Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care

Not Applicable

Not yet recruiting

• Conditions: Fatigue Syndrome, Chronic; Multiple Sclerosis
• Interventions: Device: MS Boost; Other: Standard of care

• Registration Number: NCT06386133
• Lead Sponsor: Ad scientiam

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Study Start: 2024-10-01
• Primary Completion: 2025-07-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• 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
• Able to walk with or with walking aids
• Owning a personal smartphone with a mobile operating system version higher than 14 for IOS (iPhone) and 8 for Android
• Able to read the language in which the mobile application is available and able to understand pictograms
• Affiliated to a social security system
• Having signed the free and informed consent
• Having accepted to wear an actimeter during the whole duration of study participation
• Having been on a stable disease-modifying therapy for MS for at least 6 months.

Exclusion Criteria

• 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).
• Contraindication to physical activity:
• History of cardiac events:
• Abnormal cardiac examination at last medical check-up.
• Palpitations, tachycardia or irregular heartbeat
• Pain and shortness of breath:
• Cramp-like pain in the lower limbs when walking, disappearing when walking stops, except for MS-related pain (neuropathic or spastic).
• Chest pain
• Shortness of breath at rest (appearing or worsening in the lying position)
• Shortness of breath during low-intensity exercise or usual activities
• Pain, discomfort or heaviness in the chest at rest or during exertion
• Unstable chronic diseases :
• Unstable metabolic disease
• Unstable renal disease
• Uncontrolled chronic disease
• Ankle edema
• Dizziness or syncope
• Having received fampridine, corticosteroid therapy or therapeutic cannabis within the 2 months prior to inclusion.
• Psychoactive substances and/or alcohol consumption likely to influence test performance (investigator's judgment).
• Patients confined to bed or whose daily activity is less than 2 hours.
• Persons under guardianship or curatorship.
• Pregnant or breast-feeding women.
• Subjects who have participated in another clinical study within 30 days prior to selection, or who are participating in another study that, in the opinion of the investigator, could interfere with full participation in the study or confound the participant's assessment or the study results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Boost Group	MS Boost	The Boost Group will have the MSCopilot Boost mobile application and follow personalized fatigue management advices and physical activity program
Control Group	Standard of care	The Control Group will follow standard of care with general fatigue advices

Primary Outcome Measures

Name	Time	Method
To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis	During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.	During the first in-clinic visit (Day 0), the first at-home visit (Day 1), the follow-up visit at-home (Day 89) and the follow-up visit in-clinic (Day 90)	Intraclass correlation coefficient (ICC) to assess the reproducibility between the Mobile Vision Test performed at hospital and at home; * At Day 0 and Day 1; * At Day 89 and Day 90; Higher is the number or letter stated, better is the outcome.
To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.	During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)	Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile Walking Endurance test (in meters) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.; Higher is the distance, better is the outcome.
To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home	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)	Comparison of mean improvement in results between the two groups: * For the Timed 25 Foot Walk test (in seconds); * Between Day 0 and Day 90; * Between Day 0 and Day 180; * Between Day 0 and Day 270; * Measured by actimeter: * Between Day 0 and Day 90; * Between Day 0 and Day 180; * Between Day 0 and Day 270; Shorter is the time, better is the outcome.
To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Patient Health Questionnaire-4 (PHQ-4); Score ranges from 0 to 12, with higher score indicating worse outcome.
To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.	During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)	Intra class correlation coefficient coefficient will be used to evaluate the reliability of the Mobile cognition Test (score) performed at home at Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240.; Higher is the score, better is the outcome.
To evaluate the impact of fatigue in both groups.	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)	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.
To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term)	During the first in-clinic visit (Day 0) and during the in-clinic follow-up visits (Day 90 and Day180)	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.
To compare the fatigue impact between the two groups.	During the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)	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.
To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice.	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)	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.
To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice.	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)	Comparison of the evolution of the mean overall physical activity in Metabolic Equivalent of Task (MET) measured by actimeter between the two groups: * Between Day 0 and Day 90; * Between Day 0 and Day 180; * Between Day 0 and Day 270
To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals.	During the end of study visit in-clinic (Day 270)	Descriptive analysis of collected responses from clinical benefit questionnaires in Boost group and from healthcare professionals.; Each answer propose a scale form 1 to 10 with higher score means better outcome.
To compare the proportion of patients whose symptoms improved in both groups on Walking.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Timed 25 Foot Walk test (in seconds).; Shorter is the time, better is the outcome.
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.	During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)	Pearson correlation coefficient to evaluate the correlation between the active Mobile Vision Test (number stated) performed at Day 1 (at home) with the standard Sloan Low Contrast Letter Acuity Test (number of letter stated) performed at Day 0 (at the hospital) in the Boost group.; Higher is the number of letter or number stated, better is the outcome.
Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital.	During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)	Pearson correlation coefficient to evaluate the correlation between the active Mobile Walking Endurance Test (in meters) performed at Day 1 (at home) with the standard test Timed 25 Foot Walk (in seconds) performed at Day 0 (at the hospital) in the Boost group.
To assess the number of adverse events of using MSCopilot Boost.	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)	The application's safety of use will be assessed through a descriptive analysis of adverse events and Adverse Events associated with its use. Data relative to Adverse Events will be reported on a table, numbers and percentages reported for each group, categorizing Adverse Events as mild, moderate and severe. A descriptive analysis of risk questionnaire responses in the Boost group will also be performed.
To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Modified Fatigue Impact Scale (MFIS); The score ranges from 0 to 84, with a higher score indicating a worse outcome.
Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital	During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)	Intra class correlation coefficient (ICC) to assess the correlation between electronic and standard version of the Physical Activity Level questionnaire (IPAQ) completed by patients at Day 0 and Day 270.
To compare the proportion of patients whose symptoms improved in both groups on Depression.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Beck Depression Inventory - Fast Screen (BDI- FS).; The score ranges from 0 to 21, with higher score indicating worse outcome.
To compare the proportion of patients whose symptoms improved in both groups on Fatigue.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on Fatigue with visual analog scale (from daily activities impact questionnaire); The score ranges from 0 to 10, with higher score indicating worse outcome.
To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals.	During the end of study visit in-clinic (Day 270)	Descriptive analysis of collected responses from organizational impact questionnaire administered to healthcare professionals.; Each answer propose 5 levels of intensity from totally disagree to totally agree.
To assess user compliance with MSCopilot Boost throughout the follow-up period.	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)	Number of completed evaluations per quarter compared to the theoretical maximum completion expected over time in the Boost group: * Functional tests; * Fatigue evaluation questionnaires; * Fatigue management program (tips and physical activity program)
To compare the proportion of patients whose symptoms improved in both groups on Dexterity.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the 9 Hole Peg Test (in seconds).; Shorter time indicating better outcome.
To compare the proportion of patients whose symptoms improved in both groups on Cognition.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Symbol Digit Modalities Test.; Higher is the score, better is the outcome.
To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision.	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)	Comparison of patients considered as improved at Day 90, Day 180 and Day 270 in both groups on the Sloan Low Contrast Letter Acuity Test (number stated).; Higher is the number or letter stated, better is the outcome.
To compare the effect of MSCopilot Boost on quality of life compared to standard practice.	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)	Comparison of mean improvement in EQ5D-5L results between the two groups: * Between Day 0 and Day 90; * Between Day 0 and Day 180; * Between Day 0 and Day 270; The scale ranges from 0 to 100, with higher score means better outcome.
To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost.	During at-home follow-up visit (Day 30) and in-clinic visits (Day 180 and Day 270)	Descriptive analysis of responses collected from satisfaction and user experience questionnaires in the Boost group and from healthcare professionals.; Each answer propose a scale from 1 to 5 or 1 to 10. Higher score means better outcome.