Migraine HeadachesNCT01706003
The Utility of Telemedicine in the Management of Migraine
An observational study of Migraine Headaches, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patients will be randomly assigned to receive their follow-up care via telemedicine or in-office visits. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Migraine Headaches
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients must be diagnosed with Migraine Headaches
Who may be able to join
- 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
Show all 12Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Universit of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine Headaches
- Keywords
- Migraine, Headaches, Telemedicine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice
Percentage of completed scheduled study visits for each group.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadachesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Deborah Friedman, University of Texas Southwestern Medical Center
- Investigators
- Deborah Friedman, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706003
- Sponsor's protocol ID
- MK0974-071-00
- Other IDs
- MERCK
- Status last verified
- Sep 2019
- First submitted
- 10 Oct 2012
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31450969
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Telemedicine in the Management of Migraine: A Pilot Study :MK0974-071-00
- ClinicalTrials.gov ID
- NCT01706003
- Acronym / sponsor ID
- MK0974-071-00
- Conditions
- Migraine Headaches
- Keywords
- Migraine, Headaches, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2012
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients must be diagnosed with Migraine Headaches
Key inclusion criteria (12 listed)
- 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
- Age less than 18 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31450969Friedman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Friedman, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Headaches, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.