protocolSection identificationModule nctId: NCT06264700, orgStudyIdInfo id: STUDY00003303, secondaryIdInfos id: R44HL169085, type: NIH, link: https://reporter.nih.gov/quickSearch/R44HL169085, briefTitle: Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness, acronym: ADHERE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Nationwide Children's Hospital, class: OTHER, collaborators name: Ann & Robert H Lurie Children's Hospital of Chicago, collaborators name: Hasbro Children's Hospital, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: After completing a one to three-month run-in period, participants will be randomized to receive six months of either VDOT or attention control. All participants will then complete six months of ongoing monitoring during which VDOT patients will receive intermittent communication to encourage adherence and both groups will continue to use their electronic adherence monitors., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The investigators will be blinded to prevent the possibility of any differential treatment that could affect the ability of the study team to evaluate the impact of VDOT on hydroxyurea adherence. As such, a statistician will create a randomization model and study staff will facilitate communication with participants as well as between participants and the VDOT team., whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Video Directly Observed Therapy (VDOT), interventions name: Health Reminder Tip Alerts, outcomesModule primaryOutcomes measure: Retention Rate, primaryOutcomes measure: Sustained Engagement, primaryOutcomes measure: Electronic Adherence, secondaryOutcomes measure: Pediatric SCD Medication Self-Management Questionnaire, secondaryOutcomes measure: Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations, secondaryOutcomes measure: Laboratory Studies (i.e. MCV, HbF), secondaryOutcomes measure: Treatment Satisfaction, secondaryOutcomes measure: Participant Satisfaction, eligibilityModule sex: ALL, minimumAge: 11 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lurie Children's Hospital, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Sherif Badawy, MD, role: CONTACT, phone: 312-227-4836, email: sbadawy@luriechildrens.org, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Hasbro Children's Hospital, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Patrick McGann, MD, PhD, role: CONTACT, phone: 617-519-9555, email: patrick_mcgann@brown.edu, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False