Migraine Manager (R01)

Phase 2

Recruiting

• Conditions: Migraine; Migraine Disorders
• Interventions: Behavioral: Migraine Manager

• Registration Number: NCT04567355
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Study Start: 2021-06-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Migraine Manager	Migraine Manager	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.

Primary Outcome Measures

Name	Time	Method
Headache frequency	15 months	Change in number of days with a headache

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States