NCT03559088CompletedNot Applicable
Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 120
- Locations
- 32
- Primary Endpoint
- Number of Participants Receiving a Preventive Migraine Prescription
Study Overview
Brief Summary
The purpose of this study is to determine whether using a smart phone application to foster communication between study participants and their doctor will impact care. Participants must have a history of migraine or have recently been prescribed a common medicine to treat migraine. The study will last about one year for each participant.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a diagnosis of migraine (ICD10: G43.*) since October 2015 OR a record of being prescribed a triptan prior to study
- •Have not been prescribed a preventive migraine medication within the past twelve months
- •Have not visited a neurologist in the past year
- •Have an upcoming visit with their Atrium Health primary care provider
Exclusion Criteria
- •Do not own an iOS or Android smart phone with a data plan or are unwilling to install the app on their phone
- •Are currently participating in a clinical trial involving an investigational drug
- •Have previously used the app used in this study
- •Are pregnant at the time of study entry
- •Are not able to provide informed consent
- •Cannot speak and read English fluently
Outcomes
Primary Outcomes
Number of Participants Receiving a Preventive Migraine Prescription
Time Frame: Next primary care appointment following use of app (estimated as 5 weeks)
Number of Participants Receiving a Preventive Migraine Prescription
Secondary Outcomes
- Number of Referrals to a Neurologist(Baseline through one year)
- Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates(Baseline through one year)
- Number of Months of App Use(Baseline through one year)
- Number of Emergency Room Visits(Baseline through one year)
- Number of Urgent Care Visits(Baseline through one year)
- Number of Primary Care Visits(Baseline through one year)
- Number of Acute Care Visits(Baseline through one year)
- Number of New Diagnoses of Migraine or Chronic Migraine(Baseline through one year)
Investigators
Study Sites (32)
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