Protocol for a randomized controlled trial evaluating a digital behavioral self-management intervention for...

Area of Science:

• Neurology
• Digital Health
• Adolescent Medicine

Background:

• Poor self-management of migraine is prevalent in children and adolescents, impacting morbidity.
• Existing clinic-based interventions for migraine self-management face accessibility limitations.
• The economic burden of nonadherence in healthcare exceeds $300 billion annually.

Purpose of the Study:

• To evaluate the efficacy of Migraine Manager, a novel digital therapeutic, for improving migraine self-management in adolescents.
• To assess the impact of Migraine Manager on headache frequency, health-related quality of life (HRQOL), and disability.
• To address disparities in healthcare access for pediatric migraine patients through a scalable digital solution.

Main Methods:

• A randomized controlled trial involving 160 adolescents with migraine was conducted.
• Participants were assigned to either the Migraine Manager intervention or an attention control arm.
• Outcomes including headache frequency, HRQOL, and disability were measured post-treatment and at 3-, 6-, 9-, and 12-month follow-ups.

Main Results:

• Anticipated statistically significant improvements in headache frequency, HRQOL, and migraine-related disability in the Migraine Manager arm.
• Comparison between the intervention and attention control groups at multiple follow-up points.
• Data collection focused on objective and subjective measures of migraine impact.

Conclusions:

• Migraine Manager has the potential to significantly improve self-management of migraine in adolescents.
• The digital therapeutic offers a scalable solution to enhance access to evidence-based care for pediatric migraine.
• Successful implementation could reduce healthcare disparities and serve as a model for pediatric chronic condition self-management.