Hepatitis C Self-Management
|Hepatitis C Chronic Disease||Behavioral: Self-Management Workshop Behavioral: Information Only|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
|Official Title:||A Self-Management Intervention for Veterans With Hepatitis C|
- Quality of Well-being Scale - Self-Administered (QWB-SA) [ Time Frame: Base Line, 12 months ]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.
- Hepatitis C Knowledge Questionnaire [ Time Frame: Base Line, 6 weeks ]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.
|Study Start Date:||May 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: Self-Management Workshop||
Behavioral: Self-Management Workshop
The workshop is a once per week 2.5 hour group that meets for six weeks.
|Active Comparator: Information Only||
Behavioral: Information Only
This is an individual self-paced at home study program.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328042
|United States, California|
|VA San Diego Healthcare System, San Diego, CA|
|San Diego, California, United States, 92161|
|Principal Investigator:||Erik J Groessl, PhD BA BS||VA San Diego Healthcare System, San Diego, CA|