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

NCT03157739 | Completed

• 1 other identifier: CIN001 MigraineManager
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Headache frequency

  change in number of days with headache

  15 months

Study Arms (1)

Evaluation of Optimized Prototype

EXPERIMENTAL

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.

Behavioral: MigraineManager: Individualized Self-Management Tool

Interventions

MigraineManager: Individualized Self-Management Tool 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.

Evaluation of Optimized Prototype

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Kevin Hommel

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: May 17, 2017
• Study Start: December 6, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)