NCT06264700 · Nationwide Children's Hospital
Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
(ADHERE)
What this study is about
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 randomly assigned control trial comparing video directly observed therapy (VDOT) to attention control.
View original scientific description
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.
Interventions
BEHAVIORAL
Video Directly Observed Therapy (VDOT)
VDOT is an adherence-promoting intervention that involves partnering with an adolescent with SCD (or caregiver of a young patient with SCD) and observing the patient administer their hydroxyurea. In this study, VDOT will be delivered by a small business partner, Scene Health, via a smart phone app.
BEHAVIORAL
Health Reminder Tip Alerts
Participants randomized to this arm will receive an automated, daily, short health or safety tip alert (e.g. "Time to get moving! You should be active for at least 30 minutes each day") to receive during the 180-day intervention period on their smartphone. The daily tip will be unrelated to hydroxyurea adherence. After the 180-day intervention period, participants complete a 180-day ongoing monitoring period where they will no longer receive these messages, but they will be reminded to continue to use their electronic adherence monitoring device. All participants will be offered a smart phone with a data plan at enrollment to ensure equal opportunity for participation.
Primary outcome measures
Retention Rate
Time frame: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days
The number of participants who are retained on both study arms during each study period will be reported.
Sustained Engagement
Time frame: Throughout the intervention period, which will take place from approximately 30 days after enrollment to 210 days after enrollment
The number of participants who continue to actively participate with the intervention (VDOT arm only) and who report being satisfied with the intervention on the VDOT satisfaction survey.
Electronic Adherence
Time frame: throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days
Electronic adherence data from the electronic monitors will be integrated with the prescribing and hospitalization data from participants' electronic medical record to account for days when participants may not open their electronic pill bottle but are still adherent to their prescribed regimen. Hospitalization days will be subtracted from the adherence calculation, since participants will receive hydroxyurea from the inpatient pharmacy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Chicago, Illinois
- Columbus, Ohio
- Providence, Rhode Island
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago, Hasbro Children's Hospital, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2025 · Source of record for eligibility and locations