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

Not Applicable
Completed
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
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Migraine Participants Using Application (App)Migraine AppParticipants 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
NameTimeMethod
Number of Participants Receiving a Preventive Migraine PrescriptionNext primary care appointment following use of app (estimated as 5 weeks)

Number of Participants Receiving a Preventive Migraine Prescription

Secondary Outcome Measures
NameTimeMethod
Number of Referrals to a NeurologistBaseline through one year

Number of Referrals to a Neurologist

Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, BarbituratesBaseline through one year

Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates

Number of Months of App UseBaseline through one year

Number of Months of App Use

Number of Emergency Room VisitsBaseline through one year

Number of Emergency Room Visits

Number of Urgent Care VisitsBaseline through one year

Number of Urgent Care Visits

Number of Primary Care VisitsBaseline through one year

Number of Primary Care Visits

Number of Acute Care VisitsBaseline through one year

Number of Acute Care Visits

Number of New Diagnoses of Migraine or Chronic MigraineBaseline 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

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