Optimizing Measurement of Anticoagulation Adherence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measure adherence via electronic adherence monitoring device (EAMD)
研究概览
简要总结
Single center study to evaluate the feasibility of using 3 different strategies to measure adherence among children, adolescents, and young adults prescribed an anticoagulation medication
详细描述
This is an observational study with a maximum of 5 study visits during the 12-week study period. The study visit schedule has been designed to align with current clinical care practices. Adherence will be assessed via the EAMDs device, as well as by self-report measure in the BAT and by staff telephone inquiry regarding pharmacy refill data. Adherence data will be used to compute rates and trajectories of adherence to anticoagulants.
It is anticipated that this study will conclude in approximately 2 years, including data analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticoagulated CCHMC patients ages 0 to 29.9 years and their caregivers (where applicable for patients < 18 years)
- •Able to provide informed consent
- •Duration of anticoagulation planned for the outpatient setting is 4 weeks or longer
- •Willing and able to participate in telephone and in person study visits
- •For patients < 18 years, both patient and caregiver agree to participate
排除标准
- •Unwilling or unable to provide informed consent
- •Duration of anticoagulation is planned for < 4 weeks in the outpatient setting
- •Anticoagulant drug will not fit into the EAMD
- •Unable to participate in telephone study visit
结局指标
主要结局
Measure adherence via electronic adherence monitoring device (EAMD)
时间窗: 12 weeks
Participants will be provided with a MEMS® Cap if they are prescribed an oral medication and a MEMS® Injectable if they are prescribed an injectable medication. Patients and families will then be trained by study nurse coordinator (NC) or principal investigator (PI) regarding how to use the MEMS® for medication administration throughout the study.
次要结局
- Self-reported barriers to adherence.(12 weeks)
- Rate barriers to adherence.(12 weeks)