TY - JOUR
T1 - Don't be late! Postponing cognitive decline and preventing early unemployment in people with multiple sclerosis
T2 - a study protocol
AU - Don’t be late! consortium
AU - Aarts, Jip
AU - Saddal, Shalina R D
AU - Bosmans, Judith E
AU - de Groot, Vincent
AU - de Jong, Brigit A
AU - Klein, Martin
AU - Ruitenberg, Marit F L
AU - Schaafsma, Frederieke G
AU - Schippers, Esther C F
AU - Schoonheim, Menno M
AU - Uitdehaag, Bernard M J
AU - van der Veen, Sabina
AU - Waskowiak, Pauline T
AU - Widdershoven, Guy A M
AU - van der Hiele, Karin
AU - Hulst, Hanneke E
N1 - Funding Information: MS serves on the editorial board of Neurology, Multiple Sclerosis Journal and Frontiers in Neurology, receives research support from the Dutch MS Research Foundation, Eurostars-EUREKA, ARSEP, Amsterdam Neuroscience, MAGNIMS and ZonMW (Vidi grant, project number 09150172010056) and has served as a consultant for or received research support from Atara Biotherapeutics, Biogen, Celgene/Bristol Meyers Squibb, EIP, Sanofi, MedDay and Merck. Funding Information: Members of the Don’t be late! consortium are: Participating sites (Casper E.P. van Munster, Amphia Ziekenhuis, Breda, The Netherlands; Renske G. Wieberdink, MS Centrum Stedendriehoek, Gelre, The Netherlands; Jolijn Kragt, Reinier de Graaf Ziekenhuis, Delft, The Netherlands; Judith Schouten, Rijnstate, Arnhem, The Netherlands; Erwin L.J. Hoogervorst, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands; Paul A.D. Bouma, Tergooi Ziekenhuizen, Hilversum, The Netherlands; Floris G.C.M. De Kleermaeker, Viecuri Medisch Centrum, Venlo, The Netherlands; Meike Holleman, Jeroen Bosch Ziekenhuis, ’s-Hertogenbosch, The Netherlands; Sofie Geurts, Canisius Wilhelmina Ziekenhuis, Nijmegen, The Netherlands; Christaan de Brabander, Admiraal de Ruyter Ziekenhuis, Vlissingen, The Netherlands; Nynke F. Kalkers, OLVG, Amsterdam, The Netherlands); Bram A.J. den Teuling, Pim van Oirschot, Sonja Cloosterman, Sherpa B.V., Nijmegen, The Netherlands; Jos Vermeer, Personal Fitness Nederland (PFN) B.V., Eindhoven, The Netherlands; Chris C. Schouten, Dutch MS Society, Den Donder, The Netherlands; Gerard J. Stege, Merck B.V., Schiphol-Rijk, The Netherlands; Thijs van ‘t Hullenaar, Sanofi B.V., Genzyme Europe, Amsterdam, The Netherlands. We would like to thank all members of the consortium for their contribution to the project. After data collection has finished, data will be analysed, and results will be published in scientific journals and presented at (inter)national scientific meetings. An embargo period of one year will be used before study data will be shared on a data repository. Funding Information: This project is peer-reviewed and funded by the Dutch Research Council (NOW) as part of the Dutch National Research Agenda (NWA) (file number NWA.1292.19.064). The funder has no influence on the design of the study and data collection, analysis, and interpretation and in writing the manuscript. Funding Information: HH is an editor of the Multiple Sclerosis Journal controversies sections, receives research support from the Dutch MS Research Foundation and the Dutch Research Council. She has served as a consultant for or received research support from Atara Biotherapeutics, Biogen, Novartis, Celgene/Bristol Meyers Squibb, Sanofi Genzyme, MedDay and Merck BV. Publisher Copyright: © 2024, The Author(s).
PY - 2024/12/1
Y1 - 2024/12/1
N2 - Background: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. Aims: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL). Methods: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) ‘strengthening the brain’ – a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) ‘strengthening the mind’ – a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group—receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don’t be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions. Discussion: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice. Trial registration: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023.
AB - Background: Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers their ability to work, participating in day-to-day life and ultimately reducing quality of life (QoL). Early cognitive symptoms are often less tangible to PwMS and their direct environment and are noticed only when symptoms and work functioning problems become more advanced, i.e., when (brain) damage is already advanced. Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. Aims: This study aims to evaluate the (cost-) effectiveness of two innovative preventative interventions, aimed at postponing cognitive decline and work functioning problems, compared to enhanced usual care in improving health-related QoL (HRQoL). Methods: Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 h per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are randomised across three study arms: 1) ‘strengthening the brain’ – a lifestyle intervention combining personal fitness, mental coaching, dietary advice, and cognitive training; 2) ‘strengthening the mind’ – a work-focused intervention combining the capability approach and the participatory approach in one-on-one coaching by trained work coaches who have MS themselves; 3) Control group—receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The primary outcome measure of the Don’t be late! intervention study will be HRQoL as measured with the 36-item Short Form. Secondary outcomes include cognition, work related outcomes, physical functioning, structural and functional brain changes, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions. Discussion: This study seeks to prevent (further) cognitive decline and job loss due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice. Trial registration: Retrospectively registered at ClinicalTrials.gov with reference number NCT06068582 on 10 October 2023.
KW - Cognition
KW - Employment
KW - Exercise
KW - Health-related quality of life
KW - Multiple sclerosis
KW - Prevention
UR - http://www.scopus.com/inward/record.url?scp=85182149679&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s12883-023-03513-y
DO - https://doi.org/10.1186/s12883-023-03513-y
M3 - Article
C2 - 38225561
SN - 1471-2377
VL - 24
SP - 28
JO - BMC Neurology
JF - BMC Neurology
IS - 1
M1 - 28
ER -