Implementing a digital solution for patients with migraine—Developing a methodology for comparing digitally delivered treatment with conventional treatment: A study protocol

Abstract

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. The maximum number of participants in this multi-centre, open-label, prospective, randomized study is 600, divided into eight treatment groups. The participants will take part in either a conventional or a digital intervention, performing various tests and interdisciplinary tasks. The primary outcome is expected to be a reduction in the number of headache days. We also undertake to measure various other headache-related burdens as a secondary outcome. The sample size, digital interventions not conducted via video calls, the lack of human connection, limited intervention program, and the conducting of 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.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).