Implementing a digital solution for patients with migraine - developing a methodology for comparing digitally delivered treatment to conventional treatment: A study protocol

Abstract Background Migraine is one of the most frequent and expensive neurological disease in the world. Non-pharmacological and digitally administered treatment options have long been used in the treatment of chronic pain and mental illness. Digital solutions increase the patients’ possibilities of receiving evidence-based treatment even when conventional treatment options are limited. The main goal of the study is to assess the efficacy of interdisciplinary digital interventions compared to conventional treatment.Methods The maximum number of participants in this multi-centre, open-label, prospective, randomised study is 600, divided into eight different treatment groups. The participants take part in either a conventional or a digital intervention, performing various tests and interdisciplinary tasks. The primary outcome is a reduction in the number of headache days. We also measure various other headache-related burdens as a secondary outcome.Discussion Based on preliminary data from the pilot study, digitally mediated treatment reduces a specialist’s time spent on a single patient by more than tenfold. The sample size; digital interventions not conducted via video calls; a lack of human connection; limited intervention programmes and conducting studies only in digitally sophisticated countries are all significant limitations. However, we believe that digitally mediated treatment options are at least as effective as traditional treatment options while also allowing for a significantly higher patient throughput. The future of chronic disease treatment is remote monitoring and high-quality digitally mediated interventions.Registration: The study is approved by the Ethics Committee of the University of Tartu for Human Research (permission no 315T-17, 10.08.2020) and is registered at ClinicalTrials.gov: NTC05458817 (14.07.2022)