Exploring Adherence Monitoring in Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT03708731
- Lead Sponsor
- St. Jude Children's Research Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria:<br><br> - Confirmed diagnosis of SCD (any genotype)<br><br> - Ages 12.0 - 17.99 at time of study enrollment<br><br> - Stable HU dose composed of only one capsule strength prescribed in pill formulation<br> for = 6 months without documented hematological toxicity (excluding dose adjustments<br> for weight gain)<br><br> - Lives with their legal guardian<br><br> - Anticipated to return to clinic at proposed 4-week intervals<br><br>Exclusion Criteria:<br><br> - Primary caregiver and/or youth unable to understand English and/or youth not<br> cognitively intact (known IQ < 70) such that the study questionnaire cannot be<br> understood and completed.<br><br> - Participant unable to complete the questionnaires due to refusal or current acute<br> illness (e.g., pain crisis).<br><br> - Inability or unwillingness of research participant or legal guardian/representative<br> to give written informed consent.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate the association between AdhereTech device HU adherence to caregiver-report of adherence;Estimate the association between AdhereTech device HU adherence to youth-reported adherence;Estimate the association between AdhereTech device HU adherence to fetal hemoglobin (HbF) lab values;Estimate the association between AdhereTech device HU adherence to mean corpuscular volume (MCV) lab values;Estimate the association between AdhereTech device HU adherence to the Medication Possession Ratio (MPR);Estimate the association between AdhereTech device HU adherence to pill count
- Secondary Outcome Measures
Name Time Method Estimate rate of consent to the study;Estimate rate of AdhereTech device use;Estimate rate of AdhereTech device failure;Estimate the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth