Improving Health Outcomes of Migraine Patients Who Present to the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in Migraine Disability Assessment Scale (MIDAS) Score
研究概览
简要总结
This is a pilot feasibility acceptability study to examine the impact of smartphone-based progressive muscle relaxation (PMR) on migraine quality of life, frequency, intensity, and disability. Feasibility is measured by: a) Proportion of patients who enrolled in the study/were recruited for the study, b) Number of days PMR practiced/week as determined with the backend analytics in the RELAXaHEAD app, c) Minutes/day spent doing PMR, d) Reasons for non-adherence. Acceptability is measured by: a) Satisfaction using Likert scale questions on RELAXaHEAD usability, content, and functionality b) Willingness to repeat a similar treatment intervention in the future (Definitely No/Probably No/Unsure/Probably Yes/ Definitely Yes) c) Attrition. In addition, whether use of electronically based PMR introduced in the emergency department (ED) improves migraine quality of life (MSQv2) and migraine related disability (MIDAS) at 3 months post ED-discharge (or post enrollment date if recruited post ED discharge) compared to those who are not introduced to PMR will be assessed. All participants will be asked to track their headache frequency and intensity using our smartphone application (app) and will be asked to complete migraine quality of life assessments and migraine related disability at follow-up.
详细描述
While explaining the study, potential participants will be assured that they will receive all of the medication for their acute headache that they would otherwise receive. Once consented, participants will be randomized to PMR therapy or monitored usual care (MUC). Participants will be told that either group is being tested as an enhancement to the care they typically get in the ED for headache. (At the end, they will be informed which group they were in.) The study team will collect participants' health histories (biologic variables) and baseline data in REDCap, download the app onto subjects' smartphones, and conduct the sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets migraine criteria and has 4+ headache days a month
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
- •Unable or unwilling to follow a treatment program that relies on written and audio recorded materials
- •Not having a smartphone
结局指标
主要结局
Change in Migraine Disability Assessment Scale (MIDAS) Score
时间窗: Baseline, Month 3 Post-Discharge
5-item self-administered questionnaire designed to quantify headache-related disability over a 3-month period. For each item, participants indicate the number of days over the past three months that migraine limited their ability to participant in specific activities. The score is the sum responses. Scores are classified as follows: * 0 to 5 = Little or no disability (MIDAS Grade I) * 6 to 10 = Mild disability (MIDAS Grade II) * 11 to 20 = Moderate disability (MIDAS Grade III) * 21-40 = Severe disability (MIDAS Grade IV-A) * Greater than 40 = Very severe disability (MIDAS Grade IV-B)
次要结局
- Number of Headache Days Based on MIDAS(Baseline)
- Change in Migraine-Specific Quality of Life Questionnaire-Version 2 (MSQv2) - Role Function Restrictive (RFR) Domain Scores(Baseline, Month 3 Post-Discharge)
- Change in MSQv2 - Emotional Function (EF) Domain Scores(Baseline, Month 3 Post-Discharge)
- Change in MSQv2 - Role Function Preventive (RFP) Domain Scores(Baseline, Month 3 Post-Discharge)