TY - JOUR
T1 - Feasibility and usability of remote monitoring in Alzheimer’s disease
AU - Muurling, Marijn
AU - de Boer, Casper
AU - Hinds, Chris
AU - Atreya, Alanka
AU - Doherty, Aiden
AU - Alepopoulos, Vasilis
AU - Curcic, Jelena
AU - Brem, Anna-Katharine
AU - Conde, Pauline
AU - Kuruppu, Sajini
AU - Morato, Xavier
AU - Saletti, Valentina
AU - Galluzzi, Samantha
AU - Vilarino Luis, Estefania
AU - Cardoso, Sandra
AU - Stukelj, Tina
AU - Kramberger, Milica Gregoric
AU - Roik, Dora
AU - Koychev, Ivan
AU - Hopøy, Ann-Cecilie
AU - Schwertner, Emilia
AU - Gkioka, Mara
AU - Aarsland, Dag
AU - Jelle Visser, Pieter
N1 - Funding Information:
JC is an employee and shareholder of Novartis. AD is supported by the Welcome Trust [223100/Z/21/Z]. Research of Alzheimer center Amsterdam is part of the neurodegeneration research program of Amsterdam Neuroscience. Alzheimer Center Amsterdam is supported by Stichting Alzheimer Nederland and Stichting Steun Alzheimercentrum Amsterdam. DA has received research support and/or honoraria from Astra-Zeneca, H. Lundbeck, Novartis Pharmaceuticals, Biogen, and GE Health, and served as paid consultant for H. Lundbeck, Eisai, Heptares, Mentis Cura, and Roche Diagnostics. IK declares support for this work through the National Institute of Health Research (personal award and Oxford Health Biomedical Research Centre) and the Medical Research Council (Dementias Platform UK grant), and is a paid medical advisor for digital healthcare technology companies (Five Lives SAS and Cognetivity Ltd). All other authors declare that there is no conflict of interest.
Funding Information:
The authors thank all RADAR-AD participants and clinical sites for their contribution. We thank all past and present RADAR-AD consortium members for their contribution to the project (in alphabetical order): Dag Aarsland, Halil Agin, Vasilis Alepopoulos, Alankar Atreya, Sudipta Bhattacharya, Virginie Biou, Joris Borgdorff, Anna-Katharine Brem, Neva Coello, Pauline Conde, Nick Cummins, Jelena Curcic, Casper de Boer, Yoanna de Geus, Paul de Vries, Ana Diaz, Richard Dobson, Aidan Doherty, Andre Durudas, Gul Erdemli, Amos Folarin, Suzanne Foy, Holger Froehlich, Jean Georges, Dianne Gove, Margarita Grammatikopoulou, Kristin Hannesdottir, Robbert Harms, Mohammad Hattab, Keyvan Hedayati, Chris Hinds, Adam Huffman, Dzmitry Kaliukhovich, Irene Kanter-Schlifke, Ivan Koychev, Rouba Kozak, Julia Kurps, Sajini Kuruppu, Claire Lancaster, Robert Latzman, Ioulietta Lazarou, Manuel Lentzen, Federica Lucivero, Florencia Lulita, Nivethika Mahasivam, Nikolay Manyakov, Emilio Merlo Pich, Peyman Mohtashami, Marijn Muurling, Vaibhav Narayan, Vera Nies, Spiros Nikolopoulos, Andrew Owens, Marjon Pasmooij, Dorota Religa, Gaetano Scebba, Emilia Schwertner, Rohini Sen, Niraj Shanbhag, Laura Smith, Meemansa Sood, Thanos Stavropoulos, Pieter Stolk, Ioannis Tarnanas, Srinivasan Vairavan, Nick van Damme, Natasja van Velthogen, Herman Verheij, Pieter Jelle Visser, Bert Wagner, Gayle Wittenberg, and Yuhao Wu. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The RADAR-AD project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 806999. This Joint Undertaking receives support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA and Software AG. See www.imi.europa.eu for more details. This communication reflects the views of the RADAR-AD consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein. SG declares support for this work through the Italian Ministry of Health (Ricerca Corrente).
Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The RADAR-AD project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 806999. This Joint Undertaking receives support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA and Software AG. See www.imi.europa.eu for more details. This communication reflects the views of the RADAR-AD consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein. SG declares support for this work through the Italian Ministry of Health (Ricerca Corrente).
Publisher Copyright:
© The Author(s) 2024.
PY - 2024/4/9
Y1 - 2024/4/9
N2 - Introduction: Remote monitoring technologies (RMTs) can measure cognitive and functional decline objectively at-home, and offer opportunities to measure passively and continuously, possibly improving sensitivity and reducing participant burden in clinical trials. However, there is skepticism that age and cognitive or functional impairment may render participants unable or unwilling to comply with complex RMT protocols. We therefore assessed the feasibility and usability of a complex RMT protocol in all syndromic stages of Alzheimer’s disease and in healthy control participants.Methods: For 8 weeks, participants (N=229) used two activity trackers, two interactive apps with either daily or weekly cognitive tasks, and optionally a wearable camera. A subset of participants participated in a 4-week sub-study (N=45) using fixed at-home sensors, a wearable EEG sleep headband and a driving performance device. Feasibility was assessed by evaluating compliance and drop-out rates. Usability was assessed by problem rates (e.g., understanding instructions, discomfort, forgetting to use the RMT or technical problems) as discussed during bi-weekly semi-structured interviews.Results: Most problems were found for the active apps and EEG sleep headband. Problem rates increased and compliance rates decreased with disease severity, but the study remained feasible.Conclusions: This study shows that a highly complex RMT protocol is feasible, even in a mild-to-moderate AD population, encouraging other researchers to use RMTs in their study designs. We recommend evaluating the design of individual devices carefully before finalizing study protocols, considering RMTs which allow for real-time compliance monitoring, and engaging the partners of study participants in the research.
AB - Introduction: Remote monitoring technologies (RMTs) can measure cognitive and functional decline objectively at-home, and offer opportunities to measure passively and continuously, possibly improving sensitivity and reducing participant burden in clinical trials. However, there is skepticism that age and cognitive or functional impairment may render participants unable or unwilling to comply with complex RMT protocols. We therefore assessed the feasibility and usability of a complex RMT protocol in all syndromic stages of Alzheimer’s disease and in healthy control participants.Methods: For 8 weeks, participants (N=229) used two activity trackers, two interactive apps with either daily or weekly cognitive tasks, and optionally a wearable camera. A subset of participants participated in a 4-week sub-study (N=45) using fixed at-home sensors, a wearable EEG sleep headband and a driving performance device. Feasibility was assessed by evaluating compliance and drop-out rates. Usability was assessed by problem rates (e.g., understanding instructions, discomfort, forgetting to use the RMT or technical problems) as discussed during bi-weekly semi-structured interviews.Results: Most problems were found for the active apps and EEG sleep headband. Problem rates increased and compliance rates decreased with disease severity, but the study remained feasible.Conclusions: This study shows that a highly complex RMT protocol is feasible, even in a mild-to-moderate AD population, encouraging other researchers to use RMTs in their study designs. We recommend evaluating the design of individual devices carefully before finalizing study protocols, considering RMTs which allow for real-time compliance monitoring, and engaging the partners of study participants in the research.
KW - Dementia
KW - Alzheimer disease
KW - digital health
KW - feasibility
UR - http://www.scopus.com/inward/record.url?scp=85191346793&partnerID=8YFLogxK
U2 - 10.1177/20552076241238133
DO - 10.1177/20552076241238133
M3 - Article
SN - 2055-2076
VL - 10
JO - Digital Health
JF - Digital Health
ER -