The Utility of Telemedicine in the Management of Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706003
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2012
Last Update Posted : October 26, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Deborah Friedman, University of Texas Southwestern Medical Center

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

Condition or disease
Migraine Headaches

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00
Study Start Date : October 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Migraine Headaches
People who suffer from Migraine Headaches who own a computer and have internet access

Primary Outcome Measures :
  1. Assess the utility of telemedicine for follow-up care in a headache medicine practice [ Time Frame: One Year ]
    Assess the satisfaction of patients with follow up care via telemedicine. This includes but is not limited to determining cost associated with office visits,i.e. sick time, travel expenses, child care.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients must be diagnosed with Migraine Headaches

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01706003

United States, Texas
Universit of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Deborah Friedman, MD University of Texas Southwestern Medical Center

Responsible Party: Deborah Friedman, Primary Investigator, MD, Neurology and Neurotheraputics, University of Texas Southwestern Medical Center Identifier: NCT01706003     History of Changes
Other Study ID Numbers: MK0974-071-00
MERCK ( Other Identifier: MISP )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Deborah Friedman, University of Texas Southwestern Medical Center:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms