NCT00328042

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

April 24, 2015

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

May 17, 2006

Results QC Date

August 26, 2014

Last Update Submit

April 6, 2015

Conditions

Hepatitis CChronic Disease

Keywords

Self-careQuality of LifeChronic disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Base Line, 12 months

Secondary Outcomes (1)

  • Hepatitis C Knowledge Questionnaire

    Base Line, 6 weeks

Study Arms (2)

Self-Management Workshop

EXPERIMENTAL
Behavioral: Self-Management Workshop

Information Only

ACTIVE COMPARATOR
Behavioral: Information Only

Interventions

Self-Management WorkshopBEHAVIORAL

The workshop is a once per week 2.5 hour group that meets for six weeks.

Self-Management Workshop
Information OnlyBEHAVIORAL

This is an individual self-paced at home study program.

Information Only

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • VA patient
  • Diagnosis of chronic hepatitis C viral infection

You may not qualify if:

  • Undergoing treatment with Interferon and/or Ribavirin currently or within 6 months of enrollment
  • Inability to confirm HCV diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Publications (7)

  • 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.

    PMID: 20529203RESULT

  • 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.

    PMID: 20638216RESULT

  • 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.

    PMID: 20332290RESULT

  • 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.

    PMID: 20479894RESULT

  • 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.

    PMID: 18807097RESULT

  • 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.

    PMID: 23445604RESULT

  • 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.

    PMID: 27206463DERIVED

MeSH Terms

Conditions

Hepatitis CChronic Disease

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Erik Groessl
Organization
VA San Diego
erik.groessl@va.gov
858-552-8585

Study Officials

  • Erik J Groessl, PhD BA BS

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 19, 2006

Study Start

May 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 24, 2015

Results First Posted

September 25, 2014

Record last verified: 2014-07

Locations

US(1)