Hemophilia Mobile App Usability Pilot
Primary Purpose
Hemophilia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SureSource Engage application
Sponsored by
About this trial
This is an interventional device feasibility trial for Hemophilia focused on measuring smartphones, clinical trials, weight, actigraph, tracking, hemophilia
Eligibility Criteria
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
Sites / Locations
- Healthcare Innovation and Technology Lab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Multiple device intervention SureSource Engage mobile application ActiGraph Link weight scale
Outcomes
Primary Outcome Measures
Usage of the SureSource Engage application as assessed by ActiLife software
Device usability as assessed by the System Usability Scale (SUS)
Secondary Outcome Measures
Full Information
NCT ID
NCT03168685
First Posted
May 23, 2017
Last Updated
April 17, 2018
Sponsor
Healthcare Innovation Technology Lab
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT03168685
Brief Title
Hemophilia Mobile App Usability Pilot
Official Title
Bayer/HITLAB - Hemophilia Mobile App Usability Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
May 11, 2018 (Anticipated)
Study Completion Date
May 11, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthcare Innovation Technology Lab
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia
Keywords
smartphones, clinical trials, weight, actigraph, tracking, hemophilia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Multiple device intervention
SureSource Engage mobile application
ActiGraph Link
weight scale
Intervention Type
Device
Intervention Name(s)
SureSource Engage application
Other Intervention Name(s)
ActiGraph GT9X Link, weight scale
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usage of the SureSource Engage application as assessed by ActiLife software
Time Frame
128 days
Title
Device usability as assessed by the System Usability Scale (SUS)
Time Frame
128 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Kachnowski, PhD, MPA
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan Dammerman, MD
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Innovation and Technology Lab
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Hemophilia Mobile App Usability Pilot
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