Don't be Late! Postponing Cognitive Decline and Preventing Early Unemployment in People With Multiple Sclerosis
DBL
2 other identifiers
interventional
270
1 country
1
Brief Summary
The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are:
- to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network
- to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions
- aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Apr 2023
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2023
CompletedFirst Submitted
Initial submission to the registry
August 25, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 3, 2025
March 1, 2025
3.4 years
August 25, 2023
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Quality of life assessed using the 36-item Short Form. Item-scores are summed and transformed into a total score that ranges 0-100. Higher score corresponds with better quality of life.
Baseline, Month 4, Month 10, and Month 16
Secondary Outcomes (35)
Information processing speed
Baseline, Month 4, Month 10, and Month 16
Information processing speed
Baseline, Month 4, Month 10, and Month 16
Verbal fluency
Baseline, Month 4, Month 10, and Month 16
Spatial Processing
Baseline, Month 4, Month 10, and Month 16
Verbal New Learning and Memory
Baseline, Month 4, Month 10, and Month 16
- +30 more secondary outcomes
Study Arms (3)
Strengthening the brain
EXPERIMENTALParticipants receive 30 minutes of 1-on-1 fitness training, dietary advice, and mental coaching, in addition to twice 20 minutes fitness at home, and 60 minutes of cognitive training each week for four months.
Strengthening the mind
EXPERIMENTALPartiicpants receive biweekly 1-on-1 coaching by a trained work-coach who has MS to identify challenges at work and implement solutions. It is completed when satisfactory solutions have been implemented for all challenges or after four months.
Enhanced usual care
NO INTERVENTIONParticipants receiving general information about cognitive impairment in MS and following care as usual for four months.
Interventions
Lifestyle intervention containing physical exercise, lifestyle coaching, and cognitive training. The programme contains weekly 30 minutes 1-on-1 fitness and lifestyle coaching with two moments of exercise at home for 20 minutes. Online computerized cognitive training will be done for 60 minutes per week.
Work-focused intervention combining the capability approach and the participatory approach. Together with a work-coach who has been diagnosed with MS themselves, participants will assess important work values, discover challenges participants are facing, think of solutions for these challenges, develop a plan of action and implement these solutions.
Eligibility Criteria
You may qualify if:
- Confirmed MS diagnosis according to the McDonald 2017 criteria
- Age between 18 and 67
- no current relapse or steroid treatment in the six weeks prior to study visits
- presence of mild cognitive deficits (at least one test with a Z-score of -1.0 to -1.99 below norm scores of healthy controls on the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery
- being able to participate in an exercise intervention (i.e., EDSS \< 6.0)
- fulfilling safety criteria for MRI (no metal inside body, not pregnant, no claustrophobia)
You may not qualify if:
- presence of neurological (other than MS) and psychiatric disorders
- a current or history of drug or alcohol abuse
- being unable to speak or read Dutch
- currently on sick leave for a period of 6 weeks or longer
- currently pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Universiteit Leidencollaborator
- Personal Fitness Nederlandcollaborator
- MS Vereniging Nederlandcollaborator
- Merck BVcollaborator
- Genzyme, a Sanofi Companycollaborator
- MS Sherpacollaborator
Study Sites (1)
Amsterdam University Medical Centers, location VUmc
Amsterdam, Netherlands
Related Publications (1)
Aarts J, Saddal SRD, Bosmans JE, de Groot V, de Jong BA, Klein M, Ruitenberg MFL, Schaafsma FG, Schippers ECF, Schoonheim MM, Uitdehaag BMJ, van der Veen S, Waskowiak PT, Widdershoven GAM, van der Hiele K, Hulst HE; Don't be late! consortium. Don't be late! Postponing cognitive decline and preventing early unemployment in people with multiple sclerosis: a study protocol. BMC Neurol. 2024 Jan 15;24(1):28. doi: 10.1186/s12883-023-03513-y.
PMID: 38225561DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanneke E Hulst
Leiden University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Randomization will be done by investigators who are not involved in data collection and analyses. Intervention will be carried out by people not involved in data collection and analyses
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 25, 2023
First Posted
October 5, 2023
Study Start
April 16, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 3, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- All data will become available after the project has finished. An embargo period of one year will be used. Coded data will be published in an online scientific archive without unlimited time.
- Access Criteria
- Coded data that cannot be traceable to the participant identifying information will be published in an online repository
Data relating to the main outcomes will be shared in online repository. Coded data will be published in an online scientific archive for the purpose of future research, in line with Open Science practices, and for the verification of findings. These data would not be traceable as they are not linked in any way to personal data. MRI data will be stored in OSF and other platforms that may accommodate the large capacity of the data set.