The Utility of Telemedicine in the Management of Migraine

September 29, 2019 updated by: Deborah Friedman, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Universit of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients must be diagnosed with Migraine Headaches

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Deborah Friedman, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

September 29, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK0974-071-00
  • MERCK (Other Identifier: MISP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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