Hemophilia Mobile App Usability Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bayer/HITLAB - Hemophilia Mobile App Usability Pilot

Conditions
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Hemophilia

Intervention / Treatment
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* Device: SureSource Engage application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Multiple device intervention SureSource Engage mobile application ActiGraph Link weight scale | Device: SureSource Engage application<br>* 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.<br>* Other names: weight scale;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of the SureSource Engage application as assessed by ActiLife software |  | 128 days | 
| Device usability as assessed by the System Usability Scale (SUS) |  | 128 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trials, weight, actigraph, tracking, hemophilia, smartphones