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

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.

Study Overview

• Status: Terminated
• Conditions: Hepatitis C

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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who have been diagnosed with Hepatitis C.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in hepatitis C medication therapy	Patient reported hepatitis C medication therapy. Medication type and timing will be compared against other patient-reported outcome measures looking at workforce productivity and physical health and function. Medication changes will be collected every 4 months (3 times a year).	every 4 months for 2 years
Changes in Workforce Productivity and Activity Impairment Compared to changes in hepatitis C medication therapy.	The Work Productivity and Activity Impairment Questionnaire: Hepatitis C V2.0 (WPAI:Hepatitis C, 6 questions in total) will be administered and compared to changes in Hepatitis C medication therapy. Measures will be collected every 2 weeks and data will be analyzed every 6 months.	every 2 weeks and data will be analyzed every 6 months, for a total of 2 years
Changes in Physical Function and Limitations Due to Physical Health Compared to changes in hepatitis C medication therapy.	3. The Physical Function domain and Role Limitations Due to Physical Health domain of the Medical Outcomes Study (MOS) 36-Item Short Form Survey (14 questions in total) will be administered and compared to changes in Hepatitis C medication therapy. All questions will be collected every 4 months. A subset of The Physical Function domain and Role Limitations Due to Physical Health domain of the Medical Outcomes Study (MOS) 36-Item Short Form Survey (5 questions in total) will be administered every 2 weeks. Data will be analyzed every 6 months.	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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 4, 2017
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Smartphone; Hepatitis C; app; Tracker; C Tracker
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: P00018023