MSCopilot App for Multiple Sclerosis

(MS-FLOWER Trial)

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ad scientiam

Disqualifiers: Pregnant, Guardianship, Smartphone inability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify potential optimizations to enhance its impact on both MS patients and clinicians, facilitating broader implementation. Specifically, the study will assess: * The overall integration of MSCopilot into routine clinical practice, * Patients' ability to use MSCopilot at home without supervision, * The need for patient support when using MSCopilot at home, * User behavior based on usage analytics data from the MSCopilot mobile app and dashboard, * Patient adherence to MSCopilot use in routine clinical practice, * The adequacy of the onboarding/training process for HCPs, * The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding, * The variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using the MSCopilot app, so you may not need to change your medication routine.

What data supports the effectiveness of the MSCopilot Flower mobile application treatment for multiple sclerosis?

Digital technology, including mobile apps, has been shown to help in the management of multiple sclerosis by improving symptom monitoring, treatment adherence, and self-assessment. Apps like MS Energize have been used for self-management of symptoms such as fatigue, indicating that similar digital tools can be beneficial for people with MS. ^{1 2 3 4 5}

Is the MSCopilot App safe for use in humans?

The available research does not provide specific safety data for the MSCopilot App, but it is a software tool for self-assessment in multiple sclerosis, which suggests it is non-invasive and likely safe for general use. ^{1 6 7 8 9}

How is the MSCopilot App treatment different from other treatments for multiple sclerosis?

The MSCopilot App is unique because it allows people with multiple sclerosis to self-assess their condition using a smartphone, focusing on walking, dexterity, cognition, and vision, which is different from traditional hospital tests that are more time-consuming. ^{1 2 6 7 10}

Eligibility Criteria

This trial is for individuals with Multiple Sclerosis who are interested in integrating the MSCopilot Flower mobile application into their care. Participants should be willing to use the app at home and may require some support. The study excludes details on specific exclusion criteria.

Inclusion Criteria

For patients

* With a confirmed and documented MS diagnosis, per the 2010 Revised

* McDonald criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Onboarding/Training

Onboarding and training process for HCPs to ensure successful patient onboarding

Up to 90 days

Training sessions for HCPs

Home Use and Monitoring

Participants use MSCopilot at home and are monitored for adherence and user behavior

180 days

Performance of digital tests at home at D0, D30, D60, D90, D120, D150, and D180

Follow-up

Participants are monitored for integration and effectiveness of MSCopilot in routine clinical practice

30 days

Treatment Details

Interventions

• MSCopilot Flower mobile application

Trial Overview The study is testing how well the MSCopilot mobile app can fit into routine MS care and its impact on patients and doctors. It looks at ease of integration, patient independence using the app, need for support, user behavior analytics, adherence to regular use, training effectiveness for healthcare providers (HCPs), and variations by demographics and disability scores.

Participant Groups

Group I: Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ad scientiam

Lead Sponsor

Trials

12

Recruited

1,500+

Findings from Research

Digital technology tools are increasingly being integrated into clinical trials for multiple sclerosis (MS), enhancing treatment delivery and disease monitoring through methods like psychotherapy apps and robot-assisted exercises.

These technologies improve the standardization of outcome measures and enable better detection of symptoms and treatment adherence, shifting data collection from traditional paper-based methods to more efficient internet-based systems, which can also facilitate remote rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. De Angelis, M., Lavorgna, L., Carotenuto, A., et al.[2021]

The IDoThis app, developed for self-management of multiple sclerosis (MS), was positively received by 75% of participants, indicating it effectively improved their MS self-management status after three weeks of use.

The app includes valuable features like training modules and condition monitoring, but users expressed a need for additional content on fatigue and sleep management to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mobile app (IDoThis) for multiple sclerosis self-management: development and initial evaluation. Salimzadeh, Z., Damanabi, S., Ferdousi, R., et al.[2022]

The 5 U-Turn Test (5UTT) demonstrated good-to-excellent test-retest reliability for measuring U-turn speed in people with multiple sclerosis (MS), with an intraclass correlation coefficient of 0.87, indicating it is a reliable tool for assessing gait and balance impairment.

U-turn speed from the 5UTT was significantly correlated with established in-clinic measures of walking speed and overall MS-related disability, suggesting that this smartphone-based assessment can effectively monitor mobility changes in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U-turn speed is a valid and reliable smartphone-based measure of multiple sclerosis-related gait and balance impairment. Cheng, WY., Bourke, AK., Lipsmeier, F., et al.[2021]

The MS Energize app, designed for self-management of fatigue in people with multiple sclerosis, was positively received by 11 participants over a 5-6 week period, validating their experiences and providing useful strategies based on cognitive-behavioral therapy principles.

Feedback indicated that while the app was generally helpful, it had usability issues, particularly due to excessive text, which could contribute to fatigue, highlighting the need for further refinement before clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MS Energize: Field trial of an app for self-management of fatigue for people with multiple sclerosis. Babbage, DR., van Kessel, K., Drown, J., et al.[2020]

A study involving 24 participants with multiple sclerosis (MS) across the UK, Spain, and Italy identified key barriers and facilitators for using smartphone apps and wearable devices in managing health, highlighting the need for technology that accommodates varying physical abilities.

Common themes included the importance of providing information and memory aids, as well as addressing potential negative effects on mood, suggesting that future mHealth interventions should focus on user control and practical support to enhance engagement among individuals with both relapsing remitting and progressive MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging across dimensions of diversity: A cross-national perspective on mHealth tools for managing relapsing remitting and progressive multiple sclerosis. Simblett, SK., Evans, J., Greer, B., et al.[2019]

The MSCopilot software device was validated against the Multiple Sclerosis Functional Composite (MSFC) in a study involving 141 patients with multiple sclerosis (PwMS) and 76 healthy controls, showing that it is as effective as MSFC in identifying disability in PwMS.

MSCopilot demonstrated strong correlation with MSFC scores (r = 0.81) and good reproducibility, making it a reliable tool for self-assessment of MS-related disability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MSCopilot, a new multiple sclerosis self-assessment digital solution: results of a comparative study versus standard tests. Maillart, E., Labauge, P., Cohen, M., et al.[2021]

The MSCopilot software demonstrated a strong correlation with the Expanded Disability Status Scale (EDSS) in assessing disability levels in 116 people with Multiple Sclerosis, indicating its reliability as a self-assessment tool.

MSCopilot was particularly effective in distinguishing between patients with higher disability levels (EDSS > 3.5), outperforming traditional MSFC tests by capturing nuances in different stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MSCopilot: New smartphone-based digital biomarkers correlate with Expanded Disability Status Scale scores in people with Multiple Sclerosis. Tanoh, IC., Maillart, E., Labauge, P., et al.[2021]

A study is being conducted to test whether a mobile application can significantly increase the reporting of adverse drug reactions (ADRs) among patients with relapsing-remitting multiple sclerosis (RR-MS) who are using disease-modifying drugs (DMDs).

The trial aims to enroll 180 patients across 24 centers, with the expectation that the app will boost ADR reporting by ten times compared to traditional methods, highlighting the importance of patient involvement in monitoring drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. Defer, G., Le Caignec, F., Fedrizzi, S., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Technology in Clinical Trials for Multiple Sclerosis: Systematic Review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A mobile app (IDoThis) for multiple sclerosis self-management: development and initial evaluation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

U-turn speed is a valid and reliable smartphone-based measure of multiple sclerosis-related gait and balance impairment. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

MS Energize: Field trial of an app for self-management of fatigue for people with multiple sclerosis. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Engaging across dimensions of diversity: A cross-national perspective on mHealth tools for managing relapsing remitting and progressive multiple sclerosis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

MSCopilot, a new multiple sclerosis self-assessment digital solution: results of a comparative study versus standard tests. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

MSCopilot: New smartphone-based digital biomarkers correlate with Expanded Disability Status Scale scores in people with Multiple Sclerosis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive Symptom Awareness Among Patients With Multiple Sclerosis Using a Mobile Application. [2023]