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| ID | Type | Description | Link |
|---|---|---|---|
| MERCK | Other Identifier | MISP |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | Percentage of completed scheduled study visits for each group. | One Year |
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Inclusion Criteria:• Ages 18 - 89 years
Criteria for Exclusion of Subjects:
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Patients must be diagnosed with Migraine Headaches
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Friedman, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universit of Texas Southwestern | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31450969 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Telemedicine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | Percentage of completed scheduled study visits for each group. | Posted | Number | percentage of scheduled appointments | One Year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission | Nervous system disorders | Non-systematic Assessment | Hospitalized for headache treatment as part of routine clinical care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah I. Friedman, MD, MPH, Professor of Neurology and Neurotherapeutics and Ophthalmology | UT Southwestern Medical Center | 2146483517 | Deborah.Friedman@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2012 | Jun 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Lost to Follow-up |
|
People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Migraine Disability Assessment Score (MIDAS) | The Migraine Disability Assessment Score (MIDAS) has a scale range of 0-270. Lower values represents a better outcome, higher values represents a worse outcome. | Mean | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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 | 0 | 22 | 3 | 22 | 0 | 22 |
|
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |