Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum

NCT04162938 | Recruiting

• 1 other identifier: IRB00227304
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized controlled clinical trial study in an urban emergency department in Baltimore to determine the impact of an educational app which is based on Leventhal's Common-Sense Model of Illness Representations framework, on HCV-infected ED patient's hepatitis C virus (HCV) health belief and knowledge as well as the downstream outcomes of the HCV Continuum of Care (linkage to care rate, initiation of HCV antiviral treatment, and sustained virologic response). First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging information, (2) pre-test HCV knowledge, perception of barriers to HCV care, and motivation to receive HCV care survey, (3) provide personalized HCV knowledge, facilitators and supporting information for HCV care via video clips and information sheets based on the pre-test results, and (4) provide post-test knowledge, perception, and motivation to receive HCV care. Second, the investigators will conduct a series of focus group discussion sessions to fine-tune the HCV educational app. Third, the investigators will enroll ED patients who have anti-HCV (newly diagnosed or previously diagnosed) but without HCV RNA testing information for a pilot randomized controlled clinical trial of the personalized HCV educational app.

Conditions

Hepatitis C

Keywords

HCV Linkage to Care; HCV Education

Outcome Measures

Primary Outcomes (1)

• Linkage to care rate (days)

  Linkage to care rate is defined as the time (days) between patient enrollment and the patient's first HCV-related clinic visit.

  28 months

Secondary Outcomes (6)

• Change in HCV knowledge as assessed by True/False survey questions

  Immediately before and immediately after use of the education app, up to 1 hour

• Change in perceived barriers to HCV care as assessed by a Likert Scale

  Immediately before and immediately after use of the education app, up to 1 hour

• Change in level of motivation to receive HCV care as assessed by a Likert Scale

  Immediately before and immediately after use of the education app, up to 1 hour

• Number of patients who begin HCV antiviral treatment

  28 months

• Number of patients who complete HCV antiviral treatment

  28 months

Study Arms (2)

Patient-Centered Electronic App Group

EXPERIMENTAL

Patients assigned to the intervention group will receive individualized reports regarding patients' HCV disease progress/liver fibrosis staging by a Fibrosis-4 score using the personalized HCV educational app. The individualized report will also include comprehensive knowledge to fill the gap on general HCV information, natural history of the disease, and care and treatment, if there is any, as well as level of interest in receiving HCV care based on patients' response to the short survey questionnaires on the tablet. Patients will also receive the investigators' HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore. Patients will receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.

Other: Patient-Centered Electronic App

Reference Group

NO INTERVENTION

Patients assigned to the reference group will receive the investigators' current 'static' standard of care HCV program pamphlet regarding HCV infection and disease progression, treatment, as well as information regarding clinics available for HCV care in Baltimore City. Patients will also receive standard of care, routine HCV LTC services from the investigators' ED HCV LTC program staff.

Interventions

Patient-Centered Electronic App OTHER

The coordinator will enter lab information to generate the patient's Fibrosis-4 score for liver fibrosis staging. With the information of liver fibrosis staging and survey responses, the app will generate individualized reports of the participant's comprehensive HCV disease progression, knowledge, and level of interest in receiving HCV care. The app will then deliver a streamlined, tailored, brief education message and include information regarding services and assistance for receiving HCV care.

Patient-Centered Electronic App Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Johns Hopkins Hospital ED patient
• years or older
• HCV positive without HCV RNA information

You may not qualify if:

• Younger than 18 years of age
• Unable to provide informed consent
• Altered mental status
• Incarcerated
• Critically ill

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yu-Hsiang Hsieh, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deanna Myer

CONTACT

443-287-6985; dmyer1@jhmi.edu

Tiana Jones

CONTACT

410-735-6422; tpurrin1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: March 24, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)