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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
356
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.
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.
NYU Langone Health
New York, New York, United States
RECRUITINGChange 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.
Time frame: Baseline, Week 6
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.
Time frame: Baseline, Week 6
Change in Monthly Headache Days (MHDs)
MHDs data derived from the mMIDAS questionnaire and electronic diary.
Time frame: Baseline, Week 6
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