ExAMS: Medication Adherence in Children with Sickle Cell Disease

Hydroxyurea Medication Adherence in Sickle Cell Patients

Categories:

Psychology

Sickle Cell Disease

Diseases Treated:

Non-therapeutic

Eligibility Overview:

This clinical trial is open only to patients at the St. Jude Children’s Research Hospital Hematology Clinic.

  • Diagnosis of sickle cell disease (SCD)
  • At least 12 years old and younger than 18 years old
  • On a stable hydroxyurea dose in pill formation for 6 months or longer
  • Lives with legal guardian
  • Able to return to clinic at 4-week intervals
  1. Brief Summary

    Hydroxyurea therapy has been shown to decrease morbidity and mortality in youth with sickle cell disease. Yet, pediatric hydroxyurea medication adherence rates lag below optimal levels.  Non-adherence may lead to unnecessary increases in medication dosage based on the erroneous assumption that a patient is non-responsive to treatment.

    Electronic medication adherence monitoring is widely considered the “gold standard” in objective measurement. These monitors provide continuous, real-time records and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, “drug holidays” and “white coat” adherence.

    This study will evaluate use of the AdhereTech smart bottle in pediatric patients on hydroxyurea therapy for sickle cell disease. Equipped with an electronic medicine dispenser with a wireless tracking and reminder system, the bottle records when medication is removed and the amount of medication removed. Such data are necessary to support future studies utilizing this electronic system to objectively measure disease outcomes and correlates of HU adherence over time.

    Primary Objective

    • To estimate the association between HU adherence as measured by the AdhereTech device to:
      • Caregiver report
      • Youth report
      • Lab values
      • Pill count
      • Medication Possession Ratio (MPR) adherence measures

    Eligibility Criteria

    Inclusion criteria include:

    • Diagnosis of sickle cell disease (any genotype)
    • At least 12 years old and younger than 18 years old
    • On a stable HU dose composed of only one capsule strength prescribed in pill formation for 6 months or longer without documented hematological toxicity (excluding dose adjustments for weight gain)
    • Lives with legal guardian
    • Able to return to clinic at 4-week intervals

    Exclusion Criteria include:

    • Unable to complete questionnaires

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. About this study

    Hydroxyurea is a medicine used to treat sickle cell disease. St. Jude is looking for new ways to measure how often you take your hydroxyurea as prescribed by your doctor. This study will test a new type of pill bottle to see if it can help you to remember to take your medicine regularly and at the right time. The AdhereTech smart bottle is about the same size as a normal pill bottle and has the same safety cap that opens as a regular bottle does. The bottle is approved by the U.S. Food and Drug Administration (FDA).

    In this study, you will store your medication in the smart bottle. The bottle will record when you open the container, and it will send that information to a computer server. The smart bottle can tell when your medicine is low. It can also light up, make sounds and send you text messages to remind you to take your medication.

    This study may help you learn more about your disease and how to take your medication. The information we learn from the study may also help other young sickle cell patients take their medication as prescribed.

    Purpose of this clinical trial

    The main goal of this study is to find out if the smart bottle is good at measuring whether you have taken your medication and if you like using the smart bottle.

    Eligibility overview

    • Diagnosis of sickle cell disease
    • At least 12 years old and younger than 18 years old
    • On a stable hydroxyurea dose in pill formation for 6 months or longer
    • Lives with legal guardian
    • Able to return to clinic at 4-week intervals
  3. ExAMS Quick View
    Sponsors St. Jude Children's Research Hospital
    ClinicalTrials.gov identifier NCT03708731
    Trial start date October 2018
    Estimated enrollment 36
    Study type Observational
    Conditions Sickle cell disease
    Ages 12 to 18 years old
    Principal investigator Jerlym Porter, PhD, MPH
    Study sites St. Jude Children's Research Hospital
    For a consultation or to discuss ExAMS St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.