Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328042
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2006-05-17
Brief Title:
Hepatitis C Self-Management
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Self-Management Intervention for Veterans With Hepatitis C
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 evaluationsprocedures and adherence to behaviorallifestyle 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 25-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 useabuse 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
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 25-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 useabuse 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None