Evaluation of Satisfaction With Rimegepant and Triptans Utilizing Migraine Buddy Retrospective Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,536
- 试验地点
- 1
- 主要终点
- Number of Participants Classified as Per Responses for Satisfaction of Pain Intensity
研究概览
简要总结
The purpose of this study is to collect information of the US users from the Migraine Buddy app between 20 October 2023 and 20 May 2024. Patients who used Nurtec and/or triptans as an acute treatment for migraine, with or without a background of preventive treatment (anti-CGRP, Botox or oral migraine preventive medications) and completed a survey were eligible for this study. Acute treatment is a short-term treatment. The aim of this retrospective analysis was to learn about the user´s satisfaction with Nurtec or the triptan. The level of satisfaction with Nurtec will be compared to the level of satisfaction with triptans. The benefit of this study is the real-life setting of the information collected. This means that the users were using the Migraine Buddy app for tracking their migraines in real life.
详细描述
This study will utilize retrospective data collected with the Migraine Buddy Mobile application to evaluate satisfaction of treatment with rimegepant and triptans. The study population for this study is Migraine Buddy users in the US who answered a survey about their acute treatments, displayed on the home page of the app. It generates reports that users can share with their doctors to help them establish a diagnosis and/or optimize treatment. For this retrospective study, only questions related to treatment satisfaction will be analyzed.
Users complete the satisfaction questions only once for each current acute migraine treatment. If a patient is using more than one acute treatment, they will be able to complete satisfaction questions for each acute treatment. Approximately two-thirds of the app users are currently using both rimegepant and triptans to acutely treat their migraine attacks. Questions are worded such that they ask specifically about the acute treatment e.g., Nurtec. For the surveys used in the 7-month time frame of this retrospective study, feasibility assessment showed that participants answered the satisfaction questions for a specific acute medication only once, in 97% of the cases. For the few users who responded to 2 or more waves of identical surveys, the most recent answer will be used for the analysis.
Data was gathered between October 20, 2023 & May 20, 2024, from users of the Migraine Buddy app through the "diary tracking" and the satisfaction questions were administered via survey and via the interactive data collection tool named "Taylor". All the data will be extracted from the Aptar Digital Health (ADH) platform existing database to perform the analysis described in this protocol.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who used Nurtec and/or triptans as an acute treatment for migraine, with or without a background of preventive treatment (anti-CGRP, Botox or oral migraine preventive medications).
- •Male or female participants with migraine
- •Having consented to the anonymous use of their data for research
- •Currently using Nurtec and/or triptans to treat migraine attacks
排除标准
- •Users who did not report using either medication for which they complete the survey within 60 days prior to the survey.
结局指标
主要结局
Number of Participants Classified as Per Responses for Satisfaction of Pain Intensity
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction with treatment for pain intensity using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With of Attack Duration
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction with of attack duration using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Speed of Action
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction with speed of action using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Migraine-Induced Cognitive Impact
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction with migraine-Induced cognitive impact using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
Number of Participants Classified as Per Responses for Satisfaction With Relief of Other Symptoms
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction with relief of other symptoms using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment. Other symptoms included following parameters: photophobia, phonophobia, nausea, vomiting, sensitivity to light/sound/odors).
Number of Participants Classified as Per Responses for Satisfaction of Tolerability
时间窗: Up to 60 days post last usage of treatment (from retrospective data collection period of 7 months); available retrospective data was evaluated in this observational study of a single day
Participants responded about satisfaction of tolerability using following responses: extremely satisfied, satisfied, slightly satisfied, neither satisfied nor dissatisfied, slightly dissatisfied, dissatisfied, extremely dissatisfied. Based on participants responses, the respondents were grouped into those who were satisfied (reported extremely satisfied/ satisfied/ slightly satisfied), neutral (reported neither satisfied nor dissatisfied) or dissatisfied (reported slightly dissatisfied/ dissatisfied/ extremely dissatisfied) with the treatment.
次要结局
未报告次要终点