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Psychoeducation for Hepatitis and Alcohol Behaviors

Primary Purpose

Hepatitis C, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-Responsive Psychoeducation Program (PERF)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatitis C focused on measuring Hepatitis C, Substance Abuse, Psychoeducation, Psychiatric functioning, Physical Functioning, Quality of Life, NIAAA, Alcohol

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care
  2. Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy)
  3. Age at least 18 years
  4. Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and
  5. Ability to provide informed consent for research participation. "Family" will be defined to include biological relatives, as well as any non-biological individual or significant other considered "family" by either the ill member or his/her immediate family.

Exclusion Criteria:

  1. Inability to provide informed consent such as irreversible cognitive impairment precluding participation
  2. Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and
  3. Age <18 years.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychoeducation

Arm Description

Outcomes

Primary Outcome Measures

Increased treatment readiness and better treatment adherence for treatment of HCV.

Secondary Outcome Measures

Better management of substance abuse and other psychiatric disorders.
Better social functioning and increased quality of life.

Full Information

First Posted
January 10, 2008
Last Updated
November 3, 2014
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00598416
Brief Title
Psychoeducation for Hepatitis and Alcohol Behaviors
Official Title
Psychoeducation for HCV and Alcohol Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed project will apply a unique, effective family-responsive psychoeducation program, PsychoEducation Responsive to Families (PERF), for Hepatitis C Virus (HCV) treatment. The goal is to demonstrate that the intervention will enlarge the eligibility of some patients for HCV treatment and help sustain others through it.
Detailed Description
This study aims to evaluate the utility of a psychosocial intervention (PsychoEducation Responsive to Families; PERF), applied to help patients prepare for and sustain HCV treatment in the treatment setting. Through careful psychiatric diagnosis and multiple longitudinal assessments, this study will also shed further light on the course of comorbid alcohol use, drug use, and other psychiatric syndromes and their interrelationships. The proposed study combines an innovative psychoeducation program with traditional HCV patient care and education. The goal of this work is to improve treatment adherence, allowing individual drug regimens to achieve their optimal effectiveness and reach a wider patient population. Support and sustenance of patients from a psychosocial perspective while they are in treatment should also help deliver more patients to sustained suppression of HCV as well as help presently untreated patients and populations become candidates for this therapy-ultimately reducing the disease burden of increasing numbers of patients needing liver transplantation or facing imminent death.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Substance Abuse
Keywords
Hepatitis C, Substance Abuse, Psychoeducation, Psychiatric functioning, Physical Functioning, Quality of Life, NIAAA, Alcohol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
556 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychoeducation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Family-Responsive Psychoeducation Program (PERF)
Intervention Description
Group psychoeducation for HCV patients and their primary caregiver.
Primary Outcome Measure Information:
Title
Increased treatment readiness and better treatment adherence for treatment of HCV.
Time Frame
Index, Post intervention, and 1 year follow-up
Secondary Outcome Measure Information:
Title
Better management of substance abuse and other psychiatric disorders.
Time Frame
Index, Post intervention, and 1 year follow up
Title
Better social functioning and increased quality of life.
Time Frame
Index, Post intervention, and 1 year follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who are seropositive for HCV as determined by ELISA test and confirmed by direct measure of viral load as part of their clinical care Lack progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy) Age at least 18 years Identified family member(s)/significant other(s) also willing to participate in the psychoeducation groups, and Ability to provide informed consent for research participation. "Family" will be defined to include biological relatives, as well as any non-biological individual or significant other considered "family" by either the ill member or his/her immediate family. Exclusion Criteria: Inability to provide informed consent such as irreversible cognitive impairment precluding participation Progressive or decompensated liver functions (manifest in jaundice, ascites, variceal bleeding, hepatic encephalopathy), and Age <18 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol S North, MD, MPE
Organizational Affiliation
Univeristy of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Psychoeducation for Hepatitis and Alcohol Behaviors

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