Migraine Manager (R01)

Cincinnati Children's Hospital Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Migraine Disorders; Migraine

Treatments: Behavioral: Migraine Manager

Study type: Interventional

Funder types: Other

Identifiers

NCT04567355

MM R01

R01NR019426 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Migraine Manager

Experimental group

Description:

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.

Treatment:

Behavioral: Migraine Manager

Attention Control

No Intervention group

Description:

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.