Facilitating Migraine Medication Adherence and Optimizing Medication Use
Examining Feasibility and Effectiveness of an Internet-based Intervention for Facilitating Migraine Medication Adherence and Optimizing Medication Use
研究概览
详细说明
Objective 1. To examine the feasibility and user usage patterns/demand of an online intervention designed to enhance adherence and optimize abortive medication-use for migraineurs.
Goal 1: To evaluate the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence and optimize abortive medication use.
Hypothesis 1A: That an Internet-based user environment can be appropriately suited to deliver an adherence intervention that, in turn, could be made widely accessible and readily employed.
Hypothesis 1B: That a high proportion of patients referred to the adherence facilitation Web site will actually visit and make use of the adherence intervention Web site.
Hypothesis 1C: That once the Web-based intervention is initiated, a low attrition rate will be observed and the majority of patients will complete the intervention.
Objective 2. To examine the efficacy of an online adherence facilitation and medication optimization intervention in increasing knowledge of optimal abortive medication-use.
Goal 2: To conduct a pilot trial examining the efficacy of an adherence and medication optimization intervention for improving knowledge and medication-use behavior in a wide range of migraine sufferers.
Hypothesis 2A: That patients who complete the Web-based intervention will demonstrate improved knowledge of optimal abortive medication strategies at post-treatment and this knowledge will be maintained at follow-up.
Hypothesis 2B: That patients who complete the Web-based intervention will report improved abortive medication use strategies at post-treatment and this behavior change will be maintained at follow-up.
研究类型
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria
- Adults >= 18 year-old
- Any self-reported headache disorder, from any etiology ( > 5 attacks, lifetime)
Self-reported use of any headache abortive treatment:
- Over the counter (e.g., Ibuprofen, naproxen sodium, Excedrin, etc.)
- Prescription (Triptans, CGRP antagonist, Ibuprofen, etc.)
Exclusion Criteria
- Inability to read and write English (the questionnaires are exclusively in English)
- Inability to accurately complete questionnaire or provide informed consent: (e.g., Florid psychosis, Current intoxication)
- No internet access
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Online MigraineTreatment Optimization
After providing informed consent, participants will complete a series of questionnaires related to their headaches and medication beliefs.
After completion, they will have full access to an informational website including access to text-based supplemental materials pertaining to headache and headache treatment, and a series of videos designed specifically for this trial.
Participants will be asked to watch seven videos of approximately four-minute length each and to complete a post-assessment question following the completion of each of the first 6 videos.
The total time required to complete all study activities will be approximately one hour.
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The educational videos entail a young woman (i.e., an actress) describing her experiences in managing her headaches. The informational content of the videos is organized into 7 content areas that present a wealth of information in an entertaining way:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility assessed by the practical utility of an Internet-based user environment to host an intervention designed to increase knowledge of and facilitate adherence to abortive medication use guidelines.
大体时间：Post-intervention, at the end of the 1 week study period
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Feasibility will be demonstrated based on the number of participants who complete the online videos.
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Post-intervention, at the end of the 1 week study period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Attrition assessed by the rate of attrition from the study, determined based upon the number of enrolled participants who do not complete the online video portion.
大体时间：Post-intervention, at the end of the 1 week study period
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Attrition assessed by the rate of attrition from the study, determined based upon the number of enrolled participants who do not complete the online video portion.
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Post-intervention, at the end of the 1 week study period
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合作者和调查者
调查人员
- 首席研究员：Donald B Penzien, PhD、WakeForest School of Medicine
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.