Multidisciplinary Support Program in Chronic Hepatitis C

NCT ID: NCT01850745

Last Updated: 2021-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

447 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2010-01-31

Brief Summary

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Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).

Detailed Description

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Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Conditions

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Hepatitis C, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Control

Retrospective control group. Usual treatment with peginterferon-2a and ribavirin. No multidisciplinary support program

No interventions assigned to this group

Validation cohort

Prospective group. Usual treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.

Multidisciplinary support program

Intervention Type OTHER

Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.

Pilot cohort

Prospective intervention group. Usual pharmacological treatment with peginterferon-2a and ribavirin. Multidisciplinary support program.

Multidisciplinary support program

Intervention Type OTHER

Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.

Interventions

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Multidisciplinary support program

Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic hepatitis C eligible to receive antiviral treatment.

Exclusion Criteria

* Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricard Sola, MD

Role: PRINCIPAL_INVESTIGATOR

Hsopital del Mar, Parc de Salut MAR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HMAR-MSP-CHC

Identifier Type: -

Identifier Source: org_study_id

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