FAQ

ARMR FAQ for Patients

Overview
What is the American Migraine Foundation?

The American Migraine Foundation (AMF) is a non-profit organization dedicated to the advancement of research and awareness surrounding migraine and other headache types. The AMF was founded in 2010 by the American Headache Society (AHS) to support research and to assist migraine patients and their families. The AMF provides access to information as well as resources to help the patient community. The American Registry for Migraine Research (ARMR) was founded by the AMF.

What is a registry?

A registry is a collection of detailed data related to patients with a specific diagnosis, condition, or procedure.

What is the American Registry for Migraine Research (ARMR)?

ARMR is a registry housing information about patients diagnosed with migraine and other headache types. ARMR is a valuable tool to advance research and help physicians and researchers understand the causes of migraine and other headache types. ARMR will help physicians diagnose migraine patients better and improve the management of migraine.

How is American Migraine Foundation associated with the American Registry for Migraine Research?

ARMR is founded by the AMF. The AMF founded ARMR with a mission to drive and support innovative research that will lead to improvement in the lives of individuals living with migraine and other headache types.

Why was ARMR created? What are ARMR’s goals?

Migraine affects over 36 million people in the United States and has a significant impact on those affected and society. ARMR’s goal is to collect data from patients and create a large-scale migraine and headache registry. This registry will be used to help researchers and physicians better understand migraine and the causes, improve diagnosis, and lead to better treatment.

How is ARMR being funded?

The American Migraine Foundation and ARMR are funded through the generous support of:
● Corporations
● Foundations
● Private individuals

 

The Corporate Registry Roundtable Members include:
● Platinum:
    ● The Allergan Foundation
    ● Amgen
    ● Eli Lilly
● Silver:
    ● Teva Pharmaceuticals
    ● Avanir Pharmaceuticals
    ● Promeus Pharma
● Bronze:
    ● ElectroCore

Which sites are currently participating in ARMR?

ARMR is currently enrolling patients at:

Mayo Clinic Phoenix, Arizona

Principal Investigators: David W. Dodick, MD, FRCP, FACP, FAHS
Todd J. Schwedt, MD, MSCI, FAHS
Registry Coordinator: Teri Radam, CCRP

University of Texas Health Science Center at Houston (UTHealth) Houston, Texas

Principal Investigators: Mark Burish, MD
Registry Coordinator: Elena Viverette, MS RN

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What information will be collected in ARMR?

Demographic data and health information will be collected about participants of ARMR. Broadly, patients will be asked about their:
● Age, gender, employment, education and other demographic information
● Symptoms, headache type and headache characteristics
● Impact of headache on patient quality of life and functioning
● Severity and frequency of attacks.
● Personal medical history, family medical history, and treatment history

 

Blood samples will be requested from each patient but are optional. If taken these samples will be stored in a biorepository at the Mayo Clinic Biobank. These samples may be used for future studies, such as investigating the genetic factors that may be associated with migraine and other headache types as well as blood markers that predict the response to certain treatments.

How will the data be collected?

Data may be collected from a patient’s:
● Past, present and future medical records
● Electronic medical records
● Office visits
● Medical tests
● Interviews
● ARMR procedures including:
    ● ARMR questionnaires
    ● One blood sample
    ● Daily headache diary

How will the information patients provide be used?

Researchers will use your anonymized information – and the aggregated data from many other patients – to better understand the causes of migraine and other headache types and find more effective treatments.

 

Information collected in ARMR will provide answers to a number of questions including: Are there predictors for headache progression? Can doctors develop strategies for preventing progression? Are there predictors of who will most benefit from specific therapies? What are the healthcare expenses associated with headache disorders? Are there genetic factors that predict which patients are at risk for other diseases that are associated with migraine (for example, stroke or depression)? What are the trigger factors that are unique to each individual?

Participation Requirements

Who can enroll into ARMR?

Anyone can participate in ARMR if they meet all the following criteria:
● Receiving headache care at a participating headache center.
● Suffer from migraine or other types of headaches
● Adult (18 years of age or older)
● Ability and willing to provide consent to participate
● Fluent in English
● Access to a computer or other electronic device with an internet connection

Are patients living outside US eligible to join ARMR?

ARMR is currently available to participants living in United States only.

Are patients under the age of 18 eligible for enrolling into ARMR?

Only adults (18 years of age or older) can enroll in ARMR.

What is required to participate? How much time will be required?

Patients will be asked to participate in 3 ways:

  • ARMR questionnaire: Patients will be asked to fill out a set of ARMR questionnaires. ARMR questionnaires will ask about patient medical history and other health information. These should take a few hours each year.
  • Patients will be asked to complete a daily online headache diary that will record patients’ headache symptoms and any treatments. This should take no more than 1 to 2 minutes per day. The headache diary will also be available as a mobile app.
  • Blood collection (optional): Up to 1 fluid ounce (about 2 tablespoons) will be taken and stored for future studies. The blood sample is optional.
Is internet access required to participate in ARMR?

For participation in ARMR, it is mandatory for patients to have access to a personal computer, iPad or other tablet with an internet connection.

I am interested in participating, how can I join ARMR?

If you are receiving headache care at a participating ARMR site and would like to participate, please contact the ARMR investigator or coordinator for more information. Participating sites and contact information can be found here.

Participation Benefits and Risks

Are there any benefits associated with participation in ARMR?

Patients will not directly benefit from taking part in this registry. It is for the benefit of headache research. However, as part of participation, patients will have access to a free online daily headache diary. Patients will also be contributing to the advancement of headache research for future patients.

Will participation in ARMR affect a patients’ treatment?

Participation in ARMR will not impact a patients’ treatment.

Are there any risks associated with participation?

Each participants’ doctor will discuss the risks of any tests and procedures that are part of their clinical care.
he risks of blood sample collection for ARMR are minimal, but include:
● Discomfort during the procedure
● Bruising
● Bleeding
● Swelling at the puncture site
● Infection
● Feeling lightheaded
● Fainting during the procedure.

 

As with all studies, there is a chance that confidentiality could be compromised; however, we take precautions to minimize this risk. Please see the data privacy section to learn more about how we protect patient data.

Costs/Compensation

Will patients receive any compensation for participating in ARMR?

Patients will not receive any payment or compensation (for example, money, gifts or vouchers) for participating in ARMR. Participation in ARMR is voluntary and will support the understanding of migraine and other headache disorders.

Will patients be charged for participating in ARMR?

Patients will not be charged for any activities related to participating in ARMR.

Discontinuing Participation

Can a patient discontinue participation?

Participation in ARMR is voluntary. Patients have the right to stop participation in ARMR at any time. After a patient withdraws from the registry, they will not be contacted regarding ARMR and no further information will be collected from them.

ARMR Questionnaires

What types of questions will patients be asked in ARMR questionnaires?

ARMR questionnaires ask a variety of questions to help patients and their health care providers better understand the following:
● Symptoms, headache type and headache characteristics
● Impact of headache on their quality of life and functioning
● Severity and frequency of attacks
● Personal medical history, family medical history, and other medical information

Can ARMR questionnaires be completed on behalf of a family member or friend?

No, only a consenting participant can enter information into ARMR questionnaires.

ARMR Daily Headache Diary

What is the daily headache diary?

Patients will be asked to complete a daily online headache diary that will record headache symptoms, potential trigger factors, and treatments. The headache diary will also be available as a mobile app. This should take no more than 1 to 2 minutes per day.

What information is collected in the daily headache diary?

In the daily headache diary, patients will be asked about:
● Headache symptoms
● The length of the headache
● Severity of pain
● Medications taken
● Potential trigger factors

 

Completing the diary daily will help us more fully understand your headache disorder, your response to specific treatments, and factors that may be associated with triggering headache attacks.

Biological Samples

What is a biological sample?

Biological samples are materials taken from the human body – such as tissue, blood, plasma, and urine – that can be used for diagnosis and research. For ARMR, we collect a blood sample from patients willing to provide this.

Why will blood samples be taken?

Blood samples will be used for future studies. For example, some of the future studies may examine patients’ DNA, which is the genetic information inherited from patient parents (genetic testing). Analysis of these samples will help researchers advance the understanding of headaches and develop better treatments in the future.

What will happen to the blood samples?

Blood samples will be processed and stored in a biobank for ARMR at Mayo Clinic Arizona. Future investigators may request samples from the Scientific Committee of the American Registry for Migraine Research.

Data Access and Privacy

How is patient data identified in the registry?

Only registry staff where a patient receives their headache care will be able to link patient data to the patient’s identity. In the registry, patient data will only be identified by a unique registry ID number, and not by patient name.

How is patient data stored?

Data will be stored in the ARMR data management platform. This product has been designed from its inception as a secure repository for clinical data. The database will be password protected and data entry and modification will be audited. User IDs will be provided to approved ARMR personnel and there will be no access for users who have not provided a username and password.

 

Additionally, all information submitted will be transmitted via the internet in an encrypted form. Encryption is the process of encoding data in such a way that only authorized parties can access it.

 

The servers used to store the data are located in a commercial-grade secure facility. No access to the facility is granted without proper credentials. Access to the servers requires a valid security access card and biometric scan device.

Who will be able to use or share the data collected in ARMR?

 1] Health care providers where patients receive headache care will be able access health data as they would during routine clinical care.
2] The ARMR Scientific Advisory Board will have access to patients’ de-identified (anonymized) data.
3] Researchers at other institutions who are approved by the ARMR Scientific Advisory Board will be granted access to de-identified data

Resetting a Lost Password or User Name

I have lost my password, how can I reset it?

If you have forgotten your password, you will need to reset it. In order to reset your password, you can click ‘Forgot password’ on the ARMR Registry Participant Login page.
You will be prompted for your registered e-mail address – please enter the e-mail address you provided to registry staff at enrollment.
Once you click the reset button, you will receive an e-mail with a password reset link to the e-mail address provided.

Can I change my username?

Your user name is the e-mail address you provided to registry staff at enrollment. If you would like to change your user name, please contact registry staff for assistance.

Supporting ARMR

What can I do to support ARMR?

For funding support, please review the support options and donate online at https://americanmigrainefoundation.org/american-registry-migraine-research/.

Additional Information

If I need more information, who should I contact?

If you are a current ARMR participant, you can find additional Help resources by logging in to the ARMR patient portal. The patient portal contains a ‘My ARMR Resources’ section, including patient trainings and Frequently Asked Questions for participants.

 

If you need additional information, please send us a message using the contact form located here.