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

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Migraine App
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charlotte Internal Medicine
  • Charlotte Medical Clinic
  • Carmel Family Physicians
  • Charlotte Medical Clinic-South Park
  • Randolph Internal Medicine
  • South Charlotte Primary Care
  • Mecklenburg Medical Group - Ballantyne
  • Table Rock Family Medicine
  • Mecklenburg Medical Group - Northcross
  • North Charlotte Medical Specialists - Huntersville
  • Lincoln Family Practice
  • Mecklenburg Medical Group - Matthews
  • Union Family Practice
  • Troy Medical Services
  • Shiland Family Fort Mill
  • Shiland Family Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Migraine Participants Using Application (App)

Controls Not Using App

Arm 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.

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

Outcomes

Primary Outcome Measures

Number of Participants Receiving a Preventive Migraine Prescription
Number of Participants Receiving a Preventive Migraine Prescription

Secondary Outcome Measures

Number of Months of App Use
Number of Months of App Use
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Number of Acute Care Visits
Number of Acute Care Visits
Number of Primary Care Visits
Number of Primary Care Visits
Number of Emergency Room Visits
Number of Emergency Room Visits
Number of Urgent Care Visits
Number of Urgent Care Visits
Number of Referrals to a Neurologist
Number of Referrals to a Neurologist
Number of New Diagnoses of Migraine or Chronic Migraine
Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system

Full Information

First Posted
June 4, 2018
Last Updated
July 21, 2020
Sponsor
Eli Lilly and Company
Collaborators
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03559088
Brief Title
A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care
Official Title
Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Migraine Participants Using Application (App)
Arm Type
Experimental
Arm 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.
Arm Title
Controls Not Using App
Arm Type
No Intervention
Arm Description
Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.
Intervention Type
Other
Intervention Name(s)
Migraine App
Intervention Description
Smart phone app used to report migraine burden to the EHR.
Primary Outcome Measure Information:
Title
Number of Participants Receiving a Preventive Migraine Prescription
Description
Number of Participants Receiving a Preventive Migraine Prescription
Time Frame
Next primary care appointment following use of app (estimated as 5 weeks)
Secondary Outcome Measure Information:
Title
Number of Months of App Use
Description
Number of Months of App Use
Time Frame
Baseline through one year
Title
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Description
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Time Frame
Baseline through one year
Title
Number of Acute Care Visits
Description
Number of Acute Care Visits
Time Frame
Baseline through one year
Title
Number of Primary Care Visits
Description
Number of Primary Care Visits
Time Frame
Baseline through one year
Title
Number of Emergency Room Visits
Description
Number of Emergency Room Visits
Time Frame
Baseline through one year
Title
Number of Urgent Care Visits
Description
Number of Urgent Care Visits
Time Frame
Baseline through one year
Title
Number of Referrals to a Neurologist
Description
Number of Referrals to a Neurologist
Time Frame
Baseline through one year
Title
Number of New Diagnoses of Migraine or Chronic Migraine
Description
Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system
Time Frame
Baseline through one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Charlotte Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28202
Country
United States
Facility Name
Charlotte Medical Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203-5812
Country
United States
Facility Name
Carmel Family Physicians
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Charlotte Medical Clinic-South Park
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Randolph Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
South Charlotte Primary Care
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Facility Name
Mecklenburg Medical Group - Ballantyne
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Table Rock Family Medicine
City
Glen Alpine
State/Province
North Carolina
ZIP/Postal Code
28628
Country
United States
Facility Name
Mecklenburg Medical Group - Northcross
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
North Charlotte Medical Specialists - Huntersville
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Lincoln Family Practice
City
Lincolnton
State/Province
North Carolina
ZIP/Postal Code
28092
Country
United States
Facility Name
Mecklenburg Medical Group - Matthews
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Union Family Practice
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Troy Medical Services
City
Troy
State/Province
North Carolina
ZIP/Postal Code
27371
Country
United States
Facility Name
Shiland Family Fort Mill
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29715
Country
United States
Facility Name
Shiland Family Practice
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29715
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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