Hemophilia Mobile App Usability Pilot

April 17, 2018 updated by: Healthcare Innovation Technology Lab

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Healthcare Innovation and Technology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental

Multiple device intervention

  1. SureSource Engage mobile application
  2. ActiGraph Link
  3. weight scale
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.

Other Names:
  • ActiGraph GT9X Link
  • weight scale

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Innovation Technology Lab

Collaborators

Bayer

Investigators

  • Principal Investigator: Stan Kachnowski, PhD, MPA, Healthcare Innovation Technology Lab
  • Principal Investigator: Ryan Dammerman, MD, Healthcare Innovation Technology Lab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2017

Primary Completion (ANTICIPATED)

May 11, 2018

Study Completion (ANTICIPATED)

May 11, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (ACTUAL)

May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00021564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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