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Trial record 37 of 138 for:    Recruiting, Not yet recruiting, Available Studies | "Migraine Disorders"

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

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ClinicalTrials.gov Identifier: NCT03559088
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
Atrium Health
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Migraine Other: Migraine App Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
Actual Study Start Date : June 11, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: 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.
Other: Migraine App
Smart phone app used to report migraine burden to the EHR.

No Intervention: Controls Not Using App
Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559088


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@Lilly.com

Locations
United States, North Carolina
Charlotte Medical Clinic Recruiting
Charlotte, North Carolina, United States, 28203-5812
Contact    704-355-3819      
Principal Investigator: Dr. S L Furney         
Charlotte Internal Medicine Recruiting
Charlotte, North Carolina, United States, 28204
Contact    704-355-3819      
Principal Investigator: Dr. S L Furney         
Charlotte Medical Group Recruiting
Charlotte, North Carolina, United States, 28226
Contact    704-355-3819      
Principal Investigator: Dr. S L Furney         
Union Family Practice Recruiting
Monroe, North Carolina, United States, 28112
Contact    704-355-3819      
Principal Investigator: Dr. S L Furney         
United States, South Carolina
Shiland Family Practice Recruiting
Fort Mill, South Carolina, United States, 29715
Contact    704-355-3819      
Principal Investigator: Dr. S L Furney         
Sponsors and Collaborators
Eli Lilly and Company
Atrium Health
Investigators
Study Director: 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) Eli Lilly and Company

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03559088     History of Changes
Other Study ID Numbers: 17129
I5Q-MC-CGBA ( Other Identifier: Eli Lilly and Company )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases