The Utility of Telemedicine in the Management of Migraine



Status:Completed
Conditions:Migraine Headaches, Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 89
Updated:2/9/2019
Start Date:October 2012
End Date:October 2018

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The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00

Patients will be randomly assigned to receive their follow-up care via telemedicine or
in-office visits.

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 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.

Inclusion Criteria:• 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.
We found this trial at
1
site
5323 Harry Hines Boulevard
Dallas, Texas 75390
?
mi
from
Dallas, TX
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