Medication Adherence in Youth With Sickle Cell Disease (SCD)

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.

Conditions

• Sickle Cell Disease

Interventions

BEHAVIORAL

Demographic Questionnaire

At study enrollment, participants will complete a questionnaire to collect demographic information about the participant's family background, education and living situation.

BEHAVIORAL

Medical Adherence Measure Questionnaire

At the two-month follow-up visit, participants will be asked to complete a questionnaire describing all medications prescribed for them, when they take their medications, how much medication they take each time, how many times during the week they missed taking or were late taking each medication, reasons why they missed or were late, and how they manage their medications. In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

BEHAVIORAL

Acceptability Questionnaire

At the two-month follow-up visit, participants will be asked to complete a questionnaire about their perceptions of using the Wise electronic medication container. In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Lisa Ingerski, PhD · St. Jude Children's Research Hospital

• Jerlym Porter, PhD · St. Jude Children's Research Hospital

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2015-05-31

Completion

2015-05-31

Countries

• United States

Study Locations