Brief Summary
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.
Brief Title
Clinical Decision Support for Patient Migraine Management
Detailed Description
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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
Exclusion Criteria:
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT03706794
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-5743
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Clinical Decision Support for Patient Migraine Management
Primary Outcomes
Outcome Description
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.
Outcome Measure
Adherence to Acute Migraine Management Strategies: Treat Early
Outcome Time Frame
Month 6 of the Treatment
Outcome Description
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.
Outcome Measure
Adherence to Acute Migraine Management Strategies: Overuse
Outcome Time Frame
Month 6 of the Treatment
Outcome Description
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.
Outcome Measure
Adherence to Preventive Behavioral Strategies
Outcome Time Frame
Month 6 of the Treatment
Outcome Description
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.
Outcome Measure
Adherence to Preventive Medication
Outcome Time Frame
Month 6 of the Treatment
Secondary Ids
Secondary Id
1K23NS096107-01
Secondary Outcomes
Outcome Description
Participants recorded headaches in their electronic daily headache diary. The median number of headache days/month during Month 6 was summarized and reported.
Outcome Time Frame
Month 6 of the Treatment
Outcome Measure
Headache Days
Outcome Description
Headache pain intensity was recorded in an electronic daily headache diary. If a headache was confirmed, the average one-month headache pain intensity was assessed on a 0-10 scale, where 0 indicated no pain and 10 indicated the worst pain imaginable. The median headache pain intensity during Month 6 was summarized and reported.
Outcome Time Frame
Month 6 of the Treatment
Outcome Measure
Headache Pain Intensity
Outcome Description
Migraine Disability Assessment (MIDAS) is a 5-item questionnaire used to measure migraine-related functional impairment. The survey queries as to the number of lost days of housework, job-work, and non-work activities over the prior 90-day period. Each item is an open entry allowing for input of the number of days lost over the prior 90 days. Total score ranges from 0 - 270, with higher scores indicate higher degrees of impairment/disability. Scores of 21 and above are considered "severe" levels of migraine-related disability. Group median MIDAS scores collected at Month 6 were summarized and reported.
Outcome Time Frame
Month 6 of the Treatment
Outcome Measure
Migraine-Related Disability
Outcome Description
The Migraine-Specific Quality of Life (MSQL) questionnaire (v2.1), a 14-item survey, was used to measure migraine-related quality of life. Responses on the MSQL assessed the effect on migraines on daily activity over the prior 4 weeks and were scored from 1 ("None of the Time") to 6 ("All of the Time"), for an overall total scoring range of 14-84. Higher scores indicated lower migraine-related quality of life. Group median MSQL scores at Month 6 were summarized and reported.
Outcome Time Frame
Month 6 of the Treatment
Outcome Measure
Migraine-Specific Quality of Life
Outcome Description
Pain Interference was evaluated using v1.0 of the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference (PI) Short Form (PROMIS-PI). PROMIS-PI is an 8-item survey which evaluates the self-reported consequences of pain on aspects of daily life activities and enjoyment of life over the past 7 days. Possible response options ranged from 1 ("Not at all") to 5 ("Very Much"). Raw scores were converted to T-scores using population norms with a mean of 50 and a standard deviation of 15 such that a Pain Interference score of 65 would be one SD worse than average, such that a person has more problems with pain hindering activities, and a pain interference score of 35 is one SD better than the average.
Outcome Time Frame
Month 6 of the Treatment
Outcome Measure
Pain Interference
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Elizabeth Seng
Investigator Email
elizabeth.seng@einsteinmed.org
Investigator Phone