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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This study is a fully powered, remote randomized control trial to evaluate RELAXaHEAD in people with migraine.
Patients with migraine seen across diverse primary care practices (through three different affiliated hospitals and one of the largest family health center groups in the country) will be identified via an electronic medical record system. The investigators will randomize 356 participants and examine the potential benefits to two different smartphone based interventions between baseline and weeks 3-6. The investigators will also examine the persistence of effects up to 26 weeks post-treatment, mediators to explore mechanisms, and moderators to identify subgroups of patients for whom the intervention seems most effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RELAX Group 1 | Active Comparator | Participants will receive access to the RELAXaHEAD app version 1 which contains certain features for migraine self-management with written materials. |
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| RELAX Group 2 | Active Comparator | Participants will receive access to the RELAXaHEAD app version 2 which contains certain features for migraine self-management with written and audio materials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELAXaHEAD Smartphone App Version 1 | Behavioral | RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Modified Monthly Migraine Disability Assessment Scale (mMIDAS) Score | 5-item scale designed to measure disability over the previous 4 weeks. The total score is the sum of missed days due to a migraine from paid work, school, housework, and nonwork (family, social, and leisure) activities and days at paid work or housework where productivity was reduced by at least half. A decrease in scores indicates disability decreased during the observational period. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Migraine Specific Quality of Life (MSQ) Version 2 Scores | 14-item self-assessment of how migraine affects a patient's life. Items ranked on a 6-point Likert scale, where: 1 = None of the time; 2 = A little bit of the time; 3 = Some of the time; 4 = A good bit of the time; 5 = Most of the time; and 6 = All of the time. Raw dimension scores are computed as a sum of item responses and rescaled on a 0-100 scale; higher scores indicate better quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mia T Minen, MD | Contact | 212-263-7744 | Mia.minen@nyulangone.org | |
| Erin Waire | Contact | 929-455-5591 | Erin.Waire@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Mia T Minen, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: mia.minen@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to mia.minen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| RELAXaHEAD Smartphone App Version 2 | Behavioral | RELAXaHEAD is a smartphone application that allows users to track headache frequency and severity, sleep, medication, medication side effects, and menstrual cycle, and create personal notes daily. The RELAXaHEAD app has an option for users to view their data reports and charts. This version also contains audio materials. |
|
| Baseline, Week 6 |
| Change in Monthly Headache Days (MHDs) | MHDs data derived from the mMIDAS questionnaire and electronic diary. | Baseline, Week 6 |
| D009422 | Nervous System Diseases |