N/A
N=18
Clinical Decision Support for Patient Migraine Management
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03706794 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Adherence to Acute Migraine Management Strategies: Treat Early — 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clinical Decision Support Tool (Behavioral); Headache Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Acute Migraine Management Strategies: Treat Early |
0; 2 | — |
| PRIMARY Adherence to Acute Migraine Management Strategies: Overuse |
0; 1 | — |
| PRIMARY Adherence to Preventive Behavioral Strategies |
10.1; 0.0 | — |
| PRIMARY Adherence to Preventive Medication |
15.0; 12.3 | — |
| SECONDARY Headache Days |
3.4; 4.4 | .829 |
| SECONDARY Headache Pain Intensity |
5.0; 6.0 | .633 |
| SECONDARY Migraine-Related Disability |
18.0; 12.5 | .633 |
| SECONDARY Migraine-Specific Quality of Life |
26.4; 21.6 | .633 |
| SECONDARY Pain Interference |
52.8; 55.8 | .315 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03706794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.