Individual Patient Exposure and Response in Pediatric Lupus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      The purpose of this research study is to see if an electronic pill bottle cap can help
      children and teens with systemic lupus better remember to take their medicine. It will also
      gather information on the best dose of hydroxychloroquine (Plaquenil®) for children and
      teens. Participants in this study will continue to take their usual medication as prescribed
      by their doctors. Participants will receive an electronic pill bottle cap, a smartphone, and
      a Fitbit. Over 6 months, a nurse will visit each participant 4 times to ask questions about
      symptoms, draw blood, and take a urine sample. After the study, participants will be able to
      keep the electronic pill bottle cap and Fitbit, but will return the smartphone.
    

Detailed description: 
      This is an exploratory Phase 2, single site, open-label, direct-to-family, adherence and
      exposure-response study of hydroxychloroquine (HCQ) in pediatric systemic lupus. The study
      will measure a participant's adherence to HCQ self-administration using an electronic pill
      bottle cap that records date/time of bottle opening and provides participants with a reminder
      when a dosage is due and/or missed. All participants will be provided with the electronic
      pill bottle cap to use with their regular HCQ prescription at the start of the study. For the
      first 2 weeks of the trial, the electronic notifications will be disabled to determine a
      baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will
      be turned on for all participants, resulting in a series of alerts (via electronic pill
      bottle cap alerts and smartphone push notifications, text message, and/or automated phone
      calls). Participants will continue to receive notifications via the electronic pill bottle
      cap through Visit 4. Throughout the study, participants will undergo a series of blood draws
      and urinalysis collections, and be asked to complete various questionnaires.
    

Intervention name(s): Pillsy
Intervention type(s): Behavioral
Intervention description(s): The electronic pill bottle cap, Pillsy, and its accompanying software application provides reminders to take a scheduled dosage of medication via bottle cap alerts and smartphone push notifications, text messages, and/or automated phone calls. The Pillsy application records dosing dispense date and time when the user opens the bottle. During the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls).
The electronic pill bottle cap, Pillsy, is a commercially available device marketed to consumers. The electronic pill bottle cap does not capture or store PHI. Quick tips on how to use Pillsy can be found at https://www.pillsy.com/instructions
Intervention model: Single Group Assignment
Intervention model description: Open-label, direct-to-family, adherence and exposure-response study of hydroxychloroquine (HCQ) self-administration in pediatric lupus participants with the use of an electronic pill bottle cap that provides automatic dosing reminders
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hydroxychloroquine; virtual trial