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Hepatitis C Self-Management

A Self-Management Intervention for Veterans With Hepatitis C

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00328042
Enrollment
134
Registered
2006-05-19
Start date
2007-05-31
Completion date
2010-08-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic Disease

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

BEHAVIORALSelf-Management Workshop

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

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Quality of Well-being Scale - Self-Administered (QWB-SA)Base Line, 12 monthsThe 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

MeasureTime frameDescription
Hepatitis C Knowledge QuestionnaireBase Line, 6 weeksThe 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

ArmCount
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
Total134

Baseline characteristics

CharacteristicTotalArm 1Arm 2
Age, Continuous54.6 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 Participants8 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
121 Participants61 Participants60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
33 Participants14 Participants19 Participants
Race (NIH/OMB)
More than one race
5 Participants4 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
92 Participants50 Participants42 Participants
Region of Enrollment
United States
134 participants69 participants65 participants
Sex: Female, Male
Female
4 Participants2 Participants2 Participants
Sex: Female, Male
Male
130 Participants67 Participants63 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1Quality of Well-being Scale - Self-Administered (QWB-SA)Baseline QWB-SA score.534 units on a scaleStandard Deviation 0.153
Arm 1Quality of Well-being Scale - Self-Administered (QWB-SA)12-month QWB-SA score.600 units on a scaleStandard Deviation 0.17
Arm 2Quality of Well-being Scale - Self-Administered (QWB-SA)Baseline QWB-SA score.501 units on a scaleStandard Deviation 0.163
Arm 2Quality of Well-being Scale - Self-Administered (QWB-SA)12-month QWB-SA score.504 units on a scaleStandard Deviation 0.152
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1Hepatitis C Knowledge Questionnaire6-weeks HCV Knowledge12.29 units on a scaleStandard Deviation 2.16
Arm 1Hepatitis C Knowledge QuestionnaireBaseline HCV Knowledge8.74 units on a scaleStandard Deviation 3.12
Arm 2Hepatitis C Knowledge QuestionnaireBaseline HCV Knowledge8.60 units on a scaleStandard Deviation 2.71
Arm 2Hepatitis C Knowledge Questionnaire6-weeks HCV Knowledge9.92 units on a scaleStandard Deviation 2.75

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026