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

Trial Summary

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 data supports the idea that MED-Go App for Sickle Cell Disease is an effective treatment?

The available research shows that using mobile health apps like the MED-Go App can help people with sickle cell disease manage their condition better. One study found that adolescents who used a similar app more often reported feeling better and having less pain. Another study showed that adults using a mobile app with guidelines had high participation and completion rates, suggesting they found it helpful. These findings suggest that the MED-Go App could be effective in improving self-management and reducing pain for people with sickle cell disease. ^{1 2 3 4 5}

What safety data exists for the MED-Go App for Sickle Cell Disease?

The available research does not provide specific safety data for the MED-Go App. However, similar mobile health applications for sickle cell disease, such as those evaluated in the studies, have shown high recruitment, retention, and adherence rates, indicating feasibility and acceptability. These studies suggest that mobile apps can be effective tools for self-management and education in sickle cell disease, but specific safety data for the MED-Go App itself is not mentioned. ^{2 3 6 7 8}

Is the MED-Go App a promising treatment for sickle cell disease?

Yes, the MED-Go App is a promising treatment for sickle cell disease. It helps young people manage their health better by using a mobile app, which can improve their mood, reduce pain, and boost their confidence in handling their condition. The app also supports self-management, which is important for improving the quality of life for those with sickle cell disease. ^{1 2 5 7 9}

What is the purpose of this trial?

The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Research Team

Sherif M. Badawy, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. [2022]

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

Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. [2022]

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

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. [2023]

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

Mobile health intervention for youth with sickle cell disease: Impact on adherence, disease knowledge, and quality of life. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Educational technology on COVID-19 for families of children and adolescents with sickle cell disease. [2021]

7. Germany 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. [2022]

8. United States 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. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the Challenges and Opportunities of eHealth Tools for Patients with Sickle Cell Disease. [2018]