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临床试验/NCT07847554
NCT07847554尚未招募不适用

Assessment of Work Productivity and Activities in Patients With Migraine Using the "WPAI (Work Productivity and Activity Impairment)" Questionnaire: Validity and Reliability Study of the Greek Version

National and Kapodistrian University of Athens1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Greek Version of the Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine)

研究概览

简要总结

Migraine is a common neurological disorder that can substantially impair work productivity and daily functioning through both absenteeism and presenteeism. The Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine) is a brief patient-reported measure designed to assess migraine-related impairment in work and daily activities. Although the questionnaire has demonstrated validity and reliability in other populations, a validated Greek version is currently unavailable. This study aims to evaluate the validity and reliability of the Greek version of the WPAI:Migraine in individuals with episodic or chronic migraine, thereby providing an appropriate tool for assessing migraine-related work productivity and functional impairment in the Greek population.

详细描述

Migraine is one of the most common neurological disorders among working-age individuals worldwide and a major cause of lost work productivity. Migraine attacks not only cause pain and associated symptoms but also lead to work absenteeism, reduced productivity, and limitations in daily activities [1,2]. A study including 31 countries showed that 52% of individuals with at least 4 migraine days per month experienced an overall reduction in work performance due to migraine, and that this was attributable more to presenteeism than absenteeism [3]. The American Migraine Prevalence and Prevention Study reported that the cost of presenteeism was nearly three times that of absenteeism in patients with episodic migraine [4].

The Work Productivity and Activity Impairment Questionnaire (WPAI) is a brief and widely used patient-reported outcome measure that assesses the impact of chronic diseases on work performance. WPAI:Migraine, a migraine-specific version, has been found to be valid and reliable in American and Arabic populations of patients with episodic and chronic migraine [1,5]. International Headache Society (IHS) guidelines for preventive treatment trials in episodic and chronic migraine recommend the use of the WPAI [6,7]. Therefore, it is important to evaluate the impact of migraine not only through clinical parameters but also in terms of productivity and functioning [6,7].

In Greece, migraine studies have been conducted at the population level using pharmacological treatments and assessments. However, with regard to daily life and work productivity, there is currently no validated Greek WPAI:Migraine questionnaire available to assess migraine-related productivity loss. Availability of such a scale for the Greek migraine population is important for clinical applications, health-economics research, and evaluation of treatment outcomes [8,9].

Aim of the study - Hypotheses to be tested The aim of the present study is to investigate the validity and reliability of the Greek version of the WPAI:Migraine questionnaire in individuals with migraine and to determine whether it can be used as a valid and reliable tool for assessing work productivity and functioning in the Greek population.

Hypotheses:

研究设计

研究类型
观察性
观察模型
其他
时间视角
前瞻性

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

  • Diagnosis of migraine
  • Age 18-70 years
  • Ability to understand, read, write, and speak the Greek language

排除标准

  • Presence of a headache disorder other than migraine
  • History of systemic diseases (malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions)

研究组 & 干预措施

Patients with Migraine

结局指标

主要结局

Greek Version of the Work Productivity and Activity Impairment Questionnaire for Migraine (WPAI:Migraine)

时间窗: Baseline and 7-14 days after baseline for test-retest reliability.

The validity and reliability of the Greek version of the WPAI:Migraine will be evaluated in patients with migraine. The questionnaire assesses work productivity and activity impairment over the previous 7 days, including absenteeism, presenteeism, overall work impairment, and activity impairment. Higher percentage scores indicate greater impairment.

次要结局

  • Migraine-Related Disability(Baseline)
  • Headache Impact(Baseline)
  • Migraine-Specific Quality of Life(Baseline)
  • Headache Pain Intensity(Baseline)

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Michalis Kodounis

PhD, Neurologist, Medical Doctor

National and Kapodistrian University of Athens

研究点 (1)

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标识符

NCT 编号
NCT07847554
其他研究编号
Approval Νο: 703, 3-6-2026

日期

首次提交
(8天前)
首次发布
(昨天)
主要完成日期
(8个月后)
研究完成日期
(9个月后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否

Individual participant data (IPD) are not planned to be made publicly available. Data may be considered for sharing upon reasonable request and subject to applicable ethical and institutional requirements.

是否有结果
否

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