The Utility of Telemedicine in the Management of Migraine

NCT ID: NCT01706003

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Migraine Headaches

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

Telemedicine Group

People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches

No interventions assigned to this group

In-Office Group

People who suffer from Migraine Headaches who own a computer and have internet access and will be treated in the clinician's office for migraine headaches

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Deborah Friedman

Primary Investigator, MD, Neurology and Neurotheraputics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Universit of Texas Southwestern

Dallas, Texas, United States

Countries

United States

References

Friedman DI, Rajan B, Seidmann A. A randomized trial of telemedicine for migraine management. Cephalalgia. 2019 Oct;39(12):1577-1585. doi: 10.1177/0333102419868250. Epub 2019 Aug 26.

Reference Type: DERIVED

PMID: 31450969 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MERCK

Identifier Type: OTHER

Identifier Source: secondary_id

MK0974-071-00

Identifier Type: -

Identifier Source: org_study_id