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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-11

Study Completion Date

2019-04-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Migraine App

Intervention Type OTHER

Smart phone app used to report migraine burden to the EHR.

Controls Not Using App

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Migraine App

Smart phone app used to report migraine burden to the EHR.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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