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OpenTrials
Completed

NCT Number: NCT03559088

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

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carmel Family Physicians, Charlotte, North Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Migraine App

Other

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

Primary outcomes

  1. Number of Participants Receiving a Preventive Migraine Prescription

    Time frame: Next primary care appointment following use of app (estimated as 5 weeks)

    Number of Participants Receiving a Preventive Migraine Prescription

Secondary outcomes

  1. Number of Months of App Use

    Time frame: Baseline through one year

    Number of Months of App Use

  2. Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates

    Time frame: Baseline through one year

    Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates

  3. Number of Acute Care Visits

    Time frame: Baseline through one year

    Number of Acute Care Visits

  4. Number of Primary Care Visits

    Time frame: Baseline through one year

    Number of Primary Care Visits

  5. Number of Emergency Room Visits

    Time frame: Baseline through one year

    Number of Emergency Room Visits

  6. Number of Urgent Care Visits

    Time frame: Baseline through one year

    Number of Urgent Care Visits

  7. Number of Referrals to a Neurologist

    Time frame: Baseline through one year

    Number of Referrals to a Neurologist

  8. Number of New Diagnoses of Migraine or Chronic Migraine

    Time frame: Baseline through one year

    Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Wake Forest University Health Sciences

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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