Migraine Manager (R01)

Study Overview
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Brief Summary
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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
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Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)

Conditions
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Migraine, Migraine Disorders

Intervention / Treatment
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* Behavioral: Migraine Manager


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Migraine Manager<br>The Migraine Manager portal intervention is comprised of 16 modules that are assigned in an individually tailored manner to participants based on their answers to a brief assessment battery. Once assessments are completed, a treatment plan consisting of recommended modules is automatically generated for patient and parent guidance, and the user is directed to the list of recommended modules. Participants will also complete online daily diaries for eight weeks. | Behavioral: Migraine Manager<br>* 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.<br>|
| No Intervention: Attention Control<br>Participants in this arm will complete the online daily diaries for eight weeks (i.e., equal time as the Migraine Manager arm) through the portal but will be restricted from receiving intervention content; they will also receive equal number of communications via the portal as the Migraine Manager arm. Data from migraine daily diaries will not be available to AC participants or their clinicians as this would likely be used clinically and lead to contamination of the control arm resulting from varying levels of intervention across participants based on their data. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache frequency | Change in number of days with a headache | 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine