Migraine Manager (R01)

NCT04567355 | Active Not Recruiting Phase 2

• 2 other identifiers: MM R01R01NR019426
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Migraine Disorders

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  Change in number of days with a headache

  15 months

Study Arms (2)

Migraine Manager

EXPERIMENTAL

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

Attention Control

NO INTERVENTION

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.

Interventions

Migraine Manager BEHAVIORAL

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.

Migraine Manager

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kevin Hommel, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Scott Powers, PhD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Andrew Hershey, MD, PhD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Susan LeCates, MSN, FNP

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Marielle Kabbouche-Samaha, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• James Peugh, PhD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

• Lee Ritterband, MD

  University of Virginia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only one team member (lead CRC) will have access to the assignment of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: June 10, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)