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
연구 개요
상태
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Lørenskog, 노르웨이
- Akershus University Hospital
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Oslo, 노르웨이
- Dept of general medicine, University of Oslo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Brief intervention
Behavioural brief intervention delivered by GP
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Structured behavioural Brief intervention given by trained GPs
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위약 비교기: 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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다른: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Number of medication days per month
기간: 3 months
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3 months
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Number of headache days per month
기간: 3 months
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
삶의 질
기간: 3 개월
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3 개월
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Proportion significantly improved
기간: 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)
기간: 3 months
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3 months
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Headache days/month (diary reported)
기간: 3 months
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3 months
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Average headache intensity (VAS)
기간: 3 months
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3 months
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Self-reported health related costs
기간: 3 months
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3 months
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Long term follow up of same outcomes as above plus relapse rate
기간: 12 months
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12 months
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Headache index
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Christofer Lundqvist, MD, PhD, Akershus University Hospital and University of Oslo
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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