Tool to Improve Treatment Adherence and Outcomes at Grady Liver Clinic

Hepatitis C Clinical Trial

Official title:

Use of a Psychosocial Readiness Tool to Improve Hepatitis C Treatment Adherence and Outcomes at the Grady Liver Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831555
• Other study ID #: IRB00093687
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.

Description:

The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• seen in the Grady Liver Clinic during the study time period

• have a confirmed chronic hepatitis C infection (hepatitis C antibody positive and detectable hepatitis C viral load)

Exclusion Criteria:

• no chronic hepatitis C infection

• co-infection with HIV or hepatitis B

• non-English speaking

• unable to consent to participate

• already started HCV therapy

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Behavioral:
• 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: Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment Information: knowledge about HCV treatment and one's own HCV disease status Medication Adherence: current prescribed medications and adherence to them in the prior month Self-efficacy: self-confidence about adhering to HCV treatment Social Support and Stability: stability of financial, housing, and social support resources Alcohol and substance use: alcohol and substance use behaviors and current treatment Psychiatric Stability: current psychiatric status, previous and current treatment Energy Level: sleep and fatigue Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory.

Locations

Country	Name	City	State
United States	Grady Liver Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants keeping follow-up appointments	Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.	At 4 months
Primary	Number of participants keeping follow-up appointments	Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews.	At 8 months
Primary	Number of participants refilling medications	Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.	At 4 months
Primary	Number of participants refilling medications	Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews.	At 8 months
Primary	Number of participants who keep lab visits	Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.	At 4 months
Primary	Number of participants who keep lab visits	Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews.	At 8 months
Primary	Rapid virologic response (RVR)	The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews.	At 4 weeks
Primary	Sustained virologic response (SVR)	The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews.	At 12 weeks