Clinical trial NCT03559088: A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care
Official title: Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Wake Forest University Health Sciences
First posted: 2018-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Receiving a Preventive Migraine Prescription
timeFrame: Next primary care appointment following use of app (estimated as 5 weeks)
Secondary outcomes:
measure: Number of Months of App Use
timeFrame: Baseline through one year
measure: Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
timeFrame: Baseline through one year
measure: Number of Acute Care Visits
timeFrame: Baseline through one year
measure: Number of Primary Care Visits
timeFrame: Baseline through one year
measure: Number of Emergency Room Visits
timeFrame: Baseline through one year
measure: Number of Urgent Care Visits
timeFrame: Baseline through one year
measure: Number of Referrals to a Neurologist
timeFrame: Baseline through one year
measure: Number of New Diagnoses of Migraine or Chronic Migraine
timeFrame: Baseline through one year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Internal Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Medical Clinic
state: North Carolina
city: Charlotte
country: United States
facility: Carmel Family Physicians
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Medical Clinic-South Park
state: North Carolina
city: Charlotte
country: United States
facility: Randolph Internal Medicine
state: North Carolina
city: Charlotte
country: United States
facility: South Charlotte Primary Care
state: North Carolina
city: Charlotte
country: United States
facility: Mecklenburg Medical Group - Ballantyne
state: North Carolina
city: Glen Alpine
country: United States
facility: Table Rock Family Medicine
state: North Carolina
city: Huntersville
country: United States
facility: Mecklenburg Medical Group - Northcross
state: North Carolina
city: Huntersville
country: United States
facility: North Charlotte Medical Specialists - Huntersville
state: North Carolina
city: Lincolnton
country: United States
facility: Lincoln Family Practice
state: North Carolina
city: Matthews
country: United States
facility: Mecklenburg Medical Group - Matthews
state: North Carolina
city: Monroe
country: United States
facility: Union Family Practice
state: North Carolina
city: Troy
country: United States
facility: Troy Medical Services
state: North Carolina
city: Fort Mill
country: United States
facility: Shiland Family Fort Mill
state: South Carolina
city: Fort Mill
country: United States
facility: Shiland Family Practice
state: South Carolina
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: