ADHEPTA Study: Adherence Questionnaire in Hepatitis C (ADHEPTA)
This study has been completed.
Sponsor:
Fundacion IMIM
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
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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
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 September 29, 2016