An observational study in Hepatitis C, sponsored by University of Virginia. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Virginia · Observational
The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.
The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 300 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.
Exclusion Criteria:
All participants will receive HCV treatment as determined by their provider. HCV treatment is not assigned by the study.
Other: Hepatitis C treatment as chosen by provider
Participants' providers will determine the type of HCV treatment as appropriate.
Cohort-level Hepatitis C Treatment Progress
Change in the proportion of patients at each step of the HCV care continuum (linkage to care, treatment initiation, treatment completion and sustained virologic suppression) before and after program implemenation
Time frame: 12 months
Patient Reported Quality-of-Life
Change in SF-12 scores from treatment initiation to treatment completion and sustained virologic response
Time frame: 12 months
Depression
Change in Patient Health Questionnaire-2 (PHQ-2) scores from treatment initiation to treatment completion and sustained virologic response. Scale range: 0 to 6 with a higher score indicative of greater depressive symptoms.
Time frame: 12 months
Health-Related Quality-of-Life
Change in Chronic Liver Disease Questionnaire: Hepatitis C version (CLDQ-HCV) scores from treatment initiation to treatment completion and sustained virologic response. Scores range from 1 to 7 with higher scores indicative of better quality of life. CLDQ-HCV includes a total score and 4 sub-scales (activity/energy, emotional, worry, and systemic), each scored from 1 to 7.
Time frame: 12 months
Semi-Structured Qualitative Interview about Impact of HCV Treatment
Qualitative assessment of participants' experience with HCV treatment, including its impact on substance use behaviors, activities of daily living, social interactions, and mental and physical health
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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University of Virginia