# Randomized Controlled Trial of Migraine Manager: A Digital Therapeutic Self-Management Tool for Adolescents with Migraine

> **NIH NIH R01** · CINCINNATI CHILDRENS HOSP MED CTR · 2021 · $610,186

## Abstract

Project Summary
Poor disease self-management is a significant issue in pediatric migraine as comprehensive treatment for
migraine includes pharmacological and biobehavioral interventions as well as consistent engagement in
healthy habits (i.e., adequate hydration, eating a healthy and balanced diet, regular exercise, and sufficient
sleep), and requires daily patient effort to ensure optimal outcomes. With the annual cost of nonadherence in
US health care exceeding $300 billion, self-management of chronic conditions is critical to reducing morbidity
and health care expenses. We have identified numerous factors that interfere with adolescents’ ability to
effectively self-manage including treatment burden, forgetting, catastrophizing, negative beliefs about
treatment efficacy, and lack of parental support/monitoring. Although these barriers are amenable to behavioral
intervention/CBT, many adolescents lack the self-management skills to overcome them on their own, and
clinic-based self-management efforts have proven inadequate. Through our intervention research, we have
demonstrated the efficacy of multicomponent self-management intervention and CBT for migraine treatment.
However, the proportion of the migraine population that could receive this type of treatment has been restricted
due to limited access (e.g., lack of available trained clinicians, distance between patient homes and treatment
facility). With funding from our recent R21 (NS094476) and in collaboration with key stakeholders (i.e.,
patients, parents, and clinicians), we have addressed these accessibility issues by iteratively developing the
first migraine-specific digital therapeutic self-management tool, Migraine Manager, which can be used by all
key users to address patient self-management needs. Patients receive algorithmically-derived individualized
intervention to meet their needs, and clinicians have access to patient data regarding their symptoms and self-
management intervention data that can be obtained prior to or in-between clinic visits. The proposed project
aims to conduct a randomized controlled clinical trial to test the effect of the Migraine Manager portal on
headache frequency, health-related quality of life, and migraine-related disability in 160 adolescents with
migraine compared to an attention control group. We will also test the sustainability of treatment effects
through examination of clinical endpoints at 3-, 6-, 9-, and 12-month follow-up, as well as potential
mechanisms of observed treatment effects. This study will have a significant impact on public health by
providing greater access to an evidence-based resource to a large proportion of patients who otherwise would
not receive treatment, thereby reducing health care disparities for families that have limited access to services.
Given the health and economic impact of poor self-management in migraine, this study is timely and important,
as it has the potential to positively impact health outcomes in this p...

## Key facts

- **NIH application ID:** 10247805
- **Project number:** 5R01NR019426-02
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Kevin Hommel
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $610,186
- **Award type:** 5
- **Project period:** 2020-08-26 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247805

## Citation

> US National Institutes of Health, RePORTER application 10247805, Randomized Controlled Trial of Migraine Manager: A Digital Therapeutic Self-Management Tool for Adolescents with Migraine (5R01NR019426-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10247805. Licensed CC0.

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