Study Results
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View full resultsBasic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2007-05-31
2010-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Self-Management Workshop
Self-Management Workshop
The workshop is a once per week 2.5 hour group that meets for six weeks.
Information Only
Information Only
This is an individual self-paced at home study program.
Interventions
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Self-Management Workshop
The workshop is a once per week 2.5 hour group that meets for six weeks.
Information Only
This is an individual self-paced at home study program.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic hepatitis C viral infection
Exclusion Criteria
* Inability to confirm HCV diagnosis
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Erik J Groessl, PhD BA BS
Role: PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA
Locations
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VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Countries
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References
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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.
Groessl 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.
Dieperink 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.
Pichetshote 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.
Groessl 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.
Groessl 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.
Groessl 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.
Other Identifiers
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IAC 05-067
Identifier Type: -
Identifier Source: org_study_id
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