NCT03168685

Hemophilia Mobile App Usability Pilot

Bayer/HITLAB - Hemophilia Mobile App Usability Pilot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Healthcare Innovation Technology Lab · Industry
• Sex: All
• Age: 18 Years – 63 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DEVICE	SureSource Engage application	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.

Timeline

• Start date: 2017-05-22
• Primary completion: 2018-05-11
• Completion: 2018-05-11
• First posted: 2017-05-30
• Last updated: 2018-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study