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

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ClinicalTrials.gov Identifier: NCT02568540
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Kenneth Mandl, Boston Children’s Hospital

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.

Condition or disease
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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : October 2015
Actual Primary Completion Date : December 4, 2017
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in hepatitis C medication therapy [ Time Frame: every 4 months for 2 years ]
    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).

  2. Changes in Workforce Productivity and Activity Impairment Compared to changes in hepatitis C medication therapy. [ Time Frame: every 2 weeks and data will be analyzed every 6 months, for a total of 2 years ]
    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.

  3. Changes in Physical Function and Limitations Due to Physical Health Compared to changes in hepatitis C medication therapy. [ Time Frame: 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who have been diagnosed with Hepatitis C.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568540


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
Boston Children’s Hospital

Additional Information:
Responsible Party: Kenneth Mandl, Chair in Biomedical Informatics and Population Health and Director, Computational Health informatics Program, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02568540     History of Changes
Other Study ID Numbers: P00018023
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by Kenneth Mandl, Boston Children’s Hospital:
Hepatitis C
Smartphone
app
Tracker
C Tracker

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections