Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
- Conditions
- Sickle Cell Disease
- Interventions
- Behavioral: Video Directly Observed Therapy (VDOT)Behavioral: Health Reminder Tip Alerts
- Registration Number
- NCT06264700
- Lead Sponsor
- Nationwide Children's Hospital
- Brief 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.
- Detailed 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 intermittent communication to encourage adherence and attention controls will continue to use their electronic adherence monitors.
The investigators are partnering with a small business, Scene Health, to administer VDOT. Outcomes such as engagement, retention, and satisfaction will be measured through survey data collected at routine study visits. Sickle cell-related outcomes and healthcare utilization will be abstracted from patient electronic medical records throughout each study period. Adherence data will be recorded by the electronic adherence devices.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Video Directly Observed Therapy (VDOT) Video Directly Observed Therapy (VDOT) Participants randomized to this arm will be connected with Scene Health by a study staff member (not the PI or Co-I's). After submitting and receiving approval of a test video submission, the participants' hydroxyurea dosing schedule will be entered into the VDOT app by the research staff and will be updated by these staff after their routine hematology visits and/or hospitalizations. Participants will receive VDOT for 180 days, beginning the day after randomization. After that time, they will start a 180-day ongoing monitoring period, during which VDOT participants will receive monthly telephone calls and intermittent text messages from Scene Health staff to encourage ongoing adherence. The Scene Health staff will access the electronic adherence platform and use this data to inform their communications during the ongoing monitoring period. Participants in both arms will be offered a smartphone with a data plan at enrollment to ensure equal opportunity for participation. Attention Control Health Reminder Tip Alerts Participants randomized to this arm will receive an automated, daily, short health or safety tip alert.
- Primary Outcome Measures
Name Time Method Retention Rate 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 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 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.
- Secondary Outcome Measures
Name Time Method Participant Satisfaction At the end of the study, which will be approximately 390 days after enrollment A Likert-scale survey to assess participant motivation for participating, understanding of the study and its procedures, experience interacting with research staff and completing study visits and activities.
Pediatric SCD Medication Self-Management Questionnaire At multiple points throughout the study, including at enrollment, at approximately 90 days after randomization, at approximately 180 days months after randomization, and at approximately 360 days after randomization : An adapted questionnaire to assess caregivers' hydroxyurea knowledge and expectations, perception of their adherence, their barriers to adherence, and their beliefs about hydroxyurea's efficacy.
Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days Any acute visit (e.g., emergency, day hospital, and/or hospitalization visits) that is documented in the electronic medical record during the study. Emergency and day hospital visits that result in hospitalization will be categorized as one visit. Details from each of these visits will be abstracted.
Laboratory Studies (i.e. MCV, HbF) throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days Routine hematologic labs that are collected on patients receiving hydroxyurea will be collected from the electronic medical record (EMR).
Treatment Satisfaction throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days An 11-item survey to assess hydroxyurea treatment satisfaction over four domains, side effects, effectiveness, convenience and global satisfaction.
Trial Locations
- Locations (3)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
Hasbro Children's Hospital
🇺🇸Providence, Rhode Island, United States