N/A
N=309
Hepatitis C Translating Initiatives for Depression Into Effective Solutions
Hepatitis C · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01143896 ↗Enrolled (actual)
309
Serious AEs
3.1%
Results posted
Apr 2016
Primary outcome: Primary: Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment — 11; 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Depression collaborative care model (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment |
11; 7 | — |
| PRIMARY Depression Care: Treatment Response |
36; 19 | — |
| PRIMARY Depression Care: Depression Remission |
22; 9 | — |
| PRIMARY Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months |
118.74; 109.30 | — |
| SECONDARY Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received |
.89; .83 | — |
| SECONDARY Medication Adherence: Medication Possession Ratio |
.83; .78 | — |
Summary
Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease progression and improves health related quality of life. However, ~70% of Veterans with CHC are considered ineligible for antiviral treatment. Most of these patients are excluded due to the presence of co-existing depression and substance use. The proposed project will adapt and adopt an evidence-based collaborative depression care model in CHC clinics. By removing the leading contraindication for antiviral treatment, this project will potentially yield benefits that go far beyond the obvious quality of life benefit from antidepressant therapy itself.
Eligibility Criteria
Inclusion Criteria
- confirmed untreated infection (positive HCV RNA test)
- current PHQ-9 score of 10 or more
- current treatment in the CHC clinic
Exclusion Criteria
- non-Veterans
- patients who do not have access to a telephone
- patients with current suicidal ideation
- patients with significant cognitive impairment as indicated by a score > 10 on the Blessed Orientation Memory and Concentration Test
- patients with a chart diagnosis of schizophrenia
- patients with a chart diagnosis of bipolar disorder who have been hospitalized for a mental health condition within the last 12 months
Data sourced from ClinicalTrials.gov (NCT01143896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.