NCT03708731Active, not recruiting
Exploring Adherence Monitoring in Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 17 Jun 2026
Brief summary (registry, in English)
Despite the well-documented benefits of hydroxyurea (HU) therapy in decreasing morbidity and mortality in youth with Sickle cell disease (SCD), pediatric HU adherence rates range as low as 49% and lead to discontinuation of HU regimens in 8-20%. In addition, treatment non-adherence may lead to unnecessary increases in medication dosage resulting from erroneous assumption that a patient is non-responsive to treatment (versus non-adherent to the regimen as prescribed). Given the detrimental effects of non-adherence, assessment of and intervention for HU non-adherence is essential to improving health outcomes in the pediatric SCD population. Electronic adherence monitoring is widely considered the "gold standard" in objective adherence measurement. These monitors provide continuous, real- time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays," and "white coat" adherence. Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. The primary purpose of this pilot study is to determine the use of the AdhereTech as a feasible and valid measure of HU adherence in pediatric SCD. Primary Objective Estimate the association between HU adherence as measured by the AdhereTech device to a) caregiver-report, b) youth-report, c) lab values, d) pill- count, and e) Medication Possession Ratio (MPR) adherence measures Secondary Objectives Estimate the rate of consent to the study, the rate of AdhereTech device use, the rate of AdhereTech device failure, and the perceived acceptability of using the AdhereTech device, as reported by caregivers and youth
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 4 Oct 2018
- Start date
- 12 Mar 2019
- Primary completion date
- 10 Aug 2022
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Sickle cell disease
- NCT number
- NCT03708731
What you commit to
- Study type: Observational
- Participants enrolled: 36
- From 12 Mar 2019 to the primary completion date, 10 Aug 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participant unable to complete the questionnaires due to refusal or current acute illness (e.g., pain crisis).
Other
- Primary caregiver and/or youth unable to understand English and/or youth not cognitively intact (known IQ \< 70) such that the study questionnaire cannot be understood and completed.
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Who the study is looking for
- Confirmed diagnosis of SCD (any genotype)
- Ages 12.0 - 17.99 at time of study enrollment
- Stable HU dose composed of only one capsule strength prescribed in pill formulation for ≥ 6 months without documented hematological toxicity (excluding dose adjustments for weight gain)
- Lives with their legal guardian
- Anticipated to return to clinic at proposed 4-week intervals
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.