ADHEPTA Study: Adherence Questionnaire in Hepatitis C | NCT00998621

Studies
ADHEPTA Study: Adherence Questionnaire in Hepatitis C

NCT00998621

Sponsor

Fundacion IMIM

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

1,120Actual

Phase

Not provided

Conditions

Hepatitis C, Chronic
HIV Infection

Interventions

Adherence questionnaire

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Jan 2013Actual

First Submitted Date

Oct 19, 2009

First Submission Date that Met QC Criteria

Oct 19, 2009

First Posted Date

Oct 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatitis C infection			Other: Adherence questionnaire
Hepatitis C + HIV infections			Other: Adherence questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adherence questionnaire	Other	Adherence questionnaire	Hepatitis C + HIV infections Hepatitis C infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main objective of the study is the development and validation of a Questionnaire measuring treatment adherence in patients with HCV infection.		2 years

Secondary Outcomes

Measure	Description	Time Frame
Adherence will be measured according to 80/80/80 rule.		2 years
Establish a relationship between adherence, virological response (VR) and Sustained virological response (SVR).		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with HCV and with HCV + HIV

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital del Mar		Barcelona	Barcelona	08003	Spain

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic
D015658	HIV Infections
D055118	Medication Adherence

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided