Study Design and Protocol of a Randomized Controlled Trial of the Efficacy of a Smartphone-Based Therapy of Migraine (SMARTGEM).

Background: Digitalization and electronic health (eHealth) offer new treatment approaches for patients with migraine. Current smartphone applications (apps) for migraine patients include a wide spectrum of functions ranging from digital headache diaries to app-based headache treatment by, among others, analysis of the possible triggers, behavioral therapy approaches and prophylactic non-drug treatment methods with relaxation therapy or endurance sport. Additional possibilities arise through the use of modern, location-independent communication methods, such as online consultations. However, there is currently insufficient evidence regarding the benefits and/or risks of these electronic tools for patients. To date, only few randomized controlled trials have assessed eHealth applications.
Methods: SMARTGEM is a randomized controlled trial assessing whether the provision of a new digital integrated form of care consisting of the migraine app M-sense in combination with a communication platform (with online consultations and medically moderated patient forum) leads to a reduction in headache frequency in migraine patients, improving quality of life, reducing medical costs and work absenteeism (DRKS-ID: DRKS00016328).
Discussion: SMARTGEM constitutes a new integrated approach for migraine treatment, which aims to offer an effective, location-independent, time-saving and cost-saving treatment. The design of the study is an example of how to gather high quality evidence in eHealth. Results are expected to provide insightful information on the efficacy of the use of electronic health technology in improving the quality of life in patients suffering from migraine and reducing resource consumption.
Competing Interests: BR reports research grants from Novartis, and personal fees from Allergan, Hormosan, Lilly, Novartis, and Teva. MD is a Co-founder, managing director, and shareholder of the Newsenselab GmbH (App M-sense). SH received speaking honoraria by TEVA. TJ contributed to advisory boards of Allergan, Hormosan, Lilly, Lundbeck, Novartis, and Teva and received speaking fees from Allergan, Grünenthal, Hormosan, Lilly, Lundbeck, Novartis, Sanofi, and Teva and research funding from Novartis. SN contributed to advisory boards of Hormosan, Lundbeck, Novartis, and TEVA, and received speaking fees from Allergan, Hormosan, Lilly, Novartis, and TEVA. He received research grants from Novartis. FR contributed to advisory boards of AllerganNovartis, TEVA, and received speaking fees from Allergan, Ipsen, Lilly, Novartis, and TEVA. SS is employed at Newsenselab GmbH (App M-sense). TK reported to have received research grants from the German Joint Committee and the German Ministry of Health. He further has received personal compensation from Eli Lilly & Company, Teva, TotalEnergies S.E., the BMJ, and Frontiers. UR received honoraria for consulting and lectures from Amgen, Allergan, Abbvie, Eli Lilly, Lundbeck, Novartis, electroCore, Medscape, StreaMedUp, and Teva, and research funding from the German Federal Ministry of Education and Research and Novartis. LN contributed to advisory boards of Hormosan, Lilly, Novartis, and TEVA, and received speaking fees from Allergan, Hormosan, Lilly, Novartis, and TEVA. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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