MSCopilot App for Multiple Sclerosis

(MS-FLOWER Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the MSCopilot app integrates into everyday care for people with multiple sclerosis (MS), a condition where the immune system mistakenly attacks the brain and spinal cord. The goal is to determine if patients can use the app independently at home and how it affects their daily health management. Individuals with a confirmed MS diagnosis who can use a smartphone app from home may be suitable for this study. The trial also explores how healthcare providers can best support patients in using this app. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance daily health management for those with MS.

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 prior data suggests that the MSCopilot app is safe for use by MS patients?

Research shows that specific safety information for the MSCopilot app is not available. This app helps people with multiple sclerosis (MS) assess their condition. Unlike medications or treatments, it carries fewer risks because it is software. Generally, tools like this are considered low-risk since they don't involve taking medicine or undergoing medical procedures. If concerns arise about using MSCopilot, discussing them with a doctor is advisable. A doctor can provide advice based on individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MSCopilot Flower app for multiple sclerosis because it offers a unique way to monitor and manage the condition from the comfort of home. Unlike traditional treatments that often require in-person visits and can be invasive or medication-based, this app allows patients to perform digital tests at home, providing continuous insights into their condition over time. By enabling regular tracking on days like D0, D30, and beyond up to D180, it empowers patients with real-time data, potentially leading to more personalized and timely adjustments to their care plan. This approach could revolutionize how we understand and manage multiple sclerosis, making treatment more accessible and tailored to each individual's needs.

What evidence suggests that the MSCopilot app is effective for multiple sclerosis?

Research has shown that the MSCopilot mobile app is dependable and easy to use for people with multiple sclerosis (MS). It enables patients to monitor their condition by performing tests at home, eliminating the need for clinic visits. One study found that the app's results matched those of standard clinic tests, indicating it can effectively track changes in MS-related disabilities. In this trial, participants will use the MSCopilot app to perform digital tests at home at specified intervals, allowing for regular monitoring. Overall, MSCopilot offers a convenient way for patients to track their health. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06922942

NCT06922942 | MSCopilot Users' Feedback in Real Life This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway.

2. withpower.com withpower.com/trial/phase-multiple-sclerosis-5-2025-e8aa9

MSCopilot App for Multiple Sclerosis (MS-FLOWER Trial) 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 ...

3. ctv.veeva.com ctv.veeva.com/study/mscopilot-users-feedback-in-real-life-outcomes-regarding-integration-in-patients-pathway-and-use

MSCopilot Users' Feedback in Real Life - Outcomes Regarding ... This US multicenter, prospective cohort study aims to evaluate how MSCopilot can be seamlessly integrated into the current care pathway and identify ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31538396/

MSCopilot, a new multiple sclerosis self-assessment digital ... This study confirms the reliability of MSCopilot and its usability in clinical practice for the monitoring of MS-related disability.

5. researchgate.net researchgate.net/publication/335938092_MSCopilot_a_new_Multiple_Sclerosis_self-assessment_digital_solution_results_of_a_comparative_study_versus_standard_tests

MSCopilot, a new Multiple Sclerosis self‐assessment ... The benefit of such apps lies in the collection of data from daily life, the possibility to perform functional tests independent of clinical visits, enabling ...

6. withpower.com withpower.com/trial/phase-multiple-sclerosis-5-2023-8f8ad

MSCopilot® App for Multiple Sclerosis (MS-DETECT Trial) 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 described as a ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05816122/ms-detect-early-detection-of-multiple-sclerosis-progression-with-mscopilotr-detect

MS-DETECT: Early Detection of Multiple Sclerosis ... The study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS).