 Apr 2018.