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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03559088
Enrollment
120
Registered
2018-06-15
Start date
2018-06-11
Completion date
2019-04-26
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

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.

Interventions

OTHERMigraine App

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

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Receiving a Preventive Migraine PrescriptionNext primary care appointment following use of app (estimated as 5 weeks)Number of Participants Receiving a Preventive Migraine Prescription

Secondary

MeasureTime frameDescription
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, BarbituratesBaseline through one yearNumber of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Number of Acute Care VisitsBaseline through one yearNumber of Acute Care Visits
Number of Primary Care VisitsBaseline through one yearNumber of Primary Care Visits
Number of Months of App UseBaseline through one yearNumber of Months of App Use
Number of Urgent Care VisitsBaseline through one yearNumber of Urgent Care Visits
Number of Referrals to a NeurologistBaseline through one yearNumber of Referrals to a Neurologist
Number of New Diagnoses of Migraine or Chronic MigraineBaseline through one yearDiagnoses made by International Classification of Diseases 10th revision (ICD10) coding system
Number of Emergency Room VisitsBaseline through one yearNumber of Emergency Room Visits

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026