Clinical trial NCT02568540: C Tracker, Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study
Official title: preSmartphone App for Monitoring and Reporting of Hepatitis C Related Health Information: C Tracker Hepatitis C, Care & Collaboration - Patient Reported Outcomes Survey Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Keywords: Hepatitis C
Smartphone
app
Tracker
C Tracker
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been diagnosed with Hepatitis C.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in hepatitis C medication therapy
timeFrame: every 4 months for 2 years
measure: Changes in Workforce Productivity and Activity Impairment Compared to changes in hepatitis C medication therapy.
timeFrame: every 2 weeks and data will be analyzed every 6 months, for a total of 2 years
measure: Changes in Physical Function and Limitations Due to Physical Health Compared to changes in hepatitis C medication therapy.
timeFrame: every 4 months for 2 years; a subset will be analyzed every 2 weeks and data will be analyzed every 6 months, for a total of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
References: