Status:
COMPLETED
Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
15-45 years
Phase:
NA
Brief Summary
This project proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a stepped-wedge design, The inve...
Detailed Description
The National Heart, Lung, and Blood Institute (NHLBI) created the Sickle Cell Disease Implementation Consortium (SCDIC) to apply implementation science methods to identify and address barriers to guid...
Eligibility Criteria
Inclusion
- Age 15 years up to and including 45 years
- Treated at or affiliated with one of the SCDIC sites
- English speaking
- Confirmed Sickle Cell Disease (SCD) diagnosis. An SCD diagnosis is defined as Hb fractionation test (e.g., high- performance liquid chromatography or another technique) that is diagnostic of one the following: Hb SS, Hb SC, Hb Sβ-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
- Willing and cognitively able to give informed consent
- Access to a cellular/mobile smart phone (either Android or IPhone are acceptable)
- Hydroxyurea therapy: Already receiving hydroxyurea therapy: defined as at least one prior prescription to hydroxyurea in the past 3 months and no plans to escalate the dose by more than 5 mg/kg/day. Initiating hydroxyurea therapy: defined as at least one prescription written at the time of study enrollment (the first prescription must be written on the same day as study enrollment). Patients who initiate hydroxyurea on the same day of study enrollment will not contribute to the total of 46 patients target accrual for the site. A max of 30 patients who are initiating hydroxyurea can be enrolled per site.
Exclusion
- Current pregnancy
- On a chronic transfusion program in which they receive more than 8 erythrocyte transfusions in a 12-month period.
- A red blood cell transfusion in the past 60 days
- Currently using another phone application or an online-based tool (e-health tool) to increase hydroxyurea adherence
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT04080167
Start Date
November 11 2019
End Date
August 31 2022
Last Update
November 29 2023
Active Locations (7)
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1
Georgia Regents University
Augusta, Georgia, United States, 30912
2
University of Illinois
Chicago, Illinois, United States, 60612
3
Washington University
St Louis, Missouri, United States, 63110
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029