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NCT02143076 · ClinicalTrials.gov registry record
Medication Adherence in Youth With Sickle Cell Disease (SCD)
A clinical trial, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- 36
- Enrollment target
NCT02143076: Completed study, sponsored by St. Jude Children's Research Hospital.
NCT02143076 is a clinical trial that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02143076 has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- 36 participants
- Enrollment target
Study Summary
Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage SCD. 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" (i.e. where individuals do not take medications for a specified interval of time), and "white coat" adherence (i.e., a pattern of drug adherence as a function of time where individuals display good adherence immediately before and after clinic attendance with worsening adherence in the period between). Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. Currently, only one electronic measure capable of monitoring medications in both pill and liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its validity and reliability, preliminary data support the use of Wise technology to measure adherence to medication. The current study will determine the Wise device's ability to feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD population.
Primary Outcome
Of the total number of eligible participants, the percent of participants who agree to participate.
Interventions
- BEHAVIORAL Demographic Questionnaire
- BEHAVIORAL Medical Adherence Measure Questionnaire
- BEHAVIORAL Acceptability Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-05 |
What the finished NCT02143076 record still lists
NCT02143076 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Demographic Questionnaire is the first listed.
NCT02143076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02143076 about?
NCT02143076 is a clinical study titled "Medication Adherence in Youth With Sickle Cell Disease (SCD)". Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage SCD. Electronic adherence monitoring is widely considered the gold standard in objective adherence measurement. These ...
What is the current status of trial NCT02143076?
This trial is currently completed. The enrollment target is 36 participants. The study started on 2014-05. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02143076?
The interventions under investigation include: Demographic Questionnaire (BEHAVIORAL), Medical Adherence Measure Questionnaire (BEHAVIORAL), Acceptability Questionnaire (BEHAVIORAL).
Who is sponsoring clinical trial NCT02143076?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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