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

Sponsor
Ad scientiam
Study ID
NCT06386133
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MS Boost — DEVICE
    remote 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
    General fatigue tips are given to patients who suffering from chronic fatigue such as stop smoking, eat a healthy diet...

Study Details

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.

Key Dates

First listed
Apr 26, 2024
Start date
Dec 1, 2026
Status verified
Oct 2024
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Boost Group
    The Boost Group will have the MSCopilot Boost mobile application and follow personalized fatigue management advices and physical activity program
  • Active Comparator: Control Group
    The Control Group will follow standard of care with general fatigue advices

Primary Outcome Measure

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

Central Contacts

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