title: A pilot study of electronic directly observed therapy to improve hydroxyurea adherence in pediatric patients with sickle-cell disease.
abstract: BACKGROUND
  Poor hydroxyurea (HU) adherence limits effective HU use in patients with sickle cell disease (SCD). Electronic directly observed therapy (DOT) may limit costs and achieve high HU adherence in children with SCD. This study aimed to determine if electronic DOT was feasible, acceptable, and could achieve ≥ 90% HU adherence.
  
  
  METHODS
  Children with SCD were recruited for this single institution, 6-month pilot study if they had been prescribed HU for ≥ 6 months and had daily access to a smartphone or computer. Participants submitted HU administration videos daily and received electronic reminder alerts, personalized feedback, and incentives to encourage adherence as part of electronic DOT. Primary outcomes were feasibility, participant satisfaction with electronic DOT, and HU adherence. Secondary outcomes included mean corpuscular volume (MCV), hemoglobin F percentage (HbF), and overall participant satisfaction with HU therapy.
  
  
  RESULTS
  Of 15 enrolled participants, 14 completed the study. Satisfaction surveys showed electronic DOT reminded participants to take HU and could be completed in fewer than 5 minutes daily. Participants' median medication possession ratio at study entry improved from 0.75 (0.59-0.82) to 0.91 (0.85-1.00) (P = 0.02) at the end of the study. Overall median observed HU adherence with electronic DOT was 93.3%. Median MCV and HbF increased from 96.0 to 107.2 (P = 0.009) and 10.5 to 11.4 (P = 0.03), respectively.
  
  
  CONCLUSIONS
  This study demonstrates electronic DOT is feasible, acceptable, and can achieve high HU adherence. Further study is needed to confirm that electronic DOT can improve HU adherence and impact clinical outcomes in children with SCD.
authors.affiliation: Division of Pediatric Hematology-Oncology, Nationwide Children's Hospital, Columbus, Ohio.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Creary
authors.forename: Mark T
authors.initials: MT
authors.lastname: Gladwin
authors.forename: Melissa
authors.initials: M
authors.lastname: Byrne
authors.forename: Mariana
authors.initials: M
authors.lastname: Hildesheim
authors.forename: Lakshmanan
authors.initials: L
authors.lastname: Krishnamurti
mesh_terms: D000293:Adolescent; D000755:Anemia, Sickle Cell / Q000188:drug therapy*; D000986:Antisickling Agents / Q000627:therapeutic use*; D040421:Cell Phone; D002648:Child; D002675:Child, Preschool; D023801:Directly Observed Therapy / Q000295:instrumentation / Q000379:methods*; D004334:Drug Administration Schedule; D034742:Electronic Mail; D005246:Feedback; D005260:Female; D006306:Health Surveys; D006801:Humans; D006918:Hydroxyurea / Q000627:therapeutic use*; D008297:Male; D055118:Medication Adherence; D008838:Microcomputers; D017060:Patient Satisfaction; D010865:Pilot Projects; D012052:Reimbursement, Incentive; D017010:Reminder Systems / Q000295:instrumentation*; D012201:Reward; D060145:Text Messaging; D014741:Video Recording; D055815:Young Adult
chemical_list: D000986:Antisickling Agents; D006918:Hydroxyurea
keywords: hydroxyurea; medication adherence; sickle cell