Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Clinical Decision Support Tool
Tailored education provided via a smartphone application
  • Behavioral: Clinical Decision Support Tool
    Tailored education provided via a smartphone application.
Active Comparator
Headache Education
Non-tailored education provided via a smartphone application.
  • Behavioral: Headache Education
    Non-tailored education provided via a smartphone application.

Recruiting Locations

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Elizabeth Seng, PhD
718-430-1855
Elizabeth.Seng@einstein.yu.edu

More Details

Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Elizabeth Seng, Ph.D.
646-592-4368
eseng@montefiore.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.