Hepatitis C Self-Management
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
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.
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.
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.
Recruitment for the project officially began in May, 2007 and the first workshop began in July. To date, 135 individuals have been enrolled and completed a base-line assessment. At this time follow- up assessments are being completed.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research
Self-Management Workshop, Self-management self-study, Self-Management Workshop, Self-management self-study
VA San Diego Healthcare System, San Diego
Active, not recruiting
Department of Veterans Affairs
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00328042
- Information obtained from ClinicalTrials.gov on July 15, 2010
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