RCT of Structured Brief Intervention for Medication Overuse Headache Versus Business as Usual
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Number of medication days per month
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Other complicating pain with medication treatment
结局指标
主要结局
Number of medication days per month
时间窗: 3 months
Number of headache days per month
时间窗: 3 months
次要结局
- Quality of life(3 months)
- Proportion significantly improved(3 month)
- Headache medication days per month (diary reported)(3 months)
- Headache days/month (diary reported)(3 months)
- Average headache intensity (VAS)(3 months)
- Self-reported health related costs(3 months)
- Long term follow up of same outcomes as above plus relapse rate(12 months)
- Headache index(3 months)
- Follow up of same outcomes as for 3 months(6 months)
研究者
Christofer Lundqvist
Principal investigator/Project leader
University Hospital, Akershus