DRKS00016328招募中2 期
Smartphone assisted migraine therapy - SMARTGEM
Charité Campus Charité Mitte0 个研究点目标入组 1,200 人开始时间: 2018年12月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 99 Years(—)
- 性别
- All
入选标准
- •First presentation in the headache outpatient department of the Charité Universitätsmedizn Berlin, Universitätsmedizin Rostock or Universitätsklinik Halle
- •- Diagnosis of episodic migraine with at least 5 migraine days / month or chronic migraine with or without aura according to the IHCD-3 criteria
- •- onset of migraine before the age of 50 and lasting for at least a year
- •- Own an Android or iOS enabled smartphone with mobile internet access and basic understanding of apps
- •- Ability and readiness to give a written informed consent
- •- Insured with a statutory health insurance
- •- The M-sense calendar has been completed with a compliance rate of at least 80% in the last 28 days prior to inclusion
- •- The subject documented at least 5 migraine days in the baseline phase with M-sense over a period of 28 days
排除标准
- •Previous use of the M-sense active app more than 14 days
- •Diagnosis of another headache disease besides migraine (all secondary headaches and primary headaches of the ICHD-3 group 3 and 4) Tension-type headaches (ICHD-3 group 2) are allowed, provided they do not account for more than 50% of headache days / month
- •Previous or current drug or alcohol abuse within one year prior to visit (excessive or compulsory use as determined by the study physician)
- •Current use of medication that indicates evidence of abuse or dependency (exception: analgesic or triptan overuse)
- •Taking more than 3 doses / month of opioids or barbiturates
研究者
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