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Clinical Trials/NCT00333710
NCT00333710
Completed
Not Applicable

Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD

US Department of Veterans Affairs1 site in 1 country53 target enrollmentSeptember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
US Department of Veterans Affairs
Enrollment
53
Locations
1
Primary Endpoint
Hepatitis C Virus Knowledge Questionnaire
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The main objective of this proposal is to develop and test the efficacy of two interventions (a telehealth and face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. It is hypothesized that

Detailed Description

Patients with comorbid diagnoses of HCV and PTSD may experience increased risk of diminished quality of life, given that PTSD is associated with poor self-care and medical non-compliance. To date, no systematic efforts to improve quality of life in this high-risk population have been documented. The main objective of this proposal is to develop and test the feasibility and efficacy of two cognitive-behavioral interventions (a telehealth intervention and a face-to-face intervention) designed to improve quality of life, self-care, motivation to engage in healthcare, and psychological distress in patients diagnosed with HCV and PTSD. A secondary objective is to evaluate the cost effectiveness of the interventions. I plan to develop the interventions, pilot test them, and deliver the refined treatments to veterans with HCV and PTSD. Participants will be 70 patients from VA Boston who meet study criteria. Assessment will occur at pre-treatment, post-treatment, and 3- and 6-month follow-up. Assessments will measure quality of life, self-care, motivation to engage in healthcare, and psychological distress. Analyses will examine study feasibility, the effects of the treatment conditions, and the cost effectiveness of the interventions. It is hypothesized that the telephone and face-to-face intervention will improve outcomes, as compared to treatment as usual, but that the participants will be more satisfied with the telephone intervention. In addition, it is predicted that the telephone condition will be cost effective as compared to the face-to-face intervention

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
October 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of hepatitis C
  • Clinical diagnosis of posttraumatic stress disorder
  • Need to have access to a telephone

Exclusion Criteria

  • Life threatening or acute illness
  • Current alcohol or substance dependence
  • Currently prescribed interferon treatment
  • No access to a telephone

Outcomes

Primary Outcomes

Hepatitis C Virus Knowledge Questionnaire

Time Frame: pre-treatment, post-treatment

This is a 62-item measure which assesses knowledge of the hepatitis C Virus. Range is 0 to 62. Higher scores reflect greater hepatitis C knowledge

Study Sites (1)

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