A randomized controlled trial of a multimodality digital health intervention to aid the delivery of the modified ketogenic diet therapy for epilepsy: The Keto eCoach trial protocol
Randomized trial demonstrates a multimodality digital health intervention for dietary therapy in drug-resistant epilepsy, highlighting novel approaches to enhance treatment adherence.
Key Points
To evaluate the efficacy of a 12-week multimodality digital health intervention in improving treatment adherence and clinical outcomes among adults undertaking the modified ketogenic diet for drug-resistant epilepsy.
Two-arm randomized controlled trial assigning 136 adult participants (1:1) to standard modified ketogenic diet clinical care or standard care supplemented by a digital health intervention for 12 weeks (ACTRN12624000486527).
Intervention components comprise digital tracking diaries, a novel at-home saliva-based ketone monitoring device, and dynamic dietitian support.
Primary treatment benefit is assessed using the epilepsy desirability of outcome rank, a composite measure co-designed with individuals living with drug-resistant epilepsy.
Secondary outcomes encompass seizure frequency, treatment retention rates, adverse events, psychiatric symptoms, quality of life, medication utilization, and cost-effectiveness.