Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT04080167
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT04080167
Study Brief:
Protocol Section:
NCT04080167