protocolSection identificationModule nctId: NCT06386133, orgStudyIdInfo id: MS Boost, briefTitle: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care, acronym: MSBoost, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Ad scientiam, class: OTHER, collaborators name: Assistance Publique - Hôpitaux de Paris, descriptionModule briefSummary: 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., conditionsModule conditions: Multiple Sclerosis, conditions: Fatigue Syndrome, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: MS Boost, interventions name: Standard of care, outcomesModule primaryOutcomes measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis, secondaryOutcomes measure: To evaluate the impact of fatigue in both groups., secondaryOutcomes measure: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term), secondaryOutcomes measure: To compare the fatigue impact between the two groups., secondaryOutcomes measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital., secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital, secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home., secondaryOutcomes measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home., secondaryOutcomes measure: To assess the number of adverse events of using MSCopilot Boost., secondaryOutcomes 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, secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Depression., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Walking., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Dexterity., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on Cognition., secondaryOutcomes measure: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision., secondaryOutcomes measure: To compare the effect of MSCopilot Boost on quality of life compared to standard practice., secondaryOutcomes measure: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice., secondaryOutcomes measure: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost., secondaryOutcomes measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals., secondaryOutcomes measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals., secondaryOutcomes measure: To assess user compliance with MSCopilot Boost throughout the follow-up period., otherOutcomes measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement., otherOutcomes measure: To assess the relationship between self-reported and objectively measured physical activity., otherOutcomes measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact., otherOutcomes measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home., otherOutcomes measure: To assess the evolution of overall physical activity reported by patients., otherOutcomes measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue, otherOutcomes 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., otherOutcomes 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., otherOutcomes measure: To evaluate behavioral changes in terms of physical activity and energy management., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False