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临床试验/NCT05556564
NCT05556564已完成不适用

The Impact of Migraine on Canadians' Productivity: A Real-World Pharmacy-Based Study

PeriPharm1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
The Migraine Disability Assessment (MIDAS) questionnaire

研究概览

简要总结

This is a cross-sectional, real-world observational, community pharmacy-based study in which adults treated with a triptan for their migraine will self-report productivity and activity impairment using a web-based portal or paper-based questionnaire.

详细描述

The primary objective of this study is to estimate the productivity and activity impairment associated with migraine in adults treated with a triptan.

Participant identification will be made using pharmacies member of the PROxy Network. Eligible participants will be identified using the prescription of any formulation of triptans either when filling or refilling a prescription of a triptan or in the pharmacy electronic database (patients with a renewal in the last 3 months).

The PROxy Network is a research network bringing together community pharmacies across Quebec to facilitate the generation of real-world evidence. This network is designed to better understand a disease or a treatment using patient-reported outcomes (PROs). The PROxy Network is an initiative of PeriPharm Inc., a company specializing in pharmacoeconomics and outcomes research.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

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

入选标准

  • 18 years of age or older;
  • New or current prescription (renewal in the last 3 months) of any formulation of triptans medication (i.e., almotriptan, eletriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan and frovatriptan);
  • Working full or part-time or going to school full or part-time;
  • Ability to read and understand English or French;
  • Signature of informed consent form (ICF).

排除标准

  • Patients participating in a clinical trial.
  • Patients filling a one-time vacation/emergency prescription (i.e. without a complete pharmacy file).

研究组 & 干预措施

No group

干预措施: observational study (Drug)

结局指标

主要结局

The Migraine Disability Assessment (MIDAS) questionnaire

时间窗: Baseline

Patient-reported outcome: The Migraine Disability Assessment (MIDAS) is a 5-item, self-administered questionnaire designed to quantify headache-related disability over the past 3 months. The MIDAS is scored as the sum of five questions, each measured as days in the last 3 months, and then categorized into four disability grades with higher scores indicating greater disability: ''Grade I - Little to no disability'' for 0 to 5 days, ''Grade II - Mild disability'' for 6 to 10 days, ''Grade III - Moderate disability'' for 11 to 20 days and ''Grade IV - Severe disability'' for 21 days and over.

次要结局

未报告次要终点

研究者

发起方
PeriPharm
申办方类型
Other
责任方
Sponsor

研究点 (1)

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