Study Detail

Study ID 1021
Name Integrating m-Health into SCD Care to Increase Hydroxyurea Utilization
Contact Email
Acronym SCDIC mESH
Period 2019 - 2022
Design Clinical Trial
Study PI Jane Hankins
Institution St. Jude Children's Research Hospital
Funding Agency NHLBI
Overview The purpose of this project is to improve adherence to hydroxyurea therapy. Multiple approaches for improving adherence with pharmaceutical regimens have been studied and demonstrate a need to address barriers that both providers and patients face. This project aims to test two innovative interventions utilizing mobile health (mHealth), to address both patients’ and providers’ needs: 1) an mHealth application for patients (InCharge Health app) that includes multi-component features to address the memory, motivation, and knowledge barriers to hydroxyurea use, and 2) an mHealth toolbox application for providers (HU Toolbox app) that addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea use.
Focus Areas 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge Barriers to Hydroxyurea Use.
2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors.
3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth Interventions.
Outcomes 1. Measure of the association between InCharge Health app to patient hydroxyurea adherence [ Time Frame: baseline (prior to the intervention), week 12, week 24 ]
2. Implementation of InCharge Health app. [ Time Frame: baseline, 24 weeks, 36 weeks]
3. Change in mean corpuscular volume (MCV) [ Time Frame: baseline, 24 weeks]
4. Change in fetal hemoglobin [ Time Frame: baseline, 24 weeks ]
5. Change in mean hemoglobin concentration [ Time Frame: baseline, 24 weeks ]
Data Location RTI International
Biospecimen Available Blood; Serum;
Data Consent De-identified data will be shared outside SCDIC; investigators must adhere to Data Use Agreement
Biospecimen Consent Investigators must adhere to Data Use Agreement
Contact Consent NA
Genomic Data No
Age Range 15-45
No. Subjects 293
Inclusion Criteria 1. Age 15 years up to and including 45 years
2. Treated at or affiliated with one of the SCDIC sites
3. English speaking
4. 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 Sß-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
5. Willing and cognitively able to give informed consent
6. Access to a cellular/mobile smart phone (either Android or IPhone are acceptable)
7. 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 1. Current pregnancy
2. On a chronic transfusion program in which they receive more than 8 erythrocyte transfusions in a 12-month period.
3. A red blood cell transfusion in the past 60 days
4. Currently using another phone application or an online-based tool (e-health tool) to increase hydroxyurea adherence
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