MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine

NCT ID: NCT03157739

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-06
• Study Completion Date: 2018-04-30

Brief Summary

The purpose of the study is to develop, evaluate, and optimize "MigraineManager", the first web-based comprehensive self-management tool for adolescents with migraine, their parents, and clinicians.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evaluation of Optimized Prototype

Patients and parents will use MigraineManager to complete assessment measures at baseline and post-treatment (i.e., 2 months after baseline). Answers to these measures will determine what interventions each participant will receive. Data obtained in this phase will be used to make final modifications to MigraineManager for large scale testing.

Group Type: EXPERIMENTAL

MigraineManager: Individualized Self-Management Tool

Intervention Type: 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.

Interventions

MigraineManager: Individualized Self-Management Tool

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patient is diagnosed with migraines using current International Classification of Headache Disorders criteria (ICHD-3 beta) for migraine with or without aura
• Patient has headache frequency of 8+ per month
• Access to the internet whether public (e.g., library) or private (e.g., home, personal)
• English fluency for patient, caregiver, and clinician

Exclusion Criteria

• Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
• Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kevin Hommel

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

CIN001 MigraineManager

Identifier Type: -

Identifier Source: org_study_id