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

ConditionHepatitis C
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Johns Hopkins Hospital ED patient

18 years or older

HCV positive without HCV RNA information

Disqualifiers

Younger than 18 years of age

Unable to provide informed consent

Altered mental status

Incarcerated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Patient-Centered Electronic App

    Other intervention

    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.

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: Patient-Centered Electronic App GroupExperimental treatment 1 intervention
Group B: Reference GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
28 months

Secondary outcomes

1

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

The survey uses True/False responses to twenty questions with scores ranging from 0 to 20. An increase in the patient's total number of correct answers indicates an increase in the patient's HCV knowledge.

Time frame
Immediately before and immediately after use of the education app, up to 1 hour
2

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

The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates a decrease in the patient's perceived barriers to HCV care.

Time frame
Immediately before and immediately after use of the education app, up to 1 hour
3

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

The survey uses a Likert Scale with 27 items; each item scored from 1 to 4. Overall score ranges between 27 and 108; a decrease in the patient's total score indicates an increase in the patient's motivation to receive HCV care.

Time frame
Immediately before and immediately after use of the education app, up to 1 hour
4

Number of patients who begin HCV antiviral treatment

Number of patients who begin HCV antiviral treatment will be used to measure initiation of HCV antiviral treatment rate.

Time frame
28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.