Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
36 participants
OBSERVATIONAL
2019-03-12
2026-09-30
Brief Summary
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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
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Detailed Description
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Participants ages 12.0-17.99 who are receiving HU prescribed in pill form will use the AdhereTech smart bottle for a two-month period. Participants and their caregivers will complete self-report measures of adherence at the baseline, 1 month and 2 month clinic visits, a Demographic questionnaire at the baseline clinic visit and an Acceptability questionnaire at the 1 month and 2 month clinic visits using Audio Computer-Assisted Self-Interviews (ACASI) on a password protected laptop.
Lab values and clinical information will be obtained through medical records review and adherence information from pill counts and pharmacy records.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Sickle Cell Disease
All participants who meet eligibility requirements and consent to the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Participant unable to complete the questionnaires due to refusal or current acute illness (e.g., pain crisis).
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
12 Years
17 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Jerlym Porter, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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ExAMS
Identifier Type: -
Identifier Source: org_study_id
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