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
  Purpose

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.


Condition Intervention
Hepatitis C, Chronic
HIV Infection
Other: Adherence questionnaire

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C

Resource links provided by NLM:


Further study details as provided by Fundacion IMIM:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1120
Study Start Date: October 2009
Study Completion Date: January 2013
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatitis C infection Other: Adherence questionnaire
Adherence questionnaire
Hepatitis C + HIV infections Other: Adherence questionnaire
Adherence questionnaire

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HCV and with HCV + HIV
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998621

Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Fundacion IMIM
  More Information

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT00998621     History of Changes
Other Study ID Numbers: ADH-HEPC-2009-01 
Study First Received: October 19, 2009
Last Updated: October 14, 2015
Health Authority: Spain: Ethics Committee

Keywords provided by Fundacion IMIM:
Hepatitis C, Chronic
HIV Infection
Medication Adherence
Questionnaire Design
Treatment experienced

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
HIV Infections
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepatitis, Chronic

ClinicalTrials.gov processed this record on July 21, 2016