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OpenTrials
Completed

NCT Number: NCT00998621

ADHEPTA Study: Adherence Questionnaire in 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.

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Key information

Conditions

Hepatitis C, Chronic Behavior Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infection HIV Infections Health Behavior Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adherence questionnaire

Other

Adherence questionnaire

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundacion IMIM

Other

Registry information

Official study title

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

Acronym: ADHEPTA

Important dates

Study start
2009
Primary completion
2010
Study completion
2013
First posted
Oct 20, 2009
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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