Sickle Cell Disease Clinical Trial
Official title:
ENHANCE Study (ElectroNic Hydroxyurea AdhereNCE): A Strategy to Improve Hydroxyurea Adherence in Patients With Sickle Cell Disease
HU is an FDA approved medication for the treatment of SCD. Many studies have shown that HU
can reduce SCD related symptoms, but only 50% of patients take it as often as they should.
This limits how much HU can help reduce SCD symptoms.
Researchers are interested to see if electronic directly observed therapy (Mobile DOT), a
program that uses cell phone reminder messages, videos, feedback messages, and incentives
will help patients with SCD take HU as prescribed.
This is a 12-month, single-arm, cross-over study for pediatric and adolescent patients with
SCD who are prescribed HU at Nationwide Children's Hospital in order to compare HU adherence
prior to the study, during Mobile Dot use and after using Mobile DOT.
Hydroxyurea (HU) is the only disease-modifying medication for patients with sickle cell
disease (SCD). Multiple clinical trials show that HU can reduce SCD-related complications but
only 50% of pediatric patients adhere to HU at the rates achieved in clinical trials. This
poor adherence limits its clinical effectiveness and results in increased costs and in lower
patient-reported quality of life.
An innovative, practical, inexpensive, and efficient strategy is needed to improve HU
adherence in pediatric patients with SCD. Electronic directly observed therapy (Mobile DOT)
is a pilot-tested, multi-dimensional tool that is a feasible and acceptable strategy and can
achieve >90% HU adherence rates in a small cohort of pediatric patients with SCD. This study
will provide further testing to confirm if Mobile DOT can improve adherence and improve
clinical outcomes in patients with SCD.
Mobile DOT uses patients' smart phones and computers to provide electronic reminder alerts
and to video-record patients' daily HU administrations. Patients are provided with text (SMS)
messages, e-mails, and phone call communications to encourage adherence and they receive
monetary incentives when they reach adherence goals.
Researchers will determine if video adherence correlates with self-report, biomarker, and
refill adherence. Also, surveys will be completed by participants to determine if their
self-management skills improve with Mobile DOT.
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