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
調査の概要
詳細な説明
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.
研究の種類
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Donald B Penzien, PhD、WakeForest School of Medicine
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。