The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00
Conditions: Migraine Headaches
Sponsor: University of Texas Southwestern Medical Center

The Utility of Telemedicine in the Management Migraine: A Pilot Study 
 
Principal Investigator: Deborah I. Friedman, MD, MPH 
Co-Investigator: Abraham Seidmann, PhD (Simon School of Business University of 
Rochester, Rochester, New York) 
Sponsor: Merck & Co. 
Version:  February 28, 2012 
 
Introduction and Purpose: 
This is a pilot, proof-of-concept, study assessing the utility of telemedicine for follow-up 
care in a headache medicine practice.  
 
Hypothesis: Telemedicine is a viable and effective method of delivering follow-up care to 
patients with migraine, leading to patient outcomes and patient satisfaction equivalent to 
in-person office visits. 
 
Specific aims:   
1. To pilot a telemedicine program in patients with migraine for one year as 
measured by the ability to complete the visits as scheduled  
2. Develop transferrable clinical protocols for migraine visits with Telemedicine  
3. Assess the impact of care (telemedicine vs. in-person visit) on migraine-related 
disability as assessed by the Migraine Disability Scale (MIDAS)  
4. Rate the subjects’ satisfaction with assigned care strategy using the modified 
Group Health Association of America’s Consumer Satisfaction scale and a semi-
structured interview  
5. Assess the economic and competitive impact of telemedicine  services for 
neurology patients in our region  
Secondary outcomes: 
1. Number of supplementary encounters required (in-person visits, telephone calls, 
emergency department visits, unplanned hospitalizations)  
2. Time missed from work or daily activities to receive care (including travel time)  
3. Patient scheduling, tardy visits, no shows, and physician productivity 
Background: 
Headache is a common disorder, affecting over 35 million Americans.  The most 
frequently occurring, disabling headache type is migraine.  Migraine is the second most 
cause of missed work days (absenteeism) in the U.S.  It affects 18% of women, 6% of 
men and 6% of children, touching one in four families.  Approximately 50% of individuals 
with migraine (2.5% of the US population) experience moderate to severe headaches 
impacting their employment, home and leisure/family activities.    
 
Slightly less than half of Americans with migraine have not been officially diagnosed, and 
self-medicate using over-the-counter products and non-pharmacological treatment.  
Most patients who are diagnosed with migraine are managed by their primary care 
physician or gynecologist.  While these practitioners may be able to successfully treat 
patients with relatively infrequent or mild migraines, those with complex or debilitating 

headache conditions often seek care from a neurologist.  Patients with the most 
challenging and difficult headaches may be referred to a headache specialist. 
 
The University Council of Neurological Specialties (UCNS) has offered board 
certification for physicians in the area of Headache Medicine since 2006.  There are 
currently 250 physicians in the U.S. who have additional qualifications in Headache 
Medicine; most are located in major urban areas.  The relatively small number of 
headache specialists is unable to keep pace with the number of patients seeking their 
help, and most have waiting times ranging from weeks to months for a new patient 
appointment.  Appointment availability for follow-up visits is often limited as well. 
 
The complexity of migraine management, including assessment of the effectiveness and 
side-effects of multiple medications, providing education regarding the pathophysiology 
and management strategies of migraine, managing co-morbid conditions (e.g., other co-
existing headache conditions, depression, anxiety, fibromyalgia, other chronic pain 
syndromes), monitoring patient adherence to therapy, reviewing headache diaries, 
prescribing controlled substances when appropriate, and urgent management of acute 
headache episodes is demanding and time-consuming.  Thus, follow-up care of migraine 
patients generally requires visits at relatively frequent intervals (weeks to 2-3 months) in 
order to provide optimal care.  From the patient’s perspective, this requires a 
commitment of time and resources far exceeding the duration of the office visit.  The 
hidden person costs for the patient for in-person office visits may include time missed 
from work or school, child care costs, the need for an accompanying person in cases of 
long distance travel or the inability to drive while suffering from a migraine, transportation 
and parking costs.  The hidden costs disproportionately affect patients who live long 
distances from the physician’s office, often those living in rural areas.  The provider’s 
office (particularly in the university setting) may require the navigation of a complex 
hospital layout, aggravation associated with parking in a busy environment, fluorescent 
lighting and noise, all stressors that may contribute to the development or worsening of a 
migraine.  Lastly, missed visits occurring because of illness or inclement weather may be 
difficult to reschedule in a timely fashion in a busy practice, leading to lapses in care. 
 
Telemedicine is a medium that has potential benefits in a headache medicine practice.  
In particular, it lends itself to the follow-up management of patients once they have been 
evaluated in person at the initial visit.  The initial evaluation of a patient with migraine 
includes a detailed history and physical examination to exclude a secondary cause of 
headache, such as tumor, intracranial hypertension, infection, inflammation or 
malignancy.  The initial examination includes a neurological examination, with emphasis 
on the examination of the ocular fundi.  The technology exists to perform the ophthalmic 
examination remotely from a centralized location using a technician or physician 
extender, but does not lend itself to use in non-medical settings. 
 
The follow-up visit generally requires very little in the way of physical examination, as 
most time is spent in conversation reviewing the interim history, assessing response to 
treatment, discussing the need for additional testing, suggesting additional 
pharmacological and non-pharmacological therapeutic options, counseling and 
educating the patient, and prescribing the decided course of action.  The average 
duration of a follow-up visit is 15-30 minutes.  If the initial evaluation failed to disclose an 
abnormality on the examination, it is highly unlikely that the neurological examination in 
a subsequent encounter would demonstrate new findings in the absence of a change in 
the patients’ symptoms.  With supplementation of vital signs, which could be obtained 

and recorded by the patient prior to the visit (or electronically at the time of the visit), 
telemedicine offers the opportunity for remote face-to-face contact between the patient 
and the physician, eliminating almost all of the patient’s hidden costs associated with an 
in-person office visit, and avoiding delays and missed visits related to transportation and 
inclement weather.  The additional anxiety often associated with an office visit may be 
reduced as patients will be able to interact with the physician from a convenient and 
comfortable setting while maintaining the “face-to-face” dynamic that is so important to 
the doctor-patient therapeutic alliance. 
 
This is a pilot, proof-of-concept, study assessing the utility of telemedicine for follow-up 
care in a headache medicine practice.  
 
Concise Summary of Project: 
Consecutive patients undergoing their initial evaluation for headache at the Headache 
and Facial Pain Program at UT Southwestern, and meeting ICHD-2 criteria for migraine 
will be asked to participate in the study to achieve a total of 40 evaluable subjects (20 
per group).  All subjects will have their initial evaluation in person and those who agree 
to participate will be randomly assigned to either the telemedicine group or in-office 
group.  Treatment will be determined by the P.I. on an individual basis as per usual 
standards of practice.  All subjects will have the same number of follow-up encounters 
during the course of a year, and complete the same questionnaires throughout the 
study.   
 
Study Procedures: 
After obtaining informed consent, patients will be randomly assigned to receive their 
follow-up care via telemedicine or in-office visits.  All subjects will complete a MIDAS 
questionnaire and allodynia questionnaire at their initial visit.  Follow-up visits will be 
scheduled at 4-6 weeks, 3, 6, 9 and 12 months.  In-person follow-up visits will be 
conducted in the standard fashion of the current physician’s practice, with the initial 
intake conducted by an ophthalmic technician or resident, followed by the physician visit.  
Telemedicine visits will be conducted by the physician and audio and video recorded.  
Similar information will be gathered in both groups including: current medications, interim 
medical and headache history (including visits to the ED or hospitalizations for 
headache), description of headache, response to treatment (including adverse 
reactions), allergies, blood pressure and weight.  Subjects randomized to telemedicine 
will be asked to have their blood pressure and weight measured within 5 days of their 
telemedicine session at a location convenient to them.  We will record the length of each 
visit.  Subjects in the in-person group, will be queried about travel time, and the total 
amount of time for the visit, and any activities missed to attend the visit.  We will also ask 
about other costs associated with attending the office visit, such as child care. 
 
At the one-year follow-up visit, subjects will complete the MIDAS, allodynia 
questionnaire, Modified Group Health Association of America’s Consumer Satisfaction 
scale, and have the opportunity to express their views on the aspect of care received in 
a semi-structured interview.  The follow-up questionnaires may be completed on line 
(telemedicine group, optional for in-person group) or on paper (in-person group).  
Headache diaries will be provided on line or may be done on paper, a smartphone, or a 
computer program of the subject’s choosing.  
 
All subjects will be able to access the physician by telephone, using MyChart, or with 
additional non-study visits as needed.   

 
Subjects will be responsible for the cost of the medications, treatments prescribed, and 
laboratory monitoring needed for their condition.   
 
Support staff will be available to help set up the video system for subjects assigned to 
the telemedicine group who are in need of assistance.  
 
In order to obtain 40 evaluable subjects, it is anticipated that approximately 50 subjects 
will be consented.  Participation will last approximately 13 months, to allow time to set up 
and complete to post-study interview.  Subjects may be dismissed from the study if they 
fail to carry out study procedures or may exit the study by withdrawing consent.   After 
the study period, subjects will continue their care in the practice with in-person office 
visits.  
 
All subjects will be compensated equally for their time and for completing the study 
assessments.  Every attempt has been made to make the two study arms equivalent in 
terms of financial outlay and subject compensation.  We anticipate that they 
telemedicine option will be perceived as more convenient that the in-person visit.   The 
study will supply the web camera (approximate value $25) and any software support 
needed for accessing the telemedicine system.  The study will pay the co-payments for 
the in-person group so they will not have any out-of-pocket expenses related to the visit 
charge for their follow-up visits.  We will cover travel and parking expenses for the in-
person group. 
 
Criteria for Inclusion of Subjects: 
 
Ages 18 – 89 years 
 
Diagnosis of migraine with or without aura, menstrual migraine, hemiplegic 
migraine 
 
Able to provide informed consent 
 
Able, in the opinion of the investigator, to reliably perform all aspects of the study 
 
Ownership of or access to a computer and high speed internet 
 
Criteria for Exclusion of Subjects: 
 
Age less than 18 years 
 
Headache type is not migraine 
 
No ownership or access to a computer or high speed internet 
 
Unfamiliar with basic computer operations or uncomfortable using a computer 
 
Unwilling to participate 
 
Unable to read English (because of assessment tools) 
 
History of another medical, psychiatric, social or behavioral problem that, in the 
opinion of the investigator, makes it unlikely that they will be able to complete the 
study activities.  Questions regarding mood and anxiety are asked of all patients 
as part of their initial evaluation for headache. 
 
 
Sources for Research Material: 
Information will be used from the questionnaires mentioned, post-study interviews, and 
the subjects’ medical records.  The medical record, accessed for the one year period of 
participation, will primarily be used to determine interim ED visits and hospitalizations for 
headache. The telemedicine visits will be recorded and information from those 
recordings may be used for research purposes. 

 
Recruitment and Consenting Process: 
Potential subjects will be approached  during or immediately after their initial 
examination for migraine treatment.  Potential subjects will be identified from referral 
information to the Headache and Facial Pain Program.  The consent process will occur 
during or shortly after their initial clinic visit, after it is determined that they meet ICHD-2 
criteria for migraine.  All eligible patients will be asked to participate.  
 
Potential Risks and Benefits: 
This is a minimal risk study as the risk is no greater than that associated with a routine 
visit to the physician or standard treatment for migraine.   
 
Psychological Stress  
Subjects may be asked questions that are personal and may make them feel 
uncomfortable or upset. Subjects may refuse to answer any of the questions, take a 
break or stop their participation in this study at any time. 
 
If Subjects are assigned to telemedicine visits, there is a risk to their privacy as the 
information is sent over a high-speed computer connection.  We will do our best to 
protect their privacy by using special coding and protections to our computer systems.  
  
Loss of Confidentiality 
Any time information is collected; there is a potential risk of loss of confidentiality.  Every 
effort will be made to keep subject information confidential; however, this cannot be 
guaranteed.  
 
Subject Safety and Data Monitoring: 
Any adverse events related to treatments prescribed as part of routine care will be 
handled by the P.I., her colleagues and staff at the Headache and Facial Pain Program 
in a timely manner. The P.I. will receive communication regarding any adverse events 
through Epic, and is responsible for safety and data monitoring.  
 
Procedure to Maintain Confidentiality: 
Subjects will be assigned a study number which will be used for study data collection 
and analysis. Medical records are stored in the Epic system.  Case report forms (paper) 
will be kept in a locked and secure cabinet. No identifying data will be entered into the 
data set used for analysis.  All information obtained on line and video recordings will be 
stored using encryption and password protection.  Videotapes will not be obtained or 
used without the subject’s permission. The subject’s address will be used to calculate 
the distance from their home to UTSW and will not be retained in the study materials.   
 
Potential Benefits: 
All subjects may benefit from participation as they will be evaluated by the physician 
more frequently than in routine practice.  There may or may not be a benefit from 
telemedicine participation as compared to in-person care.   
 
We hope the information learned from this study will benefit others with migraine in the 
future.  Information gained from this research could lead to better care and treatment of 
migraine, especially for people who live in a remote area or have limited access to a 
headache specialist.   
 

Biostatistics: 
 
Excel 2016 and R (version 3.5.2) were used to perform the statistical analysis. The 
primary outcome measure was the percentage of visits using telemedicine completed as 
scheduled; the sample size was chosen to provide evidence for this proof of concept.5 
Secondary outcome measures included clinical outcomes related to headache disability 
(MIDAS, number of headache days in the last 3 months, and severity on a scale of 0-10 
with 10=pain which is as bad as it can be), visit time, and perceptions of telemedicine. 
The average change from baseline to 12 months for the in-office group was compared 
with the average change for those in the telemedicine group (difference in average 
difference). The McNemar 
 test was used to examine differences in the proportion of 
participants reporting moderate to severe disability (MIDAS ≥ 11) between the baseline 
and 12 months.6 Logistic regression was used to test whether membership in the in-
office group was associated with experiencing a 50% or greater improvement in clinical 
outcomes. The logistic regression was also controlled for baseline values. Two sample t-
tests were used to estimate whether participants in different groups differed in their 
survey responses.   
 
 
REFERENCES:   
1.  Biglan KM, Voss TS, Deuel LM, et al.  Telemedicine for care of nursing home 
residents with Parkinson’s disease.  Movement Disorders 2009;24(7):1073-1075. 
2.  Hersh WR, Hickam DH, Severance SM, et al. Diagnosis, access and outcomes: 
Update of a systematic review of telemedicine services. J  Telemed Telecare 2006;12 
Suppl 2:S3-31. 
3.  García-Lizana F, Muñoz-Mayorga I.  Telemedicine for depression: a systematic 
review.  Perpect Psychiatr Care 2010 Apr;46(2):119-26.