MigraineNCT03559088
A Study of the Effect of a Disease-Specific Migraine Smart Phone Application (App) on Participant Care
A study testing Migraine App in people with Migraine, run by Eli Lilly and Company at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Migraine App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- 11 Jun 2018to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Charlotte Internal Medicine
Charlotte, North Carolina, 28202
Charlotte Medical Clinic
Charlotte, North Carolina, 28203-5812
Carmel Family Physicians
Charlotte, North Carolina, 28210
Charlotte Medical Clinic-South Park
Charlotte, North Carolina, 28211
Randolph Internal Medicine
Charlotte, North Carolina, 28211
South Charlotte Primary Care
Charlotte, North Carolina, 28226
Mecklenburg Medical Group - Ballantyne
Charlotte, North Carolina, 28277
Shiland Family Fort Mill
Fort Mill, South Carolina, 29715
Shiland Family Practice
Fort Mill, South Carolina, 29715
Table Rock Family Medicine
Glen Alpine, North Carolina, 28628
Mecklenburg Medical Group - Northcross
Huntersville, North Carolina, 28078
North Charlotte Medical Specialists - Huntersville
Huntersville, North Carolina, 28078
Lincoln Family Practice
Lincolnton, North Carolina, 28092
Mecklenburg Medical Group - Matthews
Matthews, North Carolina, 28105
Union Family Practice
Monroe, North Carolina, 28112
Troy Medical Services
Troy, North Carolina, 27371
About this study
Official title: Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
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.
- Conditions
- Migraine
- Being tested
- Migraine App
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Migraine AppOther
Smart phone app used to report migraine burden to the EHR.
| Study group | Role | What they receive |
|---|---|---|
| Migraine Participants Using Application (App) | Experimental | 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. Receives: Other: Migraine App |
| Controls Not Using App | No intervention | Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Receiving a Preventive Migraine Prescription
Number of Participants Receiving a Preventive Migraine Prescription
Measured: Next primary care appointment following use of app (estimated as 5 weeks)
Secondary outcomes (8)
Number of Months of App Use
Number of Months of App Use
Measured: Baseline through one year
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Measured: Baseline through one year
Number of Acute Care Visits
Number of Acute Care Visits
Measured: Baseline through one year
Number of Primary Care Visits
Number of Primary Care Visits
Measured: Baseline through one year
Number of Emergency Room Visits
Number of Emergency Room Visits
Measured: Baseline through one year
Number of Urgent Care Visits
Number of Urgent Care Visits
Measured: Baseline through one year
Number of Referrals to a Neurologist
Number of Referrals to a Neurologist
Measured: Baseline through one year
Number of New Diagnoses of Migraine or Chronic Migraine
Diagnoses made by International Classification of Diseases 10th revision (ICD10) coding system
Measured: Baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start11 Jun 2018
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559088
- Sponsor's protocol ID
- 17129
- Other IDs
- I5Q-MC-CGBA
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrating a Disease-Specific Migraine App Into the Management of Patients in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT03559088
- Acronym / sponsor ID
- 17129
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine Participants Using Application (App) | Experimental | Other: Migraine AppParticipants 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 intervention | –Observational history on contemporaneous matched controls at similar sites without migraine app linked to their EHR. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Migraine AppSmart phone app used to report migraine burden to the EHR. | Other | Migraine Participants Using Application (App) |
Primary outcome
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
8 secondary outcomes
Number of Months of App Use
Time frame: Baseline through one year
Number of Participants Receiving Acute and Preventive Migraine Treatments, Opioids, Barbiturates
Time frame: Baseline through one year
Number of Acute Care Visits
Time frame: Baseline through one year
Number of Primary Care Visits
Time frame: Baseline through one year
Number of Emergency Room Visits
Time frame: Baseline through one year
Number of Urgent Care Visits
Time frame: Baseline through one year
Number of Referrals to a Neurologist
Time frame: Baseline through one year
Number of New Diagnoses of Migraine or Chronic Migraine
Time frame: Baseline through one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Migraine App in people with Migraine, run by Eli Lilly and Company at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Receiving a Preventive Migraine Prescription (time frame: Next primary care appointment following use of app (estimated as 5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.