search
Back to results

Migraine Manager (R01)

Primary Purpose

Migraine, Migraine Disorders

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Migraine Manager
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura
  • Frequency of 8 or more headaches per month
  • Access to the internet whether public (e.g., library) or private (e.g., home, personal)
  • English fluency for patient and caregiver

Exclusion Criteria:

  • Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review
  • Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Migraine Manager

Attention Control

Arm Description

The Migraine Manager portal intervention is comprised of 16 modules that are assigned in an individually tailored manner to participants based on their answers to a brief assessment battery. Once assessments are completed, a treatment plan consisting of recommended modules is automatically generated for patient and parent guidance, and the user is directed to the list of recommended modules. Participants will also complete online daily diaries for eight weeks.

Participants in this arm will complete the online daily diaries for eight weeks (i.e., equal time as the Migraine Manager arm) through the portal but will be restricted from receiving intervention content; they will also receive equal number of communications via the portal as the Migraine Manager arm. Data from migraine daily diaries will not be available to AC participants or their clinicians as this would likely be used clinically and lead to contamination of the control arm resulting from varying levels of intervention across participants based on their data.

Outcomes

Primary Outcome Measures

Headache frequency
Change in number of days with a headache

Secondary Outcome Measures

Full Information

First Posted
September 23, 2020
Last Updated
May 22, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT04567355
Brief Title
Migraine Manager (R01)
Official Title
Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

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

5. Study Description

Brief Summary
The objective of this trial is to test whether an online tailored intervention, Migraine Manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. We will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. We will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. Clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. The primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. Secondary outcomes include health-related quality of life and migraine disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Migraine Disorders
Keywords
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The study PI, statistician, co-investigators, and all personnel who are involved in endpoint assessments will be blinded. Only one team member (lead CRC) will have access to the assignment of each participant.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Migraine Manager
Arm Type
Experimental
Arm Description
The Migraine Manager portal intervention is comprised of 16 modules that are assigned in an individually tailored manner to participants based on their answers to a brief assessment battery. Once assessments are completed, a treatment plan consisting of recommended modules is automatically generated for patient and parent guidance, and the user is directed to the list of recommended modules. Participants will also complete online daily diaries for eight weeks.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
Participants in this arm will complete the online daily diaries for eight weeks (i.e., equal time as the Migraine Manager arm) through the portal but will be restricted from receiving intervention content; they will also receive equal number of communications via the portal as the Migraine Manager arm. Data from migraine daily diaries will not be available to AC participants or their clinicians as this would likely be used clinically and lead to contamination of the control arm resulting from varying levels of intervention across participants based on their data.
Intervention Type
Behavioral
Intervention Name(s)
Migraine Manager
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 a headache
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura Frequency of 8 or more headaches per month Access to the internet whether public (e.g., library) or private (e.g., home, personal) English fluency for patient and caregiver Exclusion Criteria: Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Hommel, PhD
Phone
513-803-0407
Email
kevin.hommel@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica King, BA
Phone
513-803-0920
Email
jessica.king1@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Hommel, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Powers, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andrew Hershey, MD, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Susan LeCates, MSN, FNP
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marielle Kabbouche-Samaha, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James Peugh, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lee Ritterband, MD
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Hommel, PhD
Phone
513-803-0407
Email
kevin.hommel@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jessica King, BA
Phone
513-803-0920
Email
jessica.king1@cchmc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Migraine Manager (R01)

We'll reach out to this number within 24 hrs