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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157739
Other study ID # CIN001 MigraineManager
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2017
Est. completion date April 30, 2018

Study information

Verified date July 2019
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Kevin Hommel Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Headache frequency change in number of days with headache 15 months
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