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临床试验/NCT06232603
NCT06232603终止不适用

Assessing Medication Adherence in Patients With Chronic Recurrent Multifocal Osteomyelitis

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
Medication possession ratio (MPR)

研究概览

简要总结

This project aims to quantify and evaluate rates of non-adherence and barriers to medication adherence in pediatric patients with CRMO followed at Seattle Children's Hospital's robust CRMO program, which is the only clinical program in the Washington, Wyoming, Alaska, Montana, Idaho (WWAMI) region. This will be a stepped-wedge cluster-randomized trial, in which participants will be randomly assigned to one of two groups -- one which receives educational materials at the end of their first clinic visit, and the other which receives educational materials at the end of their second clinic visit. All participants will be given baseline surveys at the start of their first clinic visit, as well as follow-up surveys at the start of their second and third clinic visits. These surveys aim to evaluate rates of non-adherence and qualitative barriers to adherence, as well as efficacy of educational interventions in improving adherence rates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of CRMO
  • Receives clinical care at Seattle Children's Hospital
  • On one or more scheduled prescription medications

排除标准

  • 未提供

结局指标

主要结局

Medication possession ratio (MPR)

时间窗: 6 to 9 months

The MPR is reported as a percentage calculated as: (total prescription days of supply/ (last prescription date - the first prescription date)). For example, if a patient only filled a one-month prescription twice during 6 months, so only had 60 days of medications available during the 6 months, the MPR would be 33%. A MPR of ≥0.8 is generally accepted as good compliance. The MPR data will be calculated for T0 and T1. In order to capture adequate data to calculate the MPR, refill data was acquired for 3 months prior to the beginning of the study (MPR T0) and for 3 months after T1 (MPR T1).

次要结局

  • Barriers to adherence(6-9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongdong (Dan) Zhao

Associate professor, attending physician

Seattle Children's Hospital

研究点 (2)

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