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

NCT ID: NCT02568540

Last Updated: 2019-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-01-16

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Mandl

Chair in Biomedical Informatics and Population Health and Director, Computational Health informatics Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P00018023

Identifier Type: -

Identifier Source: org_study_id

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