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

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ClinicalTrials.gov Identifier: NCT03157739
Recruitment Status : Not yet recruiting
First Posted : May 17, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Migraine Disorders Behavioral: MigraineManager: Individualized Self-Management Tool

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Anticipated Study Start Date : August 1, 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.


Outcome Measures

Primary Outcome Measures :
  1. Headache frequency [ Time Frame: 15 months ]
    change in number of days with headache


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157739


Contacts
Contact: Kevin Hommel, PhD 513-803-0407 kevin.hommel@cchmc.org
Contact: Colleen Gerding, BA colleen.gerding@cchmc.org

Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
More Information

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03157739     History of Changes
Other Study ID Numbers: CIN001 MigraineManager
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases