Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic
NCT ID: NCT03831555
Last Updated: 2019-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2017-06-05
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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PREP-C
The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/.
PREP-C
The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
1. Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
2. Information: knowledge about HCV treatment and one's own HCV disease status
3. Medication Adherence: current prescribed medications and adherence to them in the prior month
4. Self-efficacy: self-confidence about adhering to HCV treatment
5. Social Support and Stability: stability of financial, housing, and social support resources
6. Alcohol and substance use: alcohol and substance use behaviors and current treatment
7. Psychiatric Stability: current psychiatric status, previous and current treatment
8. Energy Level: sleep and fatigue
9. Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
Standard of care
Participants will receive the standard of care (usual care) for chronic HCV infection.
No interventions assigned to this group
Interventions
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PREP-C
The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
1. Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
2. Information: knowledge about HCV treatment and one's own HCV disease status
3. Medication Adherence: current prescribed medications and adherence to them in the prior month
4. Self-efficacy: self-confidence about adhering to HCV treatment
5. Social Support and Stability: stability of financial, housing, and social support resources
6. Alcohol and substance use: alcohol and substance use behaviors and current treatment
7. Psychiatric Stability: current psychiatric status, previous and current treatment
8. Energy Level: sleep and fatigue
9. Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.
Eligibility Criteria
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Inclusion Criteria
* have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)
Exclusion Criteria
* co-infection with HIV or hepatitis B
* non-English speaking
* unable to consent to participate
* already started HCV therapy
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Lesley Miller
Associate Professor
Principal Investigators
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Lesley Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Liver Clinic
Atlanta, Georgia, United States
Countries
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Other Identifiers
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IRB00093687
Identifier Type: -
Identifier Source: org_study_id
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