Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04567355
PHASE2

Migraine Manager (R01)

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

Official title: Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)

Key Details

Gender

All

Age Range

11 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2021-06-10

Completion Date

2026-06-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Migraine Manager

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.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States