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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559088
• Other study ID #: 17129
• Secondary ID: I5Q-MC-CGBA
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: April 26, 2019

Study information

• Verified date: July 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Migraine App
Smart phone app used to report migraine burden to the EHR.

Locations

Country	Name	City	State
United States	Carmel Family Physicians	Charlotte	North Carolina
United States	Charlotte Internal Medicine	Charlotte	North Carolina
United States	Charlotte Medical Clinic	Charlotte	North Carolina
United States	Charlotte Medical Clinic-South Park	Charlotte	North Carolina
United States	Mecklenburg Medical Group - Ballantyne	Charlotte	North Carolina
United States	Randolph Internal Medicine	Charlotte	North Carolina
United States	South Charlotte Primary Care	Charlotte	North Carolina
United States	Shiland Family Fort Mill	Fort Mill	South Carolina
United States	Shiland Family Practice	Fort Mill	South Carolina
United States	Table Rock Family Medicine	Glen Alpine	North Carolina
United States	Mecklenburg Medical Group - Northcross	Huntersville	North Carolina
United States	North Charlotte Medical Specialists - Huntersville	Huntersville	North Carolina
United States	Lincoln Family Practice	Lincolnton	North Carolina
United States	Mecklenburg Medical Group - Matthews	Matthews	North Carolina
United States	Union Family Practice	Monroe	North Carolina
United States	Troy Medical Services	Troy	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Atrium Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Months of App Use	Number of Months of App Use	Baseline through one year
Secondary	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
Secondary	Number of Acute Care Visits	Number of Acute Care Visits	Baseline through one year
Secondary	Number of Primary Care Visits	Number of Primary Care Visits	Baseline through one year
Secondary	Number of Emergency Room Visits	Number of Emergency Room Visits	Baseline through one year
Secondary	Number of Urgent Care Visits	Number of Urgent Care Visits	Baseline through one year
Secondary	Number of Referrals to a Neurologist	Number of Referrals to a Neurologist	Baseline through one year
Secondary	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