Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C

Fundacion IMIM1 site in 1 country1,120 target enrollmentOctober 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis C, Chronic
Sponsor: Fundacion IMIM
Enrollment: 1120
Locations: 1
Primary Endpoint: Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.
Status: Completed
Last Updated: 10 years ago

Main objective: To study and validate a questionnaire measuring treatment adherence in patients with Hepatitis C virus (HCV) infection.

Design of the study: Multicentric, prospective, epidemiological study in the field of usual clinical practice.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

January 2013

Last Updated

10 years ago

Study Type

Observational

Sex

All

Sponsor

Fundacion IMIM

Responsible Party

Sponsor

•Ambulatory patient infected by HCV according to diagnosis criteria used en usual clinical practice.
•Patient no treated previously and beginning a treatment for HCV.
•Patient that signed the informed consent to participate in the study.
•Group A: patient with HCV monoinfection.
•Group B: patient with HCV and HCV co-infection (according to diagnosis criteria used en usual clinical practice).

•Patient that received previous treatment for HCV.
•Patient that is going to participate in a clinical trial Turing the HCV treatment period.
•Patient with cognitive impairment or patient unable to understand and answer the auto-administered questionnaire.
•Patient unable to read or write Spanish.

Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.

Time Frame: 2 years

Adherence will be measured according to 80/80/80 rule.(2 years)
Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).(2 years)