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

项目总结

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 population and serve as a model for self- management intervention across pediatric populations.