Clinical Decision Support for Patient Migraine Management

  • STATUS
    Recruiting
  • End date
    Aug 28, 2022
  • participants needed
    120
  • sponsor
    Albert Einstein College of Medicine
Updated on 7 October 2021
headache
acute treatment
triptan
acute migraine

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.

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.

Details
Condition Migraine, Primary Stabbing Headache, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines
Treatment Clinical Decision Support Tool, Headache Education
Clinical Study IdentifierNCT03706794
SponsorAlbert Einstein College of Medicine
Last Modified on7 October 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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