Multidisciplinary Support Program in Chronic Hepatitis C

NCT01850745 | Completed Results

• 1 other identifier: HMAR-MSP-CHC
• Study Type: observational
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hepatitis C, Chronic

Keywords

Chronic hepatitis C virus infection (CHC)

Outcome Measures

Primary Outcomes (1)

• Adherence to Treatment

  Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks). Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks).

  48 months

Secondary Outcomes (1)

• Efficacy of Treatment Measured by Sustained Virological Response

  baseline and 72 weeks

Study Arms (3)

Control

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

Validation cohort

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

Other: Multidisciplinary support program

Pilot cohort

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

Other: Multidisciplinary support program

Interventions

Multidisciplinary support program OTHER

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

Pilot cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic hepatitis C virus infection (CHC)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Ricard Sola
• Organization: Liver Section. Hospital del Mar

35783@parcdesalutmar.cat

0034932483200

Study Officials

• Ricard Sola, MD

  Hsopital del Mar, Parc de Salut MAR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: January 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2010
• Last Updated: September 20, 2021
• Results First Posted: July 13, 2018

Record last verified: 2013-05

Locations

ES (1)