Hepatitis C Self-Management

Study Overview
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Brief Summary
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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. Participants complete a total of four assessments. The fourth assessment, a 12-18 month assessment is an approved addition to the original study design

Detailed Description
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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 was 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: One hundred- thirty seven Veterans with HCV who receive health care at VA San Diego Healthcare System facilities were 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 was 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. 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 was collected at baseline, end-of-intervention (6 weeks), at a 12-month and 18-month follow-up visits using self-report questionnaires. In accordance with HIPAA guidelines, VA medical records and other databases were accessed to gather data on health care utilization and mortality. Data was analyzed using repeated-measures analysis of variance, ANCOVA, and linear mixed-model approaches. In addition, an exploratory cost analysis will be conducted when final analyses are conducted. Status: The study was completed in 2011. Results have been published and citations are provided on this website. An additional manuscript including a cost-effectiveness analysis is in the process of being published.

Official Title
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A Self-Management Intervention for Veterans With Hepatitis C

Conditions
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Hepatitis C, Chronic Disease

Intervention / Treatment
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* Behavioral: Self-Management Workshop
* Behavioral: Information Only


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management Workshop<br> | Behavioral: Self-Management Workshop<br>* The workshop is a once per week 2.5 hour group that meets for six weeks.<br>|
| Active Comparator: Information Only<br> | Behavioral: Information Only<br>* This is an individual self-paced at home study program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Well-being Scale - Self-Administered (QWB-SA) | The QWB-SA is a preference-based measure of health-related quality of life. Scores range from 0 to 1.0, with 0 representing death, and 1.0 representing asymptomatic, optimal functioning. Thus, higher scores indicate higher quality of life. | Base Line, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C Knowledge Questionnaire | The measure consists of 15 questions covering Hepatitis C-specific information related to disease self-management. Each correct response is scored as one point, with total scores range from 0 to 15. Higher scores indicate higher levels of Hepatitis C-specific knowledge. There are no subscales. | Base Line, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-care, Quality of Life, Chronic disease