Hepatitis C, Chronic Disease
Conditions
Keywords
Self-care, Quality of Life, Chronic disease
Brief summary
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
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.
Interventions
The workshop is a once per week 2.5 hour group that meets for six weeks.
This is an individual self-paced at home study program.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Well-being Scale - Self-Administered (QWB-SA) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis C Knowledge Questionnaire | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks. | 69 |
| Arm 2 Self-management self-study: This is an individual self-paced at home study program. | 65 |
| Total | 134 |
Baseline characteristics
| Characteristic | Total | Arm 1 | Arm 2 |
|---|---|---|---|
| Age, Continuous | 54.6 years STANDARD_DEVIATION 6.2 | 53.0 years STANDARD_DEVIATION 5.2 | 56.4 years STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 61 Participants | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 14 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 92 Participants | 50 Participants | 42 Participants |
| Region of Enrollment United States | 134 participants | 69 participants | 65 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 130 Participants | 67 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Base Line, 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Quality of Well-being Scale - Self-Administered (QWB-SA) | Baseline QWB-SA score | .534 units on a scale | Standard Deviation 0.153 |
| Arm 1 | Quality of Well-being Scale - Self-Administered (QWB-SA) | 12-month QWB-SA score | .600 units on a scale | Standard Deviation 0.17 |
| Arm 2 | Quality of Well-being Scale - Self-Administered (QWB-SA) | Baseline QWB-SA score | .501 units on a scale | Standard Deviation 0.163 |
| Arm 2 | Quality of Well-being Scale - Self-Administered (QWB-SA) | 12-month QWB-SA score | .504 units on a scale | Standard Deviation 0.152 |
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.
Time frame: Base Line, 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Hepatitis C Knowledge Questionnaire | 6-weeks HCV Knowledge | 12.29 units on a scale | Standard Deviation 2.16 |
| Arm 1 | Hepatitis C Knowledge Questionnaire | Baseline HCV Knowledge | 8.74 units on a scale | Standard Deviation 3.12 |
| Arm 2 | Hepatitis C Knowledge Questionnaire | Baseline HCV Knowledge | 8.60 units on a scale | Standard Deviation 2.71 |
| Arm 2 | Hepatitis C Knowledge Questionnaire | 6-weeks HCV Knowledge | 9.92 units on a scale | Standard Deviation 2.75 |