ArticleDigital health
IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000.
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Authors and funding
100 authors.
Walter MaetzlerDepartment of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.ORCID https://orcid.org/0000-0002-5945-4694
Stefan AveyJohnson & Johnson, Spring House, PA, USA.ORCID https://orcid.org/0000-0003-2768-4337
Andrea PilottoDepartment of Clinical and Experimental Sciences, Neurology Unit and Laboratory of Digital Neurology and biosensors, University of Brescia, Brescia, Italy.
C Janneke van der WoudeDepartment of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Christopher A LambFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Ralf ReilmannGeorge-Huntington-Institute, Münster, Germany.
Teemu AhmaniemiVTT Technical Research Centre of Finland Ltd, Tampere, Finland.
Nadir AmmourSanofi R&D, Paris, France.ORCID https://orcid.org/0009-0005-3046-5057
Svenja AufenbergGeorge-Huntington-Institute, Münster, Germany.
Luisa AvedanoEuropean Federation of Crohn's and Ulcerative Colitis, Brussels, Belgium.
Neil BasuCollege of Medical, Veterinary & Life Sciences, University of Glasgow, Glasgow, UK.
Simon BenistonMediBioSense Ltd Haxey, England, UK.
Sofia BonomelliDepartment of Clinical and Experimental Sciences, Neurology Unit and Laboratory of Digital Neurology and biosensors, University of Brescia, Brescia, Italy.
Susanne T de BotDepartment of Neurology, Leiden University Medical Center, Leiden, The Netherlands.ORCID https://orcid.org/0000-0002-3512-2468
Diogo BrancoLASIGE, Faculdade de Ciências, Universidade de Lisboa, Lisbon, Portugal.ORCID https://orcid.org/0000-0001-9756-3907
Ian BruceCentre for Epidemiology Versus Arthritis, The University of Manchester, Manchester, UK.
Christopher Neil BullOpen Lab, School of Computing, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0002-9811-4190
Neshat CharehEuropean Clinical Research Infrastructure Network, Berlin, Germany.
Meenakshi ChatterjeeJohnson & Johnson, Spring House, PA, USA.
Hector ChinoyManchester Academic Health Science Centre, Salford, UK.
Jade ChisholmDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
Hayley ConnollySchool of Allied Health, Faculty of Education and Health Sciences, and Health Research Institute, University of Limerick, Limerick, Ireland.
Francesca CormackClinical Science, Cambridge Cognition, Cambridge, UK.
Leonor Correia GuedesInstituto de Medicina Molecular João Lobo Antunes and Centro de Estudos Egas Moniz, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.ORCID https://orcid.org/0000-0002-8422-0494
Cliona CowhigDepartment of Nephrology and Transplantation, Beaumont Hospital, Dublin, Ireland.ORCID https://orcid.org/0000-0003-1060-752X
Dina De SousaEuropean Huntington's Association, Lisbon, Portugal.
Silvia Del DinFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0003-1154-4751
Monique DevillersDepartment of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Inês M DiasInstituto de Medicina Molecular João Lobo Antunes and Centro de Estudos Egas Moniz, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.ORCID https://orcid.org/0000-0002-7211-7609
Colin Bone DoddsOpen Lab, School of Computing, Newcastle University, Newcastle upon Tyne, UK.
Mary DoonaFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Annika DvinskisRheumatology Department, Cork University Hospital, Cork, Ireland.
Joaquim J FerreiraInstituto de Medicina Molecular João Lobo Antunes and Centro de Estudos Egas Moniz, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal.
Konstantinos FourlakisDepartment of Rheumatology and Clinical Immunology, University Hospital Schleswig-Holstein and University of Lübeck, Lübeck, Germany.
Ulli FunkenParkinson's UK, London, UK.
Kay GouldenManchester Academic Health Science Centre, Salford, UK.
Johanna GraeberInstitute of General Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Miriam Grande GordonAsociación Parkinson Madrid (APM), Madrid, Spain.
Hanna GraßhoffDepartment of Rheumatology and Clinical Immunology, University Hospital Schleswig-Holstein and University of Lübeck, Lübeck, Germany.
Tiago GuerreiroLASIGE, Faculdade de Ciências, Universidade de Lisboa, Lisbon, Portugal.ORCID https://orcid.org/0000-0002-0333-5792
Tina Hagen-HurleyCenter for Clinical Trials Kiel (ZKS Kiel), University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.
Clint HansenDepartment of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.
Sinead HarneyRheumatology Department, Cork University Hospital, Cork, Ireland.
Ailsa HartResearch and Innovation Department, St Marks Hospital, London North West University Healthcare NHS Trust, UK.
Chloe HinchliffeFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Sophia HinzDepartment of Internal Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Marthe Alver HovsbakkenDepartment of Rheumatology, Stavanger University Hospital, Stavanger, Norway.ORCID https://orcid.org/0009-0008-8982-532X
Michael JacksoniXscient Ltd, Twickenham, UK.
Lauren JohnDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.ORCID https://orcid.org/0009-0000-4167-9820
Hanna KaduszkiewiczInstitute of General Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Jérôme KalifaLet It Care, Paris, France.
Niamh KellyRheumatology Department, Cork University Hospital, Cork, Ireland.
Nick KennedyDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
Norelee KennedySchool of Allied Health, Faculty of Education and Health Sciences, and Health Research Institute, University of Limerick, Limerick, Ireland.ORCID https://orcid.org/0000-0001-6047-1240
Juha M KortelainenVTT Technical Research Centre of Finland Ltd, Tampere, Finland.
Laura C M KuijperDepartment of Neurology, Leiden University Medical Center, Leiden, The Netherlands.ORCID https://orcid.org/0009-0008-6084-8317
Samuel LabrecqueDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.ORCID https://orcid.org/0009-0006-9109-6205
Yasmin LaidlerFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Tanja LangeDepartment of Rheumatology and Clinical Immunology, University Hospital Schleswig-Holstein and University of Lübeck, Lübeck, Germany.ORCID https://orcid.org/0000-0001-8309-2112
Maria Boge LauvsnesDepartment of Rheumatology, Stavanger University Hospital, Stavanger, Norway.
Jimmy K LimdiManchester Academic Health Science Centre, Salford, UK.
Ellen Lirani-SilvaFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0002-7658-6883
Victoria MacraeFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0009-0002-3036-2996
Corina MaetzlerDepartment of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.ORCID https://orcid.org/0009-0007-2579-6219
Mayca MarínAsociación Parkinson Madrid (APM), Madrid, Spain.ORCID https://orcid.org/0000-0002-1720-2560
Dario MasulloJohnson & Johnson, Beerse, Belgium.
Tania NightingaleDepartment of Gastroenterology, Royal Devon University Healthcare NHS Foundation Trust, Exeter, UK.
Alessandro PadovaniDepartment of Clinical and Experimental Sciences, Neurology Unit and Laboratory of Digital Neurology and biosensors, University of Brescia, Brescia, Italy.
Miles ParkesCambridge University Hospitals NHS Foundation Trust, Cambridge, UK.ORCID https://orcid.org/0000-0002-6467-0631
Emma PaulidesDepartment of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.ORCID https://orcid.org/0000-0002-6180-2686
Clémence PinaudLet It Care, Paris, France.
Zaireen PiosResearch and Innovation Department, St Marks Hospital, London North West University Healthcare NHS Trust, UK.ORCID https://orcid.org/0009-0007-8572-4102
Costantino PitzalisQueen Mary University of London, Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, London, UK.ORCID https://orcid.org/0000-0003-1326-5051
Alexandra ProdanEmpirica Gesellschaft für Kommunikations und Technologieforschung mbH, Bonn, Germany.
Rana Zia Ur RehmanJohnson & Johnson, Buckinghamshire, UK.ORCID https://orcid.org/0000-0002-4885-7455
Gabriela RiemekastenDepartment of Rheumatology and Clinical Immunology, University Hospital Schleswig-Holstein and University of Lübeck, Lübeck, Germany.
Andrea RizzardiDepartment of Clinical and Experimental Sciences, Neurology Unit and Laboratory of Digital Neurology and biosensors, University of Brescia, Brescia, Italy.
Matthew W RocheCHDI Management/CHDI Foundation, Princeton, NJ, USA.ORCID https://orcid.org/0009-0004-9350-7499
Lynn RochesterFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Robbin RomijndersDepartment of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, Germany.ORCID https://orcid.org/0000-0002-2507-0924
Stefan SchreiberDepartment of Internal Medicine, University Hospital Schleswig-Holstein, Kiel University, Kiel, Germany.
Katarina SchwarzováDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Christian SelingerDepartment of Gastroenterology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.ORCID https://orcid.org/0000-0003-2022-5859
Klaus SeppiDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Louise StockleyCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust & University of Cambridge, UK.ORCID https://orcid.org/0009-0007-0527-0519
Sreedhar SubramanianResearch and Innovation Department, St Marks Hospital, London North West University Healthcare NHS Trust, UK.
Kai SunDepartment of Computing & Data Science Institute, Imperial College London, London, UK.
Nick TaptiklisClinical Science, Cambridge Cognition, Cambridge, UK.
Gerlynn TiongsonResearch and Innovation Department, St Marks Hospital, London North West University Healthcare NHS Trust, UK.
Kasper F van der ZwaanDepartment of Neurology, Leiden University Medical Center, Leiden, The Netherlands.
Evert-Ben van VeenMedLawconsult, Voorburg, The Netherlands.
Louise WarrenQueen Mary University of London, Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, London, UK.
David WenniXscient Ltd, Twickenham, UK.
Grzegorz WitkowskiMilitary Institute of Aviation Medicine, Warsaw, Poland.
Alison YarnallFaculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.ORCID https://orcid.org/0000-0002-3126-9163
Frederic BaribaudTranslational Development, Bristol Meyers Squibb, Spring House, PA, USA.
Geert Van GassenMedical Department, Takeda, Brussels, Belgium.
Nikolay V ManyakovJohnson & Johnson, Beerse, Belgium.ORCID https://orcid.org/0000-0001-9037-1400
Wan-Fai NgDepartment of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
IDEA-FAST Project Consortium
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Fatigue, impaired sleep quality and daytime sleepiness, common in neurodegenerative and immune-mediated diseases, are debilitating and have serious societal and economic implications. Currently, measurement of these symptoms largely relies on self-reported questionnaires, which are burdensome for patients and lack sensitivity, granularity and reliability. Methods: Building on a preceding feasibility study and qualification advice of the European Medicines Agency, the Clinical Observational Study of the European project Results: Between 2022 and 2025, 2000 people are being recruited at 24 European sites - 500 with Parkinson's disease, 500 with inflammatory bowel disease, 200 with each of the following diseases: Huntington's disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome and 200 healthy volunteers. Participants are followed over a 24-week period with four visits, each including a 1-week assessment phase at home using CE-certified digital health (including active and passive) technologies. The latter collect information on physical activity, physiology, cognition as well as social interaction and behaviour as core dimensions of the target concepts. Conclusion: This study will help to develop reliable, valid and efficient digital endpoints of fatigue, impaired sleep quality and daytime sleepiness for use in future clinical studies and trials.
Indexed as
Digital health technologiesHuntington's diseaseimmune-mediated disordersinflammatory bowel diseaseParkinson's disease
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