Web-Based App for Sickle Cell Disease

Overseen By Margie Prentice, MBA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Relocation, Transition to adult care, Neurocognitive impairment, Non-English speaking

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

Compensation: Varies

Number of Visits: Unknown

272 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app can help teens and young adults with sickle cell disease (SCD) manage their symptoms more effectively. Participants will either use the app with electronic educational materials and alerts (Voice Crisis Alert V2) or receive enhanced usual care. It suits those who have SCD, own a smartphone, and can access the internet. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance symptom management for SCD patients.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this web-based app is safe for teens and young adults with sickle cell disease?

Research has shown that electronic educational materials for sickle cell disease (SCD) are generally well-received. These materials, such as short lessons and videos, have been successfully used online to help patients better understand their condition. They proved to be safe and helpful, especially during the COVID-19 pandemic, when many patients relied on online tools.

Regarding the Voice Crisis Alert V2 app, studies have shown it helps people with SCD manage their symptoms. It allows users to report their pain levels and learn more about their condition. Users found it helpful in reducing fatigue, anxiety, and pain. This app has been used for some time and has proven to be safe and effective.

Overall, both the educational materials and the Voice Crisis Alert V2 app have proven to be safe and useful in helping people manage SCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the web-based app for sickle cell disease because it offers a novel approach to managing this condition. Unlike traditional treatments that often focus on medication and hospital visits, this app uses electronic educational materials and a Voice Crisis Alert system to empower patients with self-management tools. The app aims to enhance patient knowledge and provide timely alerts during crises, potentially reducing emergency room visits and improving overall quality of life for those with sickle cell disease. By leveraging technology, this method could offer a more personalized and proactive way to manage symptoms.

What evidence suggests that this web-based app is effective for managing sickle cell disease?

Research has shown that digital learning tools can significantly enhance understanding and confidence in managing sickle cell disease (SCD). One study found that young people's confidence and understanding increased from 47.8% to 84.6% after using a digital SCD learning tool. In this trial, participants in the intervention arm will use the Voice Crisis Alert V2 app, which helps users track their pain and learn more about SCD. This app assists teens and young adults in managing their symptoms by providing useful information and tools for self-care. Although specific data on symptom reduction is not available, these tools aim to boost users' knowledge and self-care skills, which are essential for managing SCD. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for teens and young adults with any type of Sickle Cell Disease who own a mobile device compatible with the app, have internet access, and can understand English. It's not for those planning to move or transition to adult care soon, or with neurocognitive issues affecting their ability to participate.

Inclusion Criteria

Owns mobile device compatible with the intervention

Documentation in the electronic health record of any type of SCD

Access to the internet

Exclusion Criteria

Non-English speaking

You have difficulty thinking or understanding things, which may make it hard for you to use the treatment or take part in the study.

Plans to relocate outside of study site area in the next 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a web-based intervention using a mobile app to facilitate self-management behaviors

9 months

Ongoing virtual engagement

Control

Participants receive enhanced usual care as a control group

9 months

Ongoing virtual engagement

Follow-up

Participants are monitored for self-management behaviors, quality of life, and healthcare utilization

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Electronic educational materials
• Voice Crisis Alert V2

Trial Overview The study is testing if a web-based mobile app called Voice Crisis Alert V2 along with electronic educational materials can help manage sickle cell disease by teaching patients about symptom care.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Study participants randomized to receive the intervention.

Group II: Control Active Control 1 Intervention

Study participants randomized to receive enhanced usual care (control).

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The 'Safe Patients' smartphone application significantly improved patients' knowledge about safety issues in surgical units, with correct answers increasing from 64.5% to 75.8% after its implementation, based on a study of 123 participants.

This educational tool empowers patients to engage in safety practices, potentially reducing adverse events related to surgery, highlighting the importance of patient involvement in healthcare safety initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Smartphone Application "Safe Patients" on Knowledge of Patient Safety Issues Among Surgical Patients. Cho, S., Lee, E.[2022]

An interactive voice response system (IVRS) successfully identified 21% of elderly patients post-discharge who required follow-up, indicating its potential utility in monitoring patient safety after hospital discharge.

Despite the IVRS being well-received by patients (97% found it easy to use), it only detected 9% of actual adverse events (AEs), suggesting that additional monitoring strategies are needed to effectively capture more AEs and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying patients with post-discharge care problems using an interactive voice response system. Forster, AJ., Boyle, L., Shojania, KG., et al.[2021]

Children and adolescents with sickle cell disease (SCD) successfully used smartphones to access a web-based e-Diary, achieving at least 80% accuracy in reporting symptoms compared to traditional paper-based measures.

The e-Diary facilitated timely self-reporting of symptoms, which could enhance communication with healthcare providers and improve pain and symptom management for young patients with SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability testing of a Smartphone for accessing a web-based e-diary for self-monitoring of pain and symptoms in sickle cell disease. Jacob, E., Stinson, J., Duran, J., et al.[2021]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

In a study of 848 university students in Kinshasa, 16.4% reported experiencing adverse events following immunization, highlighting a notable concern regarding vaccine reactions.

Most students (58.5%) did not seek medical help for these adverse events, indicating a need for improved communication and risk management strategies between the population and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of attitudes towards adverse events following immunization with oral poliovirus vaccine: a pilot study among high school students of Kinshasa, the Democratic Republic of Congo. Kinuani, L., Nzolo, DB., Aloni, MN., et al.[2022]

A study involving 43 adults with sickle cell disease (SCD) and their caregivers revealed a strong interest in using a mobile health (mHealth) app to improve self-management of the disease, highlighting the potential for technology to enhance access to information and support.

Participants identified key features and preferences for the mHealth app, indicating that a user-friendly design could help overcome barriers to information access, especially for families living in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study. Mayo-Gamble, TL., Quasie-Woode, D., Cunningham-Erves, J., et al.[2022]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

The study assessed the feasibility of the Voice Crisis Alert V2 mobile health application for self-management in children with sickle cell disease (SCD), involving 60 child-caregiver dyads and achieving 82% retention by the end of the intervention.

High satisfaction was reported among users, with 94% of dyads engaging with the app during the intervention, primarily for tracking health history and symptoms, although challenges with sustained use were noted post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an mHealth self-management intervention for children and adolescents with sickle cell disease and their families. Phillips, S., Kanter, J., Mueller, M., et al.[2022]

The University of South Alabama Children's & Women's Hospital implemented a new patient and family education program that provides tablet computers for accessing reliable health resources, enhancing understanding for families of children newly diagnosed with cancer and chronic illnesses.

Surveys were created to evaluate the effectiveness of these educational interventions, indicating a structured approach to improving patient and family education during critical treatment periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tablet Computer Use at the Bedside in a New Patient/Family Education Program. Fenske, RF.[2020]

The open access mobile app for patient education on orthopedic injuries was downloaded 725 times and viewed over 9,000 times in 34 months, indicating strong interest and engagement among users.

Most users (55%) found the app helpful, and 78% would recommend it, although older patients (over 55 years) showed significantly lower participation rates, highlighting a potential gap in accessibility for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Trauma Patient Experience Through Education and Engagement: Development of a Mobile Application. Childs, BR., Breslin, MA., Andres, BA., et al.[2022]

A pilot study involving 713 adult patients in a respiratory medicine department showed that using audio recordings for patient education significantly increased patient satisfaction compared to traditional methods.

Asthma patients who received audio education spent less time in face-to-face communication while achieving higher feedback rates, suggesting that audio materials can effectively enhance patient understanding and alleviate the burden on nursing staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Audio Education in Respiratory Medicine Wards. Zhao, Y., Liu, M., Fan, Z., et al.[2021]

eHealth tools have the potential to significantly improve the quality of life for patients with sickle cell disease (SCD) by enhancing self-management and health literacy, despite a limited number of studies in this area.

There is a notable gap in education for both patients and caregivers regarding SCD, indicating a need for more research and development of eHealth solutions to address these issues and improve clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Challenges and Opportunities of eHealth Tools for Patients with Sickle Cell Disease. Issom, DZ., Zosso, A., Ehrler, F., et al.[2018]

Educational materials developed for pediatric sickle cell anemia (SCA) patients and their parents significantly improved knowledge and self-efficacy in managing the condition, which can lead to better health outcomes such as decreased hospitalizations and improved medication adherence.

Feedback from focus groups with 10 participants (5 patients and 5 parents) highlighted key themes like 'Age Appropriateness' and 'Empowerment', indicating that tailored educational resources can effectively address knowledge gaps and support the transition to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering patients with sickle cell anemia and their families through innovative educational methods. Plett, R., Eling, C., Tehseen, S., et al.[2023]

An educational resource titled 'Sickle Cell Disease and COVID-19: Essential Care' was developed to help families of children with sickle cell disease understand the impact of COVID-19 and how to manage risks, validated through a rigorous Delphi technique involving 23 expert judges.

The educational technology achieved a high content validity coefficient of 0.98, indicating strong agreement among experts on its relevance and quality, making it a reliable tool for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational technology on COVID-19 for families of children and adolescents with sickle cell disease. Oliveira, PP., Gesteira, ECR., Souza, RL., et al.[2021]

A study involving 46 adolescents and young adults (AYAs) with sickle cell disease (SCD) found that 69% had daily Internet access, indicating a strong potential for mobile health interventions.

The co-designed mobile app prototype, iManage, was rated as highly feasible and beneficial, suggesting it could effectively engage AYAs in self-management strategies to improve their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. Crosby, LE., Ware, RE., Goldstein, A., et al.[2022]

Citations

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Impact of COVID-19 pandemic on access to online ... Patients with sickle cell disease may benefit from therapeutic education. •. Therapeutic education is feasible via online tools, notably for children. •.

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Testing a web-based reproductive health education program ... The long-term goal is to improve reproductive and psychosocial outcomes among adolescent and young adult males with sickle cell disease.

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Journal of Sickle Cell Disease | Oxford Academic Individuals with SCD are at heightened risk of complications, hospitalization, and mortality due to SARS-CoV-2 (COVID-19) infection; however, there is hesitancy ...