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Migraine Manager (R01)
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.
Official title: Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
Key Details
Gender
All
Age Range
11 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2021-06-10
Completion Date
2026-06-30
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Migraine Manager
Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States