Clinical Decision Support for Patient Migraine Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Adherence to Acute Migraine Management Strategies: Overuse
研究概览
简要总结
Little is known about who adheres to migraine management strategies, and circumstances that enhance adherence. This knowledge is required to develop patient-level interventions to improve adherence to migraine management strategies. The proposed project will pilot the first patient level intervention designed to improve adherence to preventive and acute migraine management strategies. The study will identify people most at risk for non-adherence to migraine management strategies. Participants will be randomly assigned to receive a tailored clinical decision support tool or education intervention.
详细描述
Participants with a diagnosis with migraine who currently meet criteria for episodic migraine (migraine with headaches that occur on fewer than 15 days per month) will be recruited from local providers. After an initial screening, eligible participants will complete 30 days of monitoring 3 times daily on an electronic headache diary (a smartphone app) to confirm study eligibility. Participants whose eligibility is confirmed will complete an additional 2 months (60 days) of monitoring headache activity and adherence to acute and preventive (medication and behavioral) strategies recommended for people with migraine. Participants who show suboptimal adherence during the first 3 months of monitoring (<50% of eligible days) will be eligible to continue to the intervention component of the study. Participants who choose to continue in the study will be randomized to receive a tailored clinical decision support tool or education intervention, both delivered through the smartphone app. Participants will continue to self-monitor, with the intervention components active, for 3 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be informed that they will receive one of two educational interventions. The "care provider" is a smartphone application; the only person aware of the condition is the research assistant assigning participants to the smartphone application conditions. The investigator, research coordinator, and all other personnel including outcomes assessors will be unaware of condition.
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
- •Have an International Classification of Headache Disorders - 3 beta diagnosis of migraine
- •Self-report and diary-confirmed 6 to 14 headache days per month
- •Are currently prescribed a triptan for acute migraine management
- •Are stable on current preventive and acute treatment regimen for migraine
- •Are between the ages of 18 and 65
- •Reads and understands English
- •Has capacity to consent
- •Completes 80% of diary recordings in the first 30 days of monitoring
排除标准
- •Probable or confirmed medication overuse headache
- •A plan to change, or changing preventive or acute migraine medication during study participation
- •Are pregnant or are planning to become pregnant during study involvement (as triptans are Category C medications)
- •Psychiatric illness or cognitive difficulties that would interfere with participation in the study
- •Participated in the pilot development of the intervention evaluated by this research protocol.
结局指标
主要结局
Adherence to Acute Migraine Management Strategies: Overuse
时间窗: Month 6 of the Treatment
Overuse is considered taking Migraine Specific Medication (MSM) more than 10 times in a month or a Nonsteroidal Anti-Inflammatory drug (NSAID) (non-combination) 15 or more times per month. The number of participants who met the definition of overuse during Month 6 is summarized and reported by study arm/group.
Adherence to Acute Migraine Management Strategies: Treat Early
时间窗: Month 6 of the Treatment
Participants record headache activity in an electronic daily headache diary and if experiencing a headache were asked about the type of headache and the level of pain experienced when they took the Migraine Specific Medication (MSM). A headache episode is coded as "Treat Early" if a participant took the MSM when the pain was mild (as opposed to moderate or severe). The number of participants who were "Treated early" during Month 6 is reported by study arm/group.
Adherence to Preventive Behavioral Strategies
时间窗: Month 6 of the Treatment
Adherence to Preventive Behavioral Strategies is determined by the mean number of documented adherent days/month for a single preventive behavioral strategy, either stress management, sleep management, or consistent eating. The behavioral strategy was selected by the investigator and determined as the strategy with which the participant had the poorest adherence during the baseline run in period. Preventive Behavioral Strategies were evaluated daily in the electronic headache diary. Adherence to one of the aforementioned Preventive Behavioral Strategies during Month 6 is reported.
Adherence to Preventive Medication
时间窗: Month 6 of the Treatment
If a participant was taking a preventive medication, adherence to preventive medication was assessed as the number of days/month participants took their preventive medication as recorded in the electronic daily headache diary. Taking preventive medication = Adherent, Not taking preventive medication = Not-adherent. The mean number of "Adherent" days/month in Month 6 are reported.
次要结局
- Headache Days(Month 6 of the Treatment)
- Headache Pain Intensity(Month 6 of the Treatment)
- Migraine-Related Disability(Month 6 of the Treatment)
- Migraine-Specific Quality of Life(Month 6 of the Treatment)
- Pain Interference(Month 6 of the Treatment)
研究者
Elizabeth Seng
Research Assistant Professor of Neurology
Albert Einstein College of Medicine