RecruitingNot Applicable

Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness

United States60 participantsStarted 2024-07-11

Plain-language summary

This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion: Adult caregivers will be eligible if they: * Are English speaking. * Have a child who is 1-10 years of age with SCD (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment. * Note: Caregivers who have multiple children meeting criteria will only be able to enroll once. Adolescents (\>11 years at enrollment) are eligible if they: * Are English speaking. * Are 11-25 years of age. * Have a diagnosis of SCD (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment. Exclusion: * Adolescents and caregivers of younger children who participated in the previous VDOT study will be excluded. * Adolescents and caregivers of younger children receiving multiple SCD modifying treatments (e.g., chronic transfusions or L-glutamine) will be excluded. Randomization: enrolled subjects will be eligible for randomization if they open their electronic adherence monitoring device at home at least once during the run-in period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retention Rate

Timeframe: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days

Sustained Engagement

Timeframe: Throughout the intervention period, which will take place from approximately 30 days after enrollment to 210 days after enrollment

Electronic Adherence

Timeframe: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days

Trial details

NCT IDNCT06264700

SponsorNationwide Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Susan Creary, MD, MSc

(614) 722-3550 susan.creary@nationwidechildrens.org

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Retention Rate

Timeframe: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days

Sustained Engagement

Timeframe: Throughout the intervention period, which will take place from approximately 30 days after enrollment to 210 days after enrollment

Electronic Adherence

Timeframe: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days