Migraine Clinical Trial
Official title:
Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
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.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 11 Years to 17 Years |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura - Frequency of 8 or more headaches per month - Access to the internet whether public (e.g., library) or private (e.g., home, personal) - English fluency for patient and caregiver Exclusion Criteria: - Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review - Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Medical Center, Cincinnati |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Headache frequency | Change in number of days with a headache | 15 months |
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