ADHEPTA Study: Adherence Questionnaire in Hepatitis C (ADHEPTA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacion IMIM
ClinicalTrials.gov Identifier:
NCT00998621
First received: October 19, 2009
Last updated: October 14, 2015
Last verified: October 2009

October 19, 2009
October 14, 2015
October 2009
September 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998621 on ClinicalTrials.gov Archive Site
  • Adherence will be measured according to 80/80/80 rule. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ADHEPTA Study: Adherence Questionnaire in Hepatitis C
Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Patients with HCV and with HCV + HIV
  • Hepatitis C, Chronic
  • HIV Infection
Other: Adherence questionnaire
Adherence questionnaire
  • Hepatitis C infection
    Intervention: Other: Adherence questionnaire
  • Hepatitis C + HIV infections
    Intervention: Other: Adherence questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1120
January 2013
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00998621
ADH-HEPC-2009-01
No
Not Provided
Not Provided
Fundacion IMIM
Fundacion IMIM
Not Provided
Not Provided
Fundacion IMIM
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP