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临床试验/NCT03559088
NCT03559088已完成不适用

Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting

Eli Lilly and Company16 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
16
主要终点
Number of Participants Receiving a Preventive Migraine Prescription

研究概览

简要总结

The purpose of this study is to determine whether using a smart phone application to foster communication between study participants and their doctor will impact care. Participants must have a history of migraine or have recently been prescribed a common medicine to treat migraine. The study will last about one year for each participant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have a diagnosis of migraine (ICD10: G43.*) since October 2015 OR a record of being prescribed a triptan prior to study
  • •Have not been prescribed a preventive migraine medication within the past twelve months
  • •Have not visited a neurologist in the past year
  • •Have an upcoming visit with their Atrium Health primary care provider

排除标准

  • •Do not own an iOS or Android smart phone with a data plan or are unwilling to install the app on their phone
  • •Are currently participating in a clinical trial involving an investigational drug
  • •Have previously used the app used in this study
  • •Are pregnant at the time of study entry
  • •Are not able to provide informed consent
  • •Cannot speak and read English fluently

研究组 & 干预措施

Migraine Participants Using Application (App)

Experimental

Participants with migraine history or a recent prescription for a common migraine medication will use a migraine app linked to their electronic health record (EHR) with results reported in their EHR.

干预措施: Migraine App (Other)

Controls Not Using App

No Intervention

Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.

结局指标

主要结局

Number of Participants Receiving a Preventive Migraine Prescription

时间窗: Next primary care appointment following use of app (estimated as 5 weeks)

Number of Participants Receiving a Preventive Migraine Prescription

次要结局

  • Number of Referrals to a Neurologist(Baseline through one year)
  • Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates(Baseline through one year)
  • Number of Months of App Use(Baseline through one year)
  • Number of Emergency Room Visits(Baseline through one year)
  • Number of Urgent Care Visits(Baseline through one year)
  • Number of Primary Care Visits(Baseline through one year)
  • Number of Acute Care Visits(Baseline through one year)
  • Number of New Diagnoses of Migraine or Chronic Migraine(Baseline through one year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (16)

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