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.|
|ClinicalTrials.gov Identifier: NCT01706003|
Recruitment Status : Enrolling by invitation
First Posted : October 15, 2012
Last Update Posted : October 26, 2017
|Condition or disease|
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|
|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|
People who suffer from Migraine Headaches who own a computer and have internet access
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01706003
|United States, Texas|
|Universit of Texas Southwestern|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Deborah Friedman, MD||University of Texas Southwestern Medical Center|