The Utility of Telemedicine in the Management of Migraine

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Deborah Friedman, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01706003
First received: October 10, 2012
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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


Condition
Migraine Headaches

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Assess the utility of telemedicine for follow-up care in a headache medicine practice [ Time Frame: One Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 46
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Migraine Headaches
People who suffer from Migraine Headaches who own a computer and have internet access

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients must be diagnosed with Migraine Headaches

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706003

Locations
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.
Investigators
Principal Investigator: Deborah Friedman, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Deborah Friedman, Primary Investigator, MD, Neurology and Neurotheraputics, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01706003     History of Changes
Other Study ID Numbers: MK0974-071-00, MERCK
Study First Received: October 10, 2012
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Migraine
Headaches
Telemedicine

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

ClinicalTrials.gov processed this record on April 15, 2014