Brief Intervention for Medication Overuse Headache (BIMOH)
RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
The investigators will perform a cluster randomised controlled study of Brief intervention (BI) for medication-overuse headache (MOH) versus business as usual. GPs will be trained to perform a structured brief intervention after identifying patients with probable MOH using the severity of dependence scale. The control arm will include patients of GPs who have not been trained in BI. Patients will be recruited by prior short postal screening of patients listed on the GPs patient lists.
The hypothesis is that BI will lead to improvement of medication-overuse and chronic headache as compared to no BI.
Main outcomes are:
- number of medication days per month
- number of headache days per month
- headache index
調査の概要
状態
詳細な説明
123 cases in all included (75 in intervention/placebo control arms and 48 in non-intervention Control arms) 19 did not meet predefined inclusion criteria for the different arms (5 and 8 in intervention arm and placebo arm respectively, 4 and 2 in chronic headache Control and population Control respectively)
1 case was lost to follow up in each of the 4 Groups prior to first assessment. Thus 60 cases remained in intervention/placebo Control arms (24 in intervention and 36 in placebo Control) and 40 in non intervention Control arms (15 chronic headache Controls, 25 population Controls).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Lørenskog、ノルウェー
- Akershus University Hospital
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Oslo、ノルウェー
- Dept of general medicine, University of Oslo
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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
説明
Inclusion Criteria:
- 18-50 years of age
- Screening positive for possible chronic headache (> 10 headache days per month) (not for population control arm)
- Screening positive for possible medication-overuse (> 15 medication days per month) (not for chronic headache control arm)
Exclusion Criteria:
- Other complicating pain with medication treatment
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Brief intervention
Behavioural brief intervention delivered by GP
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Structured behavioural Brief intervention given by trained GPs
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|
プラセボコンパレーター：Business as usual
Business as usual according to individual GP
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GPs to treat patient as they have until now based on best established practice
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他の：Chronic headache control
Screening and outcome control only.
Non-intervention Control, screened and followed-up at final time point
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No additional intervention
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他の：Population control
Screening and outcome control only.
Non-intervention Control, screened and followed-up at final time point
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No additional intervention
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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 |
時間枠 |
|---|---|
|
Number of medication days per month
時間枠：3 months
|
3 months
|
|
Number of headache days per month
時間枠：3 months
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3 months
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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 |
|---|---|---|
|
生活の質
時間枠：3ヶ月
|
3ヶ月
|
|
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Proportion significantly improved
時間枠：3 month
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proportion improved >50% and >25% in terms of no headache days/month
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3 month
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Headache medication days per month (diary reported)
時間枠：3 months
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3 months
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Headache days/month (diary reported)
時間枠：3 months
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3 months
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|
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Average headache intensity (VAS)
時間枠：3 months
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3 months
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|
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Self-reported health related costs
時間枠：3 months
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3 months
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Long term follow up of same outcomes as above plus relapse rate
時間枠：12 months
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12 months
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Headache index
時間枠：3 months
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Headache intensity x frequency x duration
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3 months
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Follow up of same outcomes as for 3 months
時間枠：6 months
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Added extra time point due to cross over of non-treated patients into intervention Group if intervention was positive at 3 months.
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6 months
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協力者と研究者
捜査官
- 主任研究者：Christofer Lundqvist, MD, PhD、Akershus University Hospital and University of Oslo
出版物と役立つリンク
一般刊行物
- Lundqvist C, Gossop M, Russell MB, Straand J, Kristoffersen ES. Severity of Analgesic Dependence and Medication-overuse Headache. J Addict Med. 2019 Sep/Oct;13(5):346-353. doi: 10.1097/ADM.0000000000000504.
- Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Predictors of successful primary care detoxification treatment for medication-overuse headache. Acta Neurol Scand. 2017 Nov;136(5):486-494. doi: 10.1111/ane.12759. Epub 2017 Mar 28.
- Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention by general practitioners for medication-overuse headache, follow-up after 6 months: a pragmatic cluster-randomised controlled trial. J Neurol. 2016 Feb;263(2):344-353. doi: 10.1007/s00415-015-7975-1. Epub 2015 Dec 8.
- Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Disability, anxiety and depression in patients with medication-overuse headache in primary care - the BIMOH study. Eur J Neurol. 2016 Jan;23 Suppl 1:28-35. doi: 10.1111/ene.12850.
- Kristoffersen ES, Straand J, Vetvik KG, Benth JS, Russell MB, Lundqvist C. Brief intervention for medication-overuse headache in primary care. The BIMOH study: a double-blind pragmatic cluster randomised parallel controlled trial. J Neurol Neurosurg Psychiatry. 2015 May;86(5):505-12. doi: 10.1136/jnnp-2014-308548. Epub 2014 Aug 11.
- Kristoffersen ES, Straand J, Benth JS, Russell MB, Lundqvist C. Study protocol: brief intervention for medication overuse headache--a double-blinded cluster randomised parallel controlled trial in primary care. BMC Neurol. 2012 Aug 10;12:70. doi: 10.1186/1471-2377-12-70.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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。
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