Individual Patient Exposure and Response in Pediatric Lupus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in proportion of dispensed doses from the first two weeks (baseline) to last two weeks of study (device use)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form and assent, when necessary
- •Age 5-17.5 years at consent
- •Enrolled in the CARRA Registry with a diagnosis of systemic lupus erythematosus as documented in the CARRA Registry
- •Receiving hydroxychloroquine as standard of care for ≥ 3 months
- •Participant and Caregiver primary language of English
- •Willing and able to comply with study procedures, at the discretion of the study principal investigator
- •Access to internet
排除标准
- •There are no pre-defined exclusion criterion for this trial.
结局指标
主要结局
Change in proportion of dispensed doses from the first two weeks (baseline) to last two weeks of study (device use)
时间窗: Days 1-14 compared to days 166-180 (+/- 30)
The Pillsy device will record the number of dispensed doses
次要结局
- Adherence to hydroxychloroquine using manual pill counts(Up to 6 months)
- Adherence to hydroxychloroquine using electronic pill counts(Up to 6 months)
- Adherence to hydroxychloroquine using the Medication Adherence Self-Reported Inventory (MASRI) score(Up to 6 months)
- Adherence to hydroxychloroquine using plasma drug levels(Up to 6 months)
- Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score collected through a remote teleresearch exam(Up to 2 months)
- Disease activity as measured by the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score recorded in the CARRA Registry(Up to 6 months)
- Disease activity as measured by Systemic Lupus Activity Questionnaire (SLAQ) score(Up to 6 months)