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Clinical Trials/NCT01706003
NCT01706003
Completed
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country45 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migraine Headaches
Sponsor
University of Texas Southwestern Medical Center
Enrollment
45
Locations
1
Primary Endpoint
Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
October 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deborah Friedman

Primary Investigator, MD, Neurology and Neurotheraputics

University of Texas Southwestern Medical Center

Eligibility 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice

Time Frame: One Year

Percentage of completed scheduled study visits for each group.

Study Sites (1)

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