Clinical trial NCT03706794: Clinical Decision Support for Patient Migraine Management
Official title: Clinical Decision Support for Patient Migraine Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2018-10-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Adherence to Acute Migraine Management Strategies: Treat Early
timeFrame: Month 6 of the Treatment
measure: Adherence to Acute Migraine Management Strategies: Overuse
timeFrame: Month 6 of the Treatment
measure: Adherence to Preventive Behavioral Strategies
timeFrame: Month 6 of the Treatment
measure: Adherence to Preventive Medication
timeFrame: Month 6 of the Treatment
Secondary outcomes:
measure: Headache Days
timeFrame: Month 6 of the Treatment
measure: Headache Pain Intensity
timeFrame: Month 6 of the Treatment
measure: Migraine-Related Disability
timeFrame: Month 6 of the Treatment
measure: Migraine-Specific Quality of Life
timeFrame: Month 6 of the Treatment
measure: Pain Interference
timeFrame: Month 6 of the Treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Elizabeth Seng, PhD
role: PRINCIPAL_INVESTIGATOR
References: