Hepatitis CNCT00328042
Hepatitis C Self-Management
A study testing Self-Management Workshop and Information Only in people with Hepatitis C and Chronic Disease, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic Disease
- What is being tested?
- Self-Management Workshop and Information Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- VA patient
- Diagnosis of chronic hepatitis C viral infection
Who cannot join
- Undergoing treatment with Interferon and/or Ribavirin currently or within 6 months of enrollment
- Inability to confirm HCV diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: A Self-Management Intervention for Veterans With Hepatitis C
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
Read the 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.
- Conditions
- Hepatitis C, Chronic Disease
- Being tested
- Self-Management Workshop, Information Only
- Keywords
- Self-care, Quality of Life, Chronic disease
- Medical subject headings
- Hepatitis C, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management WorkshopBehavioural
The workshop is a once per week 2.5 hour group that meets for six weeks.
Information OnlyBehavioural
This is an individual self-paced at home study program.
| Study group | Role | What they receive |
|---|---|---|
| Self-Management Workshop | Experimental | Not described Receives: Behavioral: Self-Management Workshop |
| Information Only | Active comparator | Not described Receives: Behavioral: Information Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Base Line, 12 months
Secondary outcomes (1)
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.
Measured: Base Line, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startMay 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erik J Groessl, PhD BA BS, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328042
- Sponsor's protocol ID
- IAC 05-067
- Status last verified
- Jul 2014
- First submitted
- 17 May 2006
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Groessl EJ, Weingart KR, Stepnowsky CJ, Gifford AL, Asch SM, Ho SB. The hepatitis C self-management programme: a randomized controlled trial. J Viral Hepat. 2011 May;18(5):358-68. doi: 10.1111/j.1365-2893.2010.01328.x.
PubMed 20529203Groessl EJ, Weingart KR, Gifford AL, Asch SM, Ho SB. Development of the hepatitis C self-management program. Patient Educ Couns. 2011 May;83(2):252-5. doi: 10.1016/j.pec.2010.06.006. Epub 2010 Jul 17.
PubMed 20638216Dieperink E, Ho SB, Heit S, Durfee JM, Thuras P, Willenbring ML. Significant reductions in drinking following brief alcohol treatment provided in a hepatitis C clinic. Psychosomatics. 2010 Mar-Apr;51(2):149-56. doi: 10.1176/appi.psy.51.2.149.
PubMed 20332290Pichetshote N, Groessl E, Yee H, Ho SB. Optimizing the dose and duration of therapy for chronic hepatitis C. Gut Liver. 2009 Mar;3(1):1-13. doi: 10.5009/gnl.2009.3.1.1. Epub 2009 Mar 31.
PubMed 20479894Groessl EJ, Weingart KR, Kaplan RM, Clark JA, Gifford AL, Ho SB. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. J Gen Intern Med. 2008 Dec;23(12):1959-65. doi: 10.1007/s11606-008-0790-y. Epub 2008 Sep 20.
PubMed 18807097Groessl EJ, Ho SB, Asch SM, Stepnowsky CJ, Laurent D, Gifford AL. The hepatitis C self-management program: sustainability of primary outcomes at 1 year. Health Educ Behav. 2013 Dec;40(6):730-40. doi: 10.1177/1090198113477112. Epub 2013 Feb 27.
PubMed 23445604Groessl EJ, Sklar M, Laurent DD, Lorig K, Ganiats TG, Ho SB. Cost-Effectiveness of the Hepatitis C Self-Management Program. Health Educ Behav. 2017 Feb;44(1):113-122. doi: 10.1177/1090198116639239. Epub 2016 Jul 9.
PubMed 27206463
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Self-Management Intervention for Veterans With Hepatitis C
- ClinicalTrials.gov ID
- NCT00328042
- Acronym / sponsor ID
- IAC 05-067
- Conditions
- Hepatitis C, Chronic Disease
- Keywords
- Self-care, Quality of Life, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 19 May 2006 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Management Workshop | Experimental | Behavioral: Self-Management Workshop |
| Information Only | Active comparator | Behavioral: Information Only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- VA patient
- Diagnosis of chronic hepatitis C viral infection
Key exclusion criteria (2 listed)
- Undergoing treatment with Interferon and/or Ribavirin currently or within 6 months of enrollment
- Inability to confirm HCV diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Management WorkshopThe workshop is a once per week 2.5 hour group that meets for six weeks. | Behavioural | Self-Management Workshop |
| Information OnlyThis is an individual self-paced at home study program. | Behavioural | Information Only |
Primary outcome
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.
1 secondary outcome
Hepatitis C Knowledge Questionnaire
Time frame: Base Line, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20529203Groessl EJ, Weingart KR, Stepnowsky CJ, Gifford AL, Asch SM, Ho SB. The hepatitis C self-management programme: a randomized controlled trial. J Viral Hepat. 2011 May;18(5):358-68. doi: 10.1111/j.1365-2893.2010.01328.x.
- Results publication: PubMed 20638216Groessl EJ, Weingart KR, Gifford AL, Asch SM, Ho SB. Development of the hepatitis C self-management program. Patient Educ Couns. 2011 May;83(2):252-5. doi: 10.1016/j.pec.2010.06.006. Epub 2010 Jul 17.
- Results publication: PubMed 20332290Dieperink E, Ho SB, Heit S, Durfee JM, Thuras P, Willenbring ML. Significant reductions in drinking following brief alcohol treatment provided in a hepatitis C clinic. Psychosomatics. 2010 Mar-Apr;51(2):149-56. doi: 10.1176/appi.psy.51.2.149.
- Results publication: PubMed 20479894Pichetshote N, Groessl E, Yee H, Ho SB. Optimizing the dose and duration of therapy for chronic hepatitis C. Gut Liver. 2009 Mar;3(1):1-13. doi: 10.5009/gnl.2009.3.1.1. Epub 2009 Mar 31.
- Results publication: PubMed 18807097Groessl EJ, Weingart KR, Kaplan RM, Clark JA, Gifford AL, Ho SB. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. J Gen Intern Med. 2008 Dec;23(12):1959-65. doi: 10.1007/s11606-008-0790-y. Epub 2008 Sep 20.
- Results publication: PubMed 23445604Groessl EJ, Ho SB, Asch SM, Stepnowsky CJ, Laurent D, Gifford AL. The hepatitis C self-management program: sustainability of primary outcomes at 1 year. Health Educ Behav. 2013 Dec;40(6):730-40. doi: 10.1177/1090198113477112. Epub 2013 Feb 27.
- Derived from this study: PubMed 27206463Groessl EJ, Sklar M, Laurent DD, Lorig K, Ganiats TG, Ho SB. Cost-Effectiveness of the Hepatitis C Self-Management Program. Health Educ Behav. 2017 Feb;44(1):113-122. doi: 10.1177/1090198116639239. Epub 2016 Jul 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik J Groessl, PhD BA BS principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Workshop and Information Only in people with Hepatitis C and Chronic Disease, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Well-being Scale - Self-Administered (QWB-SA) (time frame: Base Line, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328042, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.