Hemophilia Mobile App Usability Pilot

Hemophilia Clinical Trial

Official title:

Bayer/HITLAB - Hemophilia Mobile App Usability Pilot

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03168685
• Other study ID #: Pro00021564
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: April 17, 2018
• Start date: May 22, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: April 2018
• Source: Healthcare Innovation Technology Lab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 63 Years

Eligibility

Inclusion Criteria:

1. You own an iPhone or a Samsung (S5 or higher) smartphone

2. Your age is between 18 and 63 years

3. You reside in the New York metropolitan area

4. You are able to read, write, and speak English

5. You have participated in a concluded clinical trial in the past two years

Exclusion Criteria:

1. You do not own an iPhone or a Samsung (S5 or higher) smartphone

2. Your age is not between 18 and 63 years

3. You do not reside in the New York metropolitan area

4. You are not able to read, write, and speak English

5. You have not participated in a concluded clinical trial in the past two years

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Intervention

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.

Locations

Country	Name	City	State
United States	Healthcare Innovation and Technology Lab	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Healthcare Innovation Technology Lab	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of the SureSource Engage application as assessed by ActiLife software		128 days
Primary	Device usability as assessed by the System Usability Scale (SUS)		128 days