Medication Adherence in Youth With Sickle Cell Disease (SCD)

Completed

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT02143076

Run by

St. Jude Children's Research Hospital

People needed

36

Starts

2014-05-01

Expected to finish

2015-05-01

Last updated by the study team

2015-05-27

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of SCD (any genotype).
• Less than 18 years of age at time of study entry.
• Currently followed in the St. Jude Children's Research Hospital (SJCRH) SCD clinic.
• Stable HU dose prescribed (in pill or liquid formulation) for ≥ 6 months without documented hematological toxicity (excluding dose adjustments for weight gain).
• Lives with their primary caregiver.
• Anticipated to return to clinic at proposed 4-week or 8-week intervals.

You may not qualify if…

• 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.
• Any condition or chronic illness that in the opinion of the PI or Co-I makes participation on the study ill-advised.

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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