Migraine Headaches
Conditions
Keywords
Migraine, Headaches, Telemedicine
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.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
University of Texas Southwestern Medical Center
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | One Year | Percentage of completed scheduled study visits for each group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 23 |
| 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 | 22 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
| Overall Study | Not scheduled | 3 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 45 Participants |
| Migraine Disability Assessment Score (MIDAS) | 40.5 units on a scale | 65 units on a scale | 47.9 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 3 / 22 |
Outcome results
Primary
Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice
Percentage of completed scheduled study visits for each group.
Time frame: One Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| In-Office Group | Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | 87 percentage of scheduled appointments |
| Telemedicine Group | Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | 92.7 percentage of scheduled appointments |