Educational App for Hepatitis C

Recruiting at 1 trial location

Overseen By Tiana Jones

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Under 18, Incarcerated, Critically ill, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

308 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new educational app for people with hepatitis C. The app aims to enhance users' understanding of their condition and motivate them to seek treatment. Participants will be divided into two groups: one using the app and the other receiving standard pamphlets. Ideal participants are patients at Johns Hopkins Hospital's emergency department who have tested positive for hepatitis C but have not yet undergone further detailed testing.

As an unphased trial, this study provides a unique opportunity to contribute to innovative educational tools that could improve patient care.

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 prior data suggests that this educational app is safe for patients with Hepatitis C?

Research has shown that using electronic apps to educate patients is generally safe. In a related study, participants using an app focused on Hepatitis C reported high satisfaction, appreciating the app's design and features. No major negative effects were reported. The app aims to enhance users' understanding of their condition and encourage active involvement in their care. Evidence so far suggests a positive experience without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because the Patient-Centered Electronic App offers a personalized approach to managing Hepatitis C (HCV). Unlike standard treatments that typically provide general information, this app delivers individualized reports on a patient’s disease progress and liver health, using specific scores like the Fibrosis-4. It also bridges the knowledge gap by offering tailored education on HCV, its natural progression, and treatment options, based on patient responses to surveys. This personalized and interactive format has the potential to enhance patient understanding and engagement with their care, compared to traditional pamphlets and static information.

What evidence suggests that this educational app is effective for improving HCV health beliefs and knowledge?

Research has shown that educational apps can enhance learning and engagement in health care. In this trial, participants in the Patient-Centered Electronic App Group will use an app that offers personalized information about liver health and steps for HCV treatment, helping them manage their condition more effectively. Early studies demonstrated that similar apps keep patients better informed and motivated to adhere to their care plans. By providing tailored information, this app aims to improve the likelihood of receiving the appropriate HCV treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Yu-Hsiang Hsieh, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

You are in a very serious condition.

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

Incarcerated

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Patient-Centered Electronic App

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04162938

Use of a Patient-Centered Electronic App to Increase ED ... First, the investigators will develop a blueprinted prototype personalized HCV educational app which will (1) provide individualized liver fibrosis staging ...

2. withpower.com withpower.com/trial/phase-hepatitis-c-9-2021-24b72

Educational App for Hepatitis C This N/A medical study run by Johns Hopkins University is evaluating whether Patient-Centered Electronic App will have tolerable side effects & efficacy for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568402/

Understanding Users' Engagement in a Provider-Created ... The app was vetted by health care providers and designed to guide users through the HCV testing and treatment stages in a self-exploratory way ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421003682

Patient-centered HCV care via telemedicine for individuals ... Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for ...

5. academic.oup.com academic.oup.com/ofid/article/10/1/ofad002/6974718

Efficacy of a Primary Care-Based Mobile Application to ... The Hepatitis App delivered in primary care settings was effective in increasing HCV screening in a socioeconomically diverse Asian American cohort. This ...

6. trialx.com trialx.com/clinical-trials/listings/265527/use-of-a-patient-centered-electronic-app-to-increase-ed-patients-knowledge-on-hcv-to-improve-the-hcv-care-continuum/?&geo_lat=39.2903848&geo_lng=-76.6121893&radius=10&place=Baltimroe&user_country=United%20States

Use of a Patient-Centered Electronic App to Increase ED ... Clinical trial for Hepatitis C , Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10024261/

High Satisfaction with Patient-Centered Telemedicine for ... Participants were highly satisfied with HCV telemedicine encounters equivalent to in-person encounters. Communication augments trust facilitating delivery of ...