Sickle Cell Medication Management Study

Patient-Centered Comprehensive Medication Adherence Management System to Improve Effectiveness of Disease Modifying Therapy with Hydroxyurea in Patients with Sickle Cell Disease

Protocol Description

Through this study researchers will determine whether an interactive medication management program will help children and adults with sickle cell disease who are taking hydroxyurea (HU) for their condition. HU is the only disease-modifying therapy for SCD, and can be effective in reducing complications such as pain crisis and acute chest syndrome, and improving survival. It is, however, vastly underutilized and poorly adhered to for a variety of reasons. Through this study, structured interventions will be individualized to patient barriers and preferences, and will consist of improved access to care through virtual clinic visits and in-home testing, adherence management via video-based, directly observed therapy (Mobile-DOT), and patient support using text and telephone follow-up.

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders between the ages of 2 and 65 who have sickle cell disease and are receiving HU therapy.
Males: 2 to 65 years old
Females: 2 to 65 years old

Requirements

Participants will be placed into one of two study groups. Both will receive standard clinical care, and one will also receive interventions aimed at improving their adherence to the medication regimen. The intervention group receives reminders to take medications and a combination of other interventions, such as interviews, Mobile-DOT, clinic visits every 3 months, surveys, and medical and pharmacy record review. Through Mobile-DOT, participants use a mobile device to make a video of themselves consuming the medication and then send the recording to researchers.
Visits: 9
Duration: 2 years

Status: Open for Enrollment

Source(s) of Support

Patient-Centered Outcomes Research Institute (PCORI)

Additional Information

Study Description at PCORI

Primary Investigator

Gregory Kato, MD

Contact Information

For information about the study or enrollment, please contact:
Study Coordinator Angela Martino, BSN, RN
412-692-6467