An observational study in Migraine Headaches, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 45 is below the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must be diagnosed with Migraine Headaches
Inclusion Criteria:• Ages 18 - 89 years
Criteria for Exclusion of Subjects:
People who suffer from Migraine Headaches who own a computer and have internet access and will be treated via telemedicine for migraine headaches
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
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
| Milestone | In-Office Group | Telemedicine Group |
|---|---|---|
| Started | 23 | 22 |
| Completed | 12 | 18 |
| Not completed | 11 | 4 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Not scheduled | 3 | 0 |
| Withdrew: Lost to follow-up | 6 | 4 |
Percentage of completed scheduled study visits for each group.
| percentage of scheduled appointments | In-Office Group | Telemedicine Group |
|---|---|---|
| Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice | 87 | 92.7 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| In-Office Group | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Telemedicine Group | 0/22 (0%) | 3/22 (13.6%) | 0/22 (0%) |
| Event | In-Office Group | Telemedicine Group |
|---|---|---|
| Hospital admissionNervous system disorders | 0/23 | 3/22 |
| Age, Categorical(Participants) | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 22 | 45 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 2 | 0 | 2 |
| Race and Ethnicity Not Collected(Participants) | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| United States | 23 | 22 | 45 |
| Migraine Disability Assessment Score (MIDAS)(units on a scale) | In-Office Group | Telemedicine Group | Total |
|---|---|---|---|
| Mean | 40.5 (3 to 161) | 65 (11 to 192) | 47.9 (3 to 192) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center