Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Nationwide Children's Hospital
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.
Description
This is an investigator-blinded, multi-center pilot randomized controlled trial (RCT) of adolescents with sickle cell disease (SCD) and caregivers of young children with SCD. After completion of a run-in period, subjects will undergo randomization to either six months of video directly observed therapy (VDOT) or attention control. Electronic adherence monitors will be used to measure adherence. After the intervention period, all participants will then complete a six-month ongoing monitoring period where VDOT participants will continue to use electronic adherence monitors and receive intermitte…
Eligibility
- Age range
- 11+ years
- Sex
- All
- Healthy volunteers
- No
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 y…
Interventions
- BehavioralVideo 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.
- BehavioralHealth 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.
Locations (3)
- Lurie Children's HospitalChicago, Illinois
- Nationwide Children's HospitalColumbus, Ohio
- Hasbro Children's HospitalProvidence, Rhode Island