MED-Go App for Sickle Cell Disease

Overseen By Savannah Winkler, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: Hydroxyurea

Disqualifiers: Recent hospitalizations

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new app called MED-Go, designed to help young people with sickle cell disease adhere to their medication routines. The researchers aim to determine if using this app can improve medication adherence and, consequently, enhance overall health. Participants will be divided into two groups: one will use the app for 12 weeks, while the other will continue with their usual care. The trial seeks participants aged 12 to 21 who have sickle cell disease, are on a stable dose of hydroxyurea (a medication for sickle cell), and have a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for managing sickle cell disease.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on a steady state of hydroxyurea for 2 months to participate.

What prior data suggests that the MED-Go app is safe for adolescents and young adults with sickle cell disease?

Research shows that the MED-Go app is still under study, so specific safety data is not yet available. However, as a digital tool rather than a medication, the MED-Go app does not have the side effects associated with drugs. It is designed to help young people with sickle cell disease remember to take their medications. Although specific safety data for the app is lacking, digital tools generally pose fewer safety risks compared to new medicines.

In other studies, similar apps have shown promise in helping people adhere to their medication regimens without causing harm. These apps aim to support better health by simplifying treatment plan adherence. While exact safety data for the MED-Go app is not yet available, the nature of the tool suggests it is likely safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MED-Go App for sickle cell disease because it offers a novel digital approach to managing the condition. Unlike traditional treatments like hydroxyurea or blood transfusions, which focus on physical interventions, the MED-Go App emphasizes self-management and patient engagement over a 12-week period. This app aims to empower patients by providing tools and resources to track symptoms and manage their health, potentially leading to improved quality of life and reduced crisis episodes. This innovative use of technology could complement existing treatments and offer a more personalized approach to care.

What evidence suggests that the MED-Go app is effective for sickle cell disease?

Research has shown that mobile health apps can help teenagers and young adults with sickle cell disease improve self-care. One study demonstrated that a similar app, iManage for SCD, helped patients manage their condition more effectively. Another study found that using a mobile health app increased patients' confidence in handling their illness. In this trial, participants in the MED-Go app intervention arm will use the app for 12 weeks. These findings suggest that the MED-Go app might assist young people with sickle cell disease in adhering to their medication plans and managing their health more effectively. ^{1 2 6 7 8}

Who Is on the Research Team?

Sherif M. Badawy, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 12-21 with any type of sickle cell disease who have been on hydroxyurea steadily for at least 2 months. Participants must own or have access to a smartphone. Those recently hospitalized within the past week cannot join.

Inclusion Criteria

I am between 12 and 21 years old.

Own of have access to a smartphone during the study period

I have been taking hydroxyurea consistently for 2 months.

Exclusion Criteria

Recent hospitalizations within the past 7 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the MED-Go app intervention to improve medication adherence for 12 weeks

12 weeks

Regular app usage and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MED-Go App

Trial Overview The MED-Go app, a behavioral intervention designed to help young people with sickle cell disease take their medication regularly, is being tested for its ease of use and whether it's well-received by users in this pilot randomized controlled trial.

How Is the Trial Designed?

Group I: MED-Go app Intervention Experimental Treatment 1 Intervention

Participants will use MED-Go app intervention for a total of 12 weeks

Group II: Control Arm Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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 26 adolescents and young adults with sickle cell disease showed that using a mobile health app (iManage for SCD) can improve self-management skills and self-efficacy, especially for those who engage frequently with the app.

Increased app engagement was linked to better mood ratings and lower pain levels, suggesting that mobile health tools can be effective in helping young people manage their condition more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. Hood, AM., Nwankwo, C., Walton, A., et al.[2022]

The study showed that two-way SMS medication reminders significantly improved medication adherence among individuals with sickle cell disease, with scores increasing from 3.42 to 5.46 in the intervention group, compared to no significant change in the control group.

Recruitment was highly successful at 95%, and 82.9% of participants completed the study, indicating that SMS reminders are a feasible intervention for enhancing medication adherence in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Medication Adherence with Two-way Short Message Service Reminders in Sickle Cell Disease and Asthma. A feasibility randomized controlled trial. Pernell, BM., DeBaun, MR., Becker, K., et al.[2022]

A feasibility randomized controlled trial involving 67 adults with sickle cell disease (SCD) showed high recruitment (91%) and retention (75%) rates for a mobile health app designed to improve patient knowledge and potentially reduce hospitalizations.

All participants in the treatment group used the mHealth app, indicating strong adherence to the intervention, which suggests that mobile health tools can be effectively integrated into patient care for SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Cronin, RM., Quaye, N., Liu, X., et al.[2023]

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]

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]

The QuestLeukemia mobile app was found to be an effective educational tool for pediatric patients preparing for hematopoietic cell transplantation (HCT), enhancing their disease knowledge and autonomy, as reported by both patients and parents.

Participants rated the app highly for usability and enjoyment, with average scores indicating it was easy to use (4.93), enjoyable (4.79), and comprehensive (4.71), suggesting it could positively impact the HCT experience for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. Meyer, R., Wang, K., Yearley, A., et al.[2022]

The Intensive Training Program (ITP) mobile health intervention significantly improved medication adherence and disease knowledge among 32 youth with sickle cell disease over a 90-day period, with adherence rates increasing from 0.57 to 0.74 (P < 0.001).

Participants who completed the ITP showed better SCD-related functioning and lower pain impact compared to those who did not complete the program, highlighting the importance of engagement in achieving positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health intervention for youth with sickle cell disease: Impact on adherence, disease knowledge, and quality of life. Anderson, LM., Leonard, S., Jonassaint, J., et al.[2019]

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]

Citations

1. withpower.com withpower.com/trial/phase-anemia-sickle-cell-8-2020-13828

MED-Go App for Sickle Cell Disease A study involving 26 adolescents and young adults with sickle cell disease showed that using a mobile health app (iManage for SCD) can improve self-management ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04678037

Home-based Assessment of PRO Measures in SCD Using ... The SCD-app is able to collect PROs data as patients complete the assessment using the app platform.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6604509/

A Medication Adherence App for Children With Sickle Cell ... The aim of this study was to develop a theory-and-evidence-based medication adherence app to support children and adolescents with SCD.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8541694/

Mobile health use predicts self-efficacy and ... Results from this preliminary study suggest that a mHealth app was successfully integrated into an RCT for AYA with SCD and resulted in a clinically meaningful ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949923224000345

Development of the iManage SCD mobile health ... This paper outlines the design and implementation of iManage SCD, a self-management mobile health application for adolescents and young adults (AYA) with sickle ...

6. reporter.nih.gov reporter.nih.gov/search/JbRgAtchAUKHOoW2X1vObQ/project-details/10799704

Project Details SCD complications lead to significant declines in health-related quality of life (HRQOL), culminating in early mortality, particularly among adolescents and ...

7. mhealth.jmir.org mhealth.jmir.org/2019/6/e8130/

A Medication Adherence App for Children With Sickle Cell ... Background: Young people with sickle cell disease (SCD) often demonstrate low medication adherence and low motivation for effectively self- ...

8. aha.org aha.org/role-hospitals-breakthrough-algorithm-musc-reduces-hospitalization-youngest-sickle-cell-patients

Breakthrough algorithm from MUSC reduces ... Over a year-long trial, admissions dropped 10%, and there was no difference in readmissions — meaning that the kids who were sent home got better at home. While ...