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

  • Oliveira Gonçalves, Ana Sofia1
  • Laumeier, Inga2
  • Hofacker, Maxi Dana3
  • Raffaelli, Bianca2, 4
  • Burow, Philipp5
  • Dahlem, Markus A.6
  • Heintz, Simon5
  • Jürgens, Tim Patrick7
  • Naegel, Steffen5
  • Rimmele, Florian7
  • Scholler, Simon6
  • Kurth, Tobias1
  • Reuter, Uwe2, 8
  • Neeb, Lars2
  • 1 Institute of Public Health, Corporate Member of Freie Universität Berlin, Charité—Universitätsmedizin Berlin, Humboldt Universität zu Berlin, Berlin , (Germany)
  • 2 Department of Neurology, Corporate Member of Freie Universität Berlin, Charité—Universitätsmedizin Berlin, Humboldt Universität zu Berlin, Berlin , (Germany)
  • 3 Kath. Marienkrankenhaus gGmbH, Hamburg , (Germany)
  • 4 Clinician Scientist Program, Berlin Institute of Health (BIH), Berlin , (Germany)
  • 5 Department of Neurology, University Hospital Halle, Martin-Luther-University Halle-Wittenberg, Wittenberg , (Germany)
  • 6 Newsenselab GmbH, Berlin , (Germany)
  • 7 Department of Neurology, University of Rostock, Rostock , (Germany)
  • 8 Universitätsmedizin Greifswald, Greifswald , (Germany)
Published Article
Frontiers in Neurology
Frontiers Media SA
Publication Date
Jun 16, 2022
DOI: 10.3389/fneur.2022.912288
  • Neurology
  • Study Protocol


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.

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