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
|Condition or disease|
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|
|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|
- 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).
- 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.
- 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.
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
|United States, Massachusetts|
|Children's Hospital Boston|
|Boston, Massachusetts, United States, 02116|