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

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

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 Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Other: Migraine App

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28202
      • Charlotte Internal Medicine
    • Charlotte, North Carolina, United States, 28203-5812
      • Charlotte Medical Clinic
    • Charlotte, North Carolina, United States, 28210
      • Carmel Family Physicians
    • Charlotte, North Carolina, United States, 28211
      • Charlotte Medical Clinic-South Park
    • Charlotte, North Carolina, United States, 28211
      • Randolph Internal Medicine
    • Charlotte, North Carolina, United States, 28226
      • South Charlotte Primary Care
    • Charlotte, North Carolina, United States, 28277
      • Mecklenburg Medical Group - Ballantyne
    • Glen Alpine, North Carolina, United States, 28628
      • Table Rock Family Medicine
    • Huntersville, North Carolina, United States, 28078
      • Mecklenburg Medical Group - Northcross
    • Huntersville, North Carolina, United States, 28078
      • North Charlotte Medical Specialists - Huntersville
    • Lincolnton, North Carolina, United States, 28092
      • Lincoln Family Practice
    • Matthews, North Carolina, United States, 28105
      • Mecklenburg Medical Group - Matthews
    • Monroe, North Carolina, United States, 28112
      • Union Family Practice
    • Troy, North Carolina, United States, 27371
      • Troy Medical Services
  • South Carolina
    • Fort Mill, South Carolina, United States, 29715
      • Shiland Family Fort Mill
    • Fort Mill, South Carolina, United States, 29715
      • Shiland Family Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Migraine Participants Using Application (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.	Other: Migraine App; Smart phone app used to report migraine burden to the EHR.
No Intervention: Controls Not Using App; Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 17129; I5Q-MC-CGBA (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No