HU-Go App for Sickle Cell Disease Adherence

Overseen By Kathryn King, 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 months

68 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to better understand factors contributing to variations in hydroxyurea (HU) adherence behavior in adolescents and young adults (AYA) with sickle cell disease (SCD). To meet this objective, the researchers will conduct a prospective cohort study to determine the longitudinal relationship between HU adherence and health-related quality of life (HRQOL) overtime among AYA with SCD. The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires participants to have been on a steady dose of hydroxyurea for at least 2 months before joining.

What data supports the effectiveness of the HU-Go app treatment for sickle cell disease adherence?

Research shows that mobile health apps can improve self-management and communication with healthcare providers for people with sickle cell disease. These apps have been found to help users manage pain, improve mood, and increase disease knowledge, which can lead to better health outcomes. ^{1 2 3 4 5}

Is the HU-Go app safe for use in humans?

The safety of hydroxyurea (HU), which the HU-Go app helps patients adhere to, has been studied in people with sickle cell disease. Research shows that HU is generally safe, but adherence to its use can be challenging. ^{6 7 8 9 10}

How does the HU-Go App treatment for sickle cell disease differ from other treatments?

The HU-Go App is unique because it uses mobile health technology to improve adherence to treatment and enhance communication between patients and healthcare providers, which is not a feature of traditional drug treatments for sickle cell disease. ^{1 2 4 8 11}

Research Team

Sherif M. Badawy, MD, MS

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for young individuals aged 12-21 with any type of sickle cell disease who have been taking hydroxyurea consistently for at least 2 months. They must own or have access to a smartphone. Parents of eligible patients can also participate. Those recently hospitalized within the past week cannot join.

Inclusion Criteria

Parents of patients that meet the eligibility criteria and are enrolled in the study will be included

I am between 12 and 21 years old.

I have a type of sickle cell disease.

Exclusion Criteria

Patients with 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 HU-Go app intervention for 12 months to monitor and improve adherence to hydroxyurea

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HU-Go app

Trial Overview The study is testing the 'HU-Go app' and its impact on medication adherence over time in adolescents and young adults with sickle cell disease. It aims to understand how using this app affects their health-related quality of life and habits related to taking hydroxyurea.

Participant Groups

Group I: HU-Go app intervention arm Experimental Treatment 1 Intervention

Participants will use the HU-Go app intervention arm for 12 months.

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 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 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 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 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]

In a study of 523 pediatric patients with sickle cell disease, those treated with hydroxyurea (HU) were more likely to experience organ-specific complications, such as cardiovascular, hepatic, renal, and pulmonary issues, compared to those not treated with HU.

Despite the increased likelihood of complications in the HU-treated group, the study concluded that HU is not associated with the development of serious adverse events, suggesting it can be safely administered to severely ill children with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical complications in severe pediatric sickle cell disease and the impact of hydroxyurea. Tripathi, A., Jerrell, JM., Stallworth, JR.[2022]

References

1. 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]

2. 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]

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

Patients welcome the Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). [2022]

6. Oman pubmed.ncbi.nlm.nih.gov

Hydroxyurea: Pattern of Use, Patient Adherence, and Safety Profile in Patients with Sickle Cell Disease in Oman. [2023]

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

Clinical complications in severe pediatric sickle cell disease and the impact of hydroxyurea. [2022]

8. Egypt pubmed.ncbi.nlm.nih.gov

Integrating interactive web-based technology to assess adherence and clinical outcomes in pediatric sickle cell disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Higher hydroxyurea adherence among young adults with sickle cell disease compared to children and adolescents. [2022]

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

Technology Access and Smartphone App Preferences for Medication Adherence in Adolescents and Young Adults With Sickle Cell Disease. [2022]

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

Improved hydroxyurea effect with the use of text messaging in children with sickle cell anemia. [2017]