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
2 other identifiers
interventional
120
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedStudy Start
First participant enrolled
June 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2019
CompletedJuly 22, 2020
July 1, 2020
11 months
June 4, 2018
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Receiving a Preventive Migraine Prescription
Number of Participants Receiving a Preventive Migraine Prescription
Next primary care appointment following use of app (estimated as 5 weeks)
Secondary Outcomes (8)
Number of Months of App Use
Baseline through one year
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Baseline through one year
Number of Acute Care Visits
Baseline through one year
Number of Primary Care Visits
Baseline through one year
Number of Emergency Room Visits
Baseline through one year
- +3 more secondary outcomes
Study Arms (2)
Migraine Participants Using Application (App)
EXPERIMENTALParticipants 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.
Controls Not Using App
NO INTERVENTIONObservational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR.
Interventions
Smart phone app used to report migraine burden to the EHR.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- Wake Forest University Health Sciencescollaborator
Study Sites (16)
Charlotte Internal Medicine
Charlotte, North Carolina, 28202, United States
Charlotte Medical Clinic
Charlotte, North Carolina, 28203-5812, United States
Carmel Family Physicians
Charlotte, North Carolina, 28210, United States
Charlotte Medical Clinic-South Park
Charlotte, North Carolina, 28211, United States
Randolph Internal Medicine
Charlotte, North Carolina, 28211, United States
South Charlotte Primary Care
Charlotte, North Carolina, 28226, United States
Mecklenburg Medical Group - Ballantyne
Charlotte, North Carolina, 28277, United States
Table Rock Family Medicine
Glen Alpine, North Carolina, 28628, United States
Mecklenburg Medical Group - Northcross
Huntersville, North Carolina, 28078, United States
North Charlotte Medical Specialists - Huntersville
Huntersville, North Carolina, 28078, United States
Lincoln Family Practice
Lincolnton, North Carolina, 28092, United States
Mecklenburg Medical Group - Matthews
Matthews, North Carolina, 28105, United States
Union Family Practice
Monroe, North Carolina, 28112, United States
Troy Medical Services
Troy, North Carolina, 27371, United States
Shiland Family Fort Mill
Fort Mill, South Carolina, 29715, United States
Shiland Family Practice
Fort Mill, South Carolina, 29715, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2018
First Posted
June 15, 2018
Study Start
June 11, 2018
Primary Completion
April 26, 2019
Study Completion
April 26, 2019
Last Updated
July 22, 2020
Record last verified: 2020-07