NCT02568540

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

October 2, 2015

Last Update Submit

January 30, 2019

Conditions

Hepatitis C

Keywords

Hepatitis CSmartphoneappTrackerC Tracker

Outcome Measures

Primary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have been diagnosed with Hepatitis C.

You may qualify if:

  • Self-report a diagnosis of Hepatitis C
  • English speaking individuals
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02116, United States

Location

MeSH Terms

Conditions

Hepatitis CAlzheimer Disease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair in Biomedical Informatics and Population Health and Director, Computational Health informatics Program

Study Record Dates

First Submitted

October 2, 2015

First Posted

October 6, 2015

Study Start

October 1, 2015

Primary Completion

December 4, 2017

Study Completion

January 16, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

US(1)