A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care
- Conditions
- Migraine
- Interventions
- Other: Migraine App
- Registration Number
- NCT03559088
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Migraine Participants Using Application (App) Migraine App 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.
- Primary Outcome Measures
Name Time Method Number of Participants Receiving a Preventive Migraine Prescription Next primary care appointment following use of app (estimated as 5 weeks) Number of Participants Receiving a Preventive Migraine Prescription
- Secondary Outcome Measures
Name Time Method Number of Referrals to a Neurologist Baseline through one year Number of Referrals to a Neurologist
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates Baseline through one year Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Number of Months of App Use Baseline through one year Number of Months of App Use
Number of Emergency Room Visits Baseline through one year Number of Emergency Room Visits
Number of Urgent Care Visits Baseline through one year Number of Urgent Care Visits
Number of Primary Care Visits Baseline through one year Number of Primary Care Visits
Number of Acute Care Visits Baseline through one year Number of Acute Care Visits
Number of New Diagnoses of Migraine or Chronic Migraine Baseline through one year Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system
Trial Locations
- Locations (16)
Shiland Family Fort Mill
🇺🇸Fort Mill, South Carolina, United States
Charlotte Internal Medicine
🇺🇸Charlotte, North Carolina, United States
Charlotte Medical Clinic
🇺🇸Charlotte, North Carolina, United States
Carmel Family Physicians
🇺🇸Charlotte, North Carolina, United States
Randolph Internal Medicine
🇺🇸Charlotte, North Carolina, United States
Charlotte Medical Clinic-South Park
🇺🇸Charlotte, North Carolina, United States
South Charlotte Primary Care
🇺🇸Charlotte, North Carolina, United States
Table Rock Family Medicine
🇺🇸Glen Alpine, North Carolina, United States
Mecklenburg Medical Group - Ballantyne
🇺🇸Charlotte, North Carolina, United States
Mecklenburg Medical Group - Matthews
🇺🇸Matthews, North Carolina, United States
Mecklenburg Medical Group - Northcross
🇺🇸Huntersville, North Carolina, United States
Union Family Practice
🇺🇸Monroe, North Carolina, United States
Troy Medical Services
🇺🇸Troy, North Carolina, United States
North Charlotte Medical Specialists - Huntersville
🇺🇸Huntersville, North Carolina, United States
Lincoln Family Practice
🇺🇸Lincolnton, North Carolina, United States
Shiland Family Practice
🇺🇸Fort Mill, South Carolina, United States