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ADHEPTA Study: Adherence Questionnaire in Hepatitis C (ADHEPTA)

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ClinicalTrials.gov Identifier: NCT00998621
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Fundacion IMIM

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Hepatitis C, Chronic HIV Infection Other: Adherence questionnaire

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 1120 participants
Time Perspective: Prospective
Official Title: Development and Validation of a Questionnaire Measuring Treatment Adherence in Patients With Hepatitis C
Study Start Date : October 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Hepatitis C infection Other: Adherence questionnaire
Adherence questionnaire
Hepatitis C + HIV infections Other: Adherence questionnaire
Adherence questionnaire


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Adherence will be measured according to 80/80/80 rule. [ Time Frame: 2 years ]
  2. Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR). [ Time Frame: 2 years ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT00998621


Locations
Spain
Hospital del Mar
Barcelona, Spain, 08003
Sponsors and Collaborators
Fundacion IMIM
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Fundacion IMIM
ClinicalTrials.gov Identifier: NCT00998621     History of Changes
Other Study ID Numbers: ADH-HEPC-2009-01
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2009

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