Back to resultsMigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Primary Purpose
Migraine Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MigraineManager: Individualized Self-Management Tool
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring Migraine
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
Sites / Locations
- Kevin Hommel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Evaluation of Optimized Prototype
Arm Description
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.
Outcomes
Primary Outcome Measures
Headache frequency
change in number of days with headache
Secondary Outcome Measures
Full Information
NCT ID
NCT03157739
First Posted
April 4, 2017
Last Updated
July 23, 2019
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03157739
Brief Title
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Official Title
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Evaluation of Optimized Prototype
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MigraineManager: Individualized Self-Management Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Headache frequency
Description
change in number of days with headache
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kevin Hommel
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MigraineManager: An Individualized Self-Management Tool for Adolescents With Migraine
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