Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+8

+ Central Nervous System Diseases

+ Nervous System Diseases

From 18 to 89 Years
See all eligibility criteria
How is the trial designed

Ecologic or Community

Assessing exposures and health outcomes at the community level in order to identify population-wide health trends.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: October 25, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: October 25, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Ecologic or Community

These studies look at groups or populations rather than individuals. They explore community-wide exposures and health outcomes to understand public health trends and risks at a broader scale.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 89 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache DisordersHeadache Disorders, PrimaryHeadacheMigraine Disorders

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 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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Universit of Texas Southwestern

Dallas, United StatesOpen Universit of Texas Southwestern in Google Maps
CompletedOne Study Center