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HU-Go App for Sickle Cell Disease Adherence

N/A

Waitlist Available

Led By Sherif M. Badawy, MD, MS

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 12-21 years old

Any sickle cell disease genotype

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will look at how well young adults with sickle cell disease adhere to taking hydroxyurea, and how this affects their quality of life.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves an app, there are no direct medical side effects from interventions like drugs or surgery. However, participants may experience stress or frustration if they encounter technical issues with the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 21 years old.

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I have a type of sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hydroxyurea adherence rate

Secondary outcome measures

Adherence to Hydroxyurea using Modified Morisky Adherence Scale 8-items

Hydroxyurea

Anxiety score using Patient reported outcomes measurement information system (PROMIS) measure

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: HU-Go app intervention armExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

256 Previous Clinical Trials

5,187,812 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,428 Total Patients Enrolled

Sherif M. Badawy, MD, MSPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

2 Previous Clinical Trials

73 Total Patients Enrolled

Media Library

HU-Go app intervention arm Clinical Trial Eligibility Overview. Trial Name: NCT04691323 — N/A

Sickle Cell Disease Research Study Groups: HU-Go app intervention arm

Sickle Cell Disease Clinical Trial 2023: HU-Go app intervention arm Highlights & Side Effects. Trial Name: NCT04691323 — N/A

HU-Go app intervention arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04691323 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate individuals aged 18 and up?

"To be considered for this trial, applicants must fall between 12 and 21 years old. For those under 18 or over 65 there are dedicated studies available with 154 trials for the former group and 102 trials for the latter cohort."

Answered by AI

Are enrollment opportunities currently available for this investigation?

"Affirmative. The clinical trials website outlines that this trial is currently seeking individuals for their research. It was first posted on March 2nd 2021 and edited lastly on July 26th 2022. A total of 72 participants are needed from 1 location."

Answered by AI

Is it within my capability to sign up for this research project?

"This clinical research is aiming to enrol 72 thalassemia patients ranging from 12-21 years of age. Eligibility requirements include: being in a steady state with hydroxyurea for two months, possessing or having access to a smartphone, and the parents/guardians of enrolled youngsters also joining the trial."

Answered by AI

What is the cap of enrollments for this research trial?

"Correct. According to information on clinicaltrials.gov, this medical trial is presently enrolling individuals; it was originally posted on March 2nd 2021 and most recently modified on July 26th 2022. The study requires an influx of 72 patients from 1 centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Longitudinal Relationship of HU Adherence to HRQOL, Barriers to Adherence and Habit in SCD.

Sherif Badawy, MD 2021. "The Longitudinal Relationship of HU Adherence to HRQOL, Barriers to Adherence and Habit in SCD.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04691323.

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