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

October 10, 2012
October 18, 2012
October 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01706003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Utility of Telemedicine in the Management of Migraine
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.

Observational
Observational Model: Ecologic or Community
Time Perspective: Prospective
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Probability Sample

Patients must be diagnosed with Migraine Headaches

Migraine Headaches
Not Provided
Migraine Headaches
People who suffer from Migraine Headaches who own a computer and have internet access
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
46
April 2014
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01706003
MK0974-071-00, MERCK
No
Deborah Friedman, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Merck Sharp & Dohme Corp.
Principal Investigator: Deborah Friedman, MD University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP