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Hepatitis C Self-Management

Primary Purpose

Hepatitis C, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Management Workshop
Information Only
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis C focused on measuring Self-care, Quality of Life, Chronic disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-Management Workshop

Information Only

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2006
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00328042
Brief Title
Hepatitis C Self-Management
Official Title
A Self-Management Intervention for Veterans With Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic Disease
Keywords
Self-care, Quality of Life, Chronic disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Management Workshop
Arm Type
Experimental
Arm Title
Information Only
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Self-Management Workshop
Intervention Description
The workshop is a once per week 2.5 hour group that meets for six weeks.
Intervention Type
Behavioral
Intervention Name(s)
Information Only
Intervention Description
This is an individual self-paced at home study program.
Primary Outcome Measure Information:
Title
Quality of Well-being Scale - Self-Administered (QWB-SA)
Description
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
Secondary Outcome Measure Information:
Title
Hepatitis C Knowledge Questionnaire
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik J Groessl, PhD BA BS
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20529203
Citation
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.
Results Reference
result
PubMed Identifier
20638216
Citation
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.
Results Reference
result
PubMed Identifier
20332290
Citation
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.
Results Reference
result
PubMed Identifier
20479894
Citation
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.
Results Reference
result
PubMed Identifier
18807097
Citation
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.
Results Reference
result
PubMed Identifier
23445604
Citation
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.
Results Reference
result
PubMed Identifier
27206463
Citation
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.
Results Reference
derived

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Hepatitis C Self-Management

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