Hepatitis C Virus (HCV) Treatment Completion or Withdrawal
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00674492
First received: May 6, 2008
Last updated: April 23, 2012
Last verified: October 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 6, 2008 | ||||
| Last Updated Date | April 23, 2012 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Attributes of treatment experience identified in inductive qualitative analysis [ Time Frame: Zero to five years since ending treatment. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00674492 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hepatitis C Virus (HCV) Treatment Completion or Withdrawal | ||||
| Official Title ICMJE | Patients' View of Hepatitis C Treatment Completion or Withdrawal | ||||
| Brief Summary | Qualitative pilot study of patients' views of their experience with antiviral treatment for hepatitis C. |
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| Detailed Description | Qualitative pilot study of patient' views of their experiences with antiviral treatment for hepatitis C. Two groups of patients will be sampled: nine who completed a 24 or 48 week course of treatment and nine who withdrew from treatment prior to planned end. Interview data will be analyzed using narrative and grounded theory methods to identify attributes of treatment experience that may discriminate between completion and withdrawal. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | VHA patients who ever initiated antiviral treatment for hepatitis C. |
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| Condition ICMJE | Hepatitis C | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Group 1
patients who initiated antiviral treatment for hepatitis C |
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| Publications * | 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. Epub 2008 Sep 20. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 18 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Ever initiated anitiviral treatment for hepatitis C. Exclusion Criteria: none |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00674492 | ||||
| Other Study ID Numbers ICMJE | SHP 08-193 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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