Educational App for Hepatitis C

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Yu-Hsiang Hsieh, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Incarcerated, Critically ill, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Patient-Centered Electronic App for HCV Education treatment?

Research shows that educating patients with chronic hepatitis C can improve their response to therapy, and mobile health tools can help patients make better treatment decisions. However, many existing apps for hepatitis C treatment have quality issues, so it's important to use them carefully and involve healthcare professionals. ^{1 2 3 4 5}

How is the HCV Educational App treatment different from other hepatitis C treatments?

The HCV Educational App is unique because it uses a mobile app to educate and support patients, helping them make informed decisions about their hepatitis C treatment. Unlike traditional drug treatments, this app focuses on increasing patient knowledge and engagement, which can lead to better adherence to therapy and improved outcomes. ^{3 4 6 7 8}

Research Team

Yu-Hsiang Hsieh, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adult patients at Johns Hopkins Hospital's Emergency Department who have tested positive for Hepatitis C but don't yet have HCV RNA testing information. It excludes minors, those unable to consent, prisoners, critically ill individuals, and patients with altered mental status.

Inclusion Criteria

Johns Hopkins Hospital ED patient

I am positive for hepatitis C but don't have RNA details.

I am 18 years old or older.

Exclusion Criteria

You are in a very serious condition.

You have changes in your thinking, memory, or behavior.

Incarcerated

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use a personalized HCV educational app to receive individualized reports on HCV disease progress and liver fibrosis staging, along with comprehensive knowledge on HCV care.

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for changes in health beliefs, motivation, and linkage to care rates after using the educational app.

28 months

Treatment Details

Interventions

• Patient-Centered Electronic App (Behavioural Intervention)

Trial Overview The study tests an educational app designed to improve understanding of Hepatitis C among ED patients. The app provides personalized liver health information and aims to enhance patient knowledge and motivation regarding their care continuum from diagnosis through treatment.

Participant Groups

Group I: Patient-Centered Electronic App Group Experimental Treatment 1 Intervention

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.

Group II: Reference Group Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

Chronic hepatitis C (CH-C) patients experience significant impairment in their health-related quality of life (HRQOL), particularly in areas like fatigue and depression, which can affect treatment adherence and productivity.

New interferon-free and ribavirin-free treatment regimens show very high efficacy and lead to improvements in patient-reported outcomes as early as 2 weeks into treatment, suggesting better adherence and overall patient experience compared to older therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: patient-reported outcomes in chronic hepatitis C--the impact of liver disease and new treatment regimens. Younossi, Z., Henry, L.[2022]

A 12-week treatment with sofosbuvir-based direct-acting antivirals (DAAs) led to significant improvements in patient-reported outcomes, including health-related quality of life and fatigue, 24 weeks after treatment in 120 patients with chronic hepatitis C from Central and West Africa.

The study highlights that patients experienced better physical and mental health post-treatment, suggesting that DAAs provide benefits beyond just eradicating the virus, which can help inform treatment providers in low-to-middle-income countries about the broader advantages of DAA therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial). Marcellin, F., Mourad, A., Lemoine, M., et al.[2023]

A study involving 244 patients with chronic hepatitis C showed that systematic consultation by a nurse significantly improved treatment adherence (74.0% vs 62.8%) and sustained virologic response (38.2% vs 24.8%) compared to conventional follow-up.

Patients receiving 48 weeks of treatment benefited the most from nurse consultations, with adherence rates of 69.7% in the consultation group versus 53.2% in the conventional group, highlighting the importance of therapeutic education in enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education by a nurse increases response of patients with chronic hepatitis C to therapy with peginterferon-α2a and ribavirin. Larrey, D., Salse, A., Ribard, D., et al.[2018]

A mobile health tool called 'Take Charge, Get Cured' was developed specifically for methadone patients with Hepatitis C, using surveys and user testing to ensure it met their needs, with high satisfaction ratings (6.7-7 on a 7-point scale).

The iterative development process was crucial for creating a culturally relevant tool, highlighting the importance of formative evaluation in designing effective patient communication strategies for hard-to-reach populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Take Charge, Get Cured: The development and user testing of a culturally targeted mHealth decision tool on HCV treatment initiation for methadone patients. Bauerle Bass, S., Jessop, A., Gashat, M., et al.[2019]

Out of 316 potential apps identified for supporting hepatitis C virus (HCV) treatment, only 12 met the eligibility criteria, and only one app was rated as having good quality based on the Mobile App Rating Scale (MARS).

Most apps had decent user ratings (3.7 or above) but scored poorly on important quality aspects like interactivity and credibility, indicating that users should be cautious and seek professional guidance when using these apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores. Rodrigues, AT., Sousa, CT., Pereira, J., et al.[2021]

A pilot study involving 152 potential hepatitis C patients at a Veterans Administration medical center revealed that 71% felt there was inadequate educational material available to them regarding their condition.

The study identified that patients preferred educational presentations by healthcare professionals and expressed interest in support groups, highlighting the need for tailored educational strategies to improve knowledge and awareness about living with hepatitis C.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing educational needs of potential hepatitis C patients at a Veterans Affairs medical center. Jennings, AR.[2022]

A health education app designed for self-management was positively received by 91.2% of users, who found it more effective than traditional paper instructions, indicating its potential to enhance patient education and self-management skills.

The app was used by 23,159 patients over nearly two years, with 85.3% expressing a desire to continue receiving medical education after discharge, highlighting its role in ongoing patient support and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Application of Health Education Apps Based on WeChat for Self-Management among Patients. Yang, HL., Luan, XR., Zhao, LL., et al.[2022]

A systematic review of 21 randomized controlled trials involving 4106 participants found that using smartphone and tablet apps for patient education significantly improves knowledge, medication adherence, and satisfaction with care, with 69% of outcomes showing effectiveness compared to usual care.

The most effective interventions were those lasting less than one month and providing at least one push notification per week, leading to increased patient satisfaction and better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating Patients by Providing Timely Information Using Smartphone and Tablet Apps: Systematic Review. Timmers, T., Janssen, L., Kool, RB., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Systematic review: patient-reported outcomes in chronic hepatitis C--the impact of liver disease and new treatment regimens. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes with direct-acting antiviral treatment for hepatitis C in West and Central Africa (TAC ANRS 12311 trial). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Education by a nurse increases response of patients with chronic hepatitis C to therapy with peginterferon-α2a and ribavirin. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Take Charge, Get Cured: The development and user testing of a culturally targeted mHealth decision tool on HCV treatment initiation for methadone patients. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Applications (Apps) to Support the Hepatitis C Treatment: A Systematic Search in App Stores. [2021]

6. India pubmed.ncbi.nlm.nih.gov

Assessing educational needs of potential hepatitis C patients at a Veterans Affairs medical center. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Design and Application of Health Education Apps Based on WeChat for Self-Management among Patients. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Educating Patients by Providing Timely Information Using Smartphone and Tablet Apps: Systematic Review. [2020]