Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAd scientiam
About this trial
The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).
The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.
Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.
Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged over 18 years
With a confirmed MS diagnosis according to 2017 McDonald's revised criteria
Having an EDSS score comprised between 0 and 6.5
With a fatigue score ≥ 43 on MFIS scale
Disqualifiers
Psychiatric disorder, major visual or cognitive deficiency, as assessed by the investigator
Participation in an exercise reconditioning program at a rehabilitation center within the 6 weeks prior to inclusion
Major comorbidities that could influence fatigue management (lupus, rheumatoid arthritis, chronic obstructive pulmonary disease, chronic fatigue syndrome, etc).
Abnormal cardiac examination at last medical check-up.
Trial design
Design model
Parallel
Treatments tested in this trial
MS Boost
Deviceremote monitoring digital tool based on functional tests (walking, dexterity, vision and cognition). These digital tests may be combined with a fatigue assessment via questionnaires and, if needed, a telerehabilitation program. This program includes an algorithm comprising fatigue management advice and/or physical activity recommendations personalised to the patients, aimed at improving fatigue-related symptoms. The patient can use the telerehabilitation program without supervision
Standard of care
Other interventionGeneral fatigue tips are given to patients who suffering from chronic fatigue such as stop smoking, eat a healthy diet...
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Boost GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis
Comparison of mean decrease in the Modified Fatigue Impact Scale score (MFIS) between Boost and Control groups from Day 0 to Day 270 . The criteria will be considered as positive if the Boost group shows a mean decrease of at least a 7 point in Day 270 score, compared to the Control group. The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Time frame
During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)Secondary outcomes
1
To evaluate the impact of fatigue in both groups.
Measure of the mean decrease in Modified Fatigue Impact Scale score: * In the Boost group * Between Day 0 and Day 90 * Between Day 0 and Day 180 * Between Day 0 and Day 270 * In the Control group * Between Day 0 and Day 90 * Between Day 0 and Day180 * Between Day 0 and Day 270 The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Time frame
During the first in-clinic visit (Day 0), during the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)2
To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term)
Comparison of the mean decrease in Modified Fatigue Impact Scale score: * Between Day 0 and Day 90 * Between Day 0 and Day 180 The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Time frame
During the first in-clinic visit (Day 0) and during the in-clinic follow-up visits (Day 90 and Day180)3
To compare the fatigue impact between the two groups.
Comparison of Modified Fatigue Impact Scale score between the two groups: * At Day 90 * At Day 180 * At Day 270 The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Time frame
During the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)4
To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice.
Comparison of the mean fatigue score by using a visual analog scale (from daily activities impact questionnaire) between the two groups: * Between Day 0 and Day 90 * Between Day 0 and Day 180 * Between Day 0 and Day 270 Score ranges from 0 (not impacted) to 10 (very impacted), with a higher score indicating a worse outcome.
Time frame
During the first in-clinic visit (Day 0), during the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)Other outcomes
1
To evaluate the link between MSCopilot Boost use compliance and fatigue improvement.
Correlation coefficient between MSCopilot Boost use compliance and Modified Fatigue Impact Scale score and comparison of the mean compliance pourcentage between patients who experienced a clinically significant improvement in fatigue and those who did not.
Time frame
Throughout the study for all visits in-clinic (Day 0, Day 90, Day 180 and Day 270) and at-home visits (Day 1, D 30, Day 60, Day 89, Day 120, Day 150, Day 210 and Day 240)2
To assess the relationship between self-reported and objectively measured physical activity.
Correlation coefficient between self-reported physical activity in MSCopilot Boost and objectively measured physical activity by actimeter in the Boost group.
Time frame
Throughout the study from Day 0 to Day 2703
To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact.
Evaluation of the interaction terms between the Boost patient group versus the control patient group and covariates (socio-demographic characteristics, depression, compliance, physical activity, etc…) in a multivariate regression model with response variables: * The Modified Fatigue Impact Scale score * Fatigue with Visual analog scale score (from daily activities impact questionnaire)
Time frame
During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)4
To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home.
Descriptive analysis of responses collected from sleep and daily activities questionnaires in the Boost group. Visual Analog Scale ranges from 0 (not impacted) to 10 (very impacted), with a higher score indicating a worse outcome.
Time frame
Throughout the study for all visits in-clinic (Day 0, Day 90, Day 180 and Day 270) and at-home visits (D 30, Day 60, Day 120, Day 150, Day 210 and Day 240)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ad scientiam
Lead sponsor
URC-ECO Clinical trial unit on health Economics, Hotel-Dieu Hospital
Collaborator
Source ClinicalTrials.gov
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