C Tracker, Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study



Status:Terminated
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:October 2015
End Date:January 16, 2019

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preSmartphone App for Monitoring and Reporting of Hepatitis C Related Health Information: C Tracker Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study

Today's mobile devices (especially smartphones) are powerful ways to communicate new
information to medical researchers. For this study, researchers at Boston Children's Hospital
are asking people with hepatitis C to make use of their smartphones to help report
information about themselves that may improve how hepatitis C is treated. This study uses a
free app called C Tracker that can be installed from the Apple App Store onto the
participants iPhone. The main goal of this research study is to use this app to report
hepatitis C related health information to the researchers who are conducting this study. The
investigators will ask participants about their health,activities, medications, and ways in
which hepatitis C has impacted you. This information will be reported anonymously, which
means that the researchers doing the study won't know who the participants are.

Specific Aims/Objectives

Aim 1. Develop a free iPhone app ("C TRACKER") designed to anonymously record and report
Hepatitis C related health data to study investigators via periodic patient-reported surveys.

Aim 2. Examine the feasibility of enrolling a large cohort of geographically dispersed cohort
of subjects with hepatitis C who download and install the C TRACKER app, provide informed
consent using the app, and complete study surveys using the app. The app will be made
available to the public via the Apple App Store at no cost.

Aim 3. Pilot usage of the app to track and analyze longitudinal measures of hepatitis C
related health concerns, physical function, and physical activity via selected
disease-specific as well as more broadly applicable patient-reported instruments, including
regarding work productivity (WPAI-Hepatitis C), physical functioning (subsets/subscales of
the MOS SF-36), physical activity (collected through Apple HealthKit), and prescribed
medications.

Inclusion Criteria:

- Self-report a diagnosis of Hepatitis C

- English speaking individuals

- 18 years or older

- Must have access to an iPhone that operates on iOS version 8 or higher

- Be able to download apps from the U.S. Apple iPhone Store, and enter data themselves
or via a proxy on their behalf

Exclusion Criteria:

• Individuals not meeting inclusion criteria will be excluded.
We found this trial at
1
site
Boston, Massachusetts 02115
Principal Investigator: Kenneth D Mandl, MD, MPH
Phone: 617-355-4145
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mi
from
Boston, MA
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