Multiple SclerosisMS-FLOWERNCT06922942
MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
A study testing MSCopilot Flower mobile application in people with Multiple Sclerosis, run by Ad scientiam at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MSCopilot Flower mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Aug 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients
- 18 years and older
- With a confirmed and documented MS diagnosis, per the 2010 Revised
- McDonald criteria
- With an EDSS score ranging from 0 to 6.5
- Able to monitor their disease from home (i.e. not hospitalized or under medical assistance).
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- Having a personal smartphone with a mobile operating system above 16 for IOS (iPhone) and 8 for Android and having access to a good internet connection.
- Able to read language in which the mobile application is available and able to understand pictograms Having read the information sheet and signed the informed consent form
- For HCPs:
- Licensed neurologists trained in the management of Multiple Sclerosis patients and allowed to conduct clinical studies within their departments
- If applicable: nurses or medical assistants specifically trained in the management of Multiple Sclerosis and allowed to participate in clinical studies within their departments
- Ability to use a computer
Who cannot join
- Pregnant and nursing women
- Person under guardianship or curatorship
- Inability to use a smartphone application
- Patient who previously participated in a study using MSCopilot
- Early termination criteria (for patients):
- death,
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- abandon,
- loss of follow-up,
- investigator's decision
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Leorah Freeman
Austin, Texas, 78712
Jenny Feng
New Orleans, Louisiana, 70121
Gabriel Pardo
Oklahoma City, Oklahoma, 73104
Robert Naismith
St Louis, Missouri, 63110
About this study
Official title: MS-FLOWER: MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
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
- Conditions
- Multiple Sclerosis
- Being tested
- MSCopilot Flower mobile application
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCopilot Flower mobile applicationDevice
MSCopilot Flower includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Anxiety
| Study group | Role | What they receive |
|---|---|---|
| Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180 | Experimental | Not described Receives: Device: MSCopilot Flower mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis.
Descriptive analysis and acceptance criteria of a minimum score of >2/4 on neurologists' questionnaires regarding the ease of integrating the MSCopilot dashboard into clinical workflows Descriptive analysis and acceptance criteria of a minimum score of >2/4 on patients' questionnaires regarding the ease of use of MSCopilot at home
Measured: For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)
Secondary outcomes (11)
To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.
Descriptive analysis of neurologists' questionnaires, to be completed after each investigator's last visit, regarding the Health Care Profesionnals (HCPs) dashboard Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of neurologists' questionnaires after the last visit on the HCPs dashboard Descriptive analysis of patients' questionnaires after the last visit regarding MSCopilot app and dashboard use by the HCPs.
Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item in patients' questionnaires, to be completed after the follow-up visit, regarding MSCopilot application and dashboard use by HCPs
Measured: At Day 180 ± 30days
To assess patients' ability to use MSCopilot at home without supervision.
Descriptive analysis of patient questionnaires Acceptance criteria of a minimum of >2/4 for each item, of patient questionnaires
Measured: Day 1 (+/- 30 days)
To assess patients' ability to use MSCopilot at home without supervision.
Descriptive analysis of patient questionnaires at mid-study Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of patient questionnaires at mid-study
Measured: Day 90 (+/-30 days)
To assess the need for patient support when using MSCopilot at home
Descriptive analysis of nurses or medical assistants' questionnaires (if applicable) Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of nurses or medical assistants' questionnaires (if applicable)
Measured: Day 180 (+/-30 days)
To assess patient adherence to MSCopilot use in routine clinical practice.
Descriptive analysis of the mobile application's adherence data, including:
Number of performed tests, Number of performed sessions, Number of completed questionnaires.
Measured: Day 1 to Day 180 (+/-30 days)
To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.
Quantitative analysis of real-world utilization patterns of the MSCopilot mobile app through analytics data Quantitative analysis of real-world utilization patterns of the HCPs dashboard through analytics data
Measured: Day 1 to Day 180 (+/-30 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
Descriptive analysis of HCPs (neurologists) questionnaires Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of HCPs (neurologists) questionnaires
Measured: At the end of inclusion period (90 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
Descriptive analysis of patient questionnaires Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item, of patient questionnaires
Measured: After patient inclusion visit (90 days)
To assess the adequacy of the onboarding/training process for HCPs, including neurologists, nurses, and medical assistants, focusing on clarity, satisfaction, and confidence in using MSCopilot
Descriptive analysis of HCPs questionnaires post-onboarding/training session Descriptive analysis and acceptance criteria of a minimum score of >2/4 for each item in HCPs questionnaires post-onboarding/training
Measured: After onboarding/training session (Day 0)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
Descriptive analysis of how socio-demographic factors and EDSS scores affect patient behavior and adherence to MSCopilot mobile application.
Measured: Day 1 to Day 180 (+/-30 days)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
Descriptive analysis of how HCPs socio-demographic factors affect their behavior toward MSCopilot dashboard.
Measured: Day 1 to Day 180 (+/-30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start12 Aug 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ad scientiam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922942
- Sponsor's protocol ID
- ADS-MS-FLOWER-2025
- Acronym
- MS-FLOWER
- Status last verified
- Oct 2025
- First submitted
- 1 Apr 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MS-FLOWER: MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience
- ClinicalTrials.gov ID
- NCT06922942
- Acronym / sponsor ID
- MS-FLOWER / ADS-MS-FLOWER-2025
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ad scientiamUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180 | Experimental | Device: MSCopilot Flower mobile application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For patients
- 18 years and older
- With a confirmed and documented MS diagnosis, per the 2010 Revised
- McDonald criteria
- With an EDSS score ranging from 0 to 6.5
Key exclusion criteria (9 listed)
- Pregnant and nursing women
- Person under guardianship or curatorship
- Inability to use a smartphone application
- Patient who previously participated in a study using MSCopilot
- death,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCopilot Flower mobile applicationMSCopilot Flower includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to fatigue and Anxiety | Device | Performance of digital tests at home at day 0 (D0), D30, D60, D90, D120, D150 and D180 |
Primary outcome
To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis.
Time frame: For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)
Descriptive analysis and acceptance criteria of a minimum score of >2/4 on neurologists' questionnaires regarding the ease of integrating the MSCopilot dashboard into clinical workflows Descriptive analysis and acceptance criteria of a minimum score of >2/4 on patients' questionnaires regarding the ease of use of MSCopilot at home
11 secondary outcomes
To assess the integration of MSCopilot dashboard and application into routine clinical practice as well as perceived value for both HCPs and patients.
Time frame: At Day 180 ± 30days
To assess patients' ability to use MSCopilot at home without supervision.
Time frame: Day 1 (+/- 30 days)
To assess patients' ability to use MSCopilot at home without supervision.
Time frame: Day 90 (+/-30 days)
To assess the need for patient support when using MSCopilot at home
Time frame: Day 180 (+/-30 days)
To assess patient adherence to MSCopilot use in routine clinical practice.
Time frame: Day 1 to Day 180 (+/-30 days)
To assess user behavior based on usage analytics data from the MSCopilot mobile app and the dashboard.
Time frame: Day 1 to Day 180 (+/-30 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
Time frame: At the end of inclusion period (90 days)
To assess the effectiveness of HCPs onboarding/training in ensuring successful patient onboarding.
Time frame: After patient inclusion visit (90 days)
To assess the adequacy of the onboarding/training process for HCPs, including neurologists, nurses, and medical assistants, focusing on clarity, satisfaction, and confidence in using MSCopilot
Time frame: After onboarding/training session (Day 0)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
Time frame: Day 1 to Day 180 (+/-30 days)
To assess the variances in user behavior and adherence to MSCopilot use according to socio-demographic factors and EDSS scores.
Time frame: Day 1 to Day 180 (+/-30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSCopilot Flower mobile application in people with Multiple Sclerosis, run by Ad scientiam at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the ease of integrating the MSCopilot dashboard into clinical workflows for neurologists and the ease of use at home for patients with multiple sclerosis. (time frame: For neurologists: Day 180 (+/- 30 days) and for patients: Day 1, Day 90 and Day 180 (+/- 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.