Clinical trial NCT06386133: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care
Official title: Chronic Fatigue in Multiple Sclerosis: Validating Clinical Performance, Economic, and Organizational Benefits of MSCopilot Boost Compared to Standard Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Fatigue Syndrome, Chronic
Keywords: Mobile application
Digital monitoring
Fatigue management
Multiple sclerosis
Lead sponsor: Ad scientiam
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2024-04-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration.

Control group: Standard practice and wear of an actimeter during the whole study participation duration.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
Secondary outcomes:
measure: To evaluate the impact of fatigue in both groups.
timeFrame: 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: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term)
timeFrame: During the first in-clinic visit (Day 0) and during the in-clinic follow-up visits (Day 90 and Day180)
measure: To compare the fatigue impact between the two groups.
timeFrame: During the in-clinic follow-up visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)
measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice.
timeFrame: 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: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
timeFrame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital.
timeFrame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
timeFrame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
timeFrame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital.
timeFrame: During the first in-clinic visit (Day 0) and the first at-home visit (Day 1)
measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
timeFrame: 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)
measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
timeFrame: 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)
measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
timeFrame: 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)
measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home.
timeFrame: 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)
measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
timeFrame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
timeFrame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home.
timeFrame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
timeFrame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home.
timeFrame: During the at-home follow-up visits (Day 30, Day 60, Day 120, Day 150, Day 210 and Day 240)
measure: To assess the number of adverse events of using MSCopilot Boost.
timeFrame: 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)
measure: 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
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Depression.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Fatigue.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Walking.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Dexterity.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on Cognition.
timeFrame: 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: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision.
timeFrame: 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: To compare the effect of MSCopilot Boost on quality of life compared to standard practice.
timeFrame: 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: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice.
timeFrame: 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: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost.
timeFrame: During at-home follow-up visit (Day 30) and in-clinic visits (Day 180 and Day 270)
measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals.
timeFrame: During the end of study visit in-clinic (Day 270)
measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals.
timeFrame: During the end of study visit in-clinic (Day 270)
measure: To assess user compliance with MSCopilot Boost throughout the follow-up period.
timeFrame: 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)
Other outcomes:
measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement.
timeFrame: 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)
measure: To assess the relationship between self-reported and objectively measured physical activity.
timeFrame: Throughout the study from Day 0 to Day 270
measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact.
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home.
timeFrame: 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)
measure: To assess the evolution of overall physical activity reported by patients.
timeFrame: Throughout the study from Day 0 to Day 270
measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue
timeFrame: During the first in-clinic visit (Day 0) and the end of study visit in-clinic (Day 270)
measure: Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care.
timeFrame: 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: To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups.
timeFrame: 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: To evaluate behavioral changes in terms of physical activity and energy management.
timeFrame: During the first in-clinic visit (Day 0), during the follow-up at-home visit (Day 30), during the follow-up in-clinic visits (Day 90 and Day180) and the end of study visit in-clinic (Day 270)
Locations:
Study officials:
References: