Full Text View
Tabular View
No Study Results Posted
Related Studies
Hepatitis C Self-Management
This study is ongoing, but not recruiting participants.
First Received: May 17, 2006   Last Updated: December 17, 2008   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00328042
  Purpose

The objective of this study is to compare the efficacy of a 6-session hepatitis C self-management workshop to a hepatitis C self-management self-study program. Both interventions are designed to help people with hepatitis C learn to actively self-manage their chronic HCV infection, and ultimately, to improve health outcomes for veterans with HCV who are not receiving Interferon-based treatment.


Condition Intervention
Hepatitis C
Chronic Disease
Behavioral: Self-Management Workshop
Behavioral: Self-management self-study

MedlinePlus related topics: Coping with Chronic Illness Hepatitis Hepatitis C
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title: A Self-Management Intervention for Veterans With Hepatitis C

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Health-related quality of life, Self-efficacy [ Time Frame: Base Line, six weeks and six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue, depression [ Time Frame: Base Line, six weeks and six months ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: May 2007
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Self-Management Workshop
The workshop is a once per week 2.5 hour group that meets for six weeks.
Behavioral: Self-management self-study
This is an individual self-paced at home stufy program.
2 Behavioral: Self-Management Workshop
The workshop is a once per week 2.5 hour group that meets for six weeks.
Behavioral: Self-management self-study
This is an individual self-paced at home stufy program.

Detailed Description:

Background:

Chronic hepatitis C (HCV) is a major health concern that disproportionately affects U.S. veterans. Veterans with HCV experience impaired quality of life as a result of HCV infection and other co-morbid disorders; namely substance abuse and mental health problems. Only a small proportion of these patients currently receive and are cured of HCV with Interferon-based treatments. Treatment recommendations for HCV-infected veterans not scheduled for Interferon-based treatment include additional evaluations/procedures and adherence to behavioral/lifestyle guidelines. However, many patients with HCV and commonly occurring co-morbidities have difficulty following these recommendations without additional assistance. HCV self-management programs are one option for helping these patients adhere to treatment recommendations while improving their quality of life. Patient self-management programs augment traditional information-oriented patient education with problem-solving skills and cognitive-behavioral techniques that enable patients to manage chronic illness and their lives as a whole.

Objectives:

Our primary objective is to assess the efficacy of a 6-session self-management workshop designed to improve health outcomes for veterans with HCV who are not receiving Interferon-based treatment.

Methods:

Veterans with HCV who receive health care at VA San Diego Healthcare System facilities will be recruited and randomized to either the HCV Self-Management Workshop (HCV-SMW) or to the Information intervention study arm. The self-management intervention includes six 2.5-hour weekly workshop sessions in addition to the basic information provided to Usual Care. The HCV-SMW is co-led by a health educator and a peer-leader, and has been adapted from an existing self-management program that has been effective for patients with other chronic illnesses. Efforts will be made to recruit women and minority veterans into the study. The primary outcome for the study is health-related quality of life. Secondary outcome variables include attendance at recommended health care visits, self-reported health behaviors related to preventing viral transmission, substance use/abuse, and patient-provider communication. Data will be collected at baseline, end-of-intervention (6 weeks), and at a 12-month follow-up visit using questionnaires. In accordance with HIPAA guidelines, VA medical records and other databases will be accessed to gather data on health care utilization and mortality. Data will be analyzed using repeated-measures analysis of variance, MANCOVA, and linear mixed-model approaches. In addition, an exploratory cost analysis will be conducted.

Status:

Recruitment for the project officially began in May, 2007 and the first workshop began in July. To date, 100 individuals have been fully enrolled.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • VA patient
  • Diagnosis of chronic hepatitis C viral infection

Exclusion Criteria:

  • Undergoing treatment with Interferon and/or Ribavirin currently or within 6 months of enrollment
  • Inability to confirm HCV diagnosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328042

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Erik J. Groessl, PhD BA BS VA San Diego Healthcare System, San Diego
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Groessl, Erik - Principal Investigator )
Study ID Numbers: IAC 05-067
Study First Received: May 17, 2006
Last Updated: December 17, 2008
ClinicalTrials.gov Identifier: NCT00328042     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Self-care
Quality of Life
Chronic disease

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Quality of Life
Hepatitis, Viral, Human
Chronic Disease
Hepatitis C

Additional relevant MeSH terms:
Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Disease Attributes
Digestive System Diseases
Pathologic Processes
Flaviviridae Infections
Hepatitis, Viral, Human
Chronic Disease
Hepatitis C

ClinicalTrials.gov processed this record on May 07, 2009