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Watching patients take medicine: a new way to boost sickle cell treatment?

NCT ID NCT06264700

Disease control Sponsor: Nationwide Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study tests whether video directly observed therapy (VDOT) — where patients or caregivers use a smartphone app to record themselves taking hydroxyurea — can improve adherence in young people with sickle cell disease. Participants will use an electronic pill bottle to track their medication use and fill out questionnaires about their experience. The trial compares VDOT to simple health reminder alerts to see which approach keeps patients engaged and taking their medicine as prescribed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Video directly observed therapy (VDOT) via a smartphone app, compared with health reminder alerts
What this could lead to
If effective, this approach could help young sickle cell patients take hydroxyurea more consistently, potentially reducing pain crises and hospital visits.
What could go wrong
This is a small pilot study, so results may not apply broadly. Adherence monitoring might not change long-term habits, and the app may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jul 2024

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Lurie Children's Hospital

    Chicago, Illinois, 60611, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

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