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

ADHEPTA Study: Adherence Questionnaire in Hepatitis C

Sponsors

Lead sponsor: Fundacion IMIM

Source Fundacion IMIM
Brief Summary

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.

Overall Status Completed
Start Date October 2009
Completion Date January 2013
Primary Completion Date September 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection. 2 years
Secondary Outcome
Measure Time Frame
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
Enrollment 1120
Condition
Intervention

Intervention type: Other

Intervention name: Adherence questionnaire

Description: Adherence questionnaire

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
Hospital del Mar
Location Countries

Spain

Verification Date

October 2009

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Hepatitis C infection

Arm group label: Hepatitis C + HIV infections

Acronym ADHEPTA
Study Design Info

Time perspective: Prospective

Source: ClinicalTrials.gov