Multiple SclerosisMS FITNCT05837949
Multiple Sclerosis Falls Insight Track
A study testing MS FIT: Falls Insight Track in people with Multiple Sclerosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to develop an application: MS Falls Insight Track (MS FIT) which allows patients to log their falls and near falls, view their MS relevant data and responses to the clinic intake survey as well as communicate with their care team about falls and receive educational material on falls… 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?
- MS FIT: Falls Insight Track
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 1 Sep 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
- Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18
- Ages 18 and above
- Any MS therapy, or no treatment
- California resident to enable clinical telemedicine visits if warranted during the study visit
- EDSS 2.0-8.0 (moderate to severe impairment, 7= wheelchair but independent transfers)
- Fall risk, based on MSWS-12 score and previous report of a fall (Hopkins grade ≥1)
- Technological criteria: availability of Wi-Fi in the home or workspace for connectivity.
Who cannot join
- Cognitive dexterity or visual impairment that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to comply with the study protocol
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Multiple Sclerosis Falls Insight Track: A Personal Health Library to Reduce Falls in Patients With Multiple Sclerosis
The purpose of this study is to develop an application: MS Falls Insight Track (MS FIT) which allows patients to log their falls and near falls, view their MS relevant data and responses to the clinic intake survey as well as communicate with their care team about falls and receive educational material on falls prevention.
Read the detailed description
Falls occur in >50% patients with multiple sclerosis (MS), worsen participation in daily life and increase healthcare costs. To date there are no established, accessible, tools to evaluate and reduce fall risk. MS Falls InsightTrack is a live personal health library that combines a patient's falls-relevant clinical indicators (from the electronic health record, EHR) with patient-generated data (PGD) from commercial wearable tools and patient-reported outcomes (PROs) and community-level data (sociodemographic data from University of California, San Francisco (UCSF) Health Atlas combined with MS-specific resources from the National MS Society). The tool will track falls/near-falls in real- time and report changes in status that require intervention. It will offer customized action prompts to support fall reduction through a behaviorally informed approach. It will be accessed in the clinic and in the patient's home.
Technological features. The tool will be accessible, extensible and scalable. The investigators will use modern technologies and industry standards (e.g back-end: Python, flask framework, PostgreSQL; front-end: HTML, CSS, JavaScript and d3.js). The tool will launch from Epic via SMART on FHIR, and will communicate with patients using MyChart.
Qualifications of team and setting. The UCSF MS Center is a leading clinical research center in the digital space. Our sub-leads are experts in all aspects of the study (digital technology, human-centered design, implementation science, health literacy) with a varied and experienced Stakeholder Advisory Group.
Scientific plan. In Aim 1 (design), the investigators will use a Human-Centered Design approach, engaging 20 patients with MS, clinicians and stakeholders in a series of focus groups, to identify the critical data, devices, visualizations, resources, workflows and accessibility/digital divide considerations for the tool, and the key interventions likely to promote the COM-B model of behavioral change to reduce fall risk.
Our key outcomes will be perceived effectiveness, ease of use and likability. In Aim 2 (evaluate feasibility), investigators will deploy MS Falls Insight Track in 100 diverse adults with MS who are at risk for falls. Participants will wear a Fitbit. The tool will be used by patients in their homes and by clinicians during clinical encounters. The investigators will use an implementation science approach. Our key outcomes will be study retention, tool uptake and sustained use. The investigators will explore impact on fall risk. In Aim 3 (test generalizability) investigators will conduct focus groups with patients with other conditions where falls are common (Orthopedics, Parkinson's Disease, Geriatrics) to understand additional data and design features required to promote generalizability. Our key outcomes will parallel those in Aim 1.
Innovation and Broader Significance. MS Falls Insight Track is a unique, comprehensive, accessible personal health library that can be deployed in larger efficacy trials for falls reduction. Beyond this clinical use case, the closed-loop approach of delivering PGD to the care system and back to the patient, interpreted and actionable, using scalable technology, represents a significant innovation that can sequentially expand the number of wearables, conditions and clinics in which patients and clinical investigators can ask their own questions of PGD.
- Conditions
- Multiple Sclerosis
- Being tested
- MS FIT: Falls Insight Track
- Keywords
- Multiple Sclerosis, MS, Falls, Falling, Closed-loop, Digital health, Falls tracking, Falls prevention, FitBit, Wearables
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS FIT: Falls Insight TrackBehavioural
Participants will respond to a set of surveys every two weeks to increase communication on falls with their clinician.
| Study group | Role | What they receive |
|---|---|---|
| MS FIT: Falls Insight Track | Experimental | Participants in this arm will receive 12 months use of MS FIT mobile tool intervention Receives: Behavioral: MS FIT: Falls Insight Track |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients initially use the tool (Adoption)
This will be measured by calculating the percentage of patients who use the tool during the initial month of the study, and by the percentage of patient-clinical dyads who use the tool during the clinical visit
Measured: 6 months
Percentage of patient-clinician encounters initially use the tool (Adoption)
This will be measured by calculating the percentage of patient-clinical dyads who use the tool during the clinical visit.
Measured: 6 months
Percentage of patients who continue to use the tool (Engagement)
This will calculate the percentage of patients who continued to use the patient-facing tool at least quarterly
Measured: 12 months
Percentage of patient-clinician encounters use the tool during the 12-month visit (Engagement)
This will be calculated by the percentage of the clinician-patient dyads in Arm 1 who use the in-visit dashboard at the 12-month clinical visit.
Measured: 12 months
Percentage of patients who respond to fall prompts (Adherence)
Adherence will be measured by the percentage of falls reporting prompts adhered to per participant, as well as percentage of participants adhering to >75% falls prompts
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start12 Apr 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be given the MS FIT tool intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Riley Bove, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837949
- Sponsor's protocol ID
- 22-36680
- Other IDs
- 5R01LM013396-02
- Acronym
- MS FIT
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
Publications
Block VJ, Koshal K, Wijangco J, Miller N, Sara N, Henderson K, Reihm J, Gopal A, Mohan SD, Gelfand JM, Guo CY, Oommen L, Nylander A, Rowson JA, Brown E, Sanders S, Rankin K, Lyles CR, Sim I, Bove R. A Closed-Loop Falls Monitoring and Prevention App for Multiple Sclerosis Clinical Practice: Human-Centered Design of the Multiple Sclerosis Falls InsightTrack. JMIR Hum Factors. 2024 Jan 11;11:e49331. doi: 10.2196/49331.
PubMed 38206662
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis Falls Insight Track: A Personal Health Library to Reduce Falls in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05837949
- Acronym / sponsor ID
- MS FIT / 22-36680
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, MS, Falls, Falling, Closed-loop, Digital health, Falls tracking, Falls prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Library of Medicine (NLM)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 1 May 2023 (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.
The purpose of this study is to develop an application: MS Falls Insight Track (MS FIT) which allows patients to log their falls and near falls, view their MS relevant data and responses to the clinic intake survey as well as communicate with their care team about falls and receive educational material on falls prevention.
Detailed description
Falls occur in >50% patients with multiple sclerosis (MS), worsen participation in daily life and increase healthcare costs. To date there are no established, accessible, tools to evaluate and reduce fall risk. MS Falls InsightTrack is a live personal health library that combines a patient's falls-relevant clinical indicators (from the electronic health record, EHR) with patient-generated data (PGD) from commercial wearable tools and patient-reported outcomes (PROs) and community-level data (sociodemographic data from University of California, San Francisco (UCSF) Health Atlas combined with MS-specific resources from the National MS Society). The tool will track falls/near-falls in real- time and report changes in status that require intervention. It will offer customized action prompts to support fall reduction through a behaviorally informed approach. It will be accessed in the clinic and in the patient's home.
Technological features. The tool will be accessible, extensible and scalable. The investigators will use modern technologies and industry standards (e.g back-end: Python, flask framework, PostgreSQL; front-end: HTML, CSS, JavaScript and d3.js). The tool will launch from Epic via SMART on FHIR, and will communicate with patients using MyChart.
Qualifications of team and setting. The UCSF MS Center is a leading clinical research center in the digital space. Our sub-leads are experts in all aspects of the study (digital technology, human-centered design, implementation science, health literacy) with a varied and experienced Stakeholder Advisory Group.
Scientific plan. In Aim 1 (design), the investigators will use a Human-Centered Design approach, engaging 20 patients with MS, clinicians and stakeholders in a series of focus groups, to identify the critical data, devices, visualizations, resources, workflows and accessibility/digital divide considerations for the tool, and the key interventions likely to promote the COM-B model of behavioral change to reduce fall risk.
Our key outcomes will be perceived effectiveness, ease of use and likability. In Aim 2 (evaluate feasibility), investigators will deploy MS Falls Insight Track in 100 diverse adults with MS who are at risk for falls. Participants will wear a Fitbit. The tool will be used by patients in their homes and by clinicians during clinical encounters. The investigators will use an implementation science approach. Our key outcomes will be study retention, tool uptake and sustained use. The investigators will explore impact on fall risk. In Aim 3 (test generalizability) investigators will conduct focus groups with patients with other conditions where falls are common (Orthopedics, Parkinson's Disease, Geriatrics) to understand additional data and design features required to promote generalizability. Our key outcomes will parallel those in Aim 1.
Innovation and Broader Significance. MS Falls Insight Track is a unique, comprehensive, accessible personal health library that can be deployed in larger efficacy trials for falls reduction. Beyond this clinical use case, the closed-loop approach of delivering PGD to the care system and back to the patient, interpreted and actionable, using scalable technology, represents a significant innovation that can sequentially expand the number of wearables, conditions and clinics in which patients and clinical investigators can ask their own questions of PGD.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be given the MS FIT tool intervention
| Arm | Type | Receives |
|---|---|---|
| MS FIT: Falls Insight Track | Experimental | Behavioral: MS FIT: Falls Insight TrackParticipants in this arm will receive 12 months use of MS FIT mobile tool intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of MS (relapsing or progressive) by 2017 McDonald Criteria18
- Ages 18 and above
- Any MS therapy, or no treatment
- California resident to enable clinical telemedicine visits if warranted during the study visit
- EDSS 2.0-8.0 (moderate to severe impairment, 7= wheelchair but independent transfers)
Key exclusion criteria (2 listed)
- Cognitive dexterity or visual impairment that, in the opinion of the study neurologist (RB), would put the participant at risk or limit their ability to comply with the study protocol
- Inability to provide informed consent
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 |
|---|---|---|
| MS FIT: Falls Insight TrackParticipants will respond to a set of surveys every two weeks to increase communication on falls with their clinician. | Behavioural | MS FIT: Falls Insight Track |
Primary outcome
Percentage of patients initially use the tool (Adoption)
Time frame: 6 months
This will be measured by calculating the percentage of patients who use the tool during the initial month of the study, and by the percentage of patient-clinical dyads who use the tool during the clinical visit
Percentage of patient-clinician encounters initially use the tool (Adoption)
Time frame: 6 months
This will be measured by calculating the percentage of patient-clinical dyads who use the tool during the clinical visit.
Percentage of patients who continue to use the tool (Engagement)
Time frame: 12 months
This will calculate the percentage of patients who continued to use the patient-facing tool at least quarterly
Percentage of patient-clinician encounters use the tool during the 12-month visit (Engagement)
Time frame: 12 months
This will be calculated by the percentage of the clinician-patient dyads in Arm 1 who use the in-visit dashboard at the 12-month clinical visit.
Percentage of patients who respond to fall prompts (Adherence)
Time frame: 12 months
Adherence will be measured by the percentage of falls reporting prompts adhered to per participant, as well as percentage of participants adhering to >75% falls prompts
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 11 Aug 2026.
- Derived from this study: PubMed 38206662Block VJ, Koshal K, Wijangco J, Miller N, Sara N, Henderson K, Reihm J, Gopal A, Mohan SD, Gelfand JM, Guo CY, Oommen L, Nylander A, Rowson JA, Brown E, Sanders S, Rankin K, Lyles CR, Sim I, Bove R. A Closed-Loop Falls Monitoring and Prevention App for Multiple Sclerosis Clinical Practice: Human-Centered Design of the Multiple Sclerosis Falls InsightTrack. JMIR Hum Factors. 2024 Jan 11;11:e49331. doi: 10.2196/49331.
- Individual participant dataSharing planned: Yes. The deidentified dataset will be shared with qualified collaborators upon request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analyzed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts.
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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.
Riley Bove, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS FIT: Falls Insight Track in people with Multiple Sclerosis, run by University of California, San Francisco at 1 site 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 7 inclusion and 2 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of patients initially use the tool (Adoption) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837949, which also lists 1 linked publication.
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 11 Aug 2026.