RECRUITING

Migraine Manager (R01)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Migraine Manager: An Individualized Self-Management Tool for Adolescents With Migraine (R01)

Quick Facts

Study Start:2021-06-10
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04567355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of migraine using current International Classification of Headache Disorders Criteria (ICHD-3) for migraine with or without aura
  2. * Frequency of 8 or more headaches per month
  3. * Access to the internet whether public (e.g., library) or private (e.g., home, personal)
  4. * English fluency for patient and caregiver
  1. * Patients with a diagnosis of pervasive developmental disorder as determined by medical chart review
  2. * Patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review

Contacts and Locations

Study Contact

Kevin Hommel, PhD
CONTACT
513-803-0407
kevin.hommel@cchmc.org
Jessica King, BA
CONTACT
513-803-0920
jessica.king1@cchmc.org

Principal Investigator

Kevin Hommel, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Scott Powers, PhD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Andrew Hershey, MD, PhD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Susan LeCates, MSN, FNP
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Marielle Kabbouche-Samaha, MD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
James Peugh, PhD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Lee Ritterband, MD
STUDY_CHAIR
University of Virginia

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Kevin Hommel, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • Scott Powers, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • Andrew Hershey, MD, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • Susan LeCates, MSN, FNP, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • Marielle Kabbouche-Samaha, MD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • James Peugh, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • Lee Ritterband, MD, STUDY_CHAIR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-10
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2021-06-10
Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

  • Migraine

Additional Relevant MeSH Terms

  • Migraine
  • Migraine Disorders