Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Retention Rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Susan Creary
Associate Professor of Pediatrics and Pediatric Hematologist, Division of Hematology/Oncology/BMT
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Participant Satisfaction(At the end of the study, which will be approximately 390 days after enrollment)
- 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)
- 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)
- 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)
- Treatment Satisfaction(throughout the study at various timepoints after enrollment including: after approximately 30-90 days, 210 days, and 390 days)