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

Lilly

Status: Completed

Conditions: Migraine

Treatments: Other: Migraine App

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03559088

I5Q-MC-CGBA (Other Identifier)

17129

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Migraine Participants Using Application (App)

Experimental group

Description:

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.

Treatment:

Other: Migraine App

Controls Not Using App

No Intervention group

Description:

Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.