Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
研究概览
简要总结
Collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. The ED is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. Behavioral headache treatments (e.g., progressive muscle relaxation (PMR), biofeedback, cognitive-behavioral therapy (CBT)) are effective migraine treatment options that are essentially free of side effects. PMR has also been successful as a technique that patients can do independently. Studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment.
Several aspects of this study are innovative, including: 1. Initiation of preventive medication in a timely manner for migraineurs who present to the ED. 2. Introduction of PM+PMR in the ED at a time that can serve as a teachable moment. 3. Introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ED setting to reduce headache disability, frequency, and intensity.
详细描述
Investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ED. The intervention (PM+PMR) will combine acute treatment, migraine preventive medication-topiramate, and the APP with PMR. Data from patients in the intervention group will be compared with data from an enhanced usual care (EUC) group to examine the efficacy of the combined treatment effects.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets migraine criteria based on Information in Study Manual or based on Headache expert opinion -4+ migraines a month
- •Migraine Disability Assessment (MIDAS) score >5.
排除标准
- •Patients who have had Cognitive Behavioral Therapy, Biofeedback or other Relaxation Therapy in the past year;
- •Cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; Alcohol or other substance abuse as determined by self-report or prior documentation in the medical record;
- •Opioid or barbiturate use 10+ days a month;
- •PHQ9 score of severe depression;
- •Unable or unwilling to follow a treatment program that relies on written and audio recorded materials;
- •Not having a smartphone.
研究组 & 干预措施
Acute Treatment+ED-initiated preventive medication +PMR
All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy
干预措施: Preventative Medication (PM) (Drug)
Acute Treatment+ED-initiated preventive medication +PMR
All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy
干预措施: Enhanced Usual Care (Behavioral)
Acute Treatment+ED-initiated preventive medication +PMR
All subjects will be discharged on acute migraine therapy (naproxen, triptan) unless there is a contraindication and will also be started on topiramate (25mg/night) with a plan to increase the dose every week by 25 mg up to 100 mg/night. Subjects will receive medicine along with progressive muscle relaxation therapy
干预措施: PMR (progressive muscle relaxation therapy) (Behavioral)
Enhanced Usual Care (EUC)
Subjects will be given a general education session consisting of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently. Any migraine treatment decisions on discharge will be left up to the ED attending. The RC will load the APP onto the subjects' smart phones but the PMR component will be blocked on the version of the APP that they receive. All subjects will be asked to track headache frequency, intensity, and acute medication use on the APP.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Migraine Disability Assessment Scale (MIDAS) at 3 Months and Baseline
时间窗: 12 Weeks
A decrease of 3 points in the MIDAS score corresponds to a one day reduction in headache related disability per month, a clinically meaningful difference.
次要结局
- Perceived Stress Scale (PSS)(12 Weeks)
- Number of days/week treated with acute medications(12 Weeks)
- Number of drug administrations/week for acute medications(12 Weeks)