A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting

Conditions
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Migraine

Intervention / Treatment
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* Other: Migraine App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine Participants Using Application (App)<br>Participants with migraine history or a recent prescription for a common migraine medication will use a migraine app linked to their electronic health record (EHR) with results reported in their EHR. | Other: Migraine App<br>* Smart phone app used to report migraine burden to the EHR.<br>|
| No Intervention: Controls Not Using App<br>Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Receiving a Preventive Migraine Prescription | Number of Participants Receiving a Preventive Migraine Prescription | Next primary care appointment following use of app (estimated as 5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Months of App Use | Number of Months of App Use | Baseline through one year | 
| Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates | Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates | Baseline through one year | 
| Number of Acute Care Visits | Number of Acute Care Visits | Baseline through one year | 
| Number of Primary Care Visits | Number of Primary Care Visits | Baseline through one year | 
| Number of Emergency Room Visits | Number of Emergency Room Visits | Baseline through one year | 
| Number of Urgent Care Visits | Number of Urgent Care Visits | Baseline through one year | 
| Number of Referrals to a Neurologist | Number of Referrals to a Neurologist | Baseline through one year | 
| Number of New Diagnoses of Migraine or Chronic Migraine | Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system | Baseline through one year |