Use of WISE Device Technology to Measure Medication Adherence in Youth With Sickle Cell Disease (SCD): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percent Rate of Consent to Study Participation
研究概览
简要总结
Youth diagnosed with sickle cell disease (SCD) may have difficulty taking medication as prescribed (adherence). Hydroxyurea (HU) is one medication that youth may take to help manage SCD. Electronic adherence monitoring is widely considered the gold standard in objective adherence measurement. These monitors provide continuous, real-time records of medication adherence and reveal problematic behavior patterns, including underdosing, overdosing, delayed dosing, "drug holidays" (i.e. where individuals do not take medications for a specified interval of time), and "white coat" adherence (i.e., a pattern of drug adherence as a function of time where individuals display good adherence immediately before and after clinic attendance with worsening adherence in the period between).
Overall, electronic adherence measures are considered valid, reliable, and accurate, with clear advantages over pharmacy refill records, physician estimates and self-report measures. Currently, only one electronic measure capable of monitoring medications in both pill and liquid form is being manufactured: WisePill and WiseBag. While data are limited regarding its validity and reliability, preliminary data support the use of Wise technology to measure adherence to medication. The current study will determine the Wise device's ability to feasibly measure adherence to liquid and solid form HU medication in a pediatric SCD population.
详细描述
This research study will evaluate HU adherence using an electronic storage device (Wise device) compared to caregiver report, youth report, lab values, and pill-count adherence measures. The investigators will ask participants to store their medication in the Wise device and answer questions about their use of the device during normal clinical care visits.
PRIMARY OBJECTIVE
- To examine feasibility of the WISE device by estimating a) rate of consent to the study, b) rate of WISE device use, c) rate of WISE device failure, and d) the perceived acceptability of using the WISE device, as reported by caregivers and youth.
SECONDARY OBJECTIVE
- To estimate the association between HU adherence as measured by the Wise device, to a) caregiver-report, b) youth-report, c) lab values, d) pill-count, and e) Medication Possession Ratio (MPR) adherence measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of SCD (any genotype).
- •Less than 18 years of age at time of study entry.
- •Currently followed in the St. Jude Children's Research Hospital (SJCRH) SCD clinic.
- •Stable HU dose prescribed (in pill or liquid formulation) for ≥ 6 months without documented hematological toxicity (excluding dose adjustments for weight gain).
- •Lives with their primary caregiver.
- •Anticipated to return to clinic at proposed 4-week or 8-week intervals.
排除标准
- •Primary caregiver and/or youth unable to understand English and/or youth not cognitively intact (known IQ < 70) such that the study questionnaire cannot be understood and completed.
- •Any condition or chronic illness that in the opinion of the PI or Co-I makes participation on the study ill-advised.
结局指标
主要结局
Percent Rate of Consent to Study Participation
时间窗: Baseline
Of the total number of eligible participants, the percent of participants who agree to participate.
Percent Rate of Device Use
时间窗: Two months after baseline
The percent of the total participants who keep medicine in the device during the entire trial period.
Percent Rate of Device Failure
时间窗: Two months after baseline
Percent of devices that failed defined as a device does not register opening as verified by study staff at the time device is returned to the study team.
Acceptability of Using the Wise Device
时间窗: Two months after baseline
Responses by participants and/or caregivers to the Acceptability Questionnaire based on the Likert scale from strongly disagree to strongly agree.
次要结局
- Medication Adherence as Measured by Wise Device Compared to Other Measures of Medication Adherence(Two months after baseline)