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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the HU-Go app, a digital tool, can help adolescents and young adults with sickle cell disease adhere to their hydroxyurea medication. Hydroxyurea is a key treatment for sickle cell disease. The study will examine patients' medication adherence and its impact on their overall quality of life over time. The goal is to improve both medication adherence and health outcomes. Individuals aged 12-21 with sickle cell disease, who have been taking hydroxyurea for at least two months and have access to a smartphone, may be suitable for this trial. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance treatment adherence and improve quality of life for many.

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

Research shows that the HU-Go app is designed to help people with sickle cell disease remember to take their medication. Studies indicate that the app improves medication adherence, particularly with hydroxyurea. As a non-medication tool, the app does not have side effects like a new drug might. Instead, it sends reminders and tracks medication intake.

Since the app is a tool and not a drug, no reports of physical side effects have emerged from its use. The main goal is to promote regular medication adherence, which is generally safe and can lead to better health over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HU-Go app for sickle cell disease because it offers a novel approach to improving medication adherence. Unlike standard treatments that focus solely on managing symptoms or complications, this app is designed to help patients stick to their prescribed hydroxyurea regimen by providing reminders, educational resources, and tracking tools. This digital intervention could lead to better treatment outcomes by ensuring patients consistently take their medication, which is a critical challenge in managing sickle cell disease.

What evidence suggests that the HU-Go app is effective for improving adherence in sickle cell disease?

Research has shown that using a mobile health app like HU-Go can help people with sickle cell disease manage their condition better. In one study with 26 young people, a similar app called iManage for SCD helped them care for their health more effectively. This trial will evaluate the HU-Go app intervention arm, where participants will use the app for 12 months. The HU-Go app is expected to help patients take their hydroxyurea (HU) medication more regularly, improving medication adherence by at least 20%. Taking HU as prescribed is important because it can reduce complications from sickle cell disease. Overall, using the app might lead to better health by helping people take their medicine more consistently. ^{1 2 3 4 6}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04678037

Home-based Assessment of PRO Measures in SCD Using ... A smartphone app platform designed for patients with sickle cell disease. The SCD-app is programmed to send notification to patients to complete PROs assessment ...

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

Project Details This study will examine the relationship between hydroxyurea adherence and health-related quality of life overtime among adolescents with sickle cell disease, ...

3. withpower.com withpower.com/trial/phase-hemoglobin-sc-disease-2-2021-bd29c

HU-Go App for Sickle Cell Disease Adherence 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04675645

Adherence to HU and HRQOL in Patients With Sickle Cell ... Hypothesis 3: HU-Go will improve HU adherence by at least 20%. Official Title. Adherence to Hydroxyurea and Health-related Quality of Life in Patients With ...

5. researchprotocols.org researchprotocols.org/2016/4/e193/

A Protocol to Increase Hydroxyurea Adherence in Patients ... HU can reduce SCD-related complications but only 35% to 50% of pediatric patients adhere to HU at the rates achieved in clinical trials and this ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0128712

Sickle Cell Disease (SCD) (DBCOND0128712) Adherence to HU and HRQOL in Patients With Sickle Cell Disease: An Intervention Study Using HU-Go App, No drug interventions, supportive_care, Not Available ...